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Archive for the ‘Gene Therapy Research’ Category

Safety Concern Halts Study of Seattle Genetics’ Lymphoma Drug

SEATTLE (TheStreet) -- A small clinical study treating elderly Hodgkin lymphoma patients with a combination of Seattle Genetics' (SGEN) Adcetris and chemotherapy has been stopped temporarily due to reports of pancreatitis, a dangerous swelling of the pancreas, the company confirmed Tuesday.

The decision to suspend patient enrollment in the Adcetris study due to concerns about pancreatitis was made by researchers at Chicago's Northwestern University, which designed and is conducting the study. Seattle Genetics says none of its Adcetris studies have been halted for any toxicity reasons.

JMP Securities first picked up on the Adcetris study halt Friday following a presentation by Northwestern's Dr. Andrew Evens at a lymphoma research meeting in Lugano, Switzerland. As word filtered back through Wall Street Friday, Seattle Genetics shares sold off moderately. The stock recovered partially by the close of Friday trading after Seattle Genetics denied any knowledge of an Adcetris study being halted due to safety concerns.

Now, the company admits its denial Friday was a mistake.

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Safety Concern Halts Study of Seattle Genetics' Lymphoma Drug

Atossa Genetics to Present at Two Upcoming Investor Conferences

SEATTLE, WA--(Marketwired - Jun 26, 2013) - Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company, today announced that Kyle Guse, CFO and General Counsel, will be presenting at two upcoming investor conferences: the JMP Securities Healthcare Conference in New York City and the Life Science Innovation Northwest 2013 Conference in Seattle.

The JMP Securities Healthcare Conference presentation will take place on Tuesday, July 9, 2013, at 2:00 pm Eastern Time at the St. Regis Hotel. The Life Science Innovation Northwest 2013 Conference presentation will take place on Wednesday, July 10, 2013, at 10:45 am Pacific Time at the Washington State Convention Center.

About Atossa Genetics, Inc.

Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company, based in Seattle, WA, is focused on preventing breast cancer through the commercialization of patented, FDA-designated Class II diagnostic medical devices and patented, laboratory developed tests, including its ForeCYTE Breast Health Test which can detect precursors to breast cancer up to eight years before mammography.

The National Reference Laboratory for Breast Health (NRLBH), a wholly owned subsidiary of Atossa Genetics, Inc., is a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle, Washington.

For additional information on Atossa and its medical devices, please visit http://www.atossagenetics.com. For additional information on the ForeCYTE test and the National Reference Laboratory for Breast Health, please visit http://www.nrlbh.com.

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Atossa Genetics to Present at Two Upcoming Investor Conferences

Seattle Genetics Enters Into New Antibody-Drug Conjugate Collaboration with Bayer

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced that it has entered into a new antibody-drug conjugate (ADC) collaboration with Bayer HealthCare (Bayer). Under the latest relationship, Bayer will pay upfront and option exercise fees of up to $20 million for worldwide rights to utilize Seattle Genetics auristatin-based ADC technology with antibodies to several oncology targets. Seattle Genetics is also eligible to receive up to approximately $500 million in potential milestone payments, as well as royalties on worldwide net sales of any resulting products under the multi-target collaboration. Bayer is responsible for research, product development, manufacturing and commercialization of all products under the collaboration.

The significant clinical and preclinical progress across our ADC collaborations, and enthusiasm for our technology as demonstrated by this latest relationship with Bayer, continue to reinforce Seattle Genetics leadership position in the field, said Natasha Hernday, Vice President, Corporate Development, at Seattle Genetics. Across internal and collaborator programs, there are more than 15 ADCs in clinical development using our technology, and we have the potential to receive more than $3.5 billion in future milestones plus royalties from these strategic alliances.

