Abstract
A collection of recently published news items.
The biopharmaceutical company AbbVie announced it will acquire Sunnyvale, CA–based Pharmacyclics in a deal valued at approximately $21 billion. Pharmacyclics' lead drug is ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor approved to treat three types of blood cancer: chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenström macroglobulinemia.
After serving as the agency's commissioner for nearly 6 years, Margaret Hamburg, MD, left the FDA at the end of March. Stephen Ostroff, MD, the FDA's chief scientist, is serving as acting commissioner.
The FDA approved the use of nivolumab (Opdivo; Bristol-Myers Squibb [BMS]) to treat patients with metastatic squamous non–small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. A PD-1 inhibitor, nivolumab was approved in December to treat advanced melanoma.
BMS announced three deals that will expand its oncology pipeline. The company will acquire San Carlos, CA–based Flexus Biosciences, a biotech developing IDO and TDO inhibitors, in a deal worth up to $1.25 billion. BMS also signed an agreement worth up to $975 million with Bavarian Nordic of Kvistgaard, Denmark, to license and commercialize Prostvac, a phase III immunotherapeutic “vaccine” for the treatment of metastatic castration-resistant prostate cancer. Finally, BMS will work with Rigel Pharmaceuticals of South San Francisco, CA, to develop small-molecule TGFβ receptor kinase inhibitors, potentially netting Rigel more than $339 million.
NIH Director Francis Collins, MD, PhD, testified in support of his agency's budget request of $31.31 billion for fiscal year (FY) 2016, a 3.3% increase over FY2015, before the House Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies. He said that the request would fund 1,227 more research grants than in FY2015 and that it “allocates resources to areas of the most extraordinary promise for biomedical research while maintaining the flexibility to pursue unplanned scientific opportunities and address unforeseen health needs.”
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