LAKEWOOD, Ohio -- Thanksgiving is just two weeks away, and in Lakewood that signals the annual effort by the Lakewood Charitable Assistance Corp. to ensure that those in need have a hearty meal for the holiday.

About 300 people receive food packages for Thanksgiving from LCAC, a nonprofit, all-volunteer organization dedicated to improving the quality of life of Lakewoods families in need. The organization has offered this program for more than three decades.

Collections of non-perishable food items -- including canned goods, gravy mix, pie filling, stuffing and biscuit mixes, cereal, peanut butter and more -- are taking place in schools and churches throughout the city to help provide a foundation for the holiday meal and to help families even beyond Thanksgiving.

Cash donations also are welcome to help with costs associated with the LCAC programs.

LCAC purchases perishable items, including turkeys, potatoes, butter and pumpkin pies, just before the food distribution day, which this year will be Nov. 23.

Volunteers are needed to help sort, prepare and bag the non-perishable items, as well as to help load the food into vehicles for delivery.

Non-perishable food donations will be collected and sorted from 9 a.m. to 1 p.m. Nov. 22 on the lower level of the Lakewood Masonic Temple, 15300 Detroit Ave., Lakewood.

Additional volunteers are needed from about 6 to 7:30 p.m. Nov. 22 to form an assembly line to pack the food bags.

Then, beginning at 9 a.m. Nov. 23, volunteers are needed to bag the perishable food items, load the meals into cars and help deliver the food to those on the distribution list for Thanksgiving.

Celia Dorsch, LCAC president, said the entire organization consists of volunteers. They also deliver meals for Christmas and provide cleaning supplies in the spring.

For more information on LCAC and its programs, visit lcac.info.

Junior Womens Club meets: North Olmsted Junior Womens Club will meet at 7:30 p.m. Thursday (Nov. 14) at North Olmsted Senior Center, 28114 Lorain Road, North Olmsted.

There will be a program on pain management following the meeting. The program begins with a social time from 7 to 7:30 p.m.

The club is a diverse group of women of all ages -- 21 and older -- who want to return something to the community.

For more information, visit northolmsted.wixsite.com/nojwc.

Pride Clinic: The MetroHealth System began offering Pride Clinic services this week at the LGBT Community Center of Greater Cleveland, 6705 Detroit Ave., Cleveland. MetroHealth and the LGBT Center are working together to provide safe and supportive medical care to the Cleveland LGBTQ community in the Gordon Square neighborhood. Community members can receive many health services at the clinic.

MetroHealth primary care physician Dr. Douglas Van Auken will provide care from 12:30 to 4:30 p.m. Tuesdays.

Services include primary adult care (age 13 and older), hormone therapy, family planning, smoking cessation, cholesterol control, blood pressure control, immunizations, HIV prevention and STI testing and treatment.

In addition to primary care services being offered at the LGBT Center, MetroHealths Pride Network also offers primary care services at MetroHealths Brecksville, Cleveland Heights, Middleburg Heights, Rocky River and Thomas F. McCafferty locations.

Specialty services also include plastic surgery, gynecology, ENT, behavioral health, and physical medicine and rehabilitation.

To schedule an appointment at the LGBT Center or any of the Pride Network locations, call 216-957-4905. To learn more about MetroHealths Pride Network, visit metrohealth.org/pride.

Free produce: Cleveland residents are invited to stop by Cudell Recreation Center from 11 a.m. to 1 p.m. the third Thursday of every month (Nov. 21 this month) for free, fresh produce. Cudell is at 1910 West Blvd., Cleveland.

Produce is distributed on a first-come, first-served basis, rain or shine. Those coming for produce should bring an ID and bags to carry the items home.

On display: The North Olmsted Arts Commission displays artwork from local artists on a temporary basis at City Hall. The featured artist for November is Dennis Nelson, a North Olmsted resident.

Nelsons work includes poured acrylic, also called fluid art. He uses vibrant colors and bold patterns in his work.

Stop in during business hours at North Olmsted City Hall, 5200 Dover Center Road, North Olmsted, to see Nelsons exhibit.

The rotating displays at City Hall provide an opportunity for art groups to introduce or expand the visibility of their work. For more information or for North Olmsted artists interested in applying for exhibit space, call 440-716-4134.

Welcoming a legacy: Fairview Park Mayor Eileen Patton swore in new police officer Erik Joyce recently. He is the son of James Joyce, a retired Fairview Park police officer who served the city for 34 years, from 1984 to 2014.

The proud papa pinned his old badge onto his sons shirt after he took the oath of office.

Erik Joyce started his law enforcement career in Fairview Park when he joined the auxiliary police unit at age 19. A few years later, he served briefly with the Cuyahoga Metropolitan Housing Authority as a police officer. After that, he spent six years with the Cuyahoga County Sheriffs Office as a deputy sheriff.

Friendsgiving luncheon: Area residents ages 55 and older are invited to a free Friendsgiving luncheon on Nov. 20, provided by ONeill Healthcare North Olmsted. Attendees need not live in North Olmsted.

Lunch includes turkey, mashed potatoes and gravy, vegetables, a roll and pumpkin pie. Registration is required by Nov. 15.

For more information or to register, call 440-777-8100 or stop by the North Olmsted Senior Center, 28114 Lorain Road, North Olmsted.

We Do Care awards: Fairview Park Womens Club will host the We Do Care God & Country letter-writing contest winners at 6:30 p.m. Nov. 18, prior to the Fairview Park City Council meeting in council chambers at City Hall, 20777 Lorain Road, Fairview Park.

A small reception will follow the ceremony.

The We Do Care Committee was created in 1976 by Fairview Park resident Harriet Beekman in response to diminishing patriotism during the Vietnam War era. Beekman generated community support for local military personnel and sent care packages to them. The group continues to send boxes to troops.

Seventh- and eighth-graders at Lewis F. Mayer Middle, St. Angela Merici and Messiah Lutheran schools are invited to participate in the God & Country letter-writing contest each year to express gratitude for the sacrifices made by members of the armed forces serving overseas.

The letter-writing project began in 1976, also.

Student letters are submitted to the We Do Care Committee and judged by volunteers. Winners are selected from each school and read aloud at a City Council meeting. The winning students receive a certificate.

Information, please: Readers are invited to share information about themselves, their families and friends, organizations, church events, etc. in Fairview Park, Lakewood, North Olmsted and West Park for the A Place in the Sun column, which I write on a freelance basis. Awards, honors, milestone birthdays or anniversaries and other items are welcome. Submit information at least 10 days before the requested publication date to carolkovach@hotmail.com.

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STAINES-UPON-THAMES, United Kingdom, Nov. 12, 2019 /PRNewswire/ -- Mallinckrodt Pharmaceuticals plc (NYSE: MNK), a global biopharmaceutical company, today announced data on patient-reported outcomes (PROs) showing Acthar Gel (repository corticotropin injection) improved disease measures that impact rheumatoid arthritis (RA) patients with persistently active disease, as well as new data from an exploratory analysis.The data originate from new analyses from Mallinckrodt's Phase 4 study of Acthar Gelin RA patients with persistently active disease and was recently presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held Nov. 8-13 in Atlanta.

The study posters can be accessedhereon the company's website.

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. ActharGel is approved by theU.S. Food and Drug Administration(FDA) as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in RA, including juvenile RA (selected cases may require low-dose maintenance therapy).1 Please see Important Safety Information for Acthar Gel below.

"Patient-reported outcomes, like fatigue, pain, and physical functioning, are an important part of any trial assessing clinical treatment outcomes. These additional data shed light on managing this challenging patient population whose symptoms persist after use of first-line therapies and suggest Acthar Gel treatment improved PROs in patients with persistently active RA," said Dr. Nancy E. Lane, Distinguished Professor of Medicine, Rheumatology and Aging, and Director of the UC Davis Center for Musculoskeletal Health. "The data exploring the effect of Acthar Gel treatment on patient-reported outcomes may help clinicians better understand Acthar Gel's use for patients with difficult-to-manage RA, those who have continued symptoms following standard therapies. The need for additional treatment options in this patient population is critical."

Patient-Reported Outcomes and Impact of Treatment (Abstract #439)

New data from the company's two-part Phase 4 multicenter, placebo-controlled study assessing the efficacy and safety of Acthar Gel in patients with persistently active RA who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids showed that Acthar Gel treatment significantly improved patient-reported pain, fatigue, physical functioning and work-related impairment as early as Week 4, and resulted in clinically meaningful improvements in PROs.

The analysis examined PRO measures as a secondary endpoint from Part 1 of the study, the 12-week open-label period, and assessed mean changes at baseline and at Weeks 4, 8 and 12.

Patient-Reported Outcomes From the 12-Week Open-label RCI Treatment Perioda,2

PRO Assessment

Baseline, Mean(SD)

Week 4

Week 8

Week 12

Mean Change From Baseline (SD)

FACIT-F

22.8 (8.4)

5.0 (8.2)*

6.5 (8.4)*

8.7 (8.4)*

HAQ-DI

1.7 (0.6)

0.5 (0.5)*

0.6 (0.6)*

0.84 (0.6)*

Patient global assessment of disease activityb,3

63.4 (20.0)

17.8 (23.6)*

25.7 (25.2)*

35.0 (27.3)*

WPAI-RA

Percent work time missed due to RAc

24.9 (27.6)

7.0 (26.6)

5.2 (28.0)

10.8 (26.5)**

Percent impairment while working due to RAc

50.3 (27.1)

18.7 (24.4)*

18.0 (23.9)*

25.2 (25.3)*

Percent overall work impairment due to RAc

58.1 (28.6)

17.6 (27.0)*

17.6 (27.5)*

25.5 (29.2)*

Percent activity impairment due to RAc

63.2 (24.2)

18.1 (24.3)*

22.5 (25.3)*

32.8 (27.4)*

Patient global assessment of paind

64.9 (20.4)3

20.8 (23.3)*

27.6 (25.3)*

37.4 (27.4)*

*p<0.001 vs baseline. **p=0.003 vs baseline.

amITT population (all patients who received study drug and had any post-treatment efficacy assessment).

bMCID = 15% absolute/20% relative improvement.

cMCID = 7% absolute change.

dMCID = 11.

Abbreviations and MCID references: FACIT-F; Functional Assessment of Chronic Illness Therapy Fatigue (MCID = 3-41); HAQ-DI, Health Assessment Questionnaire Disability Index (MCID = 0.2); MCID, minimum clinically important difference; mITT, modified intent-to-treat; PRO, patient-reported outcome; RCI, repository corticotropin injection; SD, standard deviation; WPAI-RA, Work Productivity and Activity Impairment Questionnaire Rheumatoid Arthritis.

AEs observed in the Phase 4 study were consistent with those in previous trials of Acthar Gel.

Study Limitations

"Mallinckrodt remains committed to the rheumatology community and to improving the lives of patients with autoimmune-mediated diseases like RA who continue to have debilitating symptoms and disease exacerbations despite standard treatments," saidSteven Romano, M.D., Chief Scientific Officer and Executive Vice President atMallinckrodt. "We are pleased to be at this year's ACR Annual Meeting to present new data on Acthar Gel that will broaden our understanding of its utility in rheumatology clinical practice for patients with difficult-to-manage RA and areas of high unmet need."

Assessment of Bone and Cartilage Turnover Markers (Abstract #528)

A new exploratory analysis from the Phase 4 RA study assessed bone markers associated with bone loss to evaluate the impact of Acthar Gel treatment on bone turnover in patients with persistently active RA. Bone and cartilage biomarker levels were evaluated throughout the study, at baseline and Weeks 12 and 24 and included: C-terminal cross-linking telopeptide (CTX), C-terminal cross-linking telopeptide of type I collagen (CTX-I), osteoprotegrin (OPG), N-terminal propeptide of type I collagen (PINP), and soluble receptor activator of nuclear factor kappa- ligand (sRANKL) and cartilage degradation biomarkers (C-terminal cross-linking telopeptide of type II collagen (CTX-II) and CTX-II creatinine (CRT).

At Week 12, the open-label period, significant decreases in mean levels of the bone turnover biomarker PINP (P<0.01) and mean levels of cartilage degradation biomarkers CTX-II (P<0.01) and CTX-II CRT (P<0.001) were observed. At Week 24, the end of the study's double-blind period, there was a significant increase from baseline in mean sRANKL levels at both Week 12 and Week 24 (P<0.05) compared to placebo, suggesting a potential increase in osteoclast differentiation. Mean levels of all other bone and cartilage biomarkers remained stable at all time points and markers of bone degeneration remained stable.5

Results from the full RA study were presented earlier this year at the Annual European League Against Rheumatism (EULAR 2019) in Madrid in June. More information on the Phase 4 RA study can be found here on ClinicalTrials.gov.

About Rheumatoid ArthritisRA is an autoimmune disease. It is a chronic condition that causes pain, stiffness, and swelling of the jointsall symptoms caused by inflammation.6 An estimated 1.5 million U.S. adults are living with RA.7 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.8 Nonsteroidal anti-inflammatory drugs are used to ease symptoms whereas corticosteroids, disease-modifying anti-rheumatic drugs and biologics are used to slow down the disease activity.8

Acthar Gel (repository corticotropin injection)IndicationsActhar Gel is an injectable drug approved by theFDAfor the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Adverse Reactions

Other adverse events reported are included in the full Prescribing Information.

Please see fullPrescribing Information.

ABOUTMALLINCKRODTMallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com.

