Testosterone Replacement Therapy Market research report delivers a comprehensive study on production capacity, consumption, import and export for all major regions across the world. Report provides is a professional inclusive study on the current state for the market. Analysis and discussion of important industry like market trends, size, share, growth estimates are mentioned in the report.

The testosterone replacement therapy is used to improve sexual performance, accomplishing higher energy levels and building muscles. Testosterone replacement therapy has many benefits such as improved sexual desire, better blood sugar regulation, lowers bad cholesterol levels, decreased risk of diabetes, increased muscle mass and strength, improved brain function and cognitive ability, decreased body fat, improved ability to handle stress, increased confidence and a more positive mood, improved sleep and increased energy levels throughout the day. Testosterone replacement therapy has many side effects such as acne and oily skin, increased risk of heart attack, lower sperm count, which results in infertility, larger breasts, increased risk of blood clots and shrinkage of the testicles.

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Testosterone replacement therapy includes substitution of testosterone hormone in male patients when they experience the ill effects of hypogonadism and lower testosterone level. The TRT drugs are accessible in six diverse forms that are gels, infusions, inserts, buccal glues and orals, which is influencing the market growth. Settled medicinal services and high use and interest for cutting edge TRT items are causing the growth. Increase in the awareness among people about testosterone replacement therapy is the factor to drive market. The high risks of infections like cardiovascular sickness and prostate disease related with testosterone substitution treatment will limit market development, which will restrain the growth.

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Testosterone Replacement Therapy Market (2020 2027) Explosive Factors of Revenue by Key Manufacturer, Share, Future Trends, COVID-19 Market Scenario,...

Recommendation and review posted by Bethany Smith

Anabolic steroids additionally called androgenic steroids are derivatives of testosterone, significant for advancing and keeping up muscle development and creating auxiliary male sex qualities, for example, an extending voice and facial hair. They are anabolic and increment protein inside cells, particularly in skeletal muscles, Anabolic steroids utilized restoratively in ailments to animate muscle increment, set off male adolescence and treat constant squandering conditions, comprising of malignancy and AIDS.

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Increment in geriatric populace drives the androgens and anabolic steroids commercial center, as more men are susceptible to hypogonadism. Also, ascend in weight issues in men propels the overall androgens and anabolic steroids market. The growing negative health status specifically within the developing countries is projected to fuel the growth of the marketplace during the forecast period. Besides, rise in government ventures for higher human services is attributed to the growth of the overall androgens and anabolic steroids market. Increment in occurrence of hypogonadism among men is anticipated to enlarge the worldwide androgens and anabolic steroids market all through the forecast span. Rise in impotence among men due to weight problems and tiredness is expected to enhance demand for androgens and anabolic steroids during forecast duration.

Anabolic Steroids Market can be segmented on basis of compound derivatives, mode of administration, applications, Distribution channels and geography.

On basis of synthetic derivatives, Anabolic steroids market is segmented as:

On basis of Modes of administration, Anabolic steroids is segmented as:

On basis of Applications, anabolic steroids is segmented as:

On basis of Distribution channels, anabolic steroids market is segmented as:

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Anabolic steroids include di-hydro-testosterone, testosterone, and other marketers. Anabolic steroids stimulate the improvement of male sex organs and male sexual characters including growth of beard and deepening of voice. Various varieties of tissues grow due to stimulation of anabolic steroids, specifically muscle and bone. Rise in red blood cells production is due to anabolic results. Androgens and anabolic steroids are used for the remedy of breast cancer in ladies, impotence, hypogonadism in men, and alternative therapy delayed puberty in adolescent boys. Anabolic steroids are also used for the treatment of numerous conditions with hormonal imbalance, weight loss, osteoporosis, and anemia. Anabolic steroids market can be segmented based on synthetic derivatives, mode of administration, application, end-user, and region. In terms of mode of administration, the market can be categorized into oral, injection, topical, skin patches and inhaler. Based on application type, anabolic steroids market can be divided into Anabolic, Androgenic and others. Based on distribution channels anabolic steroids market can be classified into hospital pharmacies, retail pharmacies and online pharmacies. The hospital pharmacies segment dominated the market owing to elevated availability of medications and hospitals being the first point of contact for treatment.

Anabolic steroids market in North America held the biggest marketplace share due to expanded prevalence of breast cancer in women. According to many researches, breast cancers is one of the main cause of death in U.S. Europe held the second largest share in anabolic steroids market because of accelerated occurrence of hypogonadism in men and delayed puberty in adolescent boys. The Anabolic steroids market in Asia Pacific is expected to grow at a fast pace during the forecast period attributable to multiplied government initiatives to get rid of breast cancer. Anabolic steroids market in Middle East & Africa is predicted to be driven via improved occurrence of impotence, hypogonadism in men, and behind schedule puberty in adolescent boys. The market in Latin America is projected to witness robust increase at some point of the forecast length due to accelerated government tasks within the fitness care sector.

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Valeant, Endo Pharmaceuticals Solutions Inc., Germiphene Corporation, Taro Pharmaceuticals, Inc., Antares Pharma, Inc, Actavis Pharma, Inc, Sandoz, Pfizer, Unimed Pharmaceuticals, Upsher-Smith

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The Anabolic Steroids Market to sharpen in the next decade - The Monitor

Recommendation and review posted by Bethany Smith

TipRanks

Wall Streets best firms dont just look at the stocks, they look at the big picture, too. And Oppenheimers chief investment strategist, John Stoltzfus, is particularly adept at showing us the macro view. In his first note of the new year, Stoltzfus notes a series of factors that are going to impact the markets. The big news, of course, the 800-pound gorilla that cannot be ignored, is the ongoing COVID epidemic. The disease is coming back strong now that were well into winter which was somewhat expected, as its typical behavior for flu-like respiratory viruses. With the winter virus surge, we also must contend with a new round of lockdown policies, imposed from state or local levels. Its hoped that the newly available COVID vaccines will, by springtime, start to put a damper on the novel coronavirus."The length of time that households and economies have been negatively impacted by the spread of the virus across the world in our view will likely result in less resistance to inoculation against Covid-19 than many experts had feared early on in the pandemic. We expect that equity markets will remain sensitive to developments tied to the pandemic that have held the US and global economy hostage for nearly a year," Stoltzfus said.The second-biggest news, but the one most likely, in Stoltzfus view, to make an impression on the market, is the Georgia election. Both Democratic candidates won Senate seats, giving the incoming Biden Administration the ability to push policies through Congress over any opposition at least for the next two years.This Democrat victory, ensuring short-term one-party control of the Presidency and Congress, has Stoltzfus worried. In his campaign, Joe Biden promised to roll back Trumps tax policies, and to enact a series of large spending initiatives. Should he now follow through, Bidens stated policy is likely to raise both taxes and Federal spending. And in Stoltzfus view, that will probably cost the markets; Stoltzfus believes that unfettered progressive/Democrat policy enactments will leave the S&P 500 vulnerable to losses on the order of 6% to 10%.Before rushing to sell-off holdings, Oppenheimers stock analysts remind investors that compelling opportunities can still be found. The firm's analysts have tagged three stocks that they see gaining upwards of 80% for the year ahead. UsingTipRanks database, we learned that the rest of the Street is in agreement, as all three boast a Strong Buy analyst consensus. miRagen Therapeutics (MGEN)miRagen Therapeutics aims to develop new treatment options for diseases that todays therapies cannot adequately ameliorate. The company's flagship drug candidate is VRDN-001, an anti-IGF-1R monoclonal antibody in clinical-stage research as a treatment for thyroid eye disease (TED). miRagen acquired the rights to VRDN-001 late last year, after its October acquisition of Veridian Therapeutics. The monoclonal antibody is about to enter Phase 2 clinical trial, with initial results expected around mid-year 2021.miRagen is funding its current research with a $91 million capital raise, arranged in a private placement financing agreement. With that agreement in place, miRagen ended the third quarter with $144 million in cash on hand, but more importantly, a clear cash runway extending to 2023.Among the bulls is Oppenheimer analyst Leland Gershell, who rates MGEN an Outperform (i.e. Buy), along with a $37 price target. This figure indicates room for 102% one-year growth. (To watch Gershells track record, click here)Backing his stance, Gershell says, Recent Viridian acquisition and $91M raise set miRagen on a new course, as the incoming programs position it to compete in the fertile thyroid eye disease market we see ample revenue potential for [VRDN-001], and its higher potency may enable differentiation... We expect that progress in the development of MGEN's TED candidates will support outperformance. Overall, Wall Street likes the risk/reward factor at play here, as TipRanks showcases a Strong Buy consensus rooting for MGEN's success. Shares are selling for $18.26 and have an average price target of $32. This target implies a 75% upside from current levels. (See MGEN stock analysis on TipRanks)Oric Pharmaceuticals (ORIC)The success of the pharmacological industry has, ironically, caused a significant challenge: many diseases are becoming resistant to existing therapies. Many cancers are among the diseases subject to resistance and consequent relapse, serious problems that both impact the patients quality of life and increase mortality rates. Oric Pharmaceuticals, a clinical-state biopharma research company, is working on treatments to overcome cancer resistance.Orics lead candidate is ORIC-101, which shows promise as a glucocorticoid receptor (GR) antagonist. The drug is entering two separate Phase 1b trials, one for prostate cancer and one for solid tumors. Modern drug research is expensive, and Oric recently raised capital through a successful public offering of stock. The company put over 5.79 million new shares on the market back in November, at $23 each, and grossed over $133.3 million.5-star Oppenheimer analyst Kevin DeGeeter covers Oric, and he is bullish. DeGeeter backshis Outperform(i.e. Buy) rating with a $62 price target, implying a one-year upside potential of 88%. (To watch DeGeeters track record, click here)In support of his optimistic stance, DeGeeter writes, We view ORIC as an investment in a leadership team with prior history of successfully developing clinically important cancer drugs. Our thesis assumes clinical data supporting best-in-class profile of ORIC-101 based on either ease of use or superior efficacy in biomarker selected population. We believe current investor expectations assign material value to potential best-in-class profile of ORIC-101 and skills of management. Overall, ORIC shares get a unanimous thumbs up from the analyst consensus, with 3 recent Buy reviews adding up to a Strong Buy rating. The stock is priced at $32.91, while the $50.67 average price target indicates room for an ~54% growth. (See ORIC stock analysis on TipRanks)Triterras (TRIT)Next up is a unicorn, a billion-dollar fintech startup that has been on the public markets for less than three months. Triterras provides an online trading and trade finance platform, Kratos, based on blockchain technology. Trade finance, or the provision of credit services in the physical transport of market commodities, is worth an estimated $40 billion annually; Triterras platform uses the secure nature of blockchain as a selling point for online traders.Triterras went public through a SPAC merger; that is, a business combination with a special acquisition company. These companies exist to purchase a target company, injecting capital, and then put the combined entity on the public markets.Analyst Owen Lau, in his coverage of this stock for Oppenheimer, likes what he sees. Of the companys current status, he writes, results and momentum appear strong, and the full-year guidance implies a 235% and 142% YoY growth in revenue and net income off a low base. More importantly, while the company is growing faster than other high growth marketplaces, the stock trades at a discount to low growth marketplaces on average.At the bottom line, Lau is bullish, saying, We see an intriguing paper-to-electronic opportunity in Triterras, which leverages blockchain technology to disrupt the low-tech adoption in the trade and trade finance industry.In line with these comments, Lau rates TRIT shares an Outperform (i.e. Buy), and his $23 price target implies 93% growth for the year ahead. (To watch Laus track record, click here)Overall, this company has 3 recent reviews on record, and they are all to buy, making the Strong Buy analyst consensus unanimously positive. Shares are priced at $10.94 with an average price target of $19, giving the stock ~60% one-year upside potential. (See TRIT stock analysis at TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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Forum Health, LLC adds Meridian Health Center to its growing community of Integrative and Functional Medicine practitioners - Yahoo Finance

Recommendation and review posted by Bethany Smith

The treatment goals of mBC are to ameliorate symptoms, maintain quality of life, and prolong overall survival (OS).3,4 Management of mBC is based on tumor expression of estrogen receptor (ER), progesterone receptor (PR), and HER2 receptors.1 For frontline therapy in the metastatic setting in hormone receptor (HR)positive mBCs that are ER positive or PR positive, hormone therapy with either a selective ER downregulator (fulvestrant) or an aromatase inhibitor forms the foundation of treatment. If the HR-positive mBC is HER2 negative, the preferred regimen is hormone therapy combined with a CDK4/6 inhibitor. In HR-positive/HER2-positive mBC, HER2-directed therapy (trastuzumab and/or lapatinib) in combination with hormone therapy is primarily recommended.1

In HR-negative mBC, cytotoxic chemotherapy remains the backbone of treatment regimens.1,3 In HR-negative/HER2-positive mBC in the frontline setting, HER2-targeted therapy (pertuzumab plus trastuzumab) combined with docetaxel or paclitaxel is the preferred regimen.1 In subsequent lines, other cytotoxic chemotherapy agents are combined with HER2-targeted therapy. Treatment options for triple-negative breast cancer (TNBC), which is ER negative, PR negative, and HER-negative, are more limited because of the lack of therapeutic targets.3 In TNBC, sequential, single-agent cytotoxic chemotherapy remains the primary option in the frontline and later-line settings. In patients with TNBC and high tumor burden, visceral crisis, or rapidly progressing disease, chemotherapy combinations may be considered.1

