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The U.S. Court of Appeals for the Federal Circuit has affirmed an earlier judgment that Teva Pharmaceuticals has to pay $235.5 million in damages to GlaxoSmithKline (GSK) for patent infringement. Read More
To address concerns of federal regulators, vaccine maker Novavax said it will pause production of its COVID-19 vaccine lest it lose its government funding. Read More
HHS said this week that its Office of the Inspector General (OIG) is beginning an investigation into how the FDA determines who gets an accelerated approval pathway and how those prized designations are implemented. Read More
In the latest in a series of acquisitions aimed at quickly ramping up its portfolio of new drugs, Bayer is acquiring San Diego, Calif.-based biopharmaceutical firm Vividion Therapeutics in a deal worth up to $2 billion. Read More
Two industry groups and an opioid maker and distributor have asked the Supreme Court to reject a tax New York state is imposing on opioid manufacturers. Read More
Moderna said that its COVID-19 vaccine is 93 percent effective six months after the second shot, but that the company is still pressing ahead on developing booster shots. Read More
Full FDA approval for the Pfizer-BioNTech COVID-19 vaccine may be just weeks away, as reports indicate an agency-wide push to meet that goal by Labor Day — if not sooner. Read More
A federal court in Delaware has rejected a motion by Hikma Pharmaceuticals to dismiss Amarin Pharma’s patent lawsuit over Hikma’s generic version of the heart drug Vascepa (icosapent ethyl). Read More
Bristol Myers Squibb (BMS) said it plans to withdraw Istodax’s indication as a monotherapy for peripheral T-cell lymphoma (PTCL) after at least one prior therapy. Read More
The Senate Appropriations Committee yesterday voted 25-5 to advance a proposed funding bill that would give the FDA a $200 million boost in nonuser-fee funding in fiscal 2022. Read More
Sanofi drew fire for a product website that offered “inaccurate information about and out-of-date prescribing information” for Dupixent (dupilumab), which is used to treat eczema, asthma and chronic rhinosinusitis. Read More