Food and Drug Administration (FDA)

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Cambridge, Mass.-based Biogen exercised its option to acquire additional shares of South Korea’s Samsung Bioepis. Samsung Bioepis focuses on developing biosimilar drugs and is a joint venture between Samsung Biologics and Biogen formed in 2012.
FDA
Joseph Eid, head of medical at BMS, said Empliciti in combination with pomalidomide and dexamethasone has provided proof that the medication can extend the time a patient can live without the worsening of his or her disease.
Based in San Diego, Mirum entered into the agreement with Shire for the exclusive global rights to develop and market maralixibat, a Phase II oral inhibitor of the apical sodium-dependent bile acid transporter (ASBT).
Nektar Therapeutics, based in San Francisco, and New York-based Pfizer are teaming up to evaluate combination regimens in several cancer settings. Those include metastatic castration-resistant prostate cancer (mCRPC) and squamous cell carcinoma of the head and heck (SCCHN).
Cambridge, Mass.-based AVEO Oncology hit the mark in its Phase III study of a treatment for highly refractory advanced or metastatic renal cell carcinoma (RCC). The company said its drug tivozanib met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival (PFS).
Shares of South San Francisco-based Achaogen, Inc. fell more than 12 percent in Monday trading after the company signaled that it began a review of strategic alternatives that could include a sale of the company.
FDA
According to the American Cancer Society, almost 601,000 people in the U.S. died of cancer in 2017. The two most common types of cancer are lung cancer and breast cancer, followed by colorectal cancer, prostate cancer and stomach cancer.
Days after Novartis axed one-fifth of its research programs, the Swiss pharma giant said it intends to seek regulatory approval for 60 new treatments between 2019 and 2021.
An FDA advisory committee overwhelmingly votes in support of Sage’s post-partum depression drug, clearing the way for regulatory approval.
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