Recent trials of immunotherapy and BRCA mutationtargeted therapy in TNBC have shown some promise. In the phase 3 double-blind, placebo-controlled IMpassion130 trial (NCT02425891), the PD-L1 inhibitor atezolizumab improved progression-free survival (PFS) when combined with albumin-bound (nab)-paclitaxel compared with nab-paclitaxel alone in metastatic TNBC.5 In the intention-to-treat population, which included patients with and without PD-L1 cell positivity, the addition of atezolizumab to nab-paclitaxel led to a PFS of 7.2 months compared with 5.5 months in the placebo group (hazard ratio 0.80; 95% CI, 0.69-0.92; P=.0021). In patients with positive PD-L1 expression, median PFS was 7.5 months and 5.3 months in the atezolizumab and placebo groups, respectively (hazard ratio 0.63; 95% CI, 0.50-0.80; P<.0001).5 Overall survival (OS) in the intention-to-treat population was not significantly different between the arms (21.0 months vs 18.7 months; hazard ratio 0.86; 95% CI, 0.72-1.02; P=.078).5 In an exploratory analysis, patients without PD-L1 tumors did not have OS benefit. However, among patients with PD-L1positive tumors, median OS was 25.0months with atezolizumab and 18.0 months with placebo (hazard ratio 0.71; 95% CI, 0.54-0.94).5 Atezolizumab was approved in 2019 for patients with locally advanced or metastatic TNBC who have PD-L1expressing tumors when used in combination with nab-paclitaxel.6,7

Sacituzumab govitecan-hziy was also recently approved for patients with metastatic TNBC who have received at least 2 prior lines of therapy in the metastatic setting.8 Sacituzumab govitecan-hziy is an antibody-drug conjugate that contains an antibody that targets Trop-2, a glycoprotein overexpressed in many epithelial cancers, including TNBC.9,10 The monoclonal antibody delivers the toxic payload SN-38, an active metabolite of irinotecan, to the tumor microenvironment and intracellularly.9,10 Approval of this agent was based on results of a phase 1/2 single-group multicenter trial in 108 patients with metastatic TNBC.11 Included patients were heavily pretreated with a range of 2to 10 previous lines of anticancer regimens (median=3).11 After a median of 9.7 months of follow-up, the response rate was 33.3%, and the clinical benefit rate, which included patients with stable disease for 6 months or more, was 45.4%.11 The median PFS was 5.5 months (95% CI, 4.1-6.3).11

Challenges and Unmet Needs

In HR-negative mBC, chemotherapy remains the backbone of treatment regimens. The majority of recommended regimens contain agents requiring intravenous (IV) infusion or intramuscular administration (fulvestrant). The only oral agents are cyclophosphamide, capecitabine, tucatinib, lapatinib, and neratinib.1 Despite the number of treatment options for patients with mBC, unmet needs remain pertaining to disease control, prolonging the interval to intensive cytotoxic therapy, and treatment-related complications. Additionally, there is a greater need for treatment regimens that are less burdensome for patients and their caregivers, as well as reducing health care costs associated with the IV administration of anticancer regimens.

Disease Control

The past decade has marked dramatic progress in biomarker-based treatment in mBC. However, progress in the treatment of metastatic TNBC is limited by the lack of therapeutic targets. Effective therapy for patients with metastatic TNBC is an unmet need.3 The recent approvals of atezolizumab for PD-L1expressing metastatic TNBC and sacituzumab govitecan-hziy for patients with TNBC who have received at least 2 prior lines of therapy in the metastatic setting have expanded the options for this patient group. However, mBC eventually will progress in most patients.6,8 There is an immense medical need for new treatment options to prolong the interval to starting intensive cytotoxic therapy, which has potentially serious adverse effects (AEs) that can reduce the quality of life.12

Metronomic therapy has been explored to prolong the interval in the need for intensive cytotoxic therapy. Metronomic therapy is the frequent, long-term administration of chemotherapy at low doses without a break in therapy.13 Metronomic therapy maintains plasma concentration of the cytotoxic agent above the therapeutic threshold but substantially below the maximum tolerated dose. Data suggest metronomic therapy may inhibit angiogenesis and have antiproliferative and immunomodulatory activities.12 There is also possible synergy with molecularly targeted agents.13 Hence, metronomic therapy may be able to improve the therapeutic index of cytotoxic agents by decreasing treatment-associated toxicities and exerting disease control activity.12 In mBC, studies of metronomic therapy have included oral vinorelbine and cyclophosphamide.13 The addition of metronomic oral cyclophosphamide to pertuzumab plus trastuzumab in older patients with HER2-positive mBC improved PFS by 7 months compared with pertuzumab plus trastuzumab alone (12.7 months; 95% CI, 6.7-24.8 months vs 5.6 months; 95% CI, 3.6-16.8 months).14

Although metronomic therapy has the potential to increase antitumor efficacy while limiting chemotherapy-related toxicity, advancing the field of metronomic chemotherapy would require the development of oral cytotoxic agents. Oral agents, unlike IV ones, can eliminate the logistical barriers for chemotherapy to be administered as a continuous/frequent low-dose regimen. In addition, the development of oral chemotherapy agents will facilitate further clinical trials to evaluate the efficacy and toxicity of metronomic oral therapy in patients with mBC.

Treatment-Related Complications

Taxanes are widely used in mBC, but they are highly hydrophobic and insoluble.15 To make parenteral administration possible, polyoxyethylated castor oil and ethanol are used as the vehicle for paclitaxel, and polysorbate 80 and ethanol are used as the vehicle for docetaxel.15 These solvents lead to hypersensitivity reactions and prolonged peripheral neuropathy that may be irreversible.15 Patients receiving paclitaxel require premedication with corticosteroids, H2-receptor antagonists, and diphenhydramine. Despite premedication, fatal hypersensitivity reactions have occurred in patients receiving IV paclitaxel.16 Additionally, patients with certain comorbidities (eg, diabetes) may not tolerate corticosteroid premedication, which can lead to hyperglycemia requiring intensive glycemic control and monitoring.

Besides hypersensitivity reactions, the taxanes solvent vehicles may directly contribute to neutropenia. In a clinical trial comparing nab-paclitaxel and conventional paclitaxel, among patients treated with nab-paclitaxel, treatment-related grade 4 neutropenia was significantly lower than conventional paclitaxel (9% vs 22%, P<.001) despite a higher dose, suggesting that the polyoxyethylated castor oil vehicle may be partly responsible for the neutropenia associated with paclitaxel.15 Recent studies of oral paclitaxel without solvent vehicles also demonstrated a decreased incidence of peripheral neuropathy and alopecia.17 Additionally, solvents may decrease the efficacy of taxanes because of entrapment of the active drug in micelles within the patients plasma, leading to increased systemic exposure and inadequate dose-dependent antitumor activity.15

Chemotherapy also may be poorly tolerated, especially in the older population. Avoiding significant toxicities and maintaining quality of life may be just as important as prolonging survival in mBC.14 Because of the lower potential for toxicity while maintaining efficacy, oral metronomic chemotherapy at frequent, low doses is an attractive treatment option for older patients with cancer who are not suitable candidates for conventional chemotherapy.13 Indeed, a meta-analysis of patients treated by metronomic chemotherapy for various tumor types indicated that grade 3 or 4 AEs were rare (eg, neutropenia, 5.39%; anemia, 1.73%; febrile neutropenia, 0.53%).18

Complications of IV access sites also are a concern with chemotherapies administered by IV infusion. With chronic venous and/or central line access, access-related complications are not uncommon, including sclerosis of the veins (31%), extravasation (7%-17%), access-related infections (6%-13%) and catheter-associated thrombosis (6%-18%).19 Furthermore, patients are concerned about the pain associated with IV placement and the IV site. In a survey, 47.4% of patients with breast cancer reported apprehension about IV linerelated pain, and 65.7% were concerned about problems locating a vein for infusion.20

During the coronavirus disease 2019 (COVID-19) epidemic, the American Society of Clinical Oncology has encouraged physicians to use telemedicine to help exposure to and transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In addition, patients with COVID-19 should be symptom-free before receiving in-office IV therapy.21 Because of concerns regarding infusion-related AEs, disposal of cytotoxic agents, and risk of SARS-CoV-2 exposure to medical staff, home infusion generally is not recommended.21 Effective oral chemotherapy regimens, if widely available, could potentially play a substantial role in preventing transmission of SARS-CoV-2.

Patient Preference

The current mechanisms for delivery of treatment options present significant burdens for patients. One of the often overlooked considerations is the impact of a chemotherapeutic regimen on a patients daily life. With an IV regimenbesides the actual time patients and/or caregivers spend at the infusion clinicpatients must travel to and from the clinic and wait for their treatment to be administered.22 The time commitment interferes with the patients and caregivers work obligations and other responsibilities. Additionally, practical concerns exist regarding travel to and from infusion clinics. For example, in a survey study, 55.4% of patients worried about having nausea during their trip home after chemotherapy infusion.20

One solution is the use of oral chemotherapy that patients can administer at home. Findings from a survey study of 224 patients with breast cancer receiving either oral chemotherapy (n=60) or IV chemotherapy (n=164) revealed that 48.3% of patients receiving oral treatments believed they were more able to handle the disease.23 Approximately 60% of patients stated that an oral regimen gave them more autonomy outside the clinic.23 Similarly, in another survey study of 59 patients with breast cancer starting oral chemotherapy, findings showed that 67% of the patients perceived that an oral chemotherapy regimen would lessen the effort to cope with the disease.24 These results were echoed by a findings from a survey study, in which 73% patients in Spain with metastatic lung or breast cancer who had previously received IV therapy and oral chemotherapy stated that their everyday life would be less affected by oral medications.20 Among patients with mBC in this study, 66.9% were concerned about inconvenience of an IV regimen.20

Because of the interference of IV regimens with patients daily lives and autonomy, it is no surprise that the majority of patients with breast cancer prefer an oral regimen. In fact, findings from a previously mentioned study showed that 76% of patients preferred an oral regimen administered at home instead of infusion at a clinic.20 In an internet-based cross-sectional survey study in the United States, women with breast cancer were asked to indicate the acceptability of various AEs and regimens of different frequency and duration of administration.25 Most of the participants (77%) preferred an oral regimen compared with 19% who were willing to choose a less convenient regimen.25 In a utility analysis using a similar internet-based survey design, patients with breast cancer were asked to trade off the preferred oral administration in exchange for a reduction in AEs (eg, alopecia, neutropenia).26 Results showed that patients were willing to tolerate a 5% increased risk of alopecia or grade 1 to 2 hand-foot syndrome in exchange for an oral regimen.26 In general, the more infusion days per treatment cycle and the longer the infusion time (eg, 3 hours vs 30 minutes), the less willing patients were to tolerate such a regimen.26

In a review of literature on patient preference on the modes of cancer treatment administration, reasons for patients preference for oral chemotherapy regimens included the ability to take the therapy at home, convenience, desire to continue working, impact on daily life and relationships, autonomy, and an increased ability to cope with the disease.27 However, patients are generally not willing to accept reduced efficacy or increased treatment-related toxicity in exchange for a convenient regimen.27

Costs

Costs associated with IV chemotherapy can be substantial. Treatment with IV chemotherapy entails not only drug acquisition cost but also costs related to specialized supplies and equipment, personnel needed to prepare and administer the IV drug, and management of AEs related to IV administration.28 In an administrative database study, investigators evaluated costs associated with IV chemotherapy administration in 828 patients with mBC during 7406 visits for single-agent IV therapy.28 IV administration constituted 10% to 11% of the overall cost of therapy, and other visit-related services (eg, antihypercalcemic agents, hematopoietic support, anticancer drugs used off label) accounted for 31% to 32% of costs.28 Although the costs of IV administration were approximately one-tenth of overall therapy costs, they could have been avoided with the use of oral regimens.28 The authors hypothesized that even if an all-IV multiagent therapy were replaced with an oral plus IV regimen, some costs related to IV administration could still be avoided.28 In a more recent study assessing health care costs in patients with stage 0 to IV breast cancer and service types, costs associated with the day of chemotherapy accounted for more than 25% to 26% of total costs.29

Direct comparisons of health care costs between IV and oral chemotherapy have also been reported. In a population-based study, investigators compared the relative cost impact among women starting capecitabine (oral regimen, n=114) versus taxanes (IV regimen, n=619) as first-line chemotherapy for mBC from 1998 to 2002.22 Participants were identified from the North Carolina Central Cancer Registry and Medicaid claims linked databases, and their claims were followed through 2005.22 In the first year after starting the respective first-line therapies, women receiving IV taxanes had higher total health care utilization compared with those who received oral capecitabine ($43,353 vs $35,842; P=.0089). The cost differences were mainly due to higher outpatient costs associated with IV taxanes (P<.001).22 After adjusting for confounders, health care costs associated with oral capecitabine were 32% lower compared with IV taxanes (P=.0001).22

In another study, investigators conducted a budget impact model comparing the health care costs associated with trastuzumab-based therapy (IV regimen) vs lapatinib plus capecitabine (oral regimen) among an estimated 43,707 patients with mBC in the French national hospital database.30 Despite slightly lower drug acquisition costs for the IV regimen, the 1-year treatment cost per patient was 2 times higher for the IV regimen compared with the oral regimen when costs included administration and nondrug expenditures.30 Estimated annual cost difference between the IV and oral regimens was 90.8 million.30 Use of an oral regimen also would lead to 25,357 fewer outpatient hospitalizations for chemotherapy administration, resulting in substantial savings in hospital and transportation costs.30

Summary

There have been many recent advances in the treatment of mBC. The current mechanisms for delivery of these options, however, present significant burdens for patients. In addition, some IV formulations of taxanes, which are frequently used in the management of patients with mBC, may directly contribute to treatment toxicities and complications. The need for IV administration for most chemotherapy regimens increases health care costs. New approaches and delivery mechanisms are needed to optimize outcomes and maintain the quality of life in patients with mBC.