Mallinckrodtuses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with theU.S. Securities and Exchange Commission(SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTSThis release includes forward-looking statements concerning Acthar Gel including expectations regarding its potential impact on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section ofMallinckrodt'smost recent Annual Report on Form 10-K and other filings with theSEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof andMallinckrodtdoes not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACTSFor Trade Media InquiriesCaren BegunGreen Room Communications201-396-8551caren@greenroompr.com

For Financial/Dailies Media InquiriesDaniel YungerKekst CNC212-521-4879mallinckrodt@kekstcnc.com

Investor RelationsDaniel J. Speciale, CPAVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

Mallinckrodt, the "M" brand mark and theMallinckrodt Pharmaceuticalslogo are trademarks of aMallinckrodtcompany. Other brands are trademarks of aMallinckrodtcompany or their respective owners.2019Mallinckrodt.US-1901844 11/19

References

1ActharGel (repository corticotropin injection) [prescribing information].Mallinckrodt ARD LLC.

2Data on File, Mallinckrodt, 2019. Furst D, Wan G, Liu J, Zhu J, Bartels-Peculis L, Panaccio M, Fleischmann R. Improved Patient-Reported Outcomes in Patients with Persistently Active Rheumatoid Arthritis Following Treatment with Repository Corticotropin Injection. Poster presented at: 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting November 8-13, Atlanta, GA.

3Data on File, Mallinckrodt, 2019. Furst D, Wan G, Liu J, Zhu J, Bartels-Peculis L, Panaccio M, Fleischmann R. Improved Patient-Reported Outcomes in Patients with Persistently Active Rheumatoid Arthritis Following Treatment with Repository Corticotropin Injection [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/improved-patient-reported-outcomes-in-patients-with-persistently-active-rheumatoid-arthritis-following-treatment-with-repository-corticotropin-injection/. Accessed November 8, 2019.

4Fleischmann R, Furst DE, Brasington R, Connolly-Strong E, Liu J, Barton ME. A multicenter study assessing the efficacy and safety of repository corticotropin injection in patients with rheumatoid arthritis: preliminary interim data from the open-label treatment period. Poster presented at: American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting; October 19-24, 2018; Chicago, IL.

5 Data on File, Mallinckrodt, 2019. Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Assessment of Bone and Cartilage Turnover Markers Following Treatment With Repository Corticotropin Injection in Patients With Persistently Active Rheumatoid Arthritis. Poster presented at: 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting November 8-13, Atlanta, GA.

6 Mayo Clinicwebsite. Rheumatoid Arthritis. Overview. Available at:https://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/symptoms-causes/syc-20353648. AccessedNovember 5, 2019.

7 What is Rheumatoid Arthritis?Arthritis Foundation. Available at:http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. AccessedNovember 5, 2019.

8 Arthritis Foundation. Rheumatoid Arthritis Treatment. Available at:http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. AccessedNovember 5, 2019.

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Dubai: As Dubai marks World Diabetes Day on November 14, parents of children diagnosed with Type I diabetes called for greater inclusion of these young patients in schools across the UAE.

Discussing the challenges they face in helping their children manage the disease, they said lack of awareness about the condition among the general public is the main reason why children with Type 1 Diabetes feel isolated.

What is Type I diabetes?

It is an auto immune disorder affecting young children whose body makes little or no insulin. Insulin is a hormone that helps the body use sugar for energy. It is produced by the pancreas, which is an organ located behind the stomach. In Type 1 diabetes, the childs immune system becomes faulty and destroys the cells in the pancreas that makes insulin (beta cells ). As a result, children with Type 1 diabetes need to take insulin to stay healthy. The condition can be life-threatening if it is not diagnosed early. It is different from Type II diabetes which is triggered by poor nutrition, sedentary lifestyles and obesity, resulting in insulin resistance.

Individual challenges

Pained by the lack of awareness surrounding Type 1 diabetes, Dubai-based Pamela Durant, whose son was diagnosed with diabetes at 20 months, gave up her highly successful career in health care management to start her own diabetes awareness company Diapoint to educate the community. Bringing up her son, now 11, she has been a hands on mother volunteering to accompany the school on field trips to keep an eye on her child, but she says not all kids are fortunate enough to get this inclusion.

Children with Type I diabetes require to have their blood sugar monitored regularly to avoid high or low blood sugar episodes. Sometimes, a school understands the severity of what could happen, or the care required, it may be frightening for them, or may seem like too much of a liability. There are cases of children who have been turned away from schools or left out of school activities for this reason - which is heart-breaking. In other cases, some schools have asked parents if they could provide a private nurse for their child at school. Not only is this a financial burden for the family, but it affects the child socially. It adds to the social stigma of having diabetes.

In another case, Nathalie, who arrived in the UAE with her husband last year, was heartbroken when her four-and-a-half-year-old daughter was given admission to a prestigious school in Abu Dhabi only to be declined when she disclosed her condition. My daughter was diagnosed with Type 1 diabetes when she was three-and-a-half. No kid should be treated differently because of their medical condition. They are already going through a lot each and every day and do not deserve to be treated that way, especially in a place where they are supposed to learn values, respect and equality, she remarked.

Elsewhere, Louis Kiernander, a mother of two, recently faced a terrible dilemma when her 11-year-old son had to go on a school trip in a new secondary school he had recently shifted to. Kiernander said: In the primary school my son attended, he was well supported by the school staff and nurses and was never excluded from school trips or sports or treated differently. However, in the new school, there are 11 diabetics in the secondary section and my son is the youngest. While the school tries to be supportive, challenges remain. As per law, only a certified nurse is allowed to give a life-saving injection in case of hypoglycaemia. So my son was asked not to go on the regular school trip and instead go on another where the nurse could accompany him. He was segregated and felt ostracised. All they had to do is send the nurse on the regular trip and I do pay a handsome amount as school fees. I was asked to sign a form saying that if my son faced an emergency in those three days, no one would be giving him a life-saving injection. It was a horrible situation and felt like signing a death warrant.

Right to a normal life

Dr Amani Osman, paediatric endocrinologist with Imperial College of London Diabetes Centre at Al Ain, who handles several cases remarked that every child had a right to be treated well in school. This is a psychosocial element and I constantly advise parents and schools that one must not set boundaries for a child because of his diabetes. No child should be denied the right to live a normal life, play sports and go on field trips or be treated any differently because of their condition.

Dr Osman added: Children with Type I diabetes spend a considerable number of their active hours at school and it is important to have a proper diabetes management plan in place. This can be possible with proper awareness, education and communication between parents, school nurses and the childs private physician.

Diabetes Management: What parents and schools can do

Parents should be honest and not conceal a childs condition from the school and friends so that he can get help in time. Children are afraid to be different, but in this case full disclosure can be life-saving.

Once the condition is known, parents need to supply glucose testing kits, insulin vials, syringes to the school. Usually, children have automatic glucose pumps attached and only a test in presence of the nurse is required to determine the bolus (unit quantity of insulin ) required to delivered mechanically. In other cases, a certified nurse can administer an insulin shot at the school clinic.

A child with diabetes requires insulin three times a day with three major meals. Children usually have breakfast at home and have their first insulin shot at home, the second one is in school during lunch hour and the child needs to go to the nurse and check his blood sugar levels before the meal to decide on the dose he needs two hours after the meal. Usually this is the only meal a child has at school. Any snack that has less than 50 gms of carbohydrates does not require the child to take insulin.

Hypoglycaemia: Anything below 70 milligrammes per deca litre (mgdl) is low blood sugar and once detected, parents usually pack orange juice as an emergency meal. The rule is 15 gms of carbohydrates which amounts to half a glass of orange juice or a glucose gel tablet that can be given orally and 15 minutes later blood needs to be tested.

There are cases where the blood sugar could get low enough for the child to lose consciousness. Sometimes, children take insulin and in their excitement to participate in some event, say a sport, overlook eating a proper meal. In such cases, the sugar could get very low. Nurses are trained to administer an intra muscular glucagon injection to reverse the action of insulin.

Hyperglycaemia: This is blood sugar above 200 mgdl two hours after a meal. Diabetic children must check their blood sugar in school before meals and two hours after meal and have their insulin dose adjusted as per the reading, something which the school nurse can help them with. A child who has high blood sugar must not be allowed to do a sport activity as he can easily go into diabetes ketoacidosis which is a stage where the body has not enough insulin and begins to produce blood acids and burn fat as fuel. In both cases of high or low blood sugar, the nurse can intervene and advise the child. Nowadays most children carry continuous glucose monitoring devices and it is not difficult to know what a childs blood sugar levels are.

Children with Type I diabetes usually must maintain higher levels of hygiene. In case of diabetic children, it is absolutely necessary to keep them at home as their blood sugar levels can dangerously fluctuate when they are ill.

It is also advisable that Type I diabetics get seasonal flu vaccines to keep any infections at bay as more complications would mean difficulty in managing their condition.

Mothers must pay attention to meal qualities providing nutritionally balanced meals with dense carbohydrates and whole foods and discourage any processed and sugary foods that could spike blood sugar.

It is important for schools to have regular physical activity and sports and encourage every child to be active. Obesity and over-weight issues are resulting in occurrence of Type II diabetes in children as young as six.

In case of adolescent children with Type I diabetes, the school must be sensitive to not discriminate against them as these can have long term impact on their self esteem and trigger depression.

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In a world of hurt. Its a figure of speech not meant to be taken literally. But its a real place to those who inhabit the world of persistent pain, one whose moment-by-moment ramifications can upend and redefine life.

Theres a continuum in this world of hurt: Pain is variable and many manage it themselves without going to the doctor. They can hold jobs and function, albeit through varying levels of pain. For others, severe chronic pain can mean an inability to sit comfortably, or far worse, to fall off to sleep at night, day in and day out. For some, pain brings an inability to work, to get out and see friends, to travel or to take in a movie. And, with those compounding, cascading inabilities, an ever-shrinking solitary world because of hurt.

The threat of even more hurt must be defended against. When you have chronic pain, says 27-year-old Erika Delgado of South San Francisco, who has suffered with it her whole life, its like constantly being in flight mode. You constantly feel that youre in danger.

Often patients are reluctant to talk about pain that may send them to one doctor or therapist after another. Or pain that doesnt have a clear diagnosis, or pain that doesnt look obvious. They go stoic. You adapt, says David, a 68-year-old former executive who has been dealing with the after-effects of a sports injury and two back surgeries for two decades. At some point, youve got to say that what youve got is what youve got.

Despite the constant burning sensation in his back, the healthy appearing Redwood City resident tries to cope with his chronic pain quietly and, as much as possible, anonymously. Nobody wants to acknowledge their disability, says David, who nonetheless manages two contradictory things: an active schedule as a community volunteer and usually only two hours of sleep a night.

Except for those born with a rare congenital insensitivity which makes them literally feel no pain, everyone experiences it. A 2018 report for the U.S. Centers for Disease Control and Prevention estimated that 50 million Americans suffer from some form of chronic pain, and of that number, 19.6 million have pain severe enough that it frequently limits life or work activities. The economic toll is an estimated $560 billion in medical care, lost productivity and disability programs. The prevalence of pain, not surprisingly, goes up with age.

Pain, however, is actually beneficial, warning of danger so people can respond, for example, by pulling a hand away from a hot surface. Episodes of acute pain go with the territory for stubbed toes and broken bones, but the symptoms usually resolve as the tissue heals or bones mend. Persistent, or chronic pain, on the other hand, can become a disease in its own right, as the nervous system over time becomes rewired, even spreading pain beyond the original area. Thats one of the reasons why it can be so challenging to treat and so frustrating to those who live with it.

If theres good news in all of this for Peninsula residents, its that advances are being made in better understanding the causes and effective treatments for pain, and with that the ability to offer more personalized approaches for targeting individual patients. Whether high-technology brain imaging, or no-tech therapies like breathing exercises and yoga, there are more alternatives available than just going home with a prescription for pain pills something the nations opioid crisis has elevated as an urgent concern.

Dr. Sean Mackey is chief of the division of pain medicine and director of neuroscience and the pain lab at Stanford University. He leads a multidisciplinary team which brings academic research findings into a clinical setting to help patients alleviate longstanding pain and even to prevent pain, notably following surgery, from transitioning from acute to chronic. Our message, Mackey says, is that you dont have to suffer in silence, that there are approaches that can help.

Stanford Health Cares Pain Management Center at 500 Broadway in Redwood City is one of the largest, most comprehensive pain centers in the United States, if not the world, according to Mackey, and has twice been designated a Center of Excellence by the American Pain Society. Physicians from multiple disciplines including psychiatrists, physical therapists, nutritionists and others get involved treating patients.

One of the things that I think is unique to the Stanford program is that we integrate our research and clinical missions very tightly, he adds. Clinical knowledge can feed researchers with questions to go after, and research discoveries are translated into safe, effective therapies. One example of something that is being tested is transcranial magnetic stimulation brain zapping using something like a coil placed on top of the patients head. It doesnt hurt, Mackey says. Theres no pain and you can induce a current through it that generates a magnetic field that can activate different brain centers, and we can turn on and off the brain systems that are associated with pain. And weve had some really good results with it.

Stanford has been recruiting volunteers for further study of the efficacy of TMS for two kinds of pain, one of several studies that are planned. Another one is seeking evidence of the benefits of acupuncture for low back pain.

The Stanford scientists also study novel applications for medications, according to Mackey, as an example, repurposing naltrexone, which was originally used to treat drug and alcohol addiction. But at much lower doses, like one tenth of the usual dose, it has a completely different action, he says. It blocks nerve inflammation so its been very useful with fibromyalgia, which predominately affects women in their 30s, 40s and 50s, as well as some other chronic painful conditions.

