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The agency determined that it was not reasonable to assume that the market size would remain constant for the first seven years of marketing Sublocade. Read More
The U.S. Patent Trials and Appeals Board has agreed to launch an inter partes review of a GlaxoSmithKline patent aimed at a vaccine component. Read More
The House Judiciary Committee is set to mark up two pieces of bipartisan legislation today that aim to crack down on drugmakers who game the patent system. Read More
The approval is the ninth indication for Imbruvica in Canada, and the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with chronic lymphocytic leukemia. Read More
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