References

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Current Approaches and Unmet Needs in the Treatment of Metastatic Breast Cancer - AJMC.com Managed Markets Network

Recommendation and review posted by Bethany Smith

FLINT, Mich., Jan. 8, 2021 /PRNewswire/ --Forum Health, LLC, a nationwide provider of personalized functional and integrative medicine, has acquired Healing Arts Center, a functional medicine practice based in Valparaiso, Indiana.

This multidisciplinary practice is comprised of an experienced team of providers including a physician, board-certified traditional Naturopath, licensed acupuncturist, nutritionist, chiropractor, and massage therapist. The clinic delivers a broad scope of complementary health services designed to encourage well-being and health in a caring and compassionate environment.

"We are thrilled to welcome the Healing Arts Center team to the Forum Health family. The clinic's patient-focused mission for helping people overcome chronic conditions and lead healthier lives, directly aligns with our philosophy. Healing Arts Center is dedicated to providing the highest level of care possible using Forum Health's holistic and personalized medicine approach," said Forum Health CEO, Phil Hagerman.

With a focus on complementing traditional medicine with alternative health treatments, Healing Arts Center offers a wide variety of services including IV, Chelation and Ozone therapies, acupuncture, reflexology, reiki, craniosacral therapy, massage therapy, hormone testing, allergy elimination, hypnotherapy, and more. They specialize in treating Lyme disease, Parkinson's, dementia, ADD, autism, anxiety, depression, weight loss, allergies, and other specific conditions.

"My team and I are excited to join the growing network of nationwide providers at Forum Health and to offer even more to our existing patients and community," said Dr. Kimberling, founder and lead practitioner of Healing Arts Center.

About Forum Health

Forum Health, LLC is a nationwide provider of personalized healthcare. Steeped in the powerful principles of functional and integrative medicine, Forum Health providers take a root-cause approach to care. They listen and dig deep exploring lifestyle, environment, and genetics to help each patient achieve their ultimate health goals. Members have access to advanced medical treatments and technology, with care plans informed by data analytics and collaborative relationships. To learn more, visitforumhealth.com.

To learn more, visit our practice location page.

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Forum Health, LLC adds Healing Arts Center to its growing community of Integrative and Functional Medicine practitioners - Iosco County News Herald

Recommendation and review posted by Bethany Smith

A nonprofit is providing an unusual form of therapy for those on the front lines of the coronavirus pandemic puppy cams!

You spend five minutes with a puppy and try not to smile, said registered nurse Robin Lingg Lagrone.

Lingg Lagrone says watching little furballs wag their tails and prance on their paws helps her temporarily escape the darkness of the COVID-19 crisis.

Its just been a moment of sunlight for us pretty much all year, she said.

Lingg lagrone works an emotionally draining job inside in the acute respiratory care clinic at National Jewish Health in Denver, Colorado.

Its just isolating to be so alone, she said. Its been a tough year.

To help boost her and her co-workers moods, National Jewish Health recently started airing a puppy cam from Warrior Canine Connection on http://www.explore.org.

The saying is, we came for the puppies but we stayed for the mission, said Rick Yount, founder of Warrior Canine Connection, which breeds puppies to become service dogs for veterans.

Recently, his team transitioned to helping a different kind of hero health care workers.

Were trying to just get every therapeutic drop from every puppy, Yount said. A lot of people have found solace and healing from watching these puppies.

Millions of people from dozens of countries around the world are tuning into this puppy cam, which behavioral therapists say helps lower stress levels.

You just feel that emotional and biological reaction when you see puppies, said Patrick Griswold an associate professor with MSU Denvers department of human services and counseling.

At first, Griswold was skeptical about what kind of impact looking at puppies online would have on someones well-being compared to seeing these puppies in person. After watching for himself, however, Griswold says this form of virtual animal therapy can help people better handle their emotions by releasing what he calls the love hormone.

When humans look at their dogs, oxytocin levels rise in both the animal and in the human, he said. When youre watching puppies play, its hard to also think about all the other stuff going on in your life.

A much-needed emotional outlet from the daily grind of working on the front lines during the pandemic for people like Ling Lagrone.

Its been a really hard year and its just full of sadness. she said. Its hard not to feel joy when you look at a puppy.

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Nonprofit providing unusual form of therapy for those on front lines puppy cams - The Denver Channel

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In a hot market market for NASH, having big-name backers can help shine a spotlight on startup players looking to make a mark. That was certainly the case for Terns Pharmaceuticals and partner Eli Lilly, which provided seed funding and licensed three NASH candidates to the baby biotech back in 2018.

Now, with two of those candidates in the clinic, Terns has bagged new funding to help speed toward the finish line.

After scoring $120 million in two early rounds, Terns raised an $87 million Series C funding round with Deerfield Management leading alongside OrbiMed Advisors, Lilly Asia Ventures, Vivo Capital, Samsara Capital, Suvretta Capital Management and several others. Lilly also jumped aboard with a strategic equity investment.

Terns, co-founded by Novartis veteran Weidong Zhong, is funneling the money into three of its NASH programs, one of which TERN-101 is expected to produce topline Phase IIa data in the second half of 2021, and another of which TERN-501 is headed for the clinic.

In 2018, Zhong told Endpoints that the idea for the company was to partner a California-based discovery team with a small development group in China to efficiently develop new drugs primarily for the Chinese market. Lilly Asia Ventures sunk in $30 million to get it going, a move which came about a year after Lilly closed its Shanghai R&D base.

On Wednesday, after press time, a spokesperson said Terns has since shifted its strategy, focusing more on building a headquarters and development team in California. While Terns continues to have an eye on additional global markets, their current focus is on the US, where clinical trials for their three lead programs will occur, the spokesperson said.

In 2021, we expect to have three promising clinical-stage therapeutic candidates with meaningful near-term milestones, Terns CEO Senthil Sundaram said in a statement.

TERN-101, the furthest along, is a liver-directed non-bile acid farnesoid X receptor (FXR) agonist. Its being tested on 96 patients in a Phase IIa study, dubbed LIFT. While Terns faces competition from other NASH players like Intercept and AbbVie, which snagged an FXR agonist in the Allergan buyout, the company thinks its candidates safety profile is where it will stand out. In four Phase I trials, none of 119 subjects in the treatment arm reported pruritus, and their serum lipid profiles were similar to those in the placebo arm at all doses, according to the companys website.

TERN-201, a vascular adhesion protein (VAP)-1) inhibitor, is expected to enter a Phase Ib trial in the first half of 2021, with a topline data readout anticipated in the first half of 2022. And TERN-501, a thyroid hormone receptor (THR) beta agonist, is entering a Phase I trial in the first half of 2021 with topline data coming in the second half of 2021.

Terns, named after the small, tough water bird, closed an $80 million Series B in October 2018 led by Vivo Capital and OrbiMed. Zhong, who spent some time working in liver diseases at Gilead, toldEndpointsin 2018 that he liked the idea of going back to the liver and bringing in oncology as a way to distinguish the startup in China.

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UPDATED: Eli Lilly's transpacific bosom buddy Terns bags late-round funding to drive NASH hopefuls through the clinic - Endpoints News

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By RIAN JACKSONCapital News Service

LANSING Sachi Tanaka says after having COVID-19 for three weeks, she experienced insomnia in a way that she never had.

At that time, I had gotten myself into a good routine of falling asleep around 10 p.m. and waking up early, said the 24-year-old Texas woman. And then, all of the sudden, it was like I couldnt fall asleep until 6 or 7 in the morning.

Her insomnia was a nagging feeling. She tossed and turned in bed, feeling like she was at the brink of sleep, but would be interrupted by her thoughts.

Tanaka isnt alone. COVID-19 has affected many peoples sleep, whether theyve had the virus or not. Sleep neurologists call it COVID-somnia, a phenomenon where people have trouble sleeping because of the virus. And its effects can last even after the pandemic ends.

Coronavirus upended our lifestyles. Morning commutes were replaced with teleworking, which may mean less physical activity and exposure to sunlight and more screen time, said Dr. George Zureikat, a sleep medicine specialist and director of Mid Michigan Sleep Center in Grand Blanc.

That can ruin sleep by disrupting the circadian rhythm the powerhouse of our sleep-wake cycle.

Stress induced by COVID can also result in insomnia, said Zureikat, who has seen a surge of insomnia cases since the pandemic.

COVID-19 is unlike anything many people have experienced, he said. Insomniacs may lose sleep worrying about unemployment or about contracting the virus. Some people feel trapped during lockdowns and are constantly reading news articles about overcrowded hospitals and rising death numbers.

A recent study by the American Academy of Sleep Medicine found 2.77 million Google searches for insomnia in the first five months of 2020 a 58% increase compared with the same months from the previous three years. Most of those queries happened between midnight and 5 a.m., suggesting people were searching while unable to fall asleep.

Difficulties like trouble falling and staying asleep or waking up too early rose from 36% before the pandemic to 51% during it, Rebecca Robillard, a University of Ottawa professor who leads clinical sleep research at the Royals Institute of Mental Health Research, said in a Medpage Today article.

If your (circadian) rhythms are thrown off, that also throws off your sleep at night time, said Dr. Christopher Morgan, the medical director at Mercy Health Saint Marys Sleep Center in Grand Rapids. Your melatonin may not be producing the right amounts at the right time, which is part of your internal rhythms in your body.

Melatonin is the hormone that your brain produces in response to darkness. It helps time your circadian rhythms and sleep.

Humans are social animals, said Dr. Lila Massoumi, a professor of psychiatry at Michigan State University and chair of the American Psychiatric Association Caucus on Complementary & Integrative Psychiatry.

We draw both strength and calm from our fellow humans. Ripping that social support away by telling us to self-isolate removes that source of strength and calm, she said.

Unsurprisingly, those who contract the virus may also stress about their health.

Morgan said those who struggle with chronic insomnia, or insomnia experienced at least three nights a week for at least a month, may develop bad habits that can be difficult to shake.

You have an acute stressor, which is COVID, and you become an insomniac, he said. And then lets say I still havent gotten a job in six months. Now, Im sitting in bed for 10 hours a day just thinking about how terrible things are in my life, and I have insomnia.

So, now I start watching TV in bed because Im awake during the night time, and I start drinking pop in the middle of the night, and I start laying in bed even longer because I think Im not getting enough sleep. So, all these maladaptive behaviors develop.

Whats worse, according to Mayo Clinic researchers, those whove had chronic insomnia report a lower quality of life than those who sleep well. Chronic insomnia may lead to anxiety or depression, slowed reaction time while driving and increased risk of long-term diseases such as heart disease.

Many professionals treat patients with cognitive behavioral therapy. It works by identifying and replacing thoughts and behaviors that create sleep problems with ones that promote healthy sleep.

Its just a matter of just tweaking certain habits and changing certain things, said Rachel Freedland, a clinical social worker at Bright Spot Therapy, a counseling clinic in Farmington Hills. If there are other mental health needs, for example, if a person already has anxiety or depression, we address those as well.

After assessing a patients sleeping habits with sleep diaries and questionnaires, Freedland, who is certified in cognitive behavioral therapy for insomnia, and her clients design a program that helps them sleep and wake up when they want.

Yoga and mindfulness, a type of meditation where you focus on being aware of what youre feeling and sensing at the moment, can release feel-good hormones that alleviate anxiety and promote healthier sleep, according to Asha Ravindran, a clinical team lead at St. Mary Mercy hospital in Livonia.

If you dont sleep, if youre anxious, youre out of sync with your body, said Ravindran, who owns Stepping Stones Wellness Center in Plymouth and conducts virtual yoga and meditation sessions with her patients.

She advises clients to create a private space where they can journal, practice yoga and meditate. This space can be as simple as the foot of the bed.

The key is to be present in the moment, Ravindran said. From yoga poses to breathing exercises, you can de-stress with strategies that help focus on the present without worrying about the past or future.

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Experts treat insomnia, anxiety caused by COVID-19 - Spartan Newsroom - Spartan Newsroom

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Yes. Yes, probiotics have the potential to improve a persons sex life.

Whether or not they have the potential to improve your sex life, however, depends on your current gut health and your sex life.

When we talk about gut health, were typically talking about the composition of the billions of bacteria, archaea, and fungi inside the gut.

This is known as the microbiome, and it affects all sorts of things that contribute to your interest in sex and overall sexual satisfaction.

Did you know that the majority (about 95 percent!) of serotonin the happiness hormone in the body is produced in the gut? Yep!

But for the optimal amount of serotonin to be produced, the gut has to be in tip-top shape. When the gut is in suboptimal health, your serotonin and overall happiness levels can dip.

And according to Dr. Anna Cabeca, triple-board certified OB-GYN and author of The Hormone Fix: Low serotonin is associated with lower sex drives.

Makes sense. Few of us are jonesing to do anything in the sack other than sleep when were sad.

Belly bacteria helps create B vitamins, which are essential for the production of ATP (science-talk for energy). Less B vitamins = less energy.

Plus, some of the bacteria communicate with other cells in charge of blood sugar regulation, says Anthony Thomas, PhD, nutrition researcher and director of scientific affairs with probiotic brand Jarrow Formulas.

If your gut bacteria gets out of whack, your blood sugar levels can crash more easily. This can lead to more and longer lasting energy dips.

So, that too tired for sex feeling? Well, it might be linked to your gut health in more ways than one.

Fun fact: Serotonin is found in the genitals. Seriously!

Some research suggests that when your serotonin levels dip, your physical response to sexual feelings dips, too.

