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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. Read More
Boston, Mass-based Albireo Pharma said it has hit a phase 3 bull’s eye with Bylvay, an ileal bile acid transport inhibitor under investigation for the treatment of a rare pediatric liver disease called Alagille syndrome. Read More
To achieve more diverse clinical trial participation, trial sponsors and sites should be offered incentives and rewards for recruiting more participants from underrepresented groups, according to a pair of researchers who say current legislative and regulatory efforts aren’t enough. Read More
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