Among the other new alternatives, Stanford is also using implanted devices that can override pain signals to a specific nerve and provide relief.

If the body had only a single pain center, obviously treating pain would be much simpler, but many parts of the brain and neural pathways are involved in the pain experience. One of the problems when pain becomes chronic is that it can alter both the peripheral nervous systems and the brain and spinal cord so that it amplifies the experience of pain and that magnifies it, according to Mackey. When that occurs, someone who has come through an injury or surgery may no longer need the original signals to keep on feeling pain.

What is experienced as pain relies on many sensory cues, among them emotions, beliefs, thoughts and expectations, and one of the factors that can feed into chronic pain is known as catastrophizing. The big word can apply to anything. Bills. The job. The country. But with pain, rumination, hopelessness and a feeling that the condition will never get better can trap the brain in an endless loop that is very difficult to break out of.

But the pain is still real. Unfortunately, in part because its invisible, patients commonly report feeling they are being blamed for their pain, according to Stanford associate professor Dr. BethDarnall, who has a doctorate in clinical psychology and is a pain scientist. (Its) a misperception that somehow people are saying pain is all in your head. Youre making it up. Its not real. Theres not a medical basis for your pain, therefore there must be something wrong with you (But) all pain is real. I always say that at the outset. All pain is real.

One of her primary interests is in developing low-cost, accessible treatments that empower patients so they can begin participating in managing their symptoms rather than feeling at the mercy of them among them cycles of poor sleep, persistent worry and feeling helpless.Darnall, who teaches a class on this at Stanfords Redwood City clinic four times a year, says studies demonstrate that in two months or so of cognitive behavioral therapy, improvement can be shown. They have evidenced substantial volumetric increases in the regions of the brain associated with brain control so literally increasing the brain matter in those regions that associate better regulation of pain.

Its long been established that cognitive and behavioral therapies are important in addressing chronic pain. Whats different is that were now focusing more and getting people better access to what works, she says. Rapid access to relief is kind of where the rubber hits the road.

Pain physician and professor Dr. Ming-Chih Kao is chief of Stanfords network of pain clinics (including the one in Redwood City), which is expanding geographically: Patients who are already in pain benefit because they dont have to drive so far for treatments and can come in more often.

Kao started his career in internal medicine, intending to focus on cancer as his specialty, but decided to switch to pain management in part because of how common pain complaints are, headaches and back pain topping the list. In the primary clinic that I saw about 20 to 30 percent of my patients could benefit from a pain specialist, he says. But the diagnosis and treatment of pain, he also saw, is very complicated and requires a team approach.

When he started at Stanford as a fellow, patients routinely were coming in who had been prescribed very high dosages of opiates. Primary care doctors, he says, were trying to do the right thing to reduce pain but the nature of opiate medications is that patients get used to it very quickly. They develop tolerance. They had to escalate the dose again and again and again. And pretty soon, some patients are finding themselves taking astronomical doses. And still not getting pain relief.

The issue has taken on new urgency as a result of the nations opioid crisis, which is commanding more public and regulatory attention. From a period when the drugs were overpromoted and the risks minimized, the pendulum has swung the other way, and in 2016 the Centers for Disease Control and Prevention recommended against opioids as a first-line treatment for chronic pain. There has been pushback from patients and physicians alike that things have gone too far the other way. (Both Mackey andDarnallhave spoken out against forced tapering of opioids.)

Fortunately, Kao notes, there are new medications available that can be used safely to treat chronic pain, and many patients on large-dose opiates have been switching over successfully. There are 200-plus medications for pain management; 20 are opioids.

With most patients who develop chronic pain, Kao observes, usually theres not just one cause. It may start out with a herniated disk, nerve impingement, joint inflammation or a muscle or tendon issue. If pain persists and reaches a high level, secondary injuries from disuse or being bedbound can set in too.

Sofor us, a patient coming in with back pain or a headache, weve got to figure out what parts of the pain cycle are important contributors to the chronic pain and then we try to tackle them one by one, Kao says, not just with the doctors but with the rest of our team.

Lifestyle changes can make a big difference. Oftentimes patients find themselves essentially in a feedback loop where they become less and less active to avoid pain, Kao says, but unfortunately inactivity over long periods of time weakens muscles and that can cause secondarily more pain. So thats actually the cycle were trying to break for a lot of patients. The therapeutic prescription might include swimming, yoga, Nordic walking using poles, biofeedback and meditation and psychological counseling to improve coping skills and the ability to commit to a treatment program.

San Mateo Medical Center the countys safety net hospital offers a multidisciplinary pain clinic that includes similar therapies including meditation, physical therapy, yoga and art, as well as classes to help patients understand the physiology of pain. The program draws heavily on the work of Australian neuroscientist Dr. Lorimer Moseley, whose poplar and entertaining talks on You Tube help as the title of one of his books puts it Explain Pain.

Clinic patient Douglas has the autoimmune disease fibromyalgia, which makes people hypersensitive to pain. Since she enrolled in the hospitals program early this year, she feels better and has gained a new perspective about how the mind and the body are linked. This class reminds us were not crazy, she says. Our pain is real.

It would be hard to find a more enthusiastic graduate than San Bruno resident JohnAcayan, aback painsufferer who says the pain clinic has helped him get past being depressed about things he can no longer do and instead look forward to what he can do. One of the things the pain management clinic has done for me is help me to realize that (if) youre injured, perhaps youre not going to be 100 percent the same, youre not going to be able to do everything that you used to. But you can be happy. You can do other things.

He even tried acupuncture, and despite a fear of needles, It was fantastic. I couldnt believe it. It made everything go away. Ill say literally the rest of that day was so tranquil. Absolutely no pain. Zero. That night, I slept fantastic. The next morning was great, but after a few days the pain came back. He tries not to think about pain so much. At one time, in fact, he thought his medication needed to be stronger. He was taking 600 milligrams of tramadol a day and is now down to 50. The clinic team guided him to the realization that he didnt need that much. I could take a pill and be happy and lightheaded, he says, but that isnt the way I want to feel. I want to feel normal. I dont want to feel loopy.

This summer,Acayangot to try out something fairly new in the hospitals treatment toolbox virtual reality. Patients put on goggles and operate controls to throw things at friendly sea otters on a video screen and become completely engrossed. Another version has a biofeedback component that gives viewers some control as their heart rate changes.

Chief Medical Information Officer Dr. MichaelAratowsays virtual reality can calm people down in high-anxiety areas like emergency rooms. He brought the idea to Dr. MelissaFledderjohann, a licensed clinical psychologist who directs the pain management clinic, and she readily agreed to offer it in her program. Most patients get a reduced pain sensation while theyre using VR, according toFledderjohann. We know that during and right after it, they definitely feel a decrease,Aratowsays. The question is does that decrease persist until next time? The jurys still out on that one.

SaysFledderjohann: It helps reinforce the concepts in our classes, saying There are tools you can do to manage your pain, reduce your pain. Its not just an external thing thats coming at you. You yourself can do your own pain management. And this would be a good example. By going though VR, you saw your pain reduced.

SimonKoytiger, a physical therapist who manages Vibrant Care Rehabilitation in San Carlos, is also a proponent of a comprehensive and holistic approach to treating pain, which he views a symptom, not the root of the problem. Especially in the fast-paced Bay Area, lifestyle issues including lack of exercise, working long hours, stress, poor diet and anxiety can show up as back or knee problems, andKoytigertries to help patients develop healthier habits. We have this chronic pain issue, he says. Lifestyle is never going to show up on an MRI.

Exercise, he points out, helps reduce pain many ways, first by making people stronger and less fragile and improving the capacity of all tissues in the body. Exercise also has endocrine effects, releasing the happy hormones serotonin and dopamine and reducing the production of the stress hormone cortisol.

I talk to patients about these three pillars very frequently: Its physical exercise, its diet and nutrition and its mental health,Koytigeradds. AndactuallyIm a bit of a believer, even though Im a physical therapist, that the primary pillar is mental health. Because who is the one whos choosing to eat well? Who is the one whos deciding to exercise that day or not? We make those decisions and if we are at ease and we have more peace and calmness in our minds, we are going to naturally do those things that are right for our body. If we are suffering with depression and anxiety and stress, its going to be much more challenging to balance those two domains.

Coming back from chronic pain can be a long haul.

Woodside resident Brad Dary, 65, counts himself fortunate that he came out the other side of years of chronic pain, which began in 1995 with a laminectomy followed by fusion surgery for a vertebra five years later.

For the first year after the surgery, I felt like I was cut in half, he says. I moved home with my parents. I was literally in bed for a year after that operation. It would take me about a half an hour to get from the bed to the bathroom. You cant do anything without your back being involved. I used a walker. He had to take morphine for the pain but hated having a foggy brain and couldnt wait to get off of it.

He tried acupuncture once but thought it was silly. But Dary, who is a videographer, says through a slow progression of pushing himself to do exercise and the healing process, he finally recovered. You just fight it out, he says. My biggest thing was doing exercise and trying to build my muscles as best I could Everyones situation is different. I had a lot of time to heal. It was 10 years. Today he jogs three times a weekand works out with weights. He thinks having to work so hard to get where he is challenges him to be more alive.

Rose who did not want to be identified by her real name for this story has made a remarkable comeback too from barely being able to get out of a hospital bed using a walker. The southern San Mateo County resident disciplines herself to walk two miles, three times a week and has worked up to doing 15 minutes on an exercise bike at the gym. Shes arrived at this point 15 years after a series of back surgeries over four years, the first to address stenosis and then two more that turned out to be needed because of damaged disks.

When it all began, she had a job, but she had to give up working long ago.

Patients tend not to do their physical therapy if its too painful, and she was prescribed fentanyl and vicodin to help her be better able to do the therapy she would need, which it did. They put me on heavy opioids because they knew to get through years of it would be so painful because all of these core muscles were, waist to pelvis front and back, cut three times through three surgeries, Rose explains. So that is a huge amount of healing.

Fifteen years ago, her first pain management doctor assured her that it would easy to get off the opioids when the time came. Its no problem, Rose clearly recalls him saying. Literally, he told me No problem. You just gradually step off the opioids.

But when she had been on them for six years and was ready to start declining, she learned otherwise. It took three years of tapering to get off opioids, drugs so powerful that she had to cut back milligram by milligram, for a month perhaps and then wait two months to cut back again. Each time, she had to deal anew with increased pain, plus the jittery withdrawal symptoms. Her skin felt like it was crawling and she had no idea what it was until someone she knows who works with people in addiction explained it to her.

Id never done drugs, she says. I didnt know. Im such an innocent Girl Scout.

She methodically tracked her dosage on an Excel spreadsheet. With such a plodding pace, it helped to be able to look back and confirm that she really was taking less. Rose says her current pain specialist is a Kaiser Permanente doctor who has been with her every step of the way and is her cheerleader. He emphasizes the importance to her of pacing activities, not overdoing and causing more pain that will trigger a desire for more opioids. Though she was already slender, when one of Roses physicians told her that losing five pounds would reduce the pain, she lost ten. In my case, she says, it makes a huge difference.

More than anything, what has really gotten her through it all, says Rose, is her support system of her husband and friends and her Christian faith. A Bible study group from church met in her house when she could not get out, and it helped to know that they were praying for her. Prayer is meditation, she observes, and the Bible study group was group therapy.

Roses advice to others with chronic pain? From my experience, really slow is what does it, she responds with a laugh, like the old Aesops fable, the tortoise always wins.

This story was originally published in the November print edition of Climate Magazine.

See the original post:
Stanford's new, innovative tools to address chronic pain - Climate Online

Recommendation and review posted by Bethany Smith

AMA recently published a detailed study of over 180+ pages in its repository on Endometriosis Therapies market covering interesting aspects of market with supporting development scenario till 2025. The study provides market size break-up by revenue and volume* for emerging countries and important business segments along with commentary on trending factors, growth drivers. Profiled players in study from the coverage used under bottom-up approach are AbbVie Inc. (United States),Eli Lilly and Company (United States),AstraZeneca (United Kingdom),Bayer AG (Germany),Astellas Pharma, Inc. (Japan),Pfizer, Inc. (United States),Takeda Pharmaceutical Company Limited (Japan),Myovant Sciences (United Kingdom)

According to the endometriosis.org, the disorder, Endometriosis affects approximately one in 10 women during their reproductive years, estimating around 176 million women in the world. Endometriosis is a painful disorder in which the layer of tissue that normally surfaces inside the uterus, starts growing outside the uterus. This mainly occurs on the fallopian tubes, ovaries, and tissue around the uterus; however, in exceptional cases, it may occur in other parts of the body. Hormone therapies may be used as a treatment for mild endometriosis or as combined therapy, either before, or after surgery, for moderate to severe endometriosis. Further, High investment made by the Government in the R&D of endometriosis disorder and increasing female population of reproductive age is driving the Global Endometriosis Therapies market

Request a sample report @ https://www.advancemarketanalytics.com/sample-report/62980-global-endometriosis-therapies-market

Market Segmentation:by Type (Hormonal Therapy (Oral Contraceptive Pills, Progestins), Hormone Replacement Therapy (GnRH Agonists, Luteinizing-hormone-releasing hormone receptor antagonist, etc.), AromataseInhibitors, Thermal Endometrial Ablation Devices), Application (Hospital, Clinic, Other), Drug Type (Oral Contraceptives, Progestins, NSAIDs, GnRH Analogues, LNR-IUDs, Others), Synthetic Hormone (Danazol, Gestrinone), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Drug Stores, E-commerce), Surgery (Laparoscopy, Hysterectomy, Laparotomy), Treatment Type (Pain Management, Hormone Therapy)

Make an enquiry before buying this Report @ https://www.advancemarketanalytics.com/enquiry-before-buy/62980-global-endometriosis-therapies-market

Whats Trending in Market: Availability of a Large Number of Branded as Well As Generic Products

Major Players in the Market Involved In Clinical Trials

Growth Drivers:

Increasing Female Population of the Reproductive Age

Availability of Various Treatment Options

Rising Prevalence of Endometriosis in Young Adults

Restraints:

High Cost of Advanced Therapeutic Drugs

Less Number of Studies On the Disease

View Detailed Table of Content @ https://www.advancemarketanalytics.com/reports/62980-global-endometriosis-therapies-market

Country level Break-up includes:North America (United States, Canada and Mexico)Europe (Germany, France, United Kingdom, Spain, Italy, Netherlands, Switzerland, Nordic, Others)Asia-Pacific (Japan, China, Australia, India, Taiwan, South Korea, Middle East & Africa, Others)

* Customized Section/Chapter wise Reports or Regional or Country wise Chapters are also available.