Bayer is committed to translating the science of cancers into effective therapies that can help people with cancer live longer and improve their quality of life, said Prof. Andreas Busch, Member of the Bayer HealthCare Executive Committee and Head of Global Drug Discovery. Antibody-drug conjugates are promising approaches in oncology which can attack tumor cells in a much more targeted way for cancer patients, such that healthy cells are less severely affected. Antibody-drug conjugates are one of our focus areas in oncology research and we are looking forward to strengthening our portfolio in this area of personalized medicine through the collaboration with Seattle Genetics.

ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. With over a decade of experience and knowledge in ADC innovation, Seattle Genetics has developed proprietary technology employing synthetic cytotoxic agents and stable linker systems that attach these cytotoxic agents to the antibody. Seattle Genetics linker systems are designed to be stable in the bloodstream and release the potent cell-killing agent once inside targeted cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The companys lead program, ADCETRIS (brentuximab vedotin), received accelerated approval from the U.S. Food and Drug Administration in August 2011 and approval with conditions from Health Canada in February 2013 for two indications. In addition, under a collaboration with Millennium: The Takeda Oncology Company, ADCETRIS received conditional approval from the European Commission in October 2012. Seattle Genetics also has four other clinical-stage ADC programs: SGN-75, ASG-5ME, ASG-22ME and SGN-CD19A. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including AbbVie, Agensys (an affiliate of Astellas), Bayer, Celldex, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys and Genmab. More information can be found at http://www.seattlegenetics.com.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the worlds leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCares aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at http://www.healthcare.bayer.com.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential and future clinical progress, regulatory approval and commercial launch of products utilizing Seattle Genetics ADC technology. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks related to adverse clinical results as our product candidates or our collaborators product candidates move into and advance in clinical trials, risks inherent in early-stage development and failure by Seattle Genetics to secure or maintain relationships with collaborators. More information about the risks and uncertainties faced by Seattle Genetics is contained in the Companys quarterly report on Form 10-Q for the quarter ended March 31, 2013, filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Seattle Genetics Enters Into New Antibody-Drug Conjugate Collaboration with Bayer

Usapang Pangkalusugan – Stem Cell Therapy – Video


Usapang Pangkalusugan - Stem Cell Therapy

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Usapang Pangkalusugan - Stem Cell Therapy - Video

Stem Cell Therapy Sophie – Video


Stem Cell Therapy Sophie
This is a before video of Sophie. You can see she is trembling due to t he pain in her hips.

By: Tim O #39;Neill, DVM

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Stem Cell Therapy Sophie - Video

Sugar 6 months post femeral head osteotomy with stem cell therapy – Video


Sugar 6 months post femeral head osteotomy with stem cell therapy
Sugar had her femeral head and neck of the bone surgically removed and stem cells put into the hip socket 6 months before this was taken. It was amazing to s...

By: Tim O #39;Neill, DVM

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Sugar 6 months post femeral head osteotomy with stem cell therapy - Video

Stem Cell Therapy Treatment for Right brachial Plexopathy by Dr Alok Sharma, Mumbai, India. – Video


Stem Cell Therapy Treatment for Right brachial Plexopathy by Dr Alok Sharma, Mumbai, India.
Improvement seen in just 5 day after Stem Cell Therapy Treatment for Right brachial Plexopathy by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy 1. T...

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Stem Cell Therapy Treatment for Right brachial Plexopathy by Dr Alok Sharma, Mumbai, India. - Video

2 congressmen who died after stem cell therapy named

MANILA - House Speaker Sonny Belmonte said 2 congressmen died after having stem cell therapy overseas.

These are congressmen Erico Aumentado and Pedro Romualdo.

Belmonte, however, clarified that it has not been established whether stem cell therapy was the cause of death.

Belmonte said that after having stem cell therapy, the 2 felt rejuvenated and may have exerted themselves during the last election campaign.

Belmonte said Aumentado even started walking around without a cane.

Aumentado' son Aristotle, a first-term congressman, was introduced by Belmonte to media during the sidelines of the executive course the lower House sponsored for neophytes.

