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Participants in a Dec. 9, 2015, Senate hearing — which addressed drug price manipulation of generics in uncontested markets — said the best way to stem the practice is to speed competitors to market and consider using compounders. Read More
The FDA’s first public meeting on the 2017 reauthorization of the Biosimilars User Fee Act brought calls for increased transparency in terms of how the agency regulates biosimilars and a rethinking of how these products will be named. Read More
Par Pharmaceutical’s efforts to litigate its way to a generic version of Adderall XR ended with a whimper Nov. 24, after a federal judge barred the company from challenging Shire’s patents. Read More
A recent report suggests the advisory committees that the FDA relies upon to ensure medical products are safe and effective can be wildly inconsistent in their recommended approval rates. Read More
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in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance.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