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Sotatercept, Merck’s investigational activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein, has scored a phase 3 win, improving physical function and cardiopulmonary outcomes in people with pulmonary arterial hypertension (PAH). Read More
The European Medicines Agency (EMA) has endorsed an International Council for Harmonization (ICH) guideline on testing to determine whether pharmaceuticals contain cancer-causing agents. Read More
In a preliminary opinion, the European Commission told Teva Pharmaceuticals that it suspects the Israeli drugmaker breached EU antitrust law by engaging in anticompetitive practices to delay competition for its blockbuster multiple sclerosis (MS) drug Copaxone (glatiramer). Read More
Senate Republicans have introduced a bill to roll back measures in the Inflation Reduction Act that permit Medicare to negotiate drug prices and cap annual drug expenses for seniors at $2,000 a year. Read More
In the latest move in a multi-year wrangle between the FDA and Vanda Pharmaceuticals over the agency’s proposed refusal to approve a supplemental new drug application (sNDA) for Hetlioz (tasimelteon) as a treatment for jet lag, the FDA is offering Vanda a hearing — but only under specified conditions. Read More
TauRx Pharmaceuticals is claiming an Alzheimer’s win despite admitting that the study’s placebo blinding broke — and that a valid placebo-controlled trial is impossible with the drug, hydromethylthionine mesylate (HMTM). Read More
Problems with capsule weights, new equipment that hadn’t been qualified and air temperature discrepancies have resulted in a three-observation FDA Form 483 for the Fenton, Mo., plant of Mumbai-based generic drugmaker Alkem Laboratories. Read More
The FDA wants to remove Covis Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate) from the market, contending that 11 years of postmarket data have failed to show Makena actually does what Covis claims — improve neonatal outcomes in premature births. Read More