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The Supreme Court Nov. 13 dealt generic giant Teva a major blow as it denied the company’s request to stay a lower court’s ruling that will allow generic versions of the drugmaker’s blockbuster brand drug Copaxone to hit pharmacy shelves in May. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have. Read More
Just months after Sanofi began preparing regulatory filings for its blood cancer drug candidate fedratinib, the company said Monday newly raised safety concerns have forced it to scrap its plans. Read More
A drug’s active ingredient name does not need to appear every time its brand name is repeated in an advertisement, the FDA says, clarifying the most common advertising issue that drugmakers question the agency about. Read More
Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation Monday that instead allows compounders to volunteer for agency oversight. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Monday to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
AbbVie on Monday released the first of six SAPPHIRE Phase III trial results for its hepatitis C candidate, M11-646. The rosy results set the drugmaker up for regulatory filings in early 2014. Read More
The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence. Read More