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The FDA has expanded its list of priority generics applications to include ANDAs filed under government purchasing programs and applications from filers that claim “extraordinary hardship.” Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than stage by stage, which is the current policy. Read More
The FDA approved a new indication for Millennium Pharmaceutical’s profitable oncology drug Velcade, the latest attempt by the drugmaker to expand the chemotherapy product’s uses. Read More
Janssen Pharmaceuticals will launch Invokamet in the U.S. on Aug. 18, following Friday’s FDA approval of the type 2 diabetes therapy. The product is the first fixed-dose combination of an SGLT2 inhibitor plus metformin cleared for marketing in the U.S. Read More
A UK cost-effectiveness agency has recommended not covering Roche’s breast cancer drug Kadcyla because the treatment is too expensive, noting that a discount offered by the Swiss drugmaker wasn’t enough. Read More
The EU-based Innovative Medicines Initiative is launching a $4.5 billion decade-long effort to improve the success rate of clinical trials for certain drugs by 30 percent and boost exclusivity to entice sponsors to develop the drugs. Read More
The FDA has expanded its list of priority generics applications to include ANDAs filed under government purchasing programs and applications from filers who claim “extraordinary hardship,” such as catastrophic incidents or abrupt supply disruption. Read More
Drugmakers Hoffman-La Roche and Hyperion Therapeutics are taking part in Health Canada’s new orphan drugs pilot project to better understand how patient input may be gathered and incorporated into the drug submission review process. Read More