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The FDA is taking the unusual step of pressing Genervon Biopharmaceuticals to release all data from a Phase IIa trial of its amyotrophic lateral sclerosis drug, including an analysis of changes in patients’ lung function. Read More
Bristol-Myers Squibb has cut short the comparative arm of a trial of its immunotherapy drug Opdivo after interim results showed a clear benefit over chemotherapy. Read More
Otsuka is again urging a federal judge in Maryland to prevent the FDA from granting any ANDA for generic versions of Abilify, after the agency indicated this week it had not yet decided whether the blockbuster antipsychotic drug’s exclusivity bars generic approvals. Read More
In response to congressional pressure, the HHS inspector general will investigate how recent increases in generic drug prices have impacted the Medicaid rebate program and whether those increases exceeded the inflation rate in 2005 through 2014. Read More
The Federal Circuit affirmed most of a 2013 U.S. district court ruling that ordered Apotex to pay AstraZeneca slightly more than $76 million for infringing on patents for its heartburn drug Prilosec. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More