Baxter Healthcare’s drug manufacturing facility in Marion, N.C., was hit with a seven-observation Form 483 citing inadequate change controls and other quality lapses following an inspection in May. Source: Drug…
The European Medicines Agency (EMA) has set forth quality criteria for data used by EU regulators to support benefit-risk decisions. Source: Drug Industry Daily
The European Medicines Agency (EMA) has endorsed an International Council for Harmonization (ICH) guideline on testing to determine whether pharmaceuticals contain cancer-causing agents. Source: Drug Industry Daily
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…
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). Source:…
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…
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…
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).…
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…
Congress may have delayed reauthorization of the FDA’s user fee programs until almost the last hour, but the agency had its table of rates worked out and queued up for…