Strategic Points Covered in Table of Content of Global Endometriosis Therapies Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Endometriosis Therapies market

Chapter 2: Exclusive Summary the basic information of the Endometriosis Therapies Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Comptroller Software

Chapter 4: Presenting the Endometriosis Therapies Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying the by Type, End User and Region 2013-2018

Chapter 6: Evaluating the leading manufacturers of the Endometriosis Therapies market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

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Is Endometriosis Therapies Market Trapped Between Growth Expectations and Uncertainty? - Industry News Stock

Recommendation and review posted by Bethany Smith

It was like an out of body experience when Charlotte Evans was told she had breast cancer at the age of 23.

In a state of shock, the young woman started laughing uncontrollably as doctors explained the devastating news.

Charlotte, now 25, had been aware of breast cancer ever since her mum was diagnosed with the disease 12 years ago.

When she found a lump in her own breast in April 2017, Charlotte initially assumed it was hormone related and felt reassured when her doctor turned her away because of how young she was.

But when she noticed changes to the lump, she booked another appointment with her GP and took her mum along.

Shortly afterwards, Charlotte set off on a romantic break with her boyfriend Adam, and when they returned Charlotte went to the clinic for her test results.

They sat me down and said you have breast cancer and because of the shock I just started laughing uncontrollably," says Charlotte.

"It was an out of body experience and I dont think I took any of what they were saying in.

"I just remember my mum grabbing my leg and letting out a horrified gasp.

"It didnt register with me for months to be honest. I just said I cannot lose my hair.

In the months that followed Charlotte underwent chemotherapy, a double mastectomy, breast reconstruction and a course of radiotherapy.

She opted for 'cold cap' treatment so she didn't lose her hair.

Charlotte's treatment also forced a discussion about her fertility much sooner than she and Adam had planned.

"I started IVF just before my chemotherapy began and I remember going to the hospital with Adam thinking it was a joke that we had to think about this at our age," she explains.

"It felt as though we were in a parallel universe. I knew one day I wanted to have a family but going through IVF treatment at 23 felt so premature.

"Adam was 24 and he hadnt signed up for this; fertility treatment, hospital appointments, bathing me when I didnt have the energy.

"But he took it all in his stride and I cant thank him and our families enough for all that they have done for me.

"Now I can see how important it was for me to take those precautionary steps for our future together.

Charlotte, who works as cabin crew for easyJet, is sharing her story as part of the Life-saving Journeys partnership, which sees charities Breast Cancer Now and Prostate Cancer UK join forces with her employer.

She says being diagnosed with cancer at such a young age forced her to grow up quickly.

She finished radiotherapy a year ago and is now back at work after 16 months off.

There are no words, youll never think it will happen to you," she explains.

"I had to grow up so quickly and it was hard but I always tried to stay positive.

"I would go to my chemo appointments wearing the clothes and make-up that made me feel good, and I would just deal with it.

"A diagnosis of breast cancer is life-changing, but it makes you appreciate everything so much more. As a teenager, it was really tough seeing my mum go through breast cancer, but it made our family closer.

"When I turned 22 I had a thought one day, just out of the blue, about whether or not I would be diagnosed at some stage in my life. I didnt think it would be at 23, but youre never too young."

Charlotte is sharing her story as part of the Life-saving Journeys partnership, which sees charities Breast Cancer Now and Prostate Cancer UK join forces with her employer.

The six-week collaboration, which last year raised more than 430,000 for cutting-edge research, hopes to raise even more money through its on-board collections this Autumn.

Charlotte says: "It feels really special knowing that money raised by easyJet passengers and crew during this campaign will be supporting Breast Cancer Now and Prostate Cancer UK.

"As well my own diagnosis of breast cancer, and my mums, my grandad was diagnosed with prostate cancer in2014 and has since made a full recovery, so both organisations are close to my heart."

She added: "Going back to work after 16 months off was tough, but easyJet were hugely understanding and supportive and Im so pleased to be back at work in a job I love. I want to thank all of our passengers for their donations, this money will provide hope for so many by helping to fund vital research into these horrible diseases.

View original post here:
"When they told me I had breast cancer at 23 I started to laugh" - Manchester Evening News

Recommendation and review posted by Bethany Smith

The CRISPR gene-editing tool can be used to silence an important hepatitisB virus gene, a proof-of-concept invitro study suggests.

"It's the first time we've seen CRISPR editing done in a hepatitisB model," said Douglas Dieterich, MD, director of the Institute of Liver Medicine and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City.

HepatitisB can lead to liver disease and is the primary cause of hepatocellular carcinoma. In 2015, more than 250million people around the world were infected with the virus, according to the World Health Organization.

For their study, investigator Hao Zhou, from The First Hospital of Jilin University in China and the Department of Medicine at the University of Minnesota in Minneapolis, and colleagues targeted the Sgene. Zhou presented the findings at the Liver Meeting 2019 in Boston.

The Sgene gives rise to the hepatitisB surface antigen, the presence of which indicates that a person is infected with the virus. "The question is whether it's the right target," Dieterich told Medscape Medical News.

Reducing the amount of the hepatitisB surface antigen is a "good idea" because that's what is believed to inhibit the immune system from clearing the virus. Doing so might help the immune system recover and clear the virus, "with a little help from some antivirals," explained Dieterich, who was not involved in the study.

However, "the surface is not the only DNA that's integrated into the host genome," he pointed out. "I think maybe a broader application might be necessary to actually get the hepatitisB genome out of the hepatocytes."

Zhou's team used a newer CRISPR approach, called CRISPR-STOP, for their gene-editing procedure.

"The idea is that CRISPR-STOP can be as efficient as standard CRISPR editing, but it's safer," said Kiran Musunuru, MD, PhD, associate professor of cardiovascular medicine and genetics at Penn Medicine in Philadelphia, who was not involved in the study. Musunuru is cofounder of and senior scientific advisor at Verve Therapeutics, a company using gene editing to prevent cardiovascular disease.

The standard CRISPR-Cas9 approach requires a double-strand break in the genome, and the problem with that is it introduces the possibility for "mischief," he explained. "If you have more than one double-strand break occurring in the human genome at the same time, you have the potential for different parts of different chromosomes coming together in the wrong ways and then causing problems."

Instead of creating a double-strand break, CRISPR-STOP uses a base editor to chemically modify the DNA base from one base to another and introduce a stop codon into the target gene sequence, effectively hamstringing the ability of the target gene to produce a functional protein.

This is a very nice, clean way to turn off a gene effectively.

"This is a very nice, clean way to turn off a gene effectively," Musunuru told Medscape Medical News.

For their CRISPR-STOP procedure, Zhou's team first transduced liver cells infected with the hepatitisB virus using a base editor called AncBE4max. Next, to activate the base editor so that gene editing could begin, they transduced the cells with one of two lentivectors: one encoded for single-guide RNA that targets the Sgene; and an empty one, which served as the control.

With the gene-editing approach, 71% of the liver cells that expressed the base editor gained the desired stop codon in the target gene.

"That's a very robust number," said Musunuru.

In addition, hepatitisB surface antigen secretion was reduced by 92% with the gene-editing approach.

The investigators report a high degree of conservativity for hepatitisB genotypesB, C, F, and H. Specifically, 94% of the Sgene sequence was conserved for genotypeB, 92% for genotypeC, 91% for genotypeF, and 71% for genotypeH.

The Liver Meeting 2019: American Association for the Study of Liver Diseases (AASLD): Abstract86. Presented November10, 2019.

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Link:
CRISPR Used to Silence Crucial Hepatitis B Gene - Medscape

Recommendation and review posted by Bethany Smith

New cell experiments show more effective genetic cuts that could one day become the foundation of more effective gene therapies.

Researchers may have found a way to sharpen the CRISPR-Cas9 technique so it can more successfully cut out undesirable genetic information and could one day fast-track potential therapies for HIV, sickle cell disease and, potentially, other immune conditions.

This is the first time scientists have systematically gone through the guide RNA sequence to change it and improve CRISPR-Cas9 technology, said Tristan Scott, PhD, lead author of the study and a staff research scientist at City of Hopes Center for Gene Therapy.

This could lead to more clean results in cell and mouse model experiments aimed at developing new therapies because the target that was knocked out was more successfully removed. More pronounced results could quicken new the development of therapies. In theory, the therapeutic product should have more successful cuts, which could translate into an improved therapy.

The researchers experimented on cells by making changes to the trans-activating CRISPR RNA (or tracrRNA), which is derived from Streptococcus pyogenes bacteria and is a part of the components used to guide the genetic scissors (Cas9) to the right gene sequence.

They found that the modified tracrRNA improved the silencing of certain genes by increasing desirable mutations in the genetic material. In this study, the target was an essential component of HIVs lifecycle, the protein CCR5 on immune CD4+ T cells. The modified tracrRNA improved cutting at this site and inactivation of CCR5, and hopefully that will translate into better protection for the immune system.

The new design was also better at improving activity at the HBB gene and the BCL11A site, both of which are tied to sickle cell disease and are being targeted in order to develop therapies for the currently incurable blood disease that causes intense pain and premature death.

If this line of research remains consistent and we can dependably sharpen the genetic scissor, the result could eventually be new or improved genetic therapies, Scott said.

The study was published inScientific Reports.

Read more here:
Modified CRISPR gene editing tool could improve therapies - Drug Target Review

Recommendation and review posted by Bethany Smith

New Jersey, NJ, Nov. 13, 2019 (GLOBE NEWSWIRE) -- The key contributing factors for the market growth are increasing demand for enhanced crop varieties using modern breeding techniques and exponential reduction in the cost of genomic solutions. Theglobal plant breeding and CRISPR plants market is expected to grow from USD 6.3 Million in 2017 to USD 21.2 Million by 2025 at a CAGR of 16.4% during the forecast period 2018-2025, according to the new report published by Fior Markets.

The CRISPR-Cas9 system is defined as a plant breeding innovation that uses site-directed nucleases to target and transform DNA with great accuracy. It was developed in 2012 by scientists from the University of California, Berkeley, and has received a lot of focus in recent years due to its wide range of uses, including biological research, breeding and development of crops and animals, and human health applications. It also includes gene silencing, DNA-free CRISPR-Cas9 gene editing, homology-directed repair (HDR), and transient gene silencing or transcriptional repression (CRISPR).

Increasing demand for enhanced crop varieties using modern breeding techniques is a major factor driving the market. Also, exponential reduction in the cost of genomic solutions and advancements in technology ensure strong market growth. High cost associated with modern breeding methods as compared to conventional breeding, poor laboratory infrastructure and lack of validated markers hampers the growth of the market. However, rising investments from seed companies and favourable regulations for molecular breeding may boost the market in the coming years.

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Key players in the plant breeding and CRISPR plants market are Bayer, Syngenta, KWS, DowDuPont, Eurofins, SGS, Advanta Seeds, Benson Hill Biosystems, Bioconsortia, DLF, Equinom, Evogene, Groupe Limagrain, Hudson River Biotechnology, Land Olakes, Pacific Biosciences, SGS, and Syngenta among others. Key players active in the market are involved in collaborative agreements and expansion to bolster the growth of the market.

The hybridization segment held the largest market share of 45.70% in 2017

The process segment is classified into selection, hybridization and mutation breeding. The hybridization segment is dominated the Plant Breeding and CRISPR Plants Market in 2017 with a market share of 45.70%. The most successful applications of hybridization breeding are the utilization of heterosis and generation of seedless horticultural crops, such as watermelon, by employing diploid and tetraploid parents.

Biotechnological method segment valued around USD 3.99 Million in 2017

The type segment includes conventional breeding and biotechnological method. Biotechnological method segment valued around USD 3.99 Million & dominated the market in 2017. The increasing implementation of hybrid and molecular breeding techniques in developing countries and the rising cultivation of GM crops in the Americas are the factors contributing to its high growth.

The herbicide tolerance segment held the largest market share of 36.90% in 2017

Trait segment is divided into segments such as herbicide tolerance, disease resistance, yield improvement and other traits. The herbicide tolerance segment dominated the market in 2017 with a market share of 36.90%. Rising regulations on the use of chemical pesticides and increasing instances of pest attacks during the early germination phase have risen considerably due to the need for pesticide-tolerant seeds.

