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Gilead is yielding to pressure to reduce the price of its game-changing hepatitis C drug Sovaldi just weeks after it hit the U.S. market, developing an access program as well as licensing partnerships with generic drugmakers in India to manufacture cheaper versions of the drug for the Indian market. Read More
Days after the FDA said it plans to investigate the safety of testosterone replacement drugs, Abbott was hit with five lawsuits claiming the drugmaker marketed Androgel to millions of men who didn’t need it and hid the risks of heart attack and stroke associated with the drug. Read More
In an effort to build opposition to the FDA’s proposed generic drug safety labeling rule, GPhA is warning that spending on generics will rise by $4 billion per year if the rule is finalized. Read More
Merck & Amgen will collaborate on a Phase Ib/II trial evaluating Merck’s MK-3475 in combination with Amgen’s talimogene laherparepvec anti-cancer immunotherapies. Read More
Following the FDA’s lead, the Scottish Medicines Consortium (SMC) said Monday it plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More
House lawmakers have proposed legislation that would restrict the bulk distribution and use of dextromethorphan (DXM) in finished drugs in a bid to help curb adolescent abuse of OTC cold and cough medicines. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
Quebec drugmaker Valeant Pharmaceuticals is acquiring Rhode Island’s PreCision Dermatology in a transaction expected to close in the first half of this year. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More