Aristotle said his father died of pneumonia. He added there is also no proof that stem cell caused the death.

In fact, he said they were scheduled for another treatment after the elections had his father not died.

Aristotle said the Philippine Medical Association (PMA) has not approached them for the PMA's investigation into the deaths of 3 politicians who died after receiving stem cell therapy abroad.

Aristotle explained that his father had leg thrombosis for which he had to undergo bifemoral bypass and stem cell therapy .

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2 congressmen who died after stem cell therapy named

Stem cell therapy in Philippines’ 5-star hotels a scam, says group

Manila (Philippine Daily Inquirer/ANN) - This stem cell therapy could be hazardous to your health.

The Philippine Medical Association (PMA) on Sunday warned Filipinos against availing themselves of the so-called "xenogenic" stem cell therapy from foreign doctors who fly into the country and perform the procedure in five-star hotels in Metro Manila.

The doctors' organisation also announced that it had already tapped the help of the National Bureau of Investigation and the Philippine National Police to look into the scam, which it said tainted the legitimate practice of stem cell or regenerative medicine in the country.

Dr. Leo Olarte, PMA president and spokesperson of the Philippine Society for Stem Cell Medicine (PSSCM), disclosed that the two medical groups had received complaints from patients and their relatives who had undergone such stem cell procedures allegedly performed in the country by German doctors.

Based on the complaints, Olarte said the patients were asked to check in at a five-star hotel in the capital, where they were injected with animal-based stem cells at around 1 million pesos (US$22,800) per shot.

"These foreigners are not even licensed to practice medicine in the country and are in violation of the Medical Act of 1959," Olarte stressed. "We are then asking government regulators and enforcers, especially the NBI and the PNP, to investigate these criminal acts."

He warned Filipino doctors to stop collaborating with unscrupulous foreign counterparts or the organisation would file criminal cases against them.

"If you will continue doing this, we will file criminal cases against you," said Olarte, an orthopedic surgeon and practising lawyer.

The doctor also stressed that the autologous adult stem cell treatmentderived from the patient's own blood, bone marrow or fatwas the only approved stem cell therapy by the Department of Health (DOH) because it had already been proven as the safest procedure available worldwide.

He discouraged Filipinos from considering xenogenic stem cell sources or those derived from animals and plants, as well as allogeneic sources or from other human beings, due to the many instances of deadly complications from these procedures.

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Stem cell therapy in Philippines' 5-star hotels a scam, says group

Genes involved in birth defects may also lead to mental illness

Public release date: 24-Jun-2013 [ | E-mail | Share ]

Contact: Jeffrey Norris jeff.norris@ucsf.edu 415-502-6397 University of California - San Francisco

Gene mutations that cause cell signaling networks to go awry during embryonic development and lead to major birth defects may also cause subtle disruptions in the brain that contribute to psychiatric disorders such as schizophrenia, autism, and bipolar disorder, according to new research by UC San Francisco scientists.

Over the past several years, researchers in the laboratory of psychiatrist Benjamin Cheyette, MD, PhD, have shown that mice with mutations in a gene called Dact1 are born with a range of severe malformations, including some reminiscent of spina bifida in humans.

In a new study designed to explore whether Dact1 mutations exert more nuanced effects in the brain that may lead to mental illness, Cheyette, John Rubenstein, MD, PhD, and colleagues in UCSF's Nina Ireland Laboratory of Developmental Neurobiology used a genetic technique in mice to selectively delete the Dact1 protein only in interneurons, a group of brain cells that regulates activity in the cerebral cortex, including cognitive and sensory processes. Poor function of interneurons has been implicated in a range of psychiatric conditions.

As reported in the June 24, 2013 online issue of PLOS ONE, when the research team examined these genetically altered interneurons in adult mice, they found that the cells appeared relatively normal and had managed to find their proper position in the brain's circuitry during development. But the cells had significantly fewer synapses, the sites where communication with neighboring neurons takes place. In additional observations not included in the new paper, the team also noted that the cells' dendrites, fine extensions that normally form bushy arbors studded with synapses, were poorly developed and sparsely branched.

