Another recall by Indian drugmakers as U.S. FDA notes troubles
03 September 2015
Two leading Indian drug firms once again face quality in manufacturing issues with the U.S. FDA, leading in this case to voluntary recalls even as both face extensive remedial actions to bring plants back into the good graces of the regulator.
Epic Sciences to Present at World CDx Boston 2015
02 September 2015
Epic Sciences, Inc. ("Epic Sciences"), announced today that Murali Prahalad, Ph.D., president and CEO, is scheduled to present at the World CDx Boston 2015, taking place at the Hilton Boston Logan Airport, September 8 – 11, 2015.
At MIPT, virus and tumor identifier may become part of smartphone
02 September 2015
Scientists at Moscow’s Phystech (MIPT), a leading technology university, have developed an ultra-sensitive nanomechanical sensor to analyze chemical composition in a substance, Lenta.ru reported .
How openFDA's 'crazy collision' of Silicon Valley and federal culture is reshaping the regulator
02 September 2015
Over the past two years the reputation of the IT department at the FDA has changed rapidly. Once best known for burning through CIOs and receiving slapdowns from the congressional watchdog, the FDA is now garnering plaudits for its embrace of agile and open development. This new way of thinking is central to--and to an extent responsible for--the recently unveiled precisionFDA initiative.
Michael Meyers, M.D., Ph.D., Joins Syndax Pharmaceuticals As SVP And Chief Development Officer
01 September 2015
Syndax Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing entinostat as a combination therapy in multiple cancer indications, announced today the hiring of industry veteran Michael Meyers, M.D., Ph.D. to the position of Senior Vice President and Chief Development Officer. Dr. Meyers, who will report to Briggs Morrison, M.D., Chief Executive Officer of Syndax, will become a member of the senior management team, and be responsible for all aspects of clinical development of entinostat, Syndax's oral, small molecule that has direct effects on both cancer cells and immune regulatory cells, potentially enhancing anti-tumor immune responses.
Google Reveals Gigantic Ambitions To Fight Cancer, Diabetes, Parkinson's, Heart Problems
01 September 2015
Google is pumping vast amounts of cash into its cutting-edge life sciences plans , turning a secretive unit based on smart contact lenses into a high powered, expert company.
Adding new multiple myeloma meds to the mix will boost sales to $9B: report
01 September 2015
The market for multiple myeloma drugs is poised for expansion, in part thanks to a globally aging population and improved diagnostic techniques. But new meds are doing their fair share, too, and they'll help push the market's value to nearly $9 billion in 2021, a new report says.
What to Call Biologic Copycats? FDA Plans Names And Suffixes
31 August 2015
Cheaper versions of biotechnology drugs in the U.S. will be distinguished from the expensive brand-name medicine they imitate by attaching a suffix to their generic name, the Food and Drug Administration proposed, a plan that may affect how doctors prescribe the treatments.
China's reforms aim to speed drug approvals
31 August 2015
China is speeding up approval times and improving the review process for domestic and imported drugs. The ultimate aim of a series of reforms recently announced by the State Council, akin to the cabinet, is to develop a faster and better approvals system that rewards innovation.
The FDA has spoken on biosimilar names. But will its hybrid proposal work?
31 August 2015
fter much industry lobbying and public debate, the FDA has proposed a system for naming biosimilar drugs. It's a sort of hybrid of the generic name on one hand and the unique brand name on the other. And it would allow the FDA to make some biosims easy to substitute for the brand-name original--and others not so easy.
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