Good morning, everyone, and welcome to the middle of the week. You made it this far, so why not continue, yes? After all, consider the alternatives. We prefer to simply forge ahead with our mandatory cup of stimulation and the ever-growing to-do list. On that note, it is time to get cracking. So once again, here are some tidbits to help you along. Have a wonderful day and drop us a line some time when something fascinating occurs…
Robert Califf, who was nominated to head the FDA, recently coauthored a series of scientific papers raising concerns about agency oversight of clinical trials but asked that his name be removed before publication, according to other authors, Stat reports. The reason is unclear – the FDA says it was his idea, but privately, co-authors say the FDA prompted the move, which raises troubling questions about preserving the scientific record.
The recent sales of priority review vouchers at ever-higher prices has transformed what had seemed to be a failed incentive model into a hot topic, but the enthusiasm is not shared by the FDA, according to Pharma & MedTech Business Intelligence. Many in the agency are uncomfortable with a model where FDA’s ability to set review priorities is auctioned off to the highest bidder – no matter how worthy the goals may be.
The Indian government plans to spend about $270 million to ensure each state has a drug testing laboratory as part of an effort to bolster manufacturing quality, The Indian Express informs us. Labs will either be established or upgraded as part of the plan. Currently, 10 states, including the capital, New Delhi, and the heavily populated state of West Bengal, do not have any testing labs.
The reputation of the flu vaccine has taken a bit of a beating in recent years and now research points to a single component as the weak link, Stat tells us. Data being presented at an infectious diseases conference in San Diego this week show that the part of the vaccine targeting a strain known as influenza A H3N2 has cut the risk of infection by an average of only 38 percent in recent years.
The FDA placed a halt on clinical trials involving a cancer immunotherapy from Advaxis because of concerns a bacteria used to deliver the drug may have contributed to a patient death, The Street says.
Mylan unsuccessfully sought the return of one of its drugs used in the death penalty execution of a death row inmate Oct. 1, according to The Pittsburgh Business Times.
The FDA issued a safety alert and recommended a compounding pharmacy cease manufacturing operations after observing unsanitary conditions at a Californian facility, InPharma Technologist reports.
The FDA will allow 23andMe to market a genome test that screens for Bloom syndrome, a rare disorder that leads to a predisposition in carriers toward the development of cancer, Fast Company says.
French private-equity firm Astorg Partners is exploring the sale of its specialty pharmaceutical company Ethypharm amid the boom in mergers and acquisitions in health care, Bloomberg News writes.
Medicines Co. reached a partnership deal with SymBio Pharmaceuticals that provides the potential for its first product to be marketed in Japan, The Wall Street Journal tells us.
Horizon Pharma is moving headquarters and plans to triple its headcount – to 600 employees – in its corporate nerve center, Crain’s Chicago Business writes.
Data from a late-stage trial showed Roche’s Cotellic used with Zelboraf helped people with a previously untreated form of advanced melanoma live significantly longer compared to Zelboraf alone, Reuters says.Print This Post