"When you delete this gene function after initial, early development -- just eliminating it in neurons after they've formed -- they migrate to the right place and their numbers are correct, but their morphology is a little off," Cheyette said. "And that's very much in line with the kinds of pathology that people have been able to identify in psychiatric illness. Neurological illnesses tend to be focal, with lesions that you can identify or pathology you can see on an imaging study. Psychiatric illnesses? Not so much. The differences are really subtle and hard to see."

The Dact1 protein is part of a fundamental biological system known as the Wnt (pronounced "wint") signaling pathway. Interactions among proteins in the Wnt pathway orchestrate many processes essential to life in animals as diverse as fruit flies, mice, and humans, including the proper development of the immensely complex human nervous system from a single fertilized egg cell.

One way the Wnt pathway manages this task is by maintaining the "polarity" of cells during development, said Cheyette, "a process of sequestering, increasing the concentration of one set of proteins on one side of the cell and a different set of proteins on the other side of the cell." Polarity is particularly important as precursor cells transform into nerve cells, Cheyette said, because neurons are "the most polarized cells in the body," with specialized input and output zones that must wind up in the proper spots if the cells are to function normally.

Cheyette said his group is now conducting behavioral experiments with the mice analyzed in the new PLOS ONE paper and with genetically related mouse lines to test whether these mice have behavioral abnormalities in sociability, sensory perception, anxiety, or motivation that resemble symptoms in major psychiatric disorders. He also hopes to collaborate with UCSF colleagues on follow-up experiments to determine whether the activity of neurons lacking Dact1 is impaired in addition to the structural flaws identified in the new study and prior published work from his lab.

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Genes involved in birth defects may also lead to mental illness

Genetically-modified foods produced through modern biotechnology are safe – FDA

By: Jet Villa, InterAksyon.com June 25, 2013 10:48 AM

Last week, the Court of Appeals stopped the genetic engineering of Bacillus thuringiensis (Bt) eggplants nationwide. FILE PHOTO

InterAksyon.com The online news portal of TV5

MANILA, Philippines - A week after the Court of Appeals stopped the genetic engineering of Bacillus thuringiensis (Bt) eggplants nationwide, the Food and Drug Administration (FDA) on Tuesday said genetically-modified (GM) foods produced through modern biotechnology are safe.

In FDA Advisory No. 2013-014, the FDA said that all food derived from GM crops in the market have met international food standards and are as safe as and as nutritious as the food derived from conventional crops for direct use as food, feeds, and for processing.

"The FDA hereby reiterates that all GM food products derived from modern biotechnology that are currently on the market have passed food safety assessment based on the UN FAO/WHO CODEX Alimentarius Risk Analysis of Food Derived from Modern Biotechnology and Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants," FDA Advisory No. 2013-014 said.

The FDA said the safety of these specific GM crops should be assessed on a case-by-case basis, following the CODEX Alimentarius guidelines for determining their safety, including toxicity, allergenicity, and nutritional quality, or assessment of any nutritional claim.

"It is not possible to make general statements on the safety of all GM foods. As the national competent authority, the FDA supports the robust science-based evaluation system of CODEX Alimentarius Commission using data and information from field trials as well as laboratory tests," the FDA said.

"For processed food, the main focus of food safety review is on the objective characteristics of the product and on any health or nutritional claims. The focus of evaluation is on the food product and not on the technology used to produce the product," it said.

GM penetration rate

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Genetically-modified foods produced through modern biotechnology are safe - FDA

GE controls need strengthening, not slashing

24 June 2013

GE controls need strengthening, not slashing

The Green Party is calling for Environment Minister Amy Adams to back off from her threats to strip councils of their power to regulate for genetic engineering in their communities.