When our gut microbiome is unhealthy, it can lead to inflammation, says Dr. William W. Li, a physician, scientist, and author of Eat to Beat Disease: The New Science of How Your Body Can Heal Itself.

Sadly, inflammation is quite the c*ck-block.

For example, some research has found that sexual health dysfunction is common among folks with inflammatory arthritis.

Lets face it: Its pretty damn hard to be in the mood to bone when you cant leave the bathroom.

And there are certain gut conditions that cause bathroom troubles to rear their ugly heads. These include:

In addition to constipation and diarrhea, other common symptoms include:

Both the physical and emotional effects of these and other gastrointestinal (GI) conditions have the potential to affect your sex life.

The keyword here is potential.

If youve already received a diagnosis or suspect that your symptoms might be a sign of a GI condition, talk with a doctor or other healthcare provider about your concerns.

They can help you find the best management or treatment option for your individual symptoms or side effects.

By now you can probably tell that your microbiome is complicated. Well, so is your libido.

Libido in general is very complicated and is impacted by many different things, says Cabeca. Hormones, lifestyle, and relational factors also have to be considered.

So finding out if your libido fluctuations are related to your microbiome is similarly tricky. And no matter how well-intentioned, gut health mishaps can have a direct effect on your overall health.

Li recommends meeting a gastroenterologist, the medical specialist that focuses on the gut, if youre experiencing any of the below symptoms:

Note: That recommendation stands even if your libido isnt funked up.

A gastroenterologist will be able to recommend an endoscopy, colonoscopy, or a scan of your abdomen to find out whats up, explains Li.

They also may be able to check your microbiome for abnormalities by sending a stool sample for testing, he adds.

Please dont self-diagnose your gut symptoms or libido mishaps. Why? Well, because theyre both incredibly complex.

Dr. Kimberly Langdon, OB-GYN and medical advisor at telehealth provider Medzino, notes that mental health conditions like depression are often linked with low libido.

In these cases, for example, trying to course correct at home without talking to a healthcare provider may mean delaying access to helpful medications or other necessary treatment.

Many GI conditions are characterized by dysbiosis, which is medical speak for an imbalance of bacteria in your gut.

If your provider has diagnosed dysbiosis, Li says that probiotics helpful yeasts and bacteria often delivered via certain foods and supplements may help.

A word of caution: Not all probiotics are created equal.

As a general rule, probiotics that are stored in the refrigerator are higher quality than those stored on the shelf.

Cabeca adds that Lactobacillus strains are typically better than others.

Bacterial imbalance has been linked to increased inflammation, so its thought that probiotics may help alleviate symptoms associated with IBS, IBD, and other inflammatory conditions.

Probiotics may also be helpful for acute digestive conditions like gas, bloating, constipation, and diarrhea.

All that said, even if everything above sounds similar to your situation, you shouldnt start or increase your probiotic intake without first talking with a doctor or other healthcare provider.

There are two good reasons for this:

For example, if someone has small intestinal bowel overgrowth, adding probiotics can worsen gas and other symptoms, explains Cabeca.

If youve ever been probiotic shopping, youve likely stumbled across probiotics marketed for vaginas theyre all the rage, after all.

According to Langdon, these probiotics typically contain higher levels of Lactobacillus. Some research suggests that Lactobacillus helps support a healthy vaginal pH, as well as keep other pathogens at bay.

Now, if you scroll back up to the previous section, youll notice that Lactobacillus is the strain of bacteria thats best for both improving overall gut health and supporting vaginal health.

Thats why Li says, its just a marketing ploy. These probiotics are no different than any other probiotics on the market.

So do probiotics marketed for your genitals actually work? If you have a condition that can be remedied by consuming more Lactobacillus, they may.

But dont be tricked into thinking these probiotics are a one-stop solution for sexual dysfunction or the only option available.

Yep! In fact, there are quite a few things you should consider using in tandem or even instead of, in some cases.

Thats because (again, for the people in the back!) gut and sexual health conditions arent quick-fix problems.

The meds and antibiotics youre on or have been on can affect your gut microbiome, explains Thomas.

Its also widely known that antidepressant, antipsychotic, anti-epileptic, blood pressure, and cholesterol lowering meds can all impact sexual functioning.

Thats why Thomas recommends making sure your doctor knows what meds youre currently taking so they can help you troubleshoot if need be.

For gut conditions, most experts will recommend a diet shift, at least for a short period of time.

Cabeca, for example, recommends folks follow a healthy elimination diet to better understand what foods lead to their gut unrest. She also recommends incorporating gut-healing foods like bone broth and fermented veggies.

Regular exercise has been linked with higher serotonin levels.

Given serotonins relationship to both your gut and sex life, if youre currently on the sedentary side of things, moving your body more may be helpful.

If you have a condition that can be helped with a probiotic, Cabeca says, often, you can see a significant improvement of symptoms after 21 days.

And that includes symptoms related to your sex life.

Thomas, however, notes that probiotics need to be taken regularly. Benefits may ease if supplementation is discontinued, he adds.

Probiotics arent a one-size-fits-all treatment for all folks experiencing gut conditions or sexual dysfunction. But for some, they can be an incredibly beneficial part of a holistic treatment plan.

Gabrielle Kassel is a New York-based sex and wellness writer and CrossFit Level 1 Trainer. Shes become a morning person, tested over 200 vibrators, and eaten, drunk, and brushed with charcoal all in the name of journalism. In her free time, she can be found reading self-help books and romance novels, bench-pressing, or pole dancing. Follow her on Instagram.

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5 Ways Gut Health Affects Your Sex Life and How Probiotics Can Help - Healthline

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According to a now-viral TikTok video posted on Dec. 8, 2020, as much as 95% of serotonin a key neurotransmitter that plays a role in regulating mood may be produced in the gastrointestinal tract:

#edutok #fyp #foryoupage #gut #serotonin Psychology #ThinkingAbout #til #discover

original sound Gianu System

The bacteria in your gut produce about 90% of the serotonin in your body, said social media user gianusystem, a self-identified online community dedicated to bringing awareness to dissociative identity disorder, or multiple personality disorder. The woman goes on to cite an article in Discover Magazine, adding that she was skeptical of new information that she hadnt heard before.

So, I went and looked this up. Thats the low number, said in the video, which at the time of writing had been shared more than 20,500 times.

Snopes also looked up the information and found that the claim is mostly true: Estimates suggest that up to 95% of the serotonin in the body is released in the gut through certain intestinal cells. But there is an important caveat to note: Most studies that link serotonin production to the gastrointestinal system have been conducted in animals. According to an article titled Gut Bacterias Role in Anxiety and Depression: Its Not Just in Your Head, which appeared in the November 2020 issue of the science magazine Discover, author Elizabeth Svoboda reported that about 90% of serotonin produced in the human body is done so in the gut.

Serotonin is a hormone and neurotransmitter responsible for sending chemical messages between cells to play a key role in stabilizing mood, feelings, and happiness. In the brain, serotonin allows cells of the nervous system to communicate with one another and when too little serotonin is produced, a person may experience anxiety, depression, and other emotional and behavioral disorders. Such conditions are typically treated with selective serotonin reuptake inhibitors (SSRIs), or antidepressants, that the Mayo Clinic said work by increasing levels of serotonin by blocking the reuptake of serotonin into some neurons, making the hormone more available to improve the transmission of messages.

While serotonin is most well-known for its role in the brain, the hormone is also found in the stomach and intestines where it helps to maintain bowel movements and function, noted the Hormone Health Network, an affiliate of the Endocrine Society. And some researchers postulate that a greater understanding of serotonin production in the gut may inform the treatment of certain mental health conditions in the brain.

In 2015, researchers at the California Institute of Technology demonstrated that bacteria normally present in the gut can stimulate the intestinal cells to produce serotonin as much as 90% of which is made in the digestive tract. In mice, a particular mixture of bacteria also found in the human gut produced molecules that signaled to gut cells to increase the production of serotonin. Modified mice that did not have the bacteria had more than 50% of their gut serotonin missing. Adding that bacterial mixture which contained Turicibacter sanguinis and Clostridia increased serotonin back to a normal level. Though the study was conducted on mice, the scientist wrote in the journal Cell that the findings lend important insight into how the gut microbiome can influence the nervous system.

Four years later, those same researchers set out to inform how the 100 trillion or so bacteria and hormones that live in the human intestinal system may produce serotonin. This time around, researchers added serotonin to the drinking water of some mice and raised others with a mutation that increased the levels of serotonin in their guts. An analysis of the mice microbiota showed that the presence of T. sanguinis and Clostridia increased significantly when there was more serotonin in the gut. As part of the study, mice were also given fluoxetine, or Prozac, which was shown to block the serotonin transporter in the T. sanguinis, which slowed the transport of serotonin.

Previous studies from our lab and others showed that specific bacteria promote serotonin levels in the gut, said study author Thomas Fung at the time in a news release. Our new study tells us that certain gut bacteria can respond to serotonin and drugs that influence serotonin, like anti-depressants. This is a unique form of communication between bacteria and our own cells through molecules traditionally recognized as neurotransmitters.

So while it is true that a large proportion of the bodys serotonin is produced in the guts and serotonin-targeting drugs can have a major effect on the guts microbiota the exact mechanisms behind the production are not yet known. Furthermore, it is important to consider that many of the studies have been conducted on mice and not necessarily in humans.

Regardless, because most treatments for depression deal with serotonin receptors in the brain, understanding how and where the hormone is produced may help to inform future treatments into emotional and behavioral disorders such as anxiety and depression.

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Is 90% of Serotonin Found in the Gut? - Snopes.com

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Medication abortion usestwo types of pills: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy; and misoprostol, which causes contractions to expel the contents of theuterus. (VAlaSiurua, licensed underCC BY-SA 4.0)

This post originally appeared in the Hampshire Gazette. It has been republished with permission.

The COVID-19 pandemic is transforming many aspects of our lives, and abortion is no exception. Telemedicine is expanding access to abortion health care in ways that are likely to persist long after the pandemic is over.

Telemedicine abortioncombinesmedication abortionwhich uses pills to end a pregnancyandtelemedicinewhich allows health providers to supervise the use of abortion pills via videoconferencing or telephone consultations.

Approved by the FDA for use during the first 10 weeks of gestation, medication abortion usestwo types of pills: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy; and misoprostol, which causes contractions to expel the contents of theuterus.

This combination of pills is 95 percent effective and is anextremely safe wayto end an early pregnancy. In fact, medication abortion accounts for over 60 percent of abortions in the first 10 weeks, according to the Guttmacher Institute.

Despite the safety of medication abortion, politically-motivated restrictions on mifepristone have blocked easy access to the pill. After years of anti-abortion resistance, the FDA approved the drug in 2000, but placed it in the Risk Evaluation and Mitigation Strategy (REMS) drug safety program. Under this restriction, the FDA prohibited retail pharmacies from stocking and distributing mifepristone, insteadrequiringdoctors to register with the drug manufacturer and distribute the medication themselves in person to patients, who then take most of the pills at home.

Whereas the REMS program is meant to restrict dangerous drugs, mifepristone is in fact anextremely safe drugsix times safer than Viagra, which is not similarly restricted.This FDA restriction was based on politics,not medical evidence.

Here atMs., our team is continuing to report throughthis global health crisisdoing what we can to keep you informed andup-to-date on some of the most underreported issues of thispandemic.Weask that you consider supporting our work to bring you substantive, uniquereportingwe cant do it without you. Support our independent reporting and truth-telling for as little as $5 per month.

Earlier this year, the American College of Obstetricians and Gynecologists (ACOG) and SisterSong Women of Color Reproductive Justice Collective brought a lawsuit challenging the FDA requirement of an in-person appointment for patients to receive the abortion pill during the pandemic.

In July,a Maryland federal courttemporarily suspended the requirement. The Trump administration challenged the decision but it was upheld earlier this month. Reproductive rights advocates are now pressing Biden to ask the FDA to review and permanently remove the REMS restriction on mifepristone.

The other barrier to telemedicine abortion is the standard medical protocol that recommends an ultrasound to determine the number of weeks a patient is pregnant and an Rh blood test, which require an in-person visit. On March 30, 2020, however, ACOG issuedguidance stating that an ultrasound and Rh testing are often not necessary because patients can reliably tell their doctors when their last period began and their blood type. The new no-test medication abortion protocol eliminates the need for in-person visits and tests in most cases.

As a result of the lawsuit lifting the FDA restriction on medication abortion and the new no-test medical protocol, telemedicine abortionstartups are springing up across the country. These new virtual clinics screen patients remotely, then mail abortion pills to them, often using newonline pharmacies. In total, 20 states and Washington D.C. now offer legal access to telemedicine abortion from doctors within their state.

These startups are revolutionizing abortion care by offering convenient services, especially for people living in rural areas far away from reproductive health clinics. They are also making abortion health care more affordable. Whereas in-clinic care with testing can cost $500-700, telemedicine abortion costs as little as $95.

Another advantage of medication abortion is that patients can take the pills immediately after missing a period: they dont have to wait until a fetus is visible on an ultrasound (approximately 6 weeks). In fact, some health care providers are prescribing medication abortion as missed period pills, without requiring a pregnancy test, which some patients prefer.

The organization Plan C has a comprehensivewebsiteat plancpills.org with information on medication abortion. The website includes all the new avenues for pill access that now exist in the US, including telemedicine services, online pharmacies, and reliable websites selling the abortion pill from abroad. Searchable by state, the website offers patients information about all of their options wherever they live, as well as information about financial support, legality, and legal resources. Plan C also offers atoolkit for medical professionalswith a step-by-step guide on how to become a medication abortion provider.