Browse full report with TOC athttps://www.fiormarkets.com/report/global-plant-breeding-and-crispr-plants-market-by-375950.html

The cereals & grains segment valued around USD 2.40 Million in 2017

The application segment includes cereals & grains, oilseeds & pulses, fruits & vegetables and other crop types. The cereals & grains segment valued around USD 2.40 Million and dominated the market in 2017. Corn, wheat, and rice are the major cereals bred with advanced technologies such as molecular breeding and genetic techniques. The availability of germplasm for these crops encourages the adoption of advanced breeding techniques.

Regional Segment Analysis of the Plant Breeding and CRISPR Plants Market

Asia Pacific region dominated the global plant breeding and CRISPR plants market with USD 2.72 Million in 2017. The Asia Pacific region is a major manufacturing hub owing to the ever-increasing demand for commercial seeds in the Asian market aligned with the growing economic growth conditions. Also, seed producers such as Bayer, Monsanto, and Syngenta have been showing increasing interest in tapping this potential market, wherein the companies have been expanding their R&D centres across the Asia Pacific. North America is the second fastest-growing region due to the increasing industrial value for corn and soybean in the US which is encouraging breeders to adopt advanced technologies for better yield, owing to which the adoption rate for genetics in this country remains high.

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Global Plant Breeding and CRISPR Plants Market is Expected to Reach USD 21.2 Million by 2025 : Fior Markets - GlobeNewswire

Recommendation and review posted by Bethany Smith

Upon meeting for the first time at a dinner at Stanford earlier this year, Fei-Fei Li and Jennifer Doudna couldnt help but note the remarkable parallels in their experiences as scientists.

Stanfords Fei-Fei Li and Jennifer Doudna of UC Berkeley will discuss the ethics of artificial intelligence and CRISPR technology. (Image credit: Getty Images)

Both women helped kickstart twin revolutions that are profoundly reshaping society in the 21st century Li in the field of artificial intelligence (AI) and Doudna in the life sciences. Both revolutions can be traced back to 2012, the year that computer scientists collectively recognized the power of Lis approach to training computer vision algorithms and that Doudna drew attention to a new gene-editing tool known as CRISPR-Cas9 (CRISPR for short). Both pioneering scientists are also driven by a growing urgency to raise awareness about the ethical dangers of the technologies they helped create.

It was just incredible to hear how similar our stories were. Not just the timing of our scientific discoveries, but also our sense of responsibility for the ethics of the science are just so similar, said Li, who is a professor of computer science at Stanfords School of Engineering and co-director of the Stanford Institute for Human-Centered Artificial Intelligence (HAI).

The ethical angle to what we were doing was not something that either of us anticipated but that we found ourselves quickly drawn to, said Doudna, who is a professor of chemistry and of molecular and cell biology at the University of California, Berkeley.

The echoes between Li and Doudnas lives were also not lost on the dinner host that night, Stanford political science professor Rob Reich, who invited the pair to resume their conversation in public. Their talk, titled CRISPR, AI, and the Ethics of Scientific Discovery, will take place at Stanford on Nov. 19 and will be moderated by Stanford bioengineering professor Russ Altman(livestream will be available here).

The event is organized by the Stanford McCoy Family Center for Ethics in Society and HAI and is part of the Ethics, Society & Technology Integrative Hub that arose from the universitys Long-Range Vision.

The subject of the lecture hits the sweet spot of what the Integrative Hubs work is about, which is to cultivate and support the large community of faculty and students who work at the intersection of ethics, society and technology, said Reich, who directs the Center for Ethics in Society and co-directs the Integrative Hub.

I cant think of two better people to engage in a conversation and to really take seriously these questions of how, as you discover the effects of what youve created, do you bring ethical implications and societal consequences into the discussion? said Margaret Levi, a professor of political science at Stanfords School of Humanities and Sciences. Levi is also the Sara Miller McCune Director of the Center for Advanced Study in the Behavioral Sciences and co-director of the Integrative Hub.

Fei-Fei Li is a professor of computer science and co-director of Stanfords Institute for Human-Centered Artificial Intelligence. (Image credit: L.A. Cicero)

In 2006, Li wondered if computers could be taught to see the same way that children do through early exposure to countless objects and scenes, from which they could deduce visual rules and relationships. Her idea ran counter to the approach taken by most AI researchers at the time, which was to create increasingly customized computer algorithms for identifying specific objects in images.

Lis insight culminated in the creation of ImageNet, a massive dataset consisting of millions of training images, and an international computer vision competition of the same name. In 2012, the winner of the ImageNet contest beat competitors by a wide margin by training a type of AI known as a deep neural network on Lis dataset.

Li immediately understood that an important milestone in her field had just been reached, and despite being on maternity leave at Stanford, flew to Florence, Italy, to attend the award ceremony in person. I bought a last-minute ticket, Li said. I was literally on the ground for about 18 hours before flying back.

Computer vision and image recognition are largely responsible for AIs rapid ascent in recent years. They enable self-driving cars to detect objects, Facebook to tag people in photos and shopping apps to identify real-world objects using a phones camera.

Within a year or so of when the ImageNet result was announced, there was an exponential growth of interest and investment into this technology from the private industry, Li said. We recognized that AI had gone through a phase shift, from being a niche scientific field to a potential transformative force of our industry.

The field of biology underwent its own phase shift in the summer of 2012 when Doudna and her colleagues published a groundbreaking paper in the journal Science that described how components of an ancient antiviral defense system in microbes could be programmed to cut and splice DNA in any living organism, including humans, with surgical precision. CRISPR made genomes as malleable as a piece of literary prose at the mercy of an editors red pen, Doudna would later write.

CRISPR could one day enable scientists to cure myriad genetic diseases, eradicate mosquito-borne illnesses, create pest-resistant plants and resurrect extinct species. But it also raises the specter of customizable designer babies and lasting changes to the human genetic code through so-called germline editing, or edits made to reproductive cells that are transmitted to future generations.

This bioethics nightmare scenario was realized last fall when a Chinese researcher declared that he had used CRISPR to edit the genomes of twin girls in order to make them resistant to HIV. Doudna decried the act but allows that her own views on germline editing are still evolving.

Ive gone from thinking never, ever to thinking that there could be circumstances that would warrant that kind of genome editing, she said. But it would have to be under circumstances where there was a clear medical need that was unmet by any other means and the technology would have to be safe.

Both Li and Doudna fervently believe in the potential of their technologies to benefit society. But they also fear CRISPR and AI could be abused to fuel discrimination and exacerbate social inequalities.

The details are different for CRISPR and AI, but I think those concerns really apply to both, Doudna said.

Rather than just leaving such concerns to others to work out, both scientists have stepped outside of the comfort of their labs and taken actions to help ensure their worst fears dont come to pass. I almost feel that at this point of history I need to do this, not that its my natural tendency, Li said. It really is about our collective future due to technology.

Both scientists have testified before Congress about the possibilities and perils of their technologies. Li also co-launched a nonprofit called AI4All to increase inclusion and diversity among computer engineers and she co-directs Stanford HAI, which aims to develop human-centered AI technologies and applications. Doudna spends significant time talking to colleagues, students and the public about CRISPR. In 2015 she organized the first conference to discuss the safety and ethics of CRISPR genome editing.

Because we were involved in the origins of CRISPR, I felt it was especially important for my colleagues and me to be part of that discussion and really help to lead it, Doudna said. I asked myself, If I dont do it, who will?

To read all stories about Stanford science, subscribe to the biweekly Stanford Science Digest.

Altman is the Kenneth Fong Professor of Bioengineering, Genetics, Medicine, Biomedical Data Science and host of the Stanford Engineering radio show The Future of Everything. Levi is a member of Stanford Bio-X, the Wu Tsai Neurosciences Institute, and the Stanford Woods Institute for the Environment. Li is the Sequoia Capital Professor at Stanford and a member of Stanford Bio-X and the Wu-Tsai Neurosciences Institute.

Visit link:
AI and gene-editing pioneers to discuss ethics - Stanford University News

Recommendation and review posted by Bethany Smith

Heart muscle cells derived from stem cells show remarkable adaptability to their environment during and after spaceflight, according to a study publishing November 7 in the journal Stem Cell Reports.

The researchers examined cell-level cardiac function and gene expression in human heart cells cultured aboard the International Space Station for 5.5 weeks. Exposure to microgravity altered the expression of thousands of genes, but largely normal patterns of gene expression reappeared within 10 days after returning to Earth.

"Our study is novel because it is the first to use human induced pluripotent stem cells to study the effects of spaceflight on human heart function," says senior study author Joseph C. Wu of Stanford University School of Medicine.

"Microgravity is an environment that is not very well understood, in terms of its overall effect on the human body, and studies like this could help shed light on how the cells of the body behave in space, especially as the world embarks on more and longer space missions such as going to the moon and Mars."

Past studies have shown that spaceflight induces physiological changes in cardiac function, including reduced heart rate, lowered arterial pressure, and increased cardiac output. But to date, most cardiovascular microgravity physiology studies have been conducted either in non-human models or at tissue, organ, or systemic levels. Relatively little is known about the role of microgravity in influencing human cardiac function at the cellular level.

To address this question, Wu and his collaborators (including graduate student Alexa Wnorowski, former Stanford graduate student Arun Sharma, now a research fellow at Cedars-Sinai in Los Angeles, and former Stanford graduate student turned astronaut Kathleen Rubins) studied human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). They generated hiPSC lines from three individuals by reprogramming blood cells, and then differentiated them into hiPSC-CMs.

Beating hiPSC-CMs were then launched to the International Space Station aboard a SpaceX spacecraft as part of a commercial resupply service mission. Simultaneously, ground control hiPSC-CMs were cultured on Earth for comparison purposes.

Upon return to Earth, space-flown hiPSC-CMs showed normal structure and morphology. However, they did adapt by modifying their beating pattern and calcium recycling patterns.

In addition, the researchers performed RNA sequencing of hiPSC-CMs harvested at 4.5 weeks aboard the International Space Station, and 10 days after returning to Earth. These results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples.

Most notably, gene pathways related to mitochondrial function were expressed more in space-flown hiPSC-CMs. A comparison of the samples revealed that hiPSC-CMs adopt a unique gene expression pattern during spaceflight, which reverts to one that is similar to groundside controls upon return to normal gravity.

"We're surprised about how quickly human heart muscle cells are able to adapt to the environment in which they are placed, including microgravity," Wu says. "These studies may provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, or potentially lay the foundation for new insights into improving heart health on Earth."

According to Wu, limitations of the study include its short duration and the use of 2D cell culture. In future studies, the researchers plan to examine the effects of spaceflight and microgravity using more physiologically relevant hiPSC-derived 3D heart tissues with various cell types, including blood vessel cells. "We also plan to test different treatments on the human heart cells to determine if we can prevent some of the changes the heart cells undergo during spaceflight," Wu says.

Research Report: "Effects of Spaceflight on Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Structure and Function"

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Human heart cells are altered by spaceflight, but return mostly to normal on Earth - Space Daily

Recommendation and review posted by Bethany Smith

Nov. 12, 2019 14:00 UTC

LOS ALTOS, Calif. & FAIRFIELD, Calif.--(BUSINESS WIRE)-- GenomeSmart, a Silicon Valley-based company delivering the first and only AI-powered genetic risk assessment and test recommendation platform to improve access to genetic testing, announced today that NorthBay Healthcare, an independent nonprofit health system in Northern California, has selected the GenomeBrain Platform for a pilot program planned to improve the routine use of genetic testing in patient care.

Weve looked at many options to support our providers but the GenomeBrain Platform offered us more of the critical features we wanted plus gave us the ability to customize to our needs, said Lori Muir, Oncology Services Director. NorthBay Healthcare is dedicated to delivering best-in-class oncology care to the patients we serve and we believe ensuring easy access to genetic testing is a critical part of those vital services. Were looking forward to working with GenomeSmart to support our providers in better identifying patients for testing, efficiently tracking available tests, and speeding access to hereditary risk results.

"This approach to screening patients will make it much easier for people to understand why and when genetic testing can impact their healthcare decisions. We are bridging an educational gap that, until now, has made access to genetic testing difficult. Our patients will no longer wonder if genetic testing is right for themthey will know before they even come in to see me," added Karen Vikstrom, MS, Certified Genetic Counselor, NorthBay Healthcare.

The NorthBay Healthcare pilot program will be completed in conjunction with the NorthBay Breast Cancer Program. The pilot is designed to ensure patients with breast cancer receive treatment based on genetic risk and to scale testing into routine care for healthy women and men to identify potential hereditary risks, ensuring appropriate access to screening and care programs. The GenomeBrain Platform will be incorporated into the current patient workflow and evaluated for effectiveness and ease of use.

The GenomeBrain Platform is accessed online through a mobile phone, tablet, or desktop device. The simplified experience first builds a patient profile, including their relevant personal medical history, family medical history, ethnicity and age, and then instantly matches them to the appropriate genetic tests based on the latest medical guidelines for genetic testing. GenomeBrain uses AI to ingest large amounts of data from patient history, genetic tests available on the market, and medical guidelines to simplify a cumbersome manual process that usually takes days to less than ten minutes on average.

Were thrilled to be partnering with NorthBay Healthcare on this important initiative, said Sanjay Sathe, CEO and co-founder, GenomeSmart. The NorthBay teams agility and interest in innovative approaches to care make them the ideal partner for us. They are able to implement efforts quickly and provide personalized care to their local community that rivals many larger urban-based institutions, all for the betterment of their patients.

About GenomeSmart

GenomeSmart is on a mission to make genetic testing available to everyone. In May 2019, the company launched GenomeBrain, the first and only AI-powered genetic risk assessment and test recommendation platform that matches and identifies people who could benefit from genetic testing. The affordable GenomeBrain Platform multi-functional solution is available to help genetic counselors, physicians, hospital systems, genetic testing labs, insurance companies, and corporations improve the effective use of genetic testing to save lives, improve quality and reduce costs of healthcare.

