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The FDA’s Office of Prescription Drug Promotion hit Nascent Biotech with an untitled letter over claims on its website for the investigational brain cancer drug Pritumumab. Read More
The FDA hit a Rancho Cucamonga drug manufacturer with a warning letter for serious GMP violations at its facility including inadequate testing. Read More
Bristol-Myers Squibb and Celgene have agreed to sell off Celgene’s psoriasis treatment Otezla (apremilast) to resolve the Federal Trade Commission’s concerns that BMS’s proposed $74 billion acquisition of Celgene would create a monopoly for oral moderate-to-severe psoriasis treatments. Read More
The FDA handed out its 25th biosimilar approval to Pfizer’s Humira biosimilar Abrilada (adalimumab-afzb) for treating multiple inflammatory conditions. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended five new drugs and two generics for EU approval at its November meeting and called for restrictions on two others. Read More
Generic drugmakers have acknowledged to the GAO that their inability to access samples of reference drugs because of distribution limitations under certain risk evaluation and mitigation strategies (REMS) delayed or discouraged them from developing generic drugs. Read More
In a win for Mallinckrodt, the Patent Trial and Appeal Board (PTAB) invalidated BioVie’s patent on a treatment for ascites — an accumulation of abdominal fluid often linked to advanced liver cirrhosis. Read More