Pfizer's palbociclib gets expedited FDA review for advanced breast cancer | FDA OKs adenovirus molecular Dx test from Quidel | FDA widens clearance for Nanosphere's enteric pathogens test
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October 14, 2014
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Pfizer's palbociclib gets expedited FDA review for advanced breast cancer
Pfizer secured priority-review status from the FDA for its application to market palbociclib, or PD-0332991, in combination with letrozole, as a first-line therapy for ER-positive, HER-2–negative advanced breast cancer in postmenopausal women who have yet to receive systemic treatment. The decision was partly based on midstage trial data that showed the combination therapy was more effective than letrozole alone in improving patients' progression-free survival. Healio (free registration)/HemOnc Today (10/13)
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Health Care & Policy
FDA OKs adenovirus molecular Dx test from Quidel
The FDA has given Quidel 510(k) clearance to sell its real-time polymerase chain reaction-based test called the Lyra Adenovirus Assay. The qualitative test analyzes nasopharyngeal and nasal swab samples to identify the presence of human adenovirus viral DNA. GenomeWeb Daily News (free registration) (10/13)
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FDA widens clearance for Nanosphere's enteric pathogens test
The FDA has granted Nanosphere expanded 510(k) clearance for its Verigene Enteric Pathogens Nucleic Acid Test to be used in detecting rotavirus and norovirus using stool specimens. The assay, which runs on the company's Verigene molecular testing platform, was previously cleared for bacterial targets such as salmonella, campylobacter and Shigella. GenomeWeb Daily News (free registration) (10/13)
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Prosensa begins FDA application process for DMD candidate
Prosensa said it has started a rolling marketing application submission to the FDA for its experimental Duchenne muscular dystrophy drug drisapersen. The drug holds breakthrough therapy and fast-track designations in the U.S. The new drug application could be finalized this year. Zacks/Analyst blog (10/13)
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Canada's Ebola vaccine enters human trial in U.S.
NewLink Genetics initiated a clinical trial in Silver Spring, Md., to assess the safety and efficacy of an experimental Ebola vaccine in healthy individuals, according to Canada's health minister. The vaccine, licensed to NewLink Genetics, was developed by Canada's health agency. Results are expected to be available in December. Ottawa Citizen (Ontario)/The Canadian Press (10/12), Reuters (10/13)
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Company & Financial News
Funding round brings in $120M for Invitae
A Series F financing round has pulled in $120 million for Invitae, maker of a gene-based test that can be used to detect genetic conditions related to cardiology, cancer, pediatrics and neurology. The California-based company said it will use the money to expand its genetic data business infrastructure. (10/13)
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Global Developments
GlaxoSmithKline's experimental Ebola vaccine tested in Mali
A clinical trial has begun in Mali of GlaxoSmithKline's experimental Ebola vaccine, which was developed with the National Institutes of Health. Blood samples from four health workers who received the vaccine will be tested for antibody response, and another 37 volunteers will receive the vaccine within weeks. Voice of America (10/10)
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Sanofi unit kicks off Phase III trials of rotavirus vaccine in India
Phase III trials have begun in India to test the efficacy of Sanofi subsidiary Shantha Biotechnics' rotavirus vaccine in preventing severe diarrhea in children. The vaccine was designed to prevent rotavirus infections that cause gastroenteritis. Reuters (10/14)
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Featured Press Releases
Food & Agriculture
People don't understand biotech foods but still consider them bad, show finds
In a recent episode of "Jimmy Kimmel Live," the TV host sent a camera crew to a local market, and they found that many people don't understand biotech foods. Despite their lack of knowledge, many still assumed that biotech-based crops and food are harmful to their health. (10/11), The Huffington Post (10/9)
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Industrial & Environmental
Abengoa to open cellulosic ethanol plant in Kan.
Abengoa Bioenergy will hold an official opening ceremony Friday at its new cellulosic ethanol plant in Hugoton, Kan. The facility is expected to be able to produce 25 million gallons of ethanol per year from almost 350,000 tons of plant cellulose. The Wichita Eagle (Kan.) (10/10)
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News From BIO
New BIO Survey Tool: FDA/Sponsor Interactions During Drug Development
BIO is conducting a first-of-its-kind survey on FDA/Sponsor Interactions During Drug Development. BIO's new survey tool gives participants 24/7 access to provide input on their experiences with FDA regarding current drug development programs. This valuable feedback will enable BIO to provide real-time information to FDA and will inform BIO's policy priorities in the upcoming user fee negotiations that will begin in 2015. Companies are encouraged to share their insights by signing up. All data collected will be blinded and aggregated, and participants will receive exclusive access to reports and analysis throughout the survey process. If you have any questions, please contact Charles Crain.
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Editor's Note
An item in Monday's BIO SmartBrief misstated that BIO has criticized a final FDA guidance on new fixed-dose combination therapies. BIO criticized a draft guidance previously issued by the FDA. SmartBrief regrets the error.
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