Topic:
Regulatory
Latest Headlines
Latest Headlines
FDA responds to one small piece of Avandia criticism
The FDA yesterday responded to a Forbes op-ed from Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, published earlier that day. In it, Nissen railed the...
Novartis apologizes over Diovan study as probe shows employee involvement in trials
Novartis' blood pressure Diovan is on the wane as its expects generics next quarter to begin eating at its blockbuster status. But even as it comes under attack by generics, so does its reputation, as a probe by Novartis reveals that not everything in its trials in Japan followed accepted protocol.
Roche wins FDA approval for novel diabetes Dx
Roche won the FDA's blessing to market a hemoglobin-based diabetes diagnostic, the latest advance in testing for the disease and the first assay of its kind approved in the U.S.
Aveo shares shellacked after Astellas drops EU game plan on kidney cancer
Three weeks after an FDA panel overwhelmingly rejected Aveo's bid to gain an approval for its kidney cancer drug tivozanib, the biotech has earned another vote of no confidence--this time from its pharma partner.
Intuitive wins first da Vinci trial; stock jumps
Intuitive Surgical has prevailed in the first of at least 26 lawsuits over its da Vinci robotic surgery system, as a Washington jury found that the company was not negligent in its training of surgeons.
FDA ban could cost India's Wockhardt $100 million
An FDA import ban can be costly, and India's Wockhardt says the import alert it is now under could slice $100 million out of its revenues.
Why is the FDA holding Avandia hearings? Agency critic has ideas
Publicly disgraced after cardiologist Steven Nissen and his colleagues unveiled data on its cardiovascular risks in 2007, Avandia was withdrawn in Europe and put under tight rein in the U.S. Now, the FDA is revisiting the issue, and Nissen himself has issues with that.
Medtronic wins CE mark to implant CoreValve using expanded procedure
Medtronic scored a pivotal CE mark that will help expand the market for its CoreValve transcatheter aortic valve replacement (TAVR). This latest regulatory nod grants surgeons the ability to use the tech for transcathether valve-in-valve procedures where the new part is placed inside an old, expired replacement valve.
J&J consumer healthcare faces more issues, this time in Brazil
Johnson & Johnson just can't seem to get its consumer health manufacturing in order.
Daiichi accuses Ranbaxy shareholders of hiding info before buyout
Ranbaxy Laboratories' FDA woes may soon be over now that the drugmaker has forked over a $500 million settlement to the federal government. It seems owner Daiichi Sankyo's Ranbaxy woes, however, are anything but. The Japanese company now believes former Ranbaxy shareholders withheld key info when negotiating to sell Daiichi its majority stake in the Indian drugmaker.
