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The jury award for Plexxikon also includes additional royalty payments for future sales of Tafinlar in the U.S. through the life of the patents, which expire in July 2028. Read More
The House Energy and Commerce Committee wants Acting FDA Commissioner Janet Woodcock to explain how the agency plans to address the backlog of nearly 8,000 inspections accumulated during the pandemic as lawmakers worry about the potential impact on the agency’s drug reviews. Read More
The FDA explained in a new Manual of Policies and Procedures (MAPP) how generic drug sponsors can get their applications approved even if the submission coincides with labeling changes to the reference drug. Read More
Endo International has agreed in principle to pay a settlement of $35 million in a Tennessee lawsuit related to alleged abuse of its opioid drugs. Read More
The FDA has slapped Incyte with a Complete Response Letter (CRL) for its biologics license application (BLA) for retifanlimab, the company’s intravenous PD-1 inhibitor for the treatment of certain types of anal cancer, asking for additional data to show the drug’s clinical benefit. Read More
Bristol Myers Squibb (BMS) is withdrawing from the U.S. market the indication for its immune checkpoint inhibitor Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib. Read More
A Centers for Disease Control and Prevention (CDC) expert panel has recommended continued use of the single-dose Johnson & Johnson (J&J) COVID-19 vaccine despite reports of Guillain-Barré syndrome (GBS), a neurological illness, in a small number of inoculated individuals. Read More
A jury in the U.S. District Court for the Northern District of California has ordered Novartis to pay $177.8 million to Plexxikon, a subsidiary of Daiichi Sankyo, for infringing on two of the Japanese company’s patents. Read More
A new Israeli study has found that the Pfizer vaccine provided much lower efficacy against COVID-19 infections during a four-week period when the Delta variant became prevalent in that country. Read More