About NorthBay Healthcare

NorthBay Healthcare opened its first hospital in 1960 and remains Solano Countys only locally based, locally managed nonprofit health system. NorthBay Medical Center in Fairfield and NorthBay VacaValley Hospital in Vacaville offer 24-hour emergency care, intensive care, and sophisticated surgical and diagnostic services. NorthBay Cancer Center, located on the Vacaville campus, opened more than 30 years ago. NorthBay Healthcare is a member of the Mayo Clinic Care Network, giving its patients access to world-renowned physicians and Mayo Clinic research.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191112005437/en/

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GenomeSmart and NorthBay Healthcare Launch Pilot to Improve Access to Genetic Testing with GenomeBrain - BioSpace

Recommendation and review posted by Bethany Smith

I just attended theNational Society of Genetic Counselors Annual Meetingin Salt Lake City, UT where I met some of the brightest minds in genetics, heard about mind-bending new technologies, and was reminded of the many ways that genetic counseling and testing is improving health, transforming lives, and driving precision medicine forward.

With that bright promise freshly in mind, several recent stories have cast a stark reminder of the ways genetic testing can, andis,being used nefariously.I published an article on this topicjust a few short weeks ago and didnt foresee that it would need a part II so soon. Consider the following:

The Trump administration already announced that they would require DNA samples from asylum-seekers at the Mexican border for rapid DNA testing to confirm family relationships.In a move called transparently xenophobic in its intention, the Trump Administration now plans to collect DNA from individuals in federal immigration custody and add those samples to the national FBI crime database.

MIAMI : A judges gavel rests on top of a desk (Photo by Joe Raedle/Getty Images)

A Judge in the Floridas Ninth Judicial Circuit Court signed a warrant allowing a detective to successfully obtain a warrant to search GEDMatchs genetic database,even for users who opted out of appearing in police search results.This decision brings into question whether larger databases, like those of 23andMe and Ancestry, are subject to the same sort of warrants, despite their privacy policies.23andMe does not believe that this decision impacts them, but that remains to be seen.However, it is possible that any privacy policyis only as strong as a police departments ability to get a willing judge to sign a search warrant.

NEW YORK, NY - JUNE 20: (Photo by Santiago Felipe/Getty Images)

A recent genetic study on homosexualityraised eyebrows for many reasons, including that it appeared that homosexuality was being positioned as a condition or worse yet a disease to study and understand.An informativeDNA Exchange blogpost by certified genetic counselor Austin McKittrickeloquently outlined the issues, including that the study utilized data from the UK Biobank and 23andMe.Consumers consenting to 23andMe research studies may falsely believe that their data are being used only to further critical health care problems, like finding a treatment for Parkinsons disease, rather than for research that could potentially lead to discrimination or stigmatization of groups of people.Within days of this research being published an app called GenePlaza was developedthat, for about $5, could tell you how gay you are.Can you imagine this app being used at a middle school slumber party, with results posted to social media?But worse yet, the apps developer is based in Uganda,a country that announced plans that it would make homosexuality punishable by the death penalty.

Now, for just a moment, think about these three developments in unison.Our government is requiring DNA collection for immigrants in custody and those samples will enter our federal crime databases.Large databases, even for consumer entertainment, are subject to search warrant.Genetic data are being collected and used to make associations (accurate, or not) to a trait that may be punishable by death in some countries.

If we have been waiting for a sign thatwe need federal, or international, protections for genetic data and how it can be used, we now have that sign.

Continue reading here:
Waiting For The Sign that Protections Are Needed For Genetic Data? Here It Is. - Forbes

Recommendation and review posted by Bethany Smith

This year there has been quite some talk about patenting the discovery of new genes. The patency eligibility criteria for this is set to undergo major reform in the US, which is likely to have a huge impact on a number of companies offering genetic testing kits, including 23andMe and AncestryDNA. Here, McDowell of EIP, an IP and patent law firm, shares her thoughts on the reform and the potential far-reaching impact it might have in the world of genetics, gene patenting and beyond.

The question of what should and should not qualify as patent eligible subject matter has, for several years, drawn sharp debate in the United States. Since 2012, the US Supreme Court has operated under the Alice/Mayo framework, which has sought to prevent patenting of abstract ideas and naturally occurring phenomena. This has had broad repercussions within the biotechnology sector and beyond; for example, resulting in the widespread proliferation of mail-order spit-kit operations like 23andMe.

Reform of the Alice/May framework has seen strong support from parts of the biotech industry, citing lack of investment as a barrier to greater research into diagnostic methods. However, a more general concern from stakeholders in the United States is that the unpredictability caused by the Alice/Mayo framework puts the US at a disadvantage compared to International competitors; particularly in respect of some of the most cutting-edge technologies, such as AI and molecular diagnostics. A lack of patent availability is allegedly driving investment to other countries, where such inventions are more clearly patent-eligible.

Battle lines have been drawn between the biotechnology and software industries, with calls for less restrictive eligibility criteria coming from the former. The financial input needed to develop new technologies differs substantially between these industries. Lone inventors and small businesses in the software industry, with the ability to develop their products cheaply, felt stifled by overbroad patents granted to others before 2012.

Meanwhile, even small players in the biotech industry rely on high value investment before diagnostic and curative treatments can be brought to patients. Intellectual property protection is key to ensuring that investors in this sector feel secure that the vast sums of money they contribute will be recouped through effective commercialisation.

The Executive Director of Cleveland Clinic Innovations recently explained that: Ability to gain patent protection is the first factor in our assessment of whether a product can reach the market; if an invention cannot get intellectual property protection, usually that is a fatal flaw and the invention is canned at that point.

With this being a widespread stance in the pharmaceutical and diagnostics industries, it is easy to see how the current restrictions to patentability could lead to fewer treatments being developed in the US. What is more, Internationally, the US is no longer top of the list for biopharma companies launching their products; with companies citing inability to protect their ideas as a key reason for not entering the US market.

On the other hand, there are those within the biotechnology sector who side with the software industry in favouring the status quo. Genetic testing companies have reaped the benefits of a restrictive patent eligibility criteria, which has resulted in the invalidation of patents to isolated gene products, and so removed the barriers to developing genetic testing kits.

Since 2013, aided by this provision, the cost of genetic testing kits has decreased significantly leading to a boom in popularity and numerous spit-kit companies have crowded the genetic testing market. This new Bill, if enacted, will likely prove problematic for US companies such as 23andMe, who offer customers the ability to test their DNA to uncover their ancestry or genetic vulnerabilities. Consequently, this might open the door for a widespread change in the industry.

The proposed Bill stuttered when a sticking point emerged during consultations with stakeholders. A last-minute amendment to 35 U.S.C. 112F, which governs how patentees may claim their invention in functional terms (as opposed to reciting specific physical structures), has been criticised by members of the biotech industry for watering down patent protections.

The draft Bill provided that, if any patent claim element is expressed as a specified function without the recital of structure, material, or acts in support thereof, then that claim element will be limited to the corresponding structure, material, or acts described in the specification and their equivalents.

This was offered to assuage concern that overruling the patent-eligible-subject-matter case law would herald a return of nuisance patents directed to business methods and software, which often contain functionally defined terms. However, rather than reassuring stakeholders in the software industry, the proposal seems to have succeeded mainly in frightening the biotechnology sector.

Several witnesses from both sides of the debate raised concerns about the burden that drafters and inventors will face from having to enumerate every way of carrying out a claimed method under the proposed amendment to 112F.

Conflicting views on the draft proposal has meant that the initial momentum for reform has been lost for the time being. This will frustrate those in the biotech industry who are keen to see a return the ability to obtain patent protection for their products and processes, which they hope will boost research, and drive investment back into the United States.

Read the rest here:
Gene patenting reform in the US and the knock-on effect in Europe - Health Europa

Recommendation and review posted by Bethany Smith

Interest in genetic testing for screening cancer risks continues to grow. Reports and Data, for instance, expects the global market for nucleic acid testing to reach USD 4.10 billion by 2026, driven in part by such interest, according to a report published in May.

A new test that launched nationally at the end of September, +RNAinsight, combines RNA and DNA genetic testing for hereditary cancer in one clinical test. Data being shared this week suggest that the combined test could help more patients discover whether their genetics increase their cancer risks.

Lifestyle, environment, and age all factor into ones risk for developing cancer. However, genetics also play a large role, Jessica Profato, manager of product marketing at Ambry Genetics, told MD+DI. Some individuals are born with mutations errors in our DNA that cause an increased risk for cancer. Examining someones DNA and RNA to look for these mutations helps doctors and patients learn whether they have increased cancer risks.

Standard DNA testing for hereditary cancer excludes large portions of a persons DNA, thereby missing mutations, she continued. Adding RNA to DNA testing overcomes these limitations for a significant number of patients as RNA provides considerably more evidence than DNA alone about whether the genes in our DNA have mutations. +RNAinsight enables clinicians for the first time ever to conduct both DNA and RNA genetic testing at the same time.Ambry Geneticsis the first and only lab to offer paired RNA and DNA genetic testing for hereditary cancer as a commercially available clinical test, according to the company.

Ambry is sharing data from the first 2500 patients who have received +RNAinsight testing for hereditary cancer risk at this weeks National Society of Genetic Counselors Annual Conference in Salt Lake City. Collected from a prospective, nationwide pilot, the data showed that using +RNAinsight resulted in an overall relative increase in diagnostic yield (identifying mutations in DNA as disease-causing) of 6.7 percent compared with DNA testing alone, Ambry reported in a news release. The yield increased by as much as 19 percent for specific genesfor BRCA1, 14 percent more patients learned they had a mutation that increased their cancer risks than would have if they had only received DNA testing, according to the company.

Substantially more often than DNA testing alone, this paired testing identifies whether someone has a genetic mutation that either increases their risk for developing cancer or that may have contributed to their existing cancer, Profato told MD+DI. This is the first genetic testing advancement in 13 years to significantly increase the number of patients identified with a specific hereditary risk for cancer in genes like BRCA1 and BRCA2, which are associated with hereditary breast and ovarian cancer. +RNAinsight can help thousands more patients annually learn whether mutations in their DNA increase their risks for developing hereditary cancer each year, establishing a new clinical standard for genetic testing.

Profato said that discovery of such a mutation in a gene associated with increased cancer risk can have life-changing benefits: 1) it enables recommendations for cancer prevention through tools such as preventive surgery; 2) it increases surveillance for certain cancers (like mammograms) and therefore early detection; 3) it may inform treatment for cancer patients; and 4) it can enable family members to get the testing they need to understand their cancer risk.

She added that the companys studies showed that both genetic testing generally, and +RNAinsight specifically, improved medical care. If the test reveals a mutation known to increase cancer risk, doctor-recommended management can include preventive surgeryandearlier and/or more frequent cancer surveillance (e.g., mammograms and breast MRIs).

Rachid Karam, MD, PhD, lead study author and director of the Translational Genomics Lab at Ambry Genetics, summed up the significance of the data being shared this week in a statement: These findings further demonstrate that hereditary cancer panels should include both RNA and DNA genetic testing. By looking at regions of the gene that other tests dont, +RNAinsight reduces false negatives, maximizing the number of patients who learn they have higher risks for hereditary cancer.

Read the rest here:
Could Testing for RNA in Addition to DNA Make a Difference in Cancer? - Medical Device and Diagnostics Industry

Recommendation and review posted by Bethany Smith

Key Point: the Russian military will be using genetics to assess that most unpredictable of human qualities: how a person will react in combat.

Want to be a Russian paratrooper or tank commander? Then youd better hope you have the right genes.

The Russian military will be assigning soldiers based on their genetic passports.

The project is far-reaching, scientific, fundamental, Alexander Sergeyev, the chief of Russias Academy of Sciences, told Russian news agency TASS back in the summer (English translation here). Its essence is to find such genetic predispositions among military personnel, which will allow them to be properly oriented according to military specialties.

It is a question of understanding at the genetic level who is more prone to, for example, to service in the fleet, who may be more prepared to become a paratrooper or a tankman.

Advances in medical technology are making genetic testing a common medical procedure. It is used to detect genetic diseases such as cystic fibrosis, or the risk of developing certain diseases such as colorectal cancer. Pregnant women can also choose to be tested to determine whether their baby has genetic abnormalities such as Down syndrome.

But Russian President Vladimir Putin has embraced genetics with a passion. In March, the Kremlin issued a decree that called for implementation of genetic certification of the population, taking into account the legal framework for the protection of data on the personal human genome and the formation of the genetic profile of the population. Ostensibly this is to protect Russias population against chemical and biological attack, as well as safeguard Russias genetic patrimony from Western spies and saboteurs.

It has also spurred fears that Russia is edging towards a Nazi-style eugenics program in which certain groups, such as those Russians of Slavic ancestry, will be favored.

Either way, the Russian military will be using genetics to assess that most unpredictable of human qualities: how a person will react in combat. The project involves not only the assessment of the physiological state, but also the prediction of human behavior in stressful, critical situations that are associated with the military profession, says Sergeyev, Russia's chief scientist. Resistance to stress, the ability to perform physical and mental operations under the conditions of this stress, and so onall this may be contained in a soldiers genetic passport.

