The biotech index is more than a triple bagger ramp since 2010. As a student of the market for over 20 years, with clinical research funding dropping, is there a top anywhere in sight? SZIMM Exclusive Interview with David Nierengarten, Ph.D., an Analyst at Wedbush Securities Covering the Biotechnology and Biopharmaceuticals Sector TWST: What's the FDA [...]
LONDON and PITTSBURGH, Dec. 4, 2014 /PRNewswire/ -- Mylan Inc. (MYL) today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients. [...]
Puma Biotechnology Inc. (PBYI) said it will delay filing for U.S. regulatory approval of its experimental breast cancer treatment by as much as a year. The company’s shares fell 15 percent to $192.36 at 9:36 a.m. in New York, the most since June. The drugmaker announced yesterday that it would apply for Food and Drug [...]
http://www.forbes.com/sites/johnlamattina/2014/12/02/the-debate-over-the-cost-to-develop-a-new-drug/?partner=yahootix
Studyops, San Francisco California, is aggressively seeking a Rheumatologist to become the lead investigator on Clinical Trials. There are currently 1800 studies for RA listed on clinicaltrials.gov and 500 for Lupis. This is a huge area of development in the R&D space and an excellent opportunity for a Rheumatologist to participate in the advancement of [...]
The Biggest HIV/AIDS Research Breakthroughs Of 2014 http://www.huffingtonpost.com/2014/12/01/2014-hiv-aids-research_n_6251388.html
http://www.forbes.com/sites/johnlamattina/2014/12/01/should-the-fda-force-drug-makers-to-discuss-their-clinical-trials/ Companies are not required to meet with the FDA to discuss their trial design. Nor are they required to follow their recommendations. As revealed in a recent research letter to the Journal of the American Medical Association (JAMA) ), of the 35 drugs approved from February 1, 2011 to February 29, 2012, companies met [...]
Studyops and Optimus, San Francisco, CA. were awarded 2 Studies for patients with HIV. Screening will begin in January. Check out www.studyops.com for our contact information to answer any questions. Please welcome Optimus, Dr. Shawn Hassler and his team to the Studyops family.
http://www.fiercepharma.com/story/takedas-us-chief-bows-out-amid-management-shake/2014-11-25?utm_medium=nl&utm_source=internal Takeda Chief is out, EVP Lise Kingo at Novo is out, Allergan pruning the Executive offices, plenty of others. All the M&A buys pipelines, but surely does not guarantee FDA follow through. www.studyops.com
Karla Burke Life Sciences Senior Marketing Specialist at Thomson ReutersTop Contributor Leading health experts said that having decided it is ethical to use non-approved products to help deal with the Ebola virus epidemic, it would be unethical if those drugs were administered in the context of randomized clinical trials. “No one insisted Western medical workers [...]