Many people choose telemedicine abortion because it is more private and convenient than in-clinic medication abortion or procedural abortion by aspiration. Instead of having to drive to a provider and wait hours for an office visit, missing work or paying for child care, you can have your appointment from wherever you are without waiting, and take the pills when its convenient, like over the weekend or on your day off. Especially in states with few abortion clinics, or where protesters yell and scream at women entering reproductive health clinics, telemedicine abortion can increase access and reduce the stress of accessing abortion health care.

I suspect that these COVID-inspired innovations in abortion health care will persist beyond the pandemic. The cat is out of the bag. The obstacle course of expensive, burdensome and delayed abortion care should be a thing of the past. Accessible, affordable, early abortion care is possible. We just need the political will to make it happen.

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Telemedicine Is Revolutionizing Abortion Health Carein Ways Likely To Persist Long Past COVID - Ms. Magazine

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VERU-111, a next-generation form of chemotherapy, has shown promising signs of efficacy as a treatment option for men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed while receiving androgen receptor (AR)-targeting therapy.

Investigators are planning a phase 3 trial that will test VERU-111 against an alternative AR-blocking agent in men with mCRPC who have developed resistance to abiraterone acetate (Zytiga) or enzalutamide (Xtandi), which typically are administered in this treatment setting (Figure). Veru Inc, the company developing the agent, plans to launch the trial during the first quarter of 2021, pending discussions with the FDA.1

Figure. Proposed Phase 3 Trial of VERU-111 in mCRPC

VERU-111 is an oral therapy that binds to the colchicine binding site on the microtubule to crosslink and tubulin, thus inhibiting microtubule polymerization. Preclinical findings show that the agent induces apoptosis in taxane-resistant and enzalutamide-resistant CRPC cell lines.2

Findings from a phase 1b/2 study (NCT03752099) showed that daily chronic administration of VERU-111 was feasible and safe in men with previously treated mCRPC, according to data presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.2

Investigators enrolled 39 patients across 7 sites in the United States. Eligible men with mCRPC had to have received 1 prior AR-targeted therapy; those who had received 1 line of taxane-based chemotherapy for mCRPC were included. The median age of participants was 74 years (range, 61-92), the median Gleason score was 8 (range, 5-10), and 95% had ECOG performance status scores of 0 or 1.2

In the first part of the study, investigators tested a 2-part dosing schedule using a standard 3 x 3 dose-escalation strategy across 10 dosing levels ranging from 4.5 mg to 81 mg daily. The recommended phase 2 dose was established as 63 mg daily.2

Outcomes were reported for a subset of 10 men who received VERU-111 monotherapy continuously at the recommended dose for 4 or more cycles. Of these patients, 6 had a decrease in prostate-specific antigen (PSA) levels, including 4 with a decrease of 30% or more and 2 with a decrease of 50% or more. The best objective tumor response comprised 2 patients with partial responses and 8 with stable disease. The median duration of treatment without radiographic progression was more than 11 months (range, 6-17) and half of the 10 men remained on study therapy at the time of presentation.2

Additionally, investigators presented results from 1 patient, an 88-year-old man with Gleason 9, node-only mCRPC who had previously received sipuleucel-T (Provenge), enzalutamide, and abiraterone. After VERU-111 therapy, a CT scan showed a 33% decrease in size to a nonpathologic node.2 Further, the patient experienced a 63% reduction in PSA level within the first cycle of treatment and remained in the study for over 16 months.

In the safety population of 25 patients who had been treated with the recommended dose for at least 1 cycle, the most frequently observed drug-related adverse effects (AEs) included diarrhea (56%), nausea (24%), and decreased appetite, fatigue, dysgeusia, and weight loss (all, 12%). Most AEs were of grade 1 or 2 severity. An instance of fatigue that was resolved with a dose reduction was the only drug-related AE of grade 3 or worse at the 63-mg dose. Investigators did not record any reports of neurotoxicity in the study and no incidence of neutropenia at the 63-mg dosing level.2

The trials early findings are generating interest among experts in prostate cancer. One impressive aspect of this study was the PSA declinations of 50% or more, said Neal D. Shore, MD, medical director of Carolina Urologic Research Center in Myrtle Beach, South Carolina, in an interview with OncLive.

Shore said VERU-111s oral route of administration could make it an attractive choice compared with traditional taxanes such as docetaxel and cabazitaxel (Jevtana), which are given intravenously. Especially during the time of a pandemic, one recognizes the advantage for using an oral medication not requiring a clinic visit for administration, he said. The oral-based delivery may also appeal to clinicians who are not offering infusions within their clinics.

Oral delivery of a taxane or microtubule- or tubulin-inhibitor mechanism of action would be a significant addition to our therapeutic armamentarium, Shore added.

Although microtubule-targeting agents (MTAs), including taxanes and vinca alkaloids, are effective and widely used for treating a variety of cancers, resistance and toxicity can limit their clinical efficacy. In prostate cancer, resistance also builds up in patients who receive AR-targeting therapies. Approximately 15% to 25% of men do not respond to AR inhibitors and 75% to 85% progress within 9 to 15 months.3

Furthermore, as AR-targeting agents such as enzalutamide, darolutamide (Nubeqa), apalutamide (Erleada), and abiraterone are approved for earlier lines of treatment, patients with metastatic disease who progress on these agents need new options, according to Philip W. Kantoff, MD, chair of the Department of Medicine and George J. Bosl Chair at Memorial Sloan Kettering Cancer Center in New York, New York.

According to Kantoff, a 2014 Giants of Cancer Care award winner in the genitourinary cancer category, novel therapies such as VERU-111 may allow patients to overcome acquired resistance to AR inhibitors. Androgen-blocking agents are either introduced in the context of metastatic hormone-sensitive prostate cancer, nonmetastatic CRPC, or mCRPC, he said in an interview with OncLive. It is leaving a void where we dont have many drugs right now, so there is still a need for new therapies in mCRPC.

The phase 2 portion of the study reported at ESMO 2020 is fully enrolled with 40 patients, Veru announced in September.4 The open label, single-arm trial will evaluate VERU-111 for efficacy and safety in patients who have become resistant to at least 1 AR-targeting therapy but who have not received intravenous (IV) chemotherapy in the metastatic setting. The key efficacy end point of the phase 2 portion is radiographic imaging of progression-free survival (rPFS).

Looking ahead, Veru is making plans for a phase 3 trial that would enroll 250 men with mCRPC who have rising PSA levels and tumor progression while receiving AR-targeting therapy. Participants would be randomized to receive either VERU-111 continuously at 63 mg daily or standard therapy with either abiraterone or enzalutamide, depending upon their prior treatment. The primary end point would be rPFS, with secondary end points of overall survival, time to IV chemotherapy, pain progression, and PSA responses.5

VERU-111 also has demonstrated antitumor activity in preclinical models of other tumor types, including taxane-resistant triple-negative breast cancer and lung cancer, pancreatic cancer, and melanoma.5 Additionally, the agent is currently undergoing testing as a potential treatment for coronavirus disease 2019 (COVID-19) in a phase 2 trial (NCT04388826). Investigators are seeking to randomize 40 patients with COVID-19 who are at high risk for acute respiratory distress syndrome to either 18 mg of VERU-111 or placebo. The primary efficacy end point for the 62-day study is the proportion of patients alive and without respiratory failure at day 29.

More:
Next-Generation Cytotoxic Therapy Moves Forward in mCRPC - OncLive

Recommendation and review posted by Bethany Smith

50 N. Medical Drivetransgenderhealth@hsc.utah.edu801.213.2195 | uofuhealth.org/transhealth

At the core of each story in SLUGs My Body and Me issue lies the powerful force of bodily autonomy. Here, Ariel Malan, the Program Coordinator of the Master of Healthcare Administration and the Transgender Health Program at the University of Utah, talks the physical, social and emotional changes surrounding this identity-affirming body transformation.

SLUG: Can you please fill us in on the history of the Transgender Health Program? How has it changed/grown since its inception?

Malan: Thanks to the work of several dedicated healthcare providers, our Program was officially launched in 2017. Prior to this date, many meetings were held between providers and hospital leadership about the need for more coordinated care for transgender and gender-diverse patients. Since then, we have seen volumes dramatically increase across all of our specialties. We believe that this is predominantly due to the fact that there has been a gap in providing this care to patientsnot just in Utah, [but] across the nation. We are the only multidisciplinary program in the Mountain West, and although we serve primarily Utahs communities, we also see 12% of our patients from other states.

In addition to our growth, we have defined our mission and vision to better serve our communities and continue to hold the Program and our University system accountable for health outcomes:

Vision (where we are going): A patient-centric, multi-disciplinary gender health program for all gender journeys across the lifespan.

Mission (what we do): The Transgender Health Program is committed to providing comprehensive, compassionate, evidence-based care for gender-diverse individuals in a supportive, affirming environment.

Intersectionality: We will recognize the unique social and political identities that exist within gender-diverse individuals and advocate to remove inequalities within healthcare.

Coordinated Care: We will provide coordinated care through patient navigation and provider communication on all aspects of care.

Research: We will engage in research to advance knowledge and well-being for the care of gender-diverse individuals.

Education: We seek to educate providers, trainees and the public on the needs and health of gender diverse individuals.

SLUG: What are the range of services offered at the Program?

Malan: Our Program spans across eight different specialties that coordinate care for all gender-affirming services a patient might need on their gender journey. Patients and families can access the [following] range of services at our website, uofuhealth.org/transhealth: primary care and HRT, plastic surgery, fertility and family planning, voice therapy, physical therapy, laser hair removal, adolescent medicine [and] gynecologic care.

SLUG: Can you please elaborate on the range of staff at the Program? What types of professionals are available?

Malan: Currently, we have three dedicated administrative staff to our Program. This includes two Patient Coordinator roles that assist patients in navigating care and scheduling appointments, and a Program Coordinator role that manages marketing and outreach, education, strategy and other programmatic projects.

Our clinical staff is not dedicated to our Program alone in that they serve in multiple capacities. For example, we have plastic surgeons that are specially trained in gender-affirming surgery, but they also deliver other types of plastic surgery to patients that are not our transgender patients. The range of professional clinical positions include physical therapists, plastic surgeons, family-medicine providers, speech-language pathologists, endocrinologists, adolescent medicine physicians, aestheticians, physician assistants, reproductive specialists, OBGYNs and urologists.

We have high hopes that our hospital system will continue to support us in providing us with more dedicated positions both clinical and administrative.

SLUG: I read in your FAQ a bit about opening up your services to be more inclusive toward nonbinary identities and others. Can you please elaborate on the types of changes the Program is undertaking in this regard?

Malan: Transgender is an umbrella term that encompasses many gender-diverse identities, including those who identify as nonbinary. Its important that our Program is able to serve all of these identities by not assuming what someones gender journey looks like based on how they identify. This is why all of our providers consider every patients journey as unique and discusses with them what options exist. Not all transgender people pursue medical transition, and some are only interested in a handful of gender-affirming options.

We are working closely with our new Patient and Family Advisory Board to identify ways that our Program can be more inclusive to gender fluid/nonbinary identities.

SLUG: I saw a section on your website regarding events. While those are (likely) on pause right now, what are the types of events that the Program typically holds or appears at?

Malan: Many of the events we offer are educational either for patients or providers. Every month, we offer a patient-education seminar on various transgender health topics. Our providers are present to talk about the services and what to expect, and we offer a panel of patients who have had that particular service. This is free and open to the community to attend and ask questions. Since COVID, we have hosted these virtually via Zoom and will continue to do this until it is safe to resume back in person. [In these cases,] these are offered at the Utah Pride Center. Patients can visit uofuhealth.org/seminartransgenderhealth to see a list of upcoming seminars.

For our providers, we hosted our first annual conference on transgender health this year and plan to offer this and more educational offerings to community providers.

SLUG: In addition to the medical services you offer, it seems like there are a lot of other areas (counseling, voice therapy, etc.) deal with more intangible things. Can you please talk about how these areas interact with things such as surgeries, hormones, etc.?

Malan: For many of our patients, counseling or mental-health therapy may be their first point of contact in a healthcare system in talking about their gender journey. For many folks in the beginning of their journey, they may still be in whats called their social transition, finding what is most authentic to them in their own expression through body language, adjusting their voice, changing hair or clothing styles, or a legal name change.

These are reversible and fluid things that people are figuring out for themselves, so medical and surgical changes may or may not be on their list to pursue.

An unfortunate barrier that still exists to this day in accessing gender-affirming medical and surgical options are the WPATH (World Professional Association for Transgender Health) requirements. Although these guidelines provide evidence-based practices for providers offering these services, there is a list of criteria, including living in your desired gender role for at least one year, before many things can happen. These guidelines can be interpreted loosely by providers to make sure patients get the care they need, but health-insurance companies sometimes have stricter standards they go by in order to cover any services that someone may need as part of their journey.

SLUG: A significant offering at the Program are the youth and teen Transgender Health Services. Can you please elaborate on the breadth of these services and their place in the Transgender Health Program?

Malan: More and more youth are identifying under the transgender umbrella, so the services offered at our Adolescent Medicine Clinic, [such as the] Gender Management and Support are critically important for families and youth.

We have physicians who specialize in adolescent transgender medicine [and] can provide options for puberty blockers, hormone therapy, behavioral health and nutrition wellness, and coordinate care with our adult providers so the transition to those services can be seamless.

SLUG: How does the Transgender Health Program interact with other aspects of the Utah LGBTQ+ community?

Malan: We are heavily reliant [on] and grateful our community partners. We cannot do the work we do without their help and feedback. A couple of our community partnerships include:

Genderbands: Every year we partner with Genderbands to offer a top surgery grant for those who are uninsured in the community.

