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India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
The FDA plans to triple its staff in China from 13 to 39, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More
Manufacturers of prescription and over-the-counter drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance. Read More
The FDA has added a warning about risks of a rare brain infection associated with Biogen Idec’s multiple sclerosis drug Tecfidera, after the first confirmed death of a patient taking the drug. Read More
Baxter International has filed a lawsuit against generics maker Mylan over its patent challenge to the brandmaker’s heart rate control drug Brevibloc. Read More
Endo and Bayer are suing generics maker Perrigo’s subsidiary Paddock Laboratories over its patent challenge to the brand firms’ testosterone replacement therapy Aveed. Read More
With drugmakers facing a Jan. 1 deadline to begin complying with new product track-and-trace requirements, the FDA has announced a wide range of options that companies can choose from to satisfy the new law in a short guidance that contains no surprises for industry. Read More
Teva has become the second generics maker to settle a lawsuit alleging that it conspired with AstraZeneca to delay generic entry of its blockbuster heartburn therapy Nexium, a move that comes as the judge overseeing the case continues to dampen plaintiffs’ antitrust claims. Read More