The New Zealand Herald today reported that the Minister is investigating how to change the law to stop councils from putting in place controls on genetic engineering (GE) in their communities.

These councils have established that our current regulations dont adequately cover them or farmers in the event of a GE contamination and they need to step in and provide those protections, said Green Party GE spokesperson Steffan Browning.

So what is this Governments response? Same as usual, change the law to take away local democracy.

The controls that councils are putting in pace would place the responsibility, accountability, and liability on the person or company growing the crops, which is where it should be.

This is how nuclear-free New Zealand started, with local councils taking the stand their community wanted them to take and that is a stance that the whole country is very proud of now.

This Government wants to strip local councils of their ability to regulate what happens in their own regions.

Without adequate regulation from central government the burden of risk for GE is placed entirely in the wrong place; on GE-free farmers whose crops have been contaminated from neighbouring GE farms, and on the councils themselves.

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GE controls need strengthening, not slashing

GE controls need strengthening, not slashing – Adams

The Green Party is calling for Environment Minister Amy Adams to back off from her threats to strip councils of their power to regulate for genetic engineering in their communities.

The New Zealand Herald today reported that the Minister is investigating how to change the law to stop councils from putting in place controls on genetic engineering (GE) in their communities.

"These councils have established that our current regulations dont adequately cover them or farmers in the event of a GE contamination and they need to step in and provide those protections," said Green Party GE spokesperson Steffan Browning.

"So what is this Governments response? Same as usual, change the law to take away local democracy.

"The controls that councils are putting in pace would place the responsibility, accountability, and liability on the person or company growing the crops, which is where it should be.

"This is how nuclear-free New Zealand started, with local councils taking the stand their community wanted them to take and that is a stance that the whole country is very proud of now.

"This Government wants to strip local councils of their ability to regulate what happens in their own regions.

"Without adequate regulation from central government the burden of risk for GE is placed entirely in the wrong place; on GE-free farmers whose crops have been contaminated from neighbouring GE farms, and on the councils themselves.

"Its entirely rational for a council to ask GE growers to put aside resources to pay for any crop contamination, and to publically notify an application to release GE crops. Farmers have a right to know if their neighbours are going to be using GE, and ratepayers shouldnt have to pay for contamination or liability costs.

"Councils are working hard to meet the needs of their local communities; they dont need Minister Adams rolling in and riding roughshod over their local democracy," Mr Browning said.

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GE controls need strengthening, not slashing - Adams

Genetic Alliance Selects Oracle Health Sciences Network to Help Patients Gain Access to Clinical Trials

REDWOOD SHORES, CA--(Marketwired - Jun 24, 2013) - Oracle (NASDAQ: ORCL)

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About Oracle Oracle engineers hardware and software to work together in the cloud and in your data center.For more information about Oracle (NASDAQ: ORCL), visit http://www.oracle.com.

About Oracle in IndustriesOracle industry solutions leverage the company's best-in-class portfolio of products to address complex business processes relevant to health sciences, helping speed time to market, reduce costs, and gain a competitive edge.

About Oracle Health SciencesAt Oracle, we believe that a more predictive, preventive, personalized and participatory system will help improve human health.We can help accelerate this journey to personalized medicine through technology, data and insights. Oracle's solutions support industry initiatives to improve care quality and outcomes, reduce costs, and speed time to market for new treatments, therapies and devices.For more information, visit http://www.oracle.com/us/industries/health-sciences/index.html

TrademarksOracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

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Genetic Alliance Selects Oracle Health Sciences Network to Help Patients Gain Access to Clinical Trials

25 Years ALH-Genetics Movie "Adolf’s-Genetics" – Video


25 Years ALH-Genetics Movie "Adolf #39;s-Genetics"
Impression of the development of ALH-Genetics and it #39;s owner Adolf Langhout.

