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The judge previously gave the company one month to convince two dozen states that have not agreed to its proposed $10 billion settlement to go along with the injunction. 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
GSK urged the agency to “either refrain from taking action to alter Zofran’s pregnancy-related labeling or take action to alter the labeling” and explain which data warranted the labeling changes. 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
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