Import bans imposed against two of India's largest generic drugmakers are already shaving away their financial performance, even though the worst is yet to come. Both Ranbaxy Laboratories and Wockhardt today reported diminished results, with Ranbaxy being pummeled hard by a variety of factors, including the ban.
India's Ranbaxy Laboratories saw its profits laid low by a variety of issues, including a ban the FDA imposed in September on the last plant in India still approved to manufacture drugs for the U.S.
When the FDA puts drugs on the fast track for approval, they do make it to market sooner. But they're tested for a shorter period of time than are drugs reviewed under the agency's standard process, according to a new study in the Journal of the American Medical Association. And that has researchers worried.
The FDA banned products at Wockhardt's Waluj plant in May after inspectors discovered workers trying to hide significant problems with manufacturing and test data. The Indian drugmaker said at the time the import alert could cost it $100 million in lost revenues and is now starting to feel that squeeze.
Boston Scientific, the latest entrant into the transcatheter valve replacement space, has won a CE mark for its Lotus implant, nudging the company into an overseas market headlined by squabbles between Edwards Lifesciences and Medtronic.
A Tennessee congresswoman has filed a bill designed to better explain which mobile medical apps fall under FDA regulatory responsibility. Regulators attempted to establish those boundaries with new guidance announced in late September.
The FDA has approved the second imaging agent that can be used to detect a toxic protein found clustered in the fogged brains of Alzheimer's patients, but there's no guarantee it will ever find much of a market.
Offering the service positions Broad to benefit from NIH requests for CLIA-certified sequencing in its research grants.
There were no big surprises for Gilead's $11 billion hepatitis C drug sofosbuvir at today's FDA panel review. The therapy, which promises to help create an entirely new standard of care for the millions of people afflicted with the virus, won a clear endorsement from agency experts. And now it's likely headed for a near-term approval as the FDA formally considers the application.
The FDA has approved Zogenix's pain med Zohydro ER, sending its shares soaring on the reversal of fortunes for a drug that had been rejected by an expert panel late last year.