It is not just soldiers who will be genetically profiled. In December 2018, another Russian scientist announced that cosmonauts will be tested. The first area is the research into the humans genetics from the viewpoint of using it in the selection [for the cosmonaut program], said Lyudmila Buravkova, deputy director of the Institute of Medical and Biological Problems at the Russian Academy of Sciences. The second area is the attempt to remedy genetic errors as much as this should be done before a flight.

To be clear, many militaries use some kind of testing, such as the U.S. militarys Armed Services Vocational Aptitude Battery (ASVAB), to determine whether someone is qualified for military service, and whether they are suitable for certain positions such as technical jobs. The U.S. military collects DNA from soldiers to identify their bodies if they are killed. The Defense Health Agency told the National Interest that the U.S. military does not use genetic testing to assign personnel.

Thats not surprising, given that genetic testing would certainly raise concerns over privacy and racial profiling. A civil rights issue that isnt likely to be a cause of furor in an authoritarian society like Russia.

The bigger question is whether an army can decide whether someone is better suited to be a pilot, a rifleman or a cook based on their genetic profile.

Michael Peck is a contributing writer for the National Interest. He can be found on Twitter and Facebook.

View post:
The Russian Military Will Soon Assign Soldiers Based on Their "Genetic Passports" - The National Interest Online

Recommendation and review posted by Bethany Smith

The Food and Drug Administration has halted a clinical trial involving a Duchenne muscular dystrophy gene therapy from Solid Biosciences (SLDB) after a patient suffered serious kidney and blood-related injuries, the company said Tuesday.

This is the third time that the Cambridge, Mass.-based Solid has run into a serious safety problem with its gene therapy, called SGT-001. The FDA placed similar clinical holds on the same clinical trial after each prior incident, but later allowed the company to proceed with patient dosing.

SGT-001 uses an inactivated virus to deliver a miniaturized but functional version of the dystrophin gene to muscle cells. The gene therapy is designed to be a one-time and potentially curative treatment for all Duchenne patients, regardless of the mutation that causes their disease.

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Sarepta Therapeutics (SRPT) and Pfizer (PFE) are also developing their own gene therapies targeted at Duchenne.

Six patients have been dosed with SGT-001, starting with three at a lower dose; interim results in those patients were previously reported and found to be disappointing. Three more patients were then treated at a higher dose of SGT-001.

The sixth patient became ill soon after being treated in October, experiencing an over-activation of the immune system, an acute kidney injury, reductions in platelets and red blood cells, and cardio-pulmonary insufficiency, Solid said.

All of the toxicities were deemed related to SGT-001 by the patients treating doctor. The patient is being treated and is recovering, Solid said.

Solid reported the patients status to the FDA, which then placed the clinical trial on hold. In a statement, the company said it will work with the FDA in an effort to resolve the hold and determine next steps for the clinical trial.

Pfizers Duchenne gene therapy has also been tied to similar immune system over-activation and related kidney toxicity, although its clinical trial remains active.

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Solid's Duchenne gene therapy trial halted after patient suffers toxicity - STAT

Recommendation and review posted by Bethany Smith

The Food and Drug Administration has halted a clinical trial involving a Duchenne muscular dystrophy gene therapy from Solid Biosciences after a patient suffered serious kidney and blood-related injuries, the company said Tuesday.

This is the third time that the Cambridge-based Solid Biosciences has run into a serious safety problem with its gene therapy. The FDA placed similar clinical holds on the same clinical trial after each prior incident, but later allowed the company to proceed with patient dosing.

The gene therapy uses an inactivated virus to deliver a miniaturized but functional version of the dystrophin gene to muscle cells. The gene therapy is designed to be a one-time and potentially curative treatment for all Duchenne patients, regardless of the mutation that causes their disease.

Sarepta Therapeutics and Pfizer are also developing their own gene therapies targeted at Duchenne.

Six patients have been dosed with Solid Biosciences gene therapy, starting with three at a lower dose; interim results in those patients were previously reported and found to be disappointing. Three more patients were then treated at a higher dose.

The sixth patient became ill soon after being treated in October, experiencing an over-activation of the immune system, an acute kidney injury, reductions in platelets and red blood cells, and cardio-pulmonary insufficiency, the company said.

All of the toxicities were deemed related to the treatment by the patients doctor. The patient is being treated and is recovering, the company said.

Solid Biosciences reported the patients status to the FDA, which then placed the clinical trial on hold. In a statement, the company said it will work with the FDA in an effort to resolve the hold and determine next steps for the clinical trial.

Pfizers Duchenne gene therapy has also been tied to similar immune system over-activation and related kidney toxicity, although its clinical trial remains active.

Adam Feuerstein can be reached at adam.feuerstein@statnews.com.

The rest is here:
FDA halts trial of Duchenne gene therapy treatment from Solid Biosciences - The Boston Globe

Recommendation and review posted by Bethany Smith

There is not enough time in the day for Amber Olsen.

An average day for this mother means working as a business owner of the staffing company, Nextaff Gulf Coast, taking care of her two teenage daughters and finding a cure for her youngest daughter, Willow, who has a rare genetic disease.

Now 6 years old, Willow has been diagnosed with multiple sulfatase deficiency and is not expected to live past the age of 10.

Olsen has made it her mission to find a cure for this life-threatening illness, if not to save her own daughter then to help give other families a fighting chance.

Willow was born Aug. 21, 2013, after a healthy pregnancy.

She was a happy baby who loved getting kisses from her two older sisters and her parents.

Amber, now 44, noticed that Willow was delayed when it came to milestones such as crawling and walking.

I just kind of have that mama instinct, Olsen told GMA. She could walk and run, but she walked like Frankenstein ... with her arms out and stuff.

After taking Willow to a neurologist, the family learned that she was showing signs of regression, and eventually lost the ability to walk and move anything except her hands.

Through genetic testing, they learned that Willow had multiple sulfatase deficiency, a rare, inherited lysosomal storage disease, where the body is unable to rid itself of cellular waste.

"Multiple sulfatose deficiency is an ultra rare disease that affects kids from birth," Rebecca Ahrens-Nicklas, assistant professor of pediatrics at The Children's Hospital of Philadelphia told "GMA." "Basically, it can affect all parts of their body where it causes buildup of material that are clear in our body. When these materials build up, they can cause damage to all different parts of your body."

This disease tends to affect the brain the most.

When doctors first told Olsen about her daughters diagnosis in 2016, they expressed that there wasnt a real treatment or cure.

There's nothing you can do [except] take her home and be with her, and just try to keep her comfortable, and she will die, Olsen said.

It has been estimated that there is currently 50-75 kids in the United States that are currently living with MSD, according to Ahrens-Nicklas, and there is no official cure.

Nicklas says the Children's Hospital of Philadelphia is currently trying to find every child in the United States who has MSD to conduct a study of the disease.

"Because it's such a rare disease, it's somewhat variable also," Ahrens-Nicklas said. "We estimate that the life expectancy in good medical care today is between 10-20 years, but we honestly don't know and it is incredibly variable."

Shortly after she was diagnosed, Willow went back to crawling and then she reached a point where she couldnt move at all. She had to move around in a walker.

Willows mother compared the disease to Alzheimers because of the changes that the person goes through, and how difficult it can be having to adapt and kind of be on unstable ground.

Willow cannot speak, but her parents know she is still cognitively processing everything around her.

You can see the spark in her eye, Olsen shared. She smiles, she laughs, so, you know she's still there but has a lot of issues.

Olsen is devoted to making her little girl happy. She even shares a special morning routine with her daughter where she does "Superman" stretches with her to help move her limbs.

So when she learned the devastating news about her daughter's diagnosis, she was not going to sit and watch her health fade away. If no one knew of a cure, she was going to find it herself.

She immediately Googled other parents who had children with the same condition and came across a couple in Ireland, Alan & Michelle Finglas, who had created the MSD Action Foundation, inspired by their own son, Dylan, who had MSD.

"When we met the dad, he said, 'We just need time and money. It's a single gene disorder. There is science out there that could save these children, so we have to band together and work together,'" Olsen shared.

She and her husband flew back to Europe shortly after that to meet with scientists, who told them that in order to find a treatment, they needed to gather the funds.

This inspired Olsen to start fundraising and researching the disease more.

I'm not a doctor or a nurse and I never knew anything about medical stuff, she said. "It was a huge learning curve in a very quick amount of time.

Just a few months after Willows diagnosis, her mother created United MSD Foundation, a nonprofit organization that would work towards funding research to create a clinical trial to help children like Willow suffering from MSD.

The organizations goal was to raise $3 million for pre-clinical research, manufacturing of medicine and Phase 1 of the clinical trial.

Olsen helped established a scientific advisory board, put out a request for research proposal and recruited Dr. Steven Gray, associate professor of pediatrics at UT Southwestern Medical Center, to be their lead researcher in the field of gene therapy to develop a treatment for MSD.

She says her biggest challenge has been driving this organization as someone who is not a medical professional.

Despite the fact that she flunked biology when she was in grade school, Olsen takes classes in genetics and science to understand the research work for MSD.

She is committed to doing everything she can to help Willow.

With the help of scientists and volunteers, the United MSD Foundation has raised over $2 million within two years and is currently about $620,000 away from its goal to fund a gene therapy clinical trial for children.

Olsen believes that if her daughter cannot be saved, at least she has the opportunity to save the lives of others.

We all want to grow up and go to school and get married and have children, so we make a difference in the world, and she doesn't have ... very many of those opportunities, Olsen said.

I just think that's so important ... you know her legacy.

Through the grueling hours of phone calls, research and worrying, the mom has learned to cherish the little moments.

[Willows] giggling about something that I was doing with her and we're all excited that she just laughed, Olsen said. It's those little moments that I think we see and take advantage of more, way more, than we used to, and kind of slow down and appreciate that.

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Her daughter may die by age 10, but this mom keeps fighting to cure her rare disease - ABC News

Recommendation and review posted by Bethany Smith

Aytu Bioscience (NASDAQ:AYTU) will be announcing its earnings results after the market closes on Thursday, November 14th. Analysts expect the company to announce earnings of ($0.30) per share for the quarter.

Aytu Bioscience (NASDAQ:AYTU) last announced its earnings results on Thursday, September 26th. The company reported ($0.32) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.33) by $0.01. Aytu Bioscience had a negative net margin of 370.62% and a negative return on equity of 204.18%. On average, analysts expect Aytu Bioscience to post $-1 EPS for the current fiscal year and $0 EPS for the next fiscal year.

Shares of Aytu Bioscience stock opened at $1.01 on Tuesday. Aytu Bioscience has a 1 year low of $0.68 and a 1 year high of $2.61. The firm has a market cap of $21.77 million, a PE ratio of -0.29 and a beta of 4.63. The company has a 50 day simple moving average of $1.14 and a two-hundred day simple moving average of $1.56.

Several equities research analysts have issued reports on AYTU shares. Zacks Investment Research lowered shares of Aytu Bioscience from a buy rating to a hold rating in a research report on Thursday, October 3rd. LADENBURG THALM/SH SH lifted their target price on shares of Aytu Bioscience from $4.00 to $4.75 in a research report on Wednesday, September 18th. ValuEngine lowered shares of Aytu Bioscience from a buy rating to a hold rating in a research report on Monday. Finally, Northland Securities set a $10.00 target price on shares of Aytu Bioscience and gave the company a buy rating in a research report on Friday, September 27th.

Aytu Bioscience Company Profile

Aytu BioScience, Inc, a specialty healthcare company, focuses on developing and commercializing novel products in the field of hypogonadism (low testosterone), insomnia, and male infertility in the United States and internationally. The company markets Natesto, a nasal gel for the treatment of hypogonadism (low testosterone) in men; and ZolpiMist, an oral spray for the treatment of insomnia.

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Aytu Bioscience (AYTU) Scheduled to Post Quarterly Earnings on Thursday - Polson News

Recommendation and review posted by Bethany Smith

AMA recently published a detailed study of over 180+ pages in its repository on Testosterone Replacement Therapy market covering interesting aspects of market with supporting development scenario till 2025. The study provides market size break-up by revenue and volume* for emerging countries and important business segments along with commentary on trending factors, growth drivers. Profiled players in study from the coverage used under bottom-up approach are AbbVie Inc. (United States), Endo International (Ireland), Eli Lilly and Company (United States), Pfizer (United States), Bayer (Germany), Actavis (Allergan) (United States), Novartis (Switzerland), Teva (Israel), Ferring Pharmaceuticals (Switzerland), Kyowa Kirin (Japan), Mylan (United States)

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Testosterone is responsible for the development of male sexual characteristics and this hormone formed by the testicles. Insufficient production of testosterone causes erectile dysfunction. Testosterone Replacement Therapy (TRT) is generally termed as hormone therapy for men, designed to counteract the effects of reduced activity in the gonads or hypogonadism. Hypogonadism in men is clinical syndrome, which results in the failure of the testes to produce physiological levels of testosterone. Erectile dysfunction arises due to reduce testosterone production to overcome this testosterone replacement therapy is used to improve the problem.

