strong>Aduro Biotech Inc., of Berkeley, Calif., said an investigator-sponsored phase II trial is under way to evaluate its immuno-oncology product candidates Gvax Pancreas and CRS-207 in combination with Opdivo (nivolumab), a monoclonal antibody against programmed death-1 receptor, or PD-1, developed by Bristol-Myers Squibb Co., of New York. Read More
Cipher Pharmaceuticals Inc., of Mississauga, Ontario, said it strengthened its product pipeline by acquiring the worldwide rights to three products from specialty pharmaceutical company Astion Pharma A/S, of Copenhagen, Denmark. Read More
The FDA this week released two revised sections of its Manual of Policies and Procedures. One deals with classifying resubmissions of original new drug applications, biologic license applications and efficacy supplements in response to a complete response letter. Read More
Bristol-Myers Squibb Co., of New York, said data supporting the clinical development of BMS-955176, an investigational component designed to prevent the maturation of HIV-1, was described in an oral and a poster presentation at the Conference on Retroviruses and Opportunistic Infections in Seattle. Read More
Medivation Inc., of San Francisco, said U.S. net sales of Xtandi (enzalutamide) capsules, as earlier disclosed by partner Astellas Pharma Inc., of Tokyo, were $230.2 million for the quarter (up 82 percent vs. prior year) and $679.8 million for the full year 2014 (up 73 percent vs. prior year). Read More
Taking stock of the lessons being learned from the ongoing Ebola epidemic in West Africa and other health care emergencies, members of the Senate Health, Education, Labor and Pensions (HELP) Committee got an earful Thursday about the need to prepare for future emergencies rather than jumping from one crisis to the next. Read More
SHANGHAI – The evolving story of CASI Pharmaceuticals Inc. is about a Nasadaq-listed firm hoping for a fresh start as a China-focused oncology company without letting go of its American roots. Read More
Researchers at the Dana-Farber Cancer Institute have developed a biomarker that could be broadly useful to test the effectiveness of many different cancer drugs in many different tumor types. Read More
Abivax SAS dosed the first patient in a pivotal phase IIb/III trial of ABX203, a therapeutic vaccine it's testing against hepatitis B virus (HBV) e-antigen-negative active chronic HBV. Read More
Only willing to sing half the song at the moment, Lyric Pharmaceuticals Inc. drew $20.4 million in a series A round that will pay for two studies with a compound targeting a gastrointestinal (GI) condition, including a proof-of-concept experiment. Read More
Sanofi SA, of Paris, said the FDA approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily, long-acting basal insulin, to improve glycemic control in