Utah Pride Center: Pre-COVID, we used their space to offer our patient-education seminars and refer patients to them for their mental health services and support groups. Every year, we also participate in the annual Utah Pride Festival and Genderevolution conference.

We have been present at many other community organization events through outreach booths, presentations and referring patients directly to them for resources. As mentioned previously, we also have created our own Patient and Family Advisory Board made up of community patients and family members They are helping us shape the strategy and direction of our Program, which will ensure our services are patient-centric.

SLUG: Whats one thing youd like the readers to know about the work you do and the communities you work with?

Malan: We are a new and growing Program! This means that we have a long way to go in making sure our Program is remedying the historical trauma that our community has experienced directly by healthcare providers. But this also means we have many exciting opportunities to engage with our community and integrate their feedback into how we provide these services. For our allied healthcare providers, we hope to be a resource in providing education for you and your staff to better serve transgender patients. For our patients, we thank you for your continued vulnerability during our growth and aim to be [a] safe space that can meet your healthcare needs.

SLUG: If a reader is interested in obtaining services, how can they get in touch or schedule an appointment?

Malan: Call us directly at 801.213.2195, option 1, and leave us a voicemail. We receive many phone calls a day, so leaving a voicemail will make sure we can get back to you. Also, emailing us at transgenderhealth@hsc.utah.edu.

SLUG: What does the Transgender Health Program have planned for the future?

Malan: So many things! We are looking forward to creating our first five-year business plan, which will include direct patient feedback from our Advisory Board, and both clinical and administrative input on ensuring the sustainability of our services. We also are launching our first educational-needs assessment that will guide us in delivering needs-based education on LGBTQ+ communities to our providers and staff. A few others to mention: a community photoshoot to use representative photos of our community marketing materials; improving the accessibility of our patient education seminars and other patient education materials; identifying our underserved communities so we can better reach them; creating a development plan to bring fundraising dollars into the Program to fund important initiatives like scholarships for patients and research; work toward requiring standardized education for our system on LGBTQ+ people and get all of our inpatient facilities designated under the Healthcare Equality Index.

Find here a list of additional local resources for transgender individuals, compiled with the invaluable assistance ofRiver Jude August:

Read the original:
Transgender Health Program at the University of Utah - SLUG Magazine

Recommendation and review posted by Bethany Smith

Premature menopause is the permanent end of menstrual periods before age 40. It occurs because the ovaries no longer release eggs (ovulation) regularly and become less able to produce hormones.

Some women have no symptoms except being unable to become pregnant, and others have the same symptoms as those of natural menopause (such as hot flashes or night sweats). To become pregnant, women with premature menopause can have eggs from another woman implanted in their uterus.

Blood tests can confirm the diagnosis, and other tests are done to identify the cause. Various measures, including estrogen (typically taken until about age 51, when menopause occurs on average), can relieve or reduce symptoms.

Premature menopause and early menopause, whether spontaneous or induced, are associated with long-term health risks which may include premature death, cardiovascular disease, neurologic disease, osteoporosis, psychosexual dysfunction, and mood disorders.

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Premature Menopause Market 2021-28 healthcare leads to shooting revenues with Novo Nordisk A/S, Pfizer, Allergan, Eli Lily and Company, Emcure...

Recommendation and review posted by Bethany Smith

A 4-year-old with progeria, a syndrome with features of premature aging that stems from a mutated gene

By Jocelyn KaiserJan. 6, 2021 , 11:00 AM

One mouse is hunched over, graying, and barely moves at 7 months old. Others, at 11 months, have sleek black coats and run around. The videos and other results from a new study have inspired hope for treating children born with progeria, a rare, fatal, genetic disease that causes symptoms much like early aging. In mice with a progeria-causing mutation, a cousin of the celebrated genome editor known as CRISPR corrected the DNA mistake, preventing the heart damage typical of the disease, a research team reports today in Nature. Treated mice lived about 500 days, more than twice as long as untreated animals.

The outcome is incredible, says gene-therapy researcher Guangping Gao of the University of Massachusetts, who was not involved with the study.

Although the developers of the progeria therapy aim to improve it, they are also taking steps toward testing the current version in affected children, and some other scientists endorse a rush. The mouse results are beyond anyones wildest expectations, says Fyodor Urnov, a gene-editing researcher at the University of California, Berkeley. The new data are an imperative to treat a child with progeria and do so in the next 3 years.

About 400 people in the world are estimated to have Hutchinson-Gilford progeria syndrome, which results from a single-base change in the gene for a protein called lamin A that helps support the membrane forming the nucleus in cells. The resulting abnormal protein, called progerin, disrupts the nuclear membrane and is toxic to cells in many tissues. Toddlers soon become bald and have stunted growth, body fat loss, stiff joints, wrinkled skin, osteoporosis, and atherosclerosis. People with progeria die on average around age 14 from a heart attack or stroke.

Researchers have previously used CRISPR to disrupt activity of the mutated gene for lamin A in progeria mice. But their health improved only modestly, and disabling a persons good copy of the gene could cause harm. So David Liu of Harvard University and the Broad Institute turned to base editing, a DNA-changing method originally inspired by CRISPR and developed in his lab. Unlike CRISPR, which makes double-strand cuts in DNA, the base editor used in the progeria study nicks just one strand and swaps out a single base. Base editors have treated liver, eye, ear, blood, and brain disorders in mice, and Liu wanted to try one on an infamous and devastating disease that involves multiple organs or tissues.

Lius group teamed up with Vanderbilt University cardiologist Jonathan Brown and Francis Collins, director of the National Institutes of Health, whose group was one of two that identified the progeria mutation in 2003. The team first tested the base-editing approach in cultured cells from two progeria patients, finding that it corrected the mutation while making few unwanted changes elsewhere in the genome. They then packaged DNA encoding the base editor into adeno-associated viruses (AAVs), a standard delivery vehicle for gene therapies, and injected these into young mice with the progeria mutation.

The results were far better than we had dared to hope, Collins says. When the mice were examined 6 months later,between 20% and 60% of their bone, skeletal muscle, liver, heart, and aorta carried the DNA fix. Progerin levels fell and lamin A levels rose in several tissues. Even though the mice were already 2 weeks old when treated, or about age 5 in human years, their aortas months later bore virtually no signs of the fibrous tissue growth or loss of smooth muscle cells seen in mice and children with progeria. It hits home the potential of this technology, says gene-editing researcher Charles Gersbach of Duke University.

Some of the rodents eventually developed liver tumors, a problem seen before in mice receiving high-dose AAV gene therapy. No people have been shown to have developed liver tumors as a result of such treatments. Still, lowering the AAV dose to improve safety is a goal, Liu says. He and Collins are evaluating more efficient base editors to that end.

Study co-author Leslie Gordon, a Brown University physician whose son died from progeria and who co-founded the Progeria Research Foundation, doesnt want to wait for the next iteration before developing plans and raising money to test the treatment in children. Her foundation is talking to companies, including Beam Therapeutics, which Liu co-founded, in hopes of launching a clinical trial. We will find a way to get this done for these kids, Gordon says.

Go here to see the original:
'Incredible' gene-editing result in mice inspires plans to treat premature-aging syndrome in children - Science Magazine

Recommendation and review posted by Bethany Smith

During Tuesday's Mad Money program Jim Cramer cautioned viewers against the CRISPR stocks hoping that human genome editing will usher in the cure for cancer and other ailments. Genomics is indeed a hot science, he said, but it's also incredibly risky. Let's take a look at the charts of CRISPR Therapeutics AG (CRSP) again.

On Dec. 22 we looked at CRSP and concluded that, "if you are still long CRSP then you are way smarter than me. Longs should risk to $145. The round number of $200 and then the Point and Figure target of $230 are the price objectives for now."

In this updated daily bar chart of CRSP, below, we can see that prices remain in a strong uptrend above the rising 50-day moving average line and the rising 200-day moving average line. The On-Balance-Volume (OBV) line has moved higher to confirm the price gains while the Moving Average Convergence Divergence (MACD) is above the zero line and poised for a new buy signal.

In this weekly bar chart of CRSP, below, we can see a 2-1/2-year base pattern in place before the strong gains of this year. Prices are in an uptrend above the rising 40-week moving average line. The weekly OBV line is strong and so is the MACD oscillator.

In this daily Point and Figure chart of CRSP, below, we can see a price target of $200.

In this second Point and Figure chart of CRSP, below, we used weekly close-only price data with a five-box reversal filter. Here our $230 price target is confirmed.

Bottom-line strategy:Continue to hold longs risking to $149 now. Our price targets are $200 and $230 for now.

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CRISPR Therapeutics Is Still Looking Strong - RealMoney - RealMoney

Recommendation and review posted by Bethany Smith

DUBLIN, Jan. 6, 2021 /PRNewswire/ -- The "CRISPR Technology Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.

CRISPR Technology Global Market Report 2020-30: COVID-19 Growth and Change provides the strategists, marketers and senior management with the critical information they need to assess the global crispr technology market.

Major players in the CRISPR technology market are Thermo Fisher Scientific, GenScript Biotech Corporation, CRISPR Therapeutics AG, Editas Medicine, Horizon Discovery Plc., Integrated DNA Technologies, Inc. (Danaher), Origene Technologies, Inc., Transposagenbio Biopharmaceuticals (Hera Biolabs), Intellia Therapeutics Inc., and GeneCopoeia, Inc.

The global CRISPR technology market is expected to increase from $0.76 billion in 2019 to $0.92 billion in 2020 at a compound annual growth rate (CAGR) of 20.91%. The exponential growth is mainly due to the COVID-19 outbreak that has led to the research for drugs for COVID-19 with gene-editing using CRISPR technology. The market is expected to reach $1.55 billion in 2023 at a CAGR of 19.13%.

The CRISPR technology market consists of sales of CRISPR technology products and services which is a gene-editing technology that allows researchers to alter DNA sequences and modify gene function. The revenue generated by the market includes the sales of products such as design tools, plasmid & vector, Cas9 & gRNA, libraries & delivery system products and services that include design & vector construction, screening and cell line engineering.

These products and services are used in genome editing/genetic engineering, genetically modifying organisms, agricultural biotechnology and others which include gRNA database/gene library, CRISPR plasmid, human stem cell & cell line engineering by end-users. The end-users include pharmaceutical & biopharmaceutical companies, biotechnology companies, academic & research institutes and contract research organizations.

North America was the largest region in the CRISPR technology market in 2019. Europe was the second-largest region in the CRISPR technology market in 2019.

In 2019, Cardea Bio Inc., a US-based biotechnology infrastructure company that manufactures biology-gated transistors (Cardean transistors) that utilizes biocompatible graphene instead of silicon and replaces optical signal observations with direct electrical molecular signal analysis, merged with Nanosens Innovations, Inc. The merger is aimed at accelerating the development of the genome sensor that combines Nanosens' CRISPR-Chip technology with Cardea's graphene biosensor infrastructure and is the first DNA search engine globally that runs on CRISPR-Chip technology. Nanosens will be operating as a subsidiary of Cardea Bio. Nanosens Innovations, Inc. is a US-based biotechnology company that develops CRISPR-Chip and FEB technology.

The CRISPR technology market covered in this report is segmented by product type into design tools; plasmid and vector; CAS9 and G-RNA; delivery system products. It is also segmented by application into genome editing/ genetic engineering; genetically modified organisms; agricultural biotechnology; others and by end-user into industrial biotech; biological research; agricultural research; therapeutics and drug discovery.

Stringent government regulations are expected to retard the growth of the CRISPR technology market during the period. There is no existence of internationally agreed regulatory framework for gene editing products and countries are in the process of evaluating whether and to what extent current regulations are adequate for research conducted with gene editing and applications and products related to gene editing. In July 2018, the Court of Justice of the European Union ruled that it would treat gene-edited crops as genetically modified organisms, subject to stringent regulation.

In April 2019, the Australian government stated that the Office of the Gene Technology Regulator (OGTR) will regulate only the gene-editing technologies that use a template, or that insert other genetic material into the cell. According to an article of 2020, in India, as per the National Guidelines for Stem Cell Research, genome modification including gene-editing by CRISPR-Cas9 technology of stem cells, germ-line stem cells or gamete and human embryos is restricted only to in-vitro studies. Thus, strict regulations by the government present a threat to the growth of the market.

Several advancements in CRISPR technology are trending in the market during the period. Advancements in technology will help in reducing errors, limiting unintended effects, improving the accuracy of the tool, widening its applications, developing gene therapies and more. In 2019, a study published in Springer Nature stated the development of an advanced super-precise new CRISPR tool that allows researchers more control over DNA changes. This tool seems to have the capability of providing a wider variety of gene edits which might potentially open up conditions that have challenged gene-editors.

Also, in 2020, another study in Springer Nature stated that researchers have used enzyme engineering to boost the accuracy of the technique of error-prone CRISPR-Cas9 system to precisely target DNA without introducing as many unwanted mutations. The advancements in CRISPR technology will result in better tools that are capable of providing better outcomes.

The application of CRISPR technology as a diagnostic tool is expected to boost the market during the period. The Sherlock CRISPR SARS-CoV-2 kit is the first diagnostic kit based on CRISPR technology for infectious diseases caused due to COVID-19. In May 2020, FDA announced the emergency use authorization to the Sherlock BioSciences Inc's Sherlock CRISPR SARS-CoV-2 kit which is a CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) diagnostic test.