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Country level Break-up includes:North America (United States, Canada and Mexico)Europe (Germany, France, United Kingdom, Spain, Italy, Netherlands, Switzerland, Nordic, Others)Asia-Pacific (Japan, China, Australia, India, Taiwan, South Korea, Middle East & Africa, Others)

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Chapter Five and Seven: Global Testosterone Replacement Therapy, by Market Segmentation and Region (value, volume**) (2013-2024) USD2400

Global Testosterone Replacement Therapy

By Type (Creams or Gels, Patches, Injections, Buccal Adhesives, Implants, Oral)

By Application (Hospitals, Clinics)

Global Testosterone Replacement Therapy Region

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Europe (Germany, France, United Kingdom, Spain, Italy, Netherlands, Switzerland, Nordic, Others)

Asia-Pacific (Japan, China, Australia, India, Taiwan, South Korea, Middle East & Africa, Others)

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Competitive Landscape (Direct & Indirect Competitors), Market Share Analysis, Peer Group Analysis (2018), BCG Matrix, Company Profile, Downstream Buyers & Upstream Suppliers

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Chapter Nine: Methodology/Research Approach, Data Source, Disclaimer

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Testosterone Replacement Therapy Industry: Time to Invest in emerging Markets | Endo International, Pfizer, Novartis - News Description

Recommendation and review posted by Bethany Smith

Acerus Pharmaceuticals (TSE:ASP) will be announcing its earnings results before the market opens on Thursday, November 14th.

TSE ASP opened at C$0.08 on Tuesday. The stocks fifty day moving average is C$0.10 and its two-hundred day moving average is C$0.12. The firm has a market capitalization of $20.90 million and a P/E ratio of -1.25. The company has a debt-to-equity ratio of 105.08, a quick ratio of 0.40 and a current ratio of 0.74. Acerus Pharmaceuticals has a fifty-two week low of C$0.07 and a fifty-two week high of C$0.21.

About Acerus Pharmaceuticals

Acerus Pharmaceuticals Corporation, a specialty pharmaceutical company, focuses on the development, manufacture, marketing, and distribution of pharmaceutical products for men's and women's health. The company offers Natesto, a nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism; Estrace, an oral tablet for the symptomatic relief of menopausal symptoms; and UriVarx, a natural health product that helps reduce symptoms of hyperactive bladder, such as daytime urinary frequency, urgency, and nocturia.

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Acerus Pharmaceuticals (ASP) Set to Announce Earnings on Thursday - Polson News

Recommendation and review posted by Bethany Smith

1. CRISPR: the movie  Nature.com
2. CRISPR: More than just for gene editing?  Phys.org
3. Penn Med study on CRISPR cancer therapy indicates technique is safe in humans  The Daily Pennsylvanian
4. Controversial CRISPR gene-editing tool could be used to detect viruses  Daily Mail
5. Crispr Takes Its First Steps in Editing Genes to Fight Cancer  Seattle Times
6. View full coverage on Google News

Follow this link:
CRISPR: the movie - Nature.com

Recommendation and review posted by Bethany Smith

Amended Celgene collaboration to focus on engineered alpha-beta T cell medicines with a $70 million payment to Editas Medicine

Appointed Judith R. Abrams, M.D., as Chief Medical Officer

EDIT-101 (AGN-151587) for LCA10 first patient dosing expected by early 2020

EDIT-301 for hemoglobinopathies in vivo pre-clinical data to be presented at ASH

CAMBRIDGE, Mass., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today reported business highlights and financial results for the third quarter of 2019.

"Our momentum in 2019 remains strong in advancing our pipeline of in vivo CRISPR and engineered cell medicines," said Cynthia Collins, Chief Executive Officer of Editas Medicine. We announced this morning an amended agreement with Celgene to further expand and accelerate our oncology pipeline. In hemoglobinopathies, we look forward to presenting in vivo pre-clinical data for EDIT-301 at ASH that supports its potential as a best-in-class medicine. Finally, we eagerly anticipate first patient dosing with EDIT-101 for LCA10 in the coming months.

Recent Achievements and OutlookIn VivoCRISPR Medicines

Engineered Cell Medicines

Corporate

Upcoming Events

Editas Medicine will participate in the following investor events:

Editas Medicine will present pre-clinical data for EDIT-301 to address sickle cell disease and beta-thalassemia in at the 61st American Society of Hematology Annual Meeting & Exposition. Details are as follows:

Abstract Number: 4636Title: EDIT-301: An Experimental Autologous Cell Therapy Comprising Cas12a-RNP Modified mPB-CD34+ Cells for the Potential Treatment of SCDPresenter: Edouard De Dreuzy, Ph.D.Session: 801. Gene Therapy and Transfer: Poster III Time: Monday, December 9, 2019: 6:00 PM-8:00 PMLocation: Hall B, Orange County Convention Center, Orlando, FL

Third Quarter 2019 Financial Results

Cash, cash equivalents, and marketable securities at September 30, 2019, were $332.6 million, compared to $369.0 million at December 31, 2018. The $36.4 million decrease was primarily attributable to operating and capital expenses related to our on-going preclinical and clinical activities, patent costs and license fees, and employee-related costs, partially offset by $42.1 million in proceeds from financing activities.

For the three months ended September 30, 2019, net loss was $32.9 million, or $0.66 per share, compared to $15.2 million, or $0.32 per share, for the same period in 2018.

Conference Call

The Editas Medicine management team will host a conference call and webcast today at 8:00 a.m. ET to provide and discuss a corporate update and financial results for the third quarter of 2019. To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 6577216. A live webcast of the call will be available on the Investors & Media section of the Editas Medicine website at http://www.editasmedicine.com and a replay will be available approximately two hours after its completion.

About Editas MedicineAs a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit http://www.editasmedicine.com.

About EDIT-101 (AGN-151587)EDIT-101 is a CRISPR-based experimental medicine under investigation for the treatment of Leber congenital amaurosis 10 (LCA10). EDIT-101 is administered via a subretinal injection to reach and deliver the gene editing machinery directly to photoreceptor cells.

About Leber Congenital AmaurosisLeber congenital amaurosis, or LCA, is a group of inherited retinal degenerative disorders caused by mutations in at least 18 different genes. It is the most common cause of inherited childhood blindness, with an incidence of two to three per 100,000 live births worldwide. Symptoms of LCA appear within the first years of life, resulting in significant vision loss and potentially blindness. The most common form of the disease, LCA10, is a monogenic disorder caused by mutations in the CEP290 gene and is the cause of disease in approximately 2030 percent of all LCA patients.

About the Editas Medicine-Allergan AllianceIn March 2017, Editas Medicine and Allergan Pharmaceuticals International Limited (Allergan) entered a strategic alliance and option agreement under which Allergan received exclusive access and the option to license up to five of Editas Medicines genome editing programs for ocular diseases, including EDIT-101 (AGN-151587). Under the terms of the agreement, Allergan is responsible for development and commercialization of optioned products, subject to Editas Medicines option to co-develop and share equally in the profits and losses of two optioned products in the United States. In August 2018, Allergan exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10. Additionally, Editas Medicine exercised its option to co-develop and share equally in the profits and losses from EDIT-101 in the United States. Editas Medicine is also eligible to receive development and commercial milestones, as well as royalty payments on a per-program basis. The agreement covers a range of first-in-class ocular programs targeting serious, vision-threatening diseases based on Editas Medicines unparalleled CRISPR genome editing platform, including CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a).

Forward-Looking StatementsThis press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict, project, target, should, would, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the Companys plans with respect to the Brilliance Phase 1/2 clinical trial for EDIT-101 (AGN-151587), including the Companys expectations regarding the timing of dosing a patient by early 2020. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials and clinical development of the Companys product candidates; availability and timing of results from pre-clinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Companys foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption Risk Factors included in the Companys most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.

Investor ContactMark Mullikin(617) 401-9083mark.mullikin@editasmed.com

Media ContactCristi Barnett(617) 401-0113cristi.barnett@editasmed.com

Originally posted here:
Editas Medicine Announces Third Quarter 2019 Results and Update - GlobeNewswire

Recommendation and review posted by Bethany Smith

SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) today announced data from nearly 70 Company-sponsored, global alliance and investigator-initiated clinical studies evaluating Celgenes investigational and approved therapies will be presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, in Orlando, Fla.

Celgene has a deep and ongoing commitment to innovative research and development in treatments for serious blood disorders, with the potential to transform patient outcomes, said Alise Reicin, M.D., President, Global Clinical Development for Celgene. We look forward to ASH as an opportunity to highlight our commitment and leadership in the research and development of novel therapies for the treatment of blood cancers through new insights in both CD19 and BCMA targeted cell therapies and important progress in our myeloid pipeline.

In leukemia and lymphoma, highlighted studies this year include safety and efficacy results from the pivotal TRANSCEND NHL-001 study of an investigational CD-19 targeted chimeric antigen receptor (CAR) T cell therapy lisocabtagene maraleucel (liso-cel) in relapsed/refractory large B-cell non-Hodgkin lymphoma. Additional liso-cel data from three ongoing studies will evaluate the use of the therapy in an outpatient setting, as well as in transplant noneligible patients with relapsed/refractory large B-cell non-Hodgkin lymphoma (PILOT) and in patients with relapsed/refractory chronic lymphocytic leukemia (TRANSCEND CLL-004).

In multiple myeloma, other notable investigational cell therapy abstracts include the first phase 1 clinical data from the bi-specific T-Cell Engager (TCE) CC-93269 and updated phase 1 clinical data from CAR T program, bb21217, both targeting the B-cell maturation antigen (BCMA) in relapsed/refractory disease.

Several abstracts focusing on data in myeloid diseases including longer-term response data from the phase 3 MEDALIST study of luspatercept to treat anemia in patients with IPSS-R very low-, low-, or intermediate-risk myelodysplastic syndromes with ring sideroblasts who require red-blood-cell (RBC) transfusions will be presented. Additionally, the first data from a phase 2 study of luspatercept in myelofibrosis-associated anemia, results from a study of fedratinib in myelofibrosis patients with low platelet counts, and the first data from CELMoD agent CC-90009, a GSPT1 degrader in relapsed or refractory acute myeloid leukemia (AML) will be presented.

Selected abstracts include*:

Lymphoma & Chronic Lymphocytic Leukemia

Multiple Myeloma

Myeloid Diseases

Beta thalassemia

A complete listing of abstracts can be found at https://www.hematology.org/Annual-Meeting/abstracts/

The safety and efficacy of investigational agents and/or investigational uses of approved marketed products have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.

*All times Eastern Time

About REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM)

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)

REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities

REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL)

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL)

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials

REVLIMID is only available through a restricted distribution program, REVLIMID REMS.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS

REVLIMID REMS Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. Patients may require dose interruption and/or dose reduction. MM: Monitor complete blood counts (CBC) in patients taking REVLIMID + dexamethasone or REVLIMID as maintenance therapy, every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Monitor CBC in patients on therapy for del 5q MDS, weekly for the first 8 weeks of therapy and at least monthly thereafter. See Boxed WARNINGS for further information. MCL: Monitor CBC in patients taking REVLIMID for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. FL/MZL: Monitor CBC in patients taking REVLIMID for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 2-4, and then monthly thereafter

Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on the patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision

Increased Mortality in Patients With CLL: In a clinical trial in the first-line treatment of patients with CLL, single-agent REVLIMID therapy increased the risk of death as compared to single-agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID and in patients with FL or MZL receiving REVLIMID + rituximab therapy, an increase of hematologic plus solid tumor SPM, notably AML, have been observed. In MM patients, MDS was also observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment

Increased Mortality with Pembrolizumab: In clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with MM with a PD-1-or PD-L1- blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID + dexamethasone. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered

Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN, or DRESS is suspected and should not be resumed following discontinuation for these reactions

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with REVLIMID. The patients at risk of TLS are those with high tumor burden prior to treatment. Closely monitor patients at risk and take appropriate preventive approaches

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of REVLIMID for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before starting REVLIMID treatment and during therapy

Early Mortality in Patients With MCL: In another MCL study, there was an increase in early deaths (within 20 weeks); 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L)

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

Follicular Lymphoma/Marginal Zone Lymphoma

DRUG INTERACTIONS

Periodically monitor digoxin plasma levels due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin-stimulating agents or estrogen-containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

About INREBIC

INREBIC (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

IMPORTANT SAFETY INFORMATION

WARNING: ENCEPHALOPATHY INCLUDING WERNICKES

Serious and fatal encephalopathy, including Wernickes, has occurred in patients treated with INREBIC. Wernickes encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

WARNINGS AND PRECAUTIONS

Encephalopathy, including Wernickes: Serious and fatal encephalopathy, including Wernickes encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal.

Wernickes encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernickes encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernickes, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

Anemia: New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC occurred due to anemia in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent

Thrombocytopenia: New or worsening Grade 3 thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month; with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to less than or equal to Grade 2 or baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated.

Gastrointestinal Toxicity: Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patient and vomiting in 39% of patients. Grade 3 diarrhea 5% and vomiting 3.1% occurred. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic anti-emetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with anti-diarrheal medications promptly at the first onset of symptoms. Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or less or baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed.

Hepatic Toxicity: Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If re-occurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC.

Amylase and Lipase Elevation: Grade 3 or higher amylase 2% and/or lipase 10% elevations developed in INREBIC-treated patients. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n=608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose.

ADVERSE REACTIONS: The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%).

DRUG INTERACTIONS: Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Avoid INREBIC with dual CYP3A4 and CYP2C19 inhibitor. Coadministration of INREBIC with drugs that are CYP3A4 substrates, CYP2C19 substrates, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC.

PREGNANCY/LACTATION: Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose.

RENAL IMPAIRMENT: Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions.

HEPATIC IMPAIRMENT: Avoid use of INREBIC in patients with severe hepatic impairment.

Please see full Prescribing Information, including Boxed WARNING.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit http://www.celgene.com. Follow Celgene on Social Media: Twitter, Pinterest, LinkedIn, Facebook and YouTube.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: management's time and attention is diverted on transaction related issues, including the planned divestiture of OTEZLA; disruption from the proposed transaction makes it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel.

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