By: ALHLongwood

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25 Years ALH-Genetics Movie "Adolf's-Genetics" - Video

Feeding the World through Plant Breeding and Genetics – Video


Feeding the World through Plant Breeding and Genetics
Ariel Chan, a graduate student at Cornell University, discusses how advances in plant breeding and genetics are essential to secure the world #39;s food supply i...

By: plantbreedgenomics

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Feeding the World through Plant Breeding and Genetics - Video

Genetics key to addicted children

Australian fetuses could become alcoholics and drug addicts before they even leave the womb, new research shows.

The National Drug and Alcohol Research Centre (NDARC) at the University of NSW reveals that genetics and family history can increase the risk of young Australians developing addictions.

NDARC director Professor Michael Farrell at a speech to be delivered on Tuesday night will say that the research helps to determine which genetic and social factors lead to drug and alcohol abuse, as well as mental health problems later in life.

'While we need to recognise there are varying degrees of mental ill health and that it's a complex issue, research confirms that early detection of certain contributing factors is possible,' Dr Farrell said in a statement.

'With the growing trend for buying drugs online and using synthetic drugs or legal highs' among young Australians, now is the time to focus on these solutions.'

The UNSW Medicine Dean's Lecture will address a range of issues affecting young people, including the self-harm epidemic, the effects of adolescent exposure to drugs and alcohol on the wider community and how early intervention might save them, as well as offering preventative solutions for mental illness and risky behaviours.

One in two young Australians suffer from mental illness, said Pat McGorry, Professor of Youth Mental Health at the University of Melbourne.

He said studies indicated that mental illness experienced in their childhood can impact people's jobs and social lives well into their 30s, including having a lower earning capacity and fewer friends.

Mental health costs the Australian economy $7 billion a year, a figure that is set to double over the next 20 years.

The issue doesn't discriminate and can affect any household, said Professor McGorry.

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Genetics key to addicted children

Bearish 3-way bet in Seattle Genetics

A bearish trade dominates today's option activity in Seattle Genetics. Total option volume in SGEN is 9,085 contracts so far, compared to a daily average of just 572 in the last month. Virtually all of the volume is in one three-way put combination.

optionMONSTER systems show that a trader bought 3,000 September 25 puts for the ask price of $1.60 and, seconds later, sold 3,000 September 20 puts for $0.45 to create a vertical spread . He or she then sold 1,800 September 35 calls for $1.20 and another 1,200 for $1.25. The volume at all three strikes was multiples of the open interest, so this is a new position.

The bearish strategy will take a maximum profit if SGEN is at or below $25 at expiration, while the trader risks having to sell shares above $35. This could also be a collar to protect long shares, at least down to that lower strike. (See our Education section)

SGEN is down 2.24 percent to $29.62 this morning, its lowest level since early March. Shares of the biopharmaceutical company were up to $39 toward the end of April but have been trending lower since retesting that level in mid-May.

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Bearish 3-way bet in Seattle Genetics

Good Start Genetics Receives Approval to Conduct Genetic Screening in New York

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Good Start Genetics, Inc.,an innovative molecular diagnostics company harnessing a powerful, proprietary next-generation DNA sequencing (NGS) capability, announced today that it has received a clinical laboratory permit from the New York State Department of Health to provide its GoodStart Select carrier screening tests to in-vitro fertilization (IVF) and other reproductive health practitioners in the state. GoodStart Select, the companys menu of carrier screening tests, detects far more disease-causing mutations than any other carrier screening test routinely used in clinical practice. With this license, Good Start becomes the first laboratory to offer extensively validated NGS-based carrier screening in New York, where nearly 25 percent of all reproductive health carrier screening is performed each year.

Couples planning to conceive want to make sure they have the healthiest pregnancy possible, said David L. Keefe, M.D., Stanley H. Kaplan Professor of Obstetrics and Gynecology and chair, Department of Obstetrics and Gynecology at NYU Langone Medical Center. Good Start's approach to pre-conceptual genetic testing draws on the latest technology developed from the Human Genome Project and delivers remarkable accuracy and sensitivity in the detection of genetic conditions that might afflict their baby.