This test helps in specifically targeting RNA or DNA sequences of the SARS-CoV-2 virus from specimens or samples such as nasal swabs from the upper respiratory tract and fluid in the lungs from bronchoalveolar lavage specimens. This diagnostic kit has high specificity and sensitivity and does not provide false negative or positive results. Widening the application of CRISPR technology for the diagnosis of infectious diseases will increase the demand for CRISPR technology products and services.

Key Topics Covered:

1. Executive Summary

2. CRISPR Technology Market Characteristics

3. CRISPR Technology Market Size And Growth

3.1. Global CRISPR Technology Historic Market, 2015 - 2019, $ Billion

3.1.1. Drivers Of The Market

3.1.2. Restraints On The Market

3.2. Global CRISPR Technology Forecast Market, 2019 - 2023F, 2025F, 2030F, $ Billion

3.2.1. Drivers Of The Market

3.2.2. Restraints On the Market

4. CRISPR Technology Market Segmentation

4.1. Global CRISPR Technology Market, Segmentation By Product Type, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.2. Global CRISPR Technology Market, Segmentation By Application, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.3. Global CRISPR Technology Market, Segmentation By End-User, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

5. CRISPR Technology Market Regional And Country Analysis 5.1. Global CRISPR Technology Market, Split By Region, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion 5.2. Global CRISPR Technology Market, Split By Country, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Companies Mentioned

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Global CRISPR Technology Market Report 2020: COVID-19 Growth and Change - Market is Expected to Recover to Reach $1.55 Billion in 2023 - Forecast to...

Recommendation and review posted by Bethany Smith

Crispr Therapeutics AG (CRSP) stock has gained 35.58% over the past week and gets a Bullish rating from InvestorsObserver's Sentiment Indicator.

In investing, sentiment generally means whether or not a given security is in favor with investors. It is typically a pretty short-term metric that relies entirely on technical analysis. That means it doesnt incorporate anything to do with the health or profitability of the underlying company.

Recent trends are a good indicator of current market sentiments. In its most basic form, stocks that are trending up are desirable by investors while stocks currently falling must be unattractive.

InvestorsObserver's Sentimental Indicator tracks both changes in price and volume to analyze the most recent trends. Typically an increase in volume indicates ongoing trends are getting stronger, while a decrease in volume usually signals an end to the current trend.

Available options can also represent current sentiments for a given stock. Since investors are able to bet on future trends of stocks using options, we consider the ratio of calls to puts when analyzing market sentiments .

Crispr Therapeutics AG (CRSP) stock is trading at $207.58 as of 10:53 AM on Friday, Jan 8, an increase of $13.15, or 6.76% from the previous closing price of $194.43. The stock has traded between $196.11 and $210.39 so far today. Volume today is below average. So far 1,482,585 shares have traded compared to average volume of 2,079,604 shares.

To see InvestorsObserver's Sentiment Score for Crispr Therapeutics AG click here.

CRISPR Therapeutics AG is a gene-editing company. It is engaged in the development of CRISPR/Cas9-based therapeutics. CRISPR/Cas9 is a technology that allows for precise, directed changes to genomic DNA. The company advanced programs target beta-thalassemia and sickle cell disease, two hemoglobinopathies that have a high unmet medical need.

Click Here to get the full Stock Score Report on Crispr Therapeutics AG (CRSP) Stock.

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What is the Market's View on Crispr Therapeutics AG (CRSP) Stock's Price and Volume Trends - InvestorsObserver

Recommendation and review posted by Bethany Smith

Three years ago, the Food and Drug Administration granted a landmark approval to the first gene therapy for an inherited disease, clearing a blindness treatment called Luxturna.

Since then, the regulator has approved one more gene therapy,the spinal muscular atrophy treatment Zolgensma, and given a green light for dozens of biotech and pharmaceutical companies to start clinical testing on others. Genetic medicines for a range of diseases, including hemophilia, sickle cell and several muscular dystrophies, appear in reach, and new science is galvanizing research.

But, entering 2021, the gene therapy field faces major questions after a series of regulatory and clinical setbacks have shaded optimism. "The ups and downs of adolescence are on full display" analysts at Piper Sandler wrote in September, summing up the state of gene therapy research.

Here are five questions facing scientists, drugmakers and investors this year. How they're answered will matter greatly to the patients and families holding out hope for one-time disease treatments.

The FDA was widely expected last year to approve a closely watched gene therapy for hemophilia A, the more common type of the blood disease. Instead, the agency in August surprisingly rejected the treatment, called Roctavian, and asked its developer, BioMarin Pharmaceutical, to gather more data.

The next day, Audentes Therapeutics reported news came a third clinical trial participant had died after receiving the biotech's experimental gene therapy for a rare neuromuscular disease. The tragedy brought flashbacks to past safety scares in gene therapy, although the current wave of treatments being tested have generally appeared safe.

A little less than five months later, the gene therapy field is grappling with two more setbacks. UniQure is exploring whether a study volunteer's liver cancer was caused by its gene therapy for hemophilia B. And Sarepta, one of the sector's top developers, faces significant doubts about its top treatment for Duchenne muscular dystrophy after disclosing a key study missed one of its main goals.

In each case, the drugmakers involved offered explanations and reasons for optimism. BioMarin still expects to obtain an approval; Audentes' trial is now cleared by the FDA to resume testing; UniQure thinks it's unlikely the cancer case is linked to treatment; and Sarepta argued its negative data were the product of unlucky study design.

But taken together, the developments are powerful reminders of both the stakes and uncertainty still facing gene therapy.

All four events also highlighted lingering worries about one-time genetic treatment. In rejecting Roctavian, for example, the FDA seemed to be concerned the impressive benefit hemophilia patients initially experienced may wane over time. The deaths in Audentes' study, meanwhile,renewed warnings about extremely high doses of gene therapy. Researchers have long watched for evidence that replacing or altering genes may cause cancer to develop in rare instances, particularly after four infants developed leukemia in a gene therapy study in the early 2000s.And Sarepta's negative findings were surprising because early signs of dramatic biological benefit that didn't seem to translate into clear-cut functional gains for all patients.

Experts are still confident gene therapy can deliver on its promise. Bu recent events suggest getting there may take a bit longer than some expected.

"The process is the product," is an often-used cliche about gene therapy, which are complex treatments with exacting manufacturing standards.

Most of the roughly 60,000 pages in Spark Therapeutics' application for approval of Luxturna, for instance, involved what's known in the industry as "chemistry, manufacturing and controls."

The therapeutic basis for gene therapy, by contrast, is much clearer for many of the rare, monogenic diseases that developers are targeting. If mutations in a single gene lead to disease, replacing or otherwise fixing that gene should have a large benefit.

"Genetic medicine is not industrialized serendipity," said Gbola Amusa, an analyst at Chardan, contrasting gene therapy with chemical-based drugs."It often is an engineering question."

In 2020, the FDA gave ample notice that it's watching gene (and cell) therapy manufacturing closely.Sarepta,Voyager Therapeutics,Iovance Biotherapeuticsand Bluebird biowere all forced to revise their development timelines after the agency asked for new details about production processes.

"The FDA is saying to companies that you've got to up your standards," Amusa added.

For their part, FDA officials have indicated the spate of data requests are a product of the sharply higher numbers of companies advancing through clinical testing.

While setbacks have piled up for therapies that seek to replace genes, 2020 was a "transformative year" for therapies designed to edit them, according to Geulah Livshits, an analyst at Chardan.

CRISPR gene editing, already widely recognized as a scientific breakthrough, gained further prestige with the awarding of the Nobel Prize in Chemistry to two early pioneers, Jennifer Doudna and Emmanuelle Charpentier.

But the year also brought important progress from early biotech adopters.Editas Medicine and Intellia Therapeutics, for example, notched CRISPR firsts with use of the editing technology inside the human body.

And CRISPR Therapeutics and partner Vertex showed their experimental therapy, which uses CRISPR to edit stem cells, worked exceptionally well in the first 10 patients with either sickle cell disease or beta thalassemia treated in two early studies.

The data are the most concrete sign yet that CRISPR's clinical use can live up to its laboratory promise. While all three companies' therapies are still in early stages, their advances have ginned up substantial investor enthusiasm.

Together, the market value of CRISPR Therapeutics, Editas and Intellia totals nearly $25 billion. Beam Therapeutics, a startup that uses a more precise form of gene editing, is worth nearly $6 billion.

"Gene therapy will have a big role to play," said John Evans, Beam's CEO. "But I do think in the last year or so there's a growing realization that, when possible, you'd probably rather edit than add an extra gene."

Clinical tests will prove that out but, until then, the large upswing in share price for gene editing companies may not be sustainable as valuations creep higher and higher. Some of the recent run-up, for instance,appears driven by money flowing from generalist investors through exchange-trade funds, rather than from investors experienced in handicapping preclinical- or early clinical-stage companies.

"They're overdue for some type of rationalization," predicted Brad Loncar, CEO of Loncar Investments, adding that many companies are targeting similar diseases, most commonly sickle cell and beta thalassemia.

Tasked with replacing faulty genes with functional ones, scientists for the most part have turned to two types of viruses to safely shuttle genetic instructions into cells. Adeno-associated viruses, or AAVs,are typically used for infused treatments, while researchers working on cells extracted from patients generally opt for lentiviruses.

Each virus class has advantages, but also notable drawbacks. AAVs, for instance, can trigger pre-existing immune defenses in some people, making those individuals ineligible or poor candidates for gene therapy. Lentiviruses, by contrast, are known to integrate their DNA directly into the genomes of cells they infect a useful attribute in some regards but limiting in others.

Over decades of gene therapy research, scientists have found ways to tweak and modify these viral vectors to better suit their needs, but the basic tools are the same. Jim Wilson, a gene therapy pioneer who ran the study that led to the death of teenager Jesse Gelsinger in 1999, told attendees at a STAT conference last fall that he's "somewhat disappointed" by slow progress in viral vector research.

And as more and more gene therapies enter clinical testing, the limitations of current viral vectors have become more apparent.

The pace of research might be picking up, however. Recently, a number of companies aiming to build better delivery tools have launched, including Harvard University spinout Dyno Therapeutics and 4D Molecular Therapeutics, which recently raised $222 million in an initial public offering.

Larger companies are interested, too. Roche, Sarepta and Novartis have all partnered with Dyno, for example.

In gene editing, meanwhile, researchers are developing new ways to cut DNA, while Beam and others are advancing different editing approaches altogether.

Billions of dollars have flowed from pharmaceutical companies into gene therapy over the past few years, leaving few large multinational drugmakers without a research presence.

2020 was no different, with sizable acquisitions inked by Bayer and Eli Lilly, as well as an array of smaller investments from Pfizer, Novartis, Johnson & Johnson, Biogen,and UCB. And CSL Behring, best known for its blood plasma products, spent nearly half a billion dollars to buy UniQure's most advanced gene therapy, a treatment for hemophilia B.

Over the past three years, there's been at least $30 billion spent on biotechs involved in gene or cell therapy. (Four deals account for the majority of that value.)

All of that dealmaking, while following promising and compelling science, is ultimately a bet that one-time genetic treatments can be scaled up and commercialized into a lucrative business.

Many of the acquired companies are working on therapies for very rare disorders affecting hundreds or thousands of people. A handful, however, are taking aim at more prevalent conditions, starting with still relatively uncommon diseases like hemophilia to ones affecting millions of people like Parkinson's.

"For gene therapy to meet our lofty expectations not just for investors, but for society it has to make the leap from these ultra-rare diseases," said Loncar.

Commercially, the track record for the few therapies on the market in the U.S. is mixed.Luxturna, now owned by Roche, is a niche product.Zolgensma has broader use and earned Novartis about $1 billion in the year and a half it's been commercially available.

Two cell therapies from Novartis and Gilead, meanwhile, have struggled to gain traction.

Gene therapy's biggest commercial test yet was supposed to come this year, with the expected approval of BioMarin's Roctavian in hemophilia A. The FDA's surprise rejection could mean a yearslong delay in the U.S., but the challenges of pricing, reimbursement and patient access in gene therapy remain dauntingly large.

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5 questions facing gene therapy in 2021 - BioPharma Dive

Recommendation and review posted by Bethany Smith

This article was originally published here

Infection. 2021 Jan 3. doi: 10.1007/s15010-020-01554-w. Online ahead of print.

ABSTRACT

PURPOSE: CRISPR gene-editing technology has the potential to transform the diagnosis and treatment of infectious diseases, but most clinicians are unaware of its broad applicability. Derived from an ancient microbial defence system, these so-called molecular scissors enable precise gene editing with a low error rate. However, CRISPR systems can also be targeted against pathogenic DNA or RNA sequences. This potential is being combined with innovative delivery systems to develop new therapeutic approaches to infectious diseases.

METHODS: We searched Pubmed and Google Scholar for CRISPR-based strategies in the diagnosis and treatment of infectious diseases. Reference lists were reviewed and synthesized for narrative review.

RESULTS: CRISPR-based strategies represent a novel approach to many challenging infectious diseases. CRISPR technologies can be harnessed to create rapid, low-cost diagnostic systems, as well as to identify drug-resistance genes. Therapeutic strategies, such as CRISPR systems that cleave integrated viral genomes or that target resistant bacteria, are in development. CRISPR-based therapies for emerging viruses, such as SARS-CoV-2, have also been proposed. Finally, CRISPR systems can be used to reprogram human B cells to produce neutralizing antibodies. The risks of CRISPR-based therapies include off-target and on-target modifications. Strategies to control these risks are being developed and a phase 1 clinical trials of CRISPR-based therapies for cancer and monogenic diseases are already underway.

CONCLUSIONS: CRISPR systems have broad applicability in the field of infectious diseases and may offer solutions to many of the most challenging human infections.

PMID:33393066 | DOI:10.1007/s15010-020-01554-w

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CRISPR-based strategies in infectious disease diagnosis and therapy - DocWire News

Recommendation and review posted by Bethany Smith

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Plant breeding and CRISPR plants market is expected to reach USD 21.78 billion by 2027 growing with the growth rate of 13.70% in the forecast period 2020 to 2027. Rising importance for sustainable crop production drives the growth of plant breeding and CRISPR plants market in the forecast period of 2020- 2027.

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Bayer AG, KWS SAAT SE & Co. KGaA, DuPont, SGS SA, DLF Seeds Ltd, BioConsortia Inc., Hudson River Biotechnology., Pacific Biosciences of California, Inc, Eurofins Scientific, Syngenta, SGS SA, Land OLakes, Inc, Advanta Seeds Pty Ltd, J.R. Simplot Company among other domestic and global players.

Market Scope, Segments and Forecast of the Plant Breeding and CRISPR Plants Market

The Plant Breeding and CRISPR Plants Market is witnessing high demand due to the rise in demand of the product across different end-use areas. On the basis of product, geography and application the market is bi-furcated into different sub-segments as per the feasibility check and market estimation from 2020 to 2027 have been provided for these segments.

Market Overview, Key Trends Market Dynamics

The market would gain significant growth rate during the forecast period, reaching a substantial market size by 2020. The market has been analyzed taking into considerations the different factors which includes the market drivers, restraints, opportunities, key competitor landscape, trend analysis, outlook, estimate and forecast factors. The impact of COVID -19 could be seen on the market; however, the Plant Breeding and CRISPR Plants Market would recover from this pandemic by end of the next year. We have also mentioned the key trends of the market that would impact the growth of the market at present and in the coming years as well.

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Geographical Coverage of Plant Breeding and CRISPR Plants Market

Table of Contents

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Plant Breeding And CRISPR Plants Market Is Expected To Reach USD 21.78 Billion By 2027 | Top Companies- Bayer AG, KWS SAAT SE & Co. KGaA, DuPont,...

Recommendation and review posted by Bethany Smith

A rating of 80 puts Crispr Therapeutics AG (CRSP) near the top of the Biotechnology industry according to InvestorsObserver. Crispr Therapeutics AG's score of 80 means it scores higher than 80% of stocks in the industry. Crispr Therapeutics AG also received an overall rating of 64, putting it above 64% of all stocks. Biotechnology is ranked 30 out of the 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 64 would rank higher than 64 percent of all stocks.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

Crispr Therapeutics AG (CRSP) stock is trading at $180.75 as of 10:23 AM on Thursday, Jan 7, a rise of $16.90, or 10.32% from the previous closing price of $163.85. The stock has traded between $169.39 and $185.43 so far today. Volume today is light. So far 888,487 shares have traded compared to average volume of 1,989,285 shares.

Click Here to get the full Stock Score Report on Crispr Therapeutics AG (CRSP) Stock.

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Where Does Crispr Therapeutics AG (CRSP) Stock Fall in the Biotechnology Field? - InvestorsObserver

Recommendation and review posted by Bethany Smith

CRISPR and CAS Gene Market witness to garner US$ 7,603.8 Million at a booming CAGR of +20% by the term of 2021-28.

CRISPR-Cas9 is a unique technology that enables geneticists and medical researchers to edit parts of the genome by removing, adding or altering sections of the DNA sequence. It is currently the simplest, most versatile and precise method of genetic manipulation and is therefore causing a buzz in the science world.

CRISPR is a tool that can be used to edit genes and, as such, will likely change the world. The essence of CRISPR is simple: its a way of finding a specific bit of DNA inside a cell. After that, the next step in CRISPR gene editing is usually to alter that piece of DNA.

When viruses infect bacteria, bacteria will produce this type of DNA and bind to virus DNAs; with working with one nuclease, called Cas, the Cas enzyme will cut the invaded DNA into pieces. Thus, CRISPR/Cas is a type of acquired immune defense mechanism for prokaryotes against virus.

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Key Players:

Caribou Biosciences Inc., CRISPR Therapeutics, Mirus Bio LLC, Editas Medicine, Takara Bio Inc., Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc.

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CRISPR and CAS Gene Market Report Segment: by application

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CRISPR and CAS Gene Market 2021-2028 shooting revenue at US$ 7,603.8 Million with CRISPR Therapeutics, Mirus Bio, Caribou Biosciences, Editas...

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass.--(BUSINESS WIRE)--The 221b Foundation, a nonprofit organization established by Sherlock Biosciences to address the global COVID-19 pandemic and diverse representation in STEM, today announced an initiative with the Ministry of Health and Population (MoHP) in Nepal to control the spread of SARS-CoV-2 throughout the country. With contributions from Sherlock Biosciences, Open Philanthropy, Integrated DNA Technologies and MoHP, The 221b Foundation will provide support to the country of Nepal through financial assistance and donations of equipment and Sherlock CRISPR SARS-CoV-2 kits, which the country has designated as an essential diagnostic test for combating the pandemic. The total value of the donations is $200,000.

Dr. Dig Bijay Mahat worked closely with Sherlock Biosciences and MoHP to introduce and facilitate the adoption of Sherlock CRISPR SARS-CoV-2 testing kits in Nepal. In addition to his work with the coalition, Dr. Mahat is also a research scientist in the lab of Nobel Laureate Phillip A. Sharp at the Koch Institute for Integrative Cancer Research at MIT.

According to MoHP, the daily COVID-19 positivity rate in Nepal is around 20-25%. Nepals capital, Kathmandu, and surrounding areas account for more than a third of all infections, raising concerns about the ability of hospitals to support the growing need for ventilators and intensive care.

When we established The 221b Foundation, we felt strongly that we needed to support efforts worldwide to confront COVID-19, said Rahul Dhanda, co-founder, president and CEO of Sherlock Biosciences and founding board member of The 221b Foundation. By establishing a strong coalition to support Nepal and its Ministry of Health, we are collectively working to provide a critical testing need to assist a region facing a surging challenge with this pandemic.

The testing will be supervised by MoHP with initial tests validated and run in the National Public Health Laboratory in Kathmandu. Initial efforts will support major cities, and the ramp up to support country-wide testing is expected to occur over the next few months. With infections increasing at alarming rates, a national testing strategy is the foundation of Nepals effort to manage the pandemic.

COVID-19 has become a severe threat to our national public health, and we have established a plan to contain its spread, which is built on a strong testing platform, said Dr. Jageshwor Gautam, the spokesperson for MoHP. Sherlocks CRISPR SARS-CoV-2 kit is ideally suited to address Nepals national diagnostic needs, and it represents one of many critical components in a broader plan that will successfully contain this pandemic.

The coalition members have each committed to addressing the pandemic through testing, tracing, providing equipment or supporting communities most severely affected by the pandemic. The Sherlock CRISPR SARS-CoV-2 kit should provide capacity for a single site to run thousands of tests per day on simple and accessible equipment.

The SHERLOCK diagnostic platform can achieve single molecule detection of nucleic acid targets; its name stands for Specific High Sensitivity Enzymatic Reporter unLOCKing. SHERLOCK utilizes CRISPR activity for smart amplicon detection and can be adapted for use with existing diagnostic instruments, improving time to result due to its significant multiplexing capacity. When a specific sequence of DNA or RNA is present, a CRISPR enzyme is activated and, much like a pair of scissors, starts cutting nearby genetic material, releasing a fluorescent signal that indicates a positive result. In May 2020, Sherlock received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Sherlock CRISPR SARS-CoV-2 kit, the first FDA-authorized use of CRISPR technology.

About The 221b Foundation

The 221b Foundation was founded with the dual mission to assist in the eradication of COVID-19, while supporting racial and gender diversity in STEM. By providing support and intellectual property that enables both non-profit and for-profit entities to develop CRISPR-based diagnostic testing, The 221b Foundation seeks to aid in the fight against the global COVID-19 pandemic while furthering access and diversity in STEM industries. Led by industry experts in the fields of diagnostic testing, STEM and diversity, The 221b Foundation envisions a world where advances in CRISPR technology fuel the innovations that will put an end to the COVID-19 pandemic. For more information, please visit: 221bfoundation.org.

About Sherlock Biosciences

Sherlock Biosciences is dedicated to providing global access to the simplest and most accurate tests that empower individuals to control their own healthcare. Through its Engineering Biology platforms, the company is developing applications of SHERLOCK, a CRISPR-based method for smart amplicon detection, and INSPECTR, a synthetic biology-based molecular diagnostics platform that is instrument-free. SHERLOCK and INSPECTR can be used in virtually any setting without complex instrumentation, opening up a wide range of potential applications in areas including precision oncology, infection identification, food safety, at-home tests and disease detection in the field. In 2020, the company made history with the first FDA-authorized use of CRISPR technology. For more information visit Sherlock.bio.

Continue reading here:
The 221b Foundation Establishes Coalition to Control the Spread of COVID-19 in Nepal - Business Wire

Recommendation and review posted by Bethany Smith

Watch this on-demand webinar to learn more about manipulating the genes within physiologically relevant human immune cells

In this on-demand SelectScience webinar, immunology expert Dr. Verena Brucklacher-Waldert, Horizon Discovery, shares successful strategies for the manipulation of genes within physiologically relevant human immune cells. A number of case studies are presented to highlight the techniques used in a variety of applications employed for gene interrogation, including CRISPRko, RNAi and more.

Read on for highlights from our Q&A session that followed the live webinar with Ryan Donnelly, Senior Product Manager for Gene Editing at Horizon Discovery.

RD: We've spoken to a lot of customers who do what we call orthogonal studies for hit follow-up. Say you run a CRISPR knockout screen, and you get a handful of hits back, you can then see what reagents are available, maybe via traditional RNAi methods, so siRNA or shRNA. You can then run those to see if you can replicate some of the phenotypes that you saw in your knockout screen for those specific hits. The thought is, if you see a positive correlation, you now have stronger evidence that that hit was actually real, since you've now generated a similar phenotype by targeting both DNA, with your CRISPR knockout screen, as well as the RNA with those traditional kinds of RNAi methods.

In essence, you've generated a similar phenotype by targeting two different sections of the central dogma. One of the nice things about Horizon is we have readily available reagents, all genome-wide for both CRISPR knockout, CRISPR activation, siRNA and shRNAs. So, most combinations that you would be looking at for validation, we can support.

RD: There are a few. But the first one that comes to mind is when working with primary immune cells, the availability and variability of the cell type. We can extract those cells from blood samples, but there's usually a limited amount of those types of cells that we can extract from each donor. We then need to keep in mind that there can be specific variability between donors. The complexities that come along with trying to stimulate immune cells, like T cells, also need to be considered.

Another challenge that we usually see is just in the biological differences between immune cell types. We talked a lot about proliferating cell types. Some cell types lose the ability to proliferate once they've been extracted from blood.

Lastly, is a variable that we look at routinely that also comes down to cell type: cells that are in suspension versus adherent cells. This can make screening protocols quite different, depending on whether your cell types are in suspension or if they're stuck down in the bottom of a well. Those are the three main considerations when looking to conduct screening experiments within immune cells.

RD: In principle, we usually suggest a minimum of three donors, but this is all cell type dependent. Functional assays can show a high degree of variability when using cell types such as natural killer cells. But if you shift into myeloid cells, that variability in functional assays is much more limited. Another thing to keep in mind is that donor variability is not necessarily a bad thing. By mixing donors, you spread a wider vision on things like the ethnicity of those donors, sex, age, and genetics that make up the donor pool. Since they're randomized, it will give you good insight into how a variety of donors would respond and can give you higher confidence in the performance characteristics of the target that you've identified within your screen.

RD: Controls, and multiple types of controls, are absolutely critical when doing this type of work. Without them, it's really impossible to check the efficiencies in large, arrayed screens.

At Horizon, we use multiple different types of controls, and for anybody that is taking these projects on, we would recommend a similar approach. For checking the transduction efficiency, we use a combination of both lethal controls and essential genes. This will give us a nice viability readout. In essence, the more cells that die, the higher the rate of transduction efficiency.

We also incorporate non-targeting controls, and a ROSA26 guide RNA. The non-targeting control won't cut the DNA, so incurs no DNA damage. The ROSA26 guide RNA will cut, but it cuts without a functional impact to the cell. This will give us insights into the potential for DNA damage, as well as a cutting efficiency control. Lastly, we would pick a positive control based on the cell type of interest. For example, in T cells, we target CD3, as it's consistently expressed as part of the T cell receptor complex.

By doing this, we have the ability to monitor across donors, across plates, and across replicates, to look at assay performance as a whole, with the screening experiment.

Q: How does pooled screening differ from arrayed screens? And what are the advantages?

RD: The main advantage of performing a pooled screen over an arrayed screen is really the ability to scale up and analyze the whole genome with a reasonably small amount of resources. Mining the whole genome is very important when we're looking to understand new biology without any preconceived ideas. It's really a discovery approach.

Thinking about using a pool versus an arrayed screen comes down to the biological question you're attempting to answer. If it's a simple, black and white question, such as "Do my cells survive a particular stimulus?", a pooled screen is a really nice way to go. If, however, the screen needs to assess multiple different types of outcomes that use different techniques so maybe combining FACS and HTRF assays for looking at more than one parameter, arrayed screens are what you would need to use.

Learn more about modulating gene function in primary immune cells: Watch this webinar on demand here>>

SelectScience runs 10+ webinars a month across various scientific topics, discover more of our upcoming webinars>>

See original here:
Strategies and applications for CRISPRko, RNAi and beyond - SelectScience

Recommendation and review posted by Bethany Smith