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Teva Pharmaceuticals is trying to divest assets in anticipation of regulatory objections to its purchase of Allergan’s generics division, according to a corporate filing. Read More
An international aid group has negotiated a multi-year licensing agreement with Bristol-Myers Squibb to produce generic hepatitis C medicines in many developing nations. Read More
Two months into the new federal fiscal year, generic approvals are faring considerably better compared to the same year-ago time frame, according to the FDA’s Generic Drug Program database. Read More
The nation’s largest pharmacy benefits manager is throwing its support behind a cheaper alternative to Turing Pharmaceuticals’ expensive toxoplasmosis/HIV treatment, threatening its monopoly on the market. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
In a win for branded drugmakers, President Barack Obama signed into law a bill extending the exclusivity periods for many new drugs and biologics. The measure — H.R. 639, referred to as the “Improving Regulatory Transparency for New Medical Therapies Act” — was signed into law Nov. 25, congressional records show. Read More
The FDA is receiving criticism for again delaying a final rule on generic labeling, with some accusing the agency of putting patients at risk. Read More