We congratulate Good Start on being awarded its New York state license and look forward to offering the next generation of genetic testing to our patients, adds Alan Copperman M.D., co-director of Reproductive Medicine Associates of New York, vice chairman of the Department of Obstetrics, Gynecology, and Reproductive Science at Mount Sinai Medical Center, and long-standing adviser to Good Start Genetics.

GoodStart Select was launched in the U.S. in April 2012. Since then, Good Start Genetics high-complexity, CLIA- and CAP-accredited laboratory has processed well over 100,000 tests, detecting both common disease-causing mutations as well as rare, pathogenic mutations that would have otherwise gone undetected by laboratories using traditional genotyping-based technologies. Last week, Good Start Genetics published its comprehensive validation study in Genomics in Medicine.

In addition, Good Starts tests are clinically validated to detect genetic mutations specific to individuals of Ashkenazi Jewish or Eastern European descent. Nearly one in three Ashkenazi Jews in the U.S. is a carrier of at least one of 19 severe inherited diseases, and one-third of the U.S. Jewish population, the vast majority of which are Ashkenazi, resides in the state of New York.

Obtaining the New York state license is an important achievement for Good Start, and were very proud our operation has passed the rigorous New York inspection and approval process, said Don Hardison, president and chief executive officer of Good Start Genetics. We have seen strong adoption by reproductive health specialists across the country, and now look forward to providing our highly accurate and clinically actionable tests to physicians and patients in New York.

About GoodStart Select

GoodStart Select is Good Start Genetics menu of carrier screening tests that, for diseases such as cystic fibrosis, detects many more disease-causing mutations than any other routine carrier screening test, regardless of patient ethnicity. After years of development and rigorous validation, Good Start Genetics has harnessed the power of its sophisticated technologies, including next-generation DNA sequencing (NGS), to provide highly accurate and actionable tests resulting in higher mutation detection rates and fewer missed carriers. Good Start offers genetic screening tests for all disorders recommended by the American Congress of Obstetricians and Gynecologists (ACOG), the American College of Medical Genetics and Genomics (ACMG), and leading Jewish advocacy groups.

To support the companys gold standard genetic screening capabilities, Good Start has a dedicated team of customer care specialists, board certified medical geneticists and genetic counselors who provide step-by-step support, from test selection through results, analysis and reporting. For these reasons, reproductive health specialists and their patients can have the highest degree of confidence in their genetic carrier screening results.

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Good Start Genetics Receives Approval to Conduct Genetic Screening in New York

Gene Therapy for the Treatment of Hemophilia B: Andrew M. Davidoff, MD at TEDxSonomaCounty – Video


Gene Therapy for the Treatment of Hemophilia B: Andrew M. Davidoff, MD at TEDxSonomaCounty
Andrew Davidoff, MD is the Chairman of the Department of Surgery at St. Jude Children #39;s Research Hospital and the St. Jude Children #39;s Research Hospital Endow...

By: TEDxTalks

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Gene Therapy for the Treatment of Hemophilia B: Andrew M. Davidoff, MD at TEDxSonomaCounty - Video

Gene Therapy for Parkinson’s Disease – Video


Gene Therapy for Parkinson #39;s Disease
An animation shows what happens during gene therapy for Parkinson #39;s Disease.

By: BrainSpineCenter

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Gene Therapy for Parkinson's Disease - Video

GOODIEMOB with Cee-Lo Performing LIVE "Cell Therapy" – Video


GOODIEMOB with Cee-Lo Performing LIVE "Cell Therapy"
The Atlanta Hip Hop group, GOODIEMOB, performs in Hollywood. Original member and "The Voice #39;s" Cee-Lo Green performs their rap music hit, "Cell Therapy", wit...

By: ellenoir1

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GOODIEMOB with Cee-Lo Performing LIVE "Cell Therapy" - Video

Powerful gene-editing tool appears to cause off-target mutations in human cells

Public release date: 23-Jun-2013 [ | E-mail | Share ]

Contact: Sue McGreevey smcgreevey@partners.org 617-724-2764 Massachusetts General Hospital

In the past year a group of synthetic proteins called CRISPR-Cas RNA-guided nucleases (RGNs) have generated great excitement in the scientific community as gene-editing tools. Exploiting a method that some bacteria use to combat viruses and other pathogens, CRISPR-Cas RGNs can cut through DNA strands at specific sites, allowing the insertion of new genetic material. However, a team of Massachusetts General Hospital (MGH) researchers has found a significant limitation to the use of CRISPR-Cas RGNs, production of unwanted DNA mutations at sites other than the desired target.

"We found that expression of CRISPR-Cas RGNs in human cells can have off-target effects that, surprisingly, can occur at sites with significant sequence differences from the targeted DNA site," says J. Keith Joung, MD, PhD, associate chief for Research in the Massachusetts General Hospital (MGH) Department of Pathology and co-senior author of the report receiving online publication in Nature Biotechnology. "RGNs continue to have tremendous advantages over other genome editing technologies, but these findings have now focused our work on improving their precision."

Consisting of a DNA-cutting enzyme called Cas 9, coupled with a short, 20-nucleotide segment of RNA that matches the target DNA segment, CRISPR-Cas RGNs mimic the primitive immune systems of certain bacteria. When these microbes are infected by viruses or other organisms, they copy a segment of the invader's genetic code and incorporate it into their DNA, passing it on to future bacterial generations. If the same pathogen is encountered in the future, the bacterial enzyme called Cas9, guided by an RNA sequence the matches the copied DNA segment, inactivates the pathogen by cutting its DNA at the target site.

About a year ago, scientists reported the first use of programmed CRISPR-Cas RGNs to target and cut specific DNA sites. Since then several research teams, including Joung's, have succesfully used CRISPR-Cas RGNs to make genomic changes in fruit flies, zebrafish, mice and in human cells including induced pluripotent stem cells which have many of the characteristics of embryonic stem cells. The technology's reliance on such a short RNA segment makes CRISPR-Cas RGNs much easier to use than other gene-editing tools called zinc finger nucleases (ZFNs) and transcription activator-like effector nucleases (TALENs), and RGNs can be programmed to introduce several genetic changes at the same time.

However, the possibility that CRISPR-Cas RGNs might cause additional, unwanted genetic changes has been largely unexplored, so Joung's team set out to investigate the occurrence of "off-target" mutations in human cells expressing CRISPR-Cas RGNs. Since the interaction between the guiding RNA segment and the target DNA relies on only 20 nucleotides, they hypothesized that the RNA might also recognize DNA segments that differed from the target by a few nucleotides.

Although previous studies had found that a single-nucleotide mismatch could prevent the action of some CRISPR-Cas RGNs, the MGH team's experiments in human cell lines found multiple instances in which mismatches of as many as five nucleotides did not prevent cleavage of an off-target DNA segment. They also found that the rates of mutation at off-target sites could be as high or even higher than at the targeted site, something that has not been observed with off-target mutations associated with ZFNs or TALENs.

"Our results don't mean that RGNs cannot be important research tools, but they do mean that researchers need to account for these potentially confounding effects in their experiments. They also suggest that the existing RGN platform may not be ready for therapeutic applications," says Joung, who is an associate professor of Pathology at Harvard Medical School. "We are now working on ways to reduce these off-target effects, along with methods to identify all potential off-target sites of any given RGN in human cells so that we can assess whether any second-generation RGN platforms that are developed will be actually more precise on a genome-wide scale. I am optimistic that we can further engineer this system to achieve greater specificity so that it might be used for therapy of human diseases."

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Powerful gene-editing tool appears to cause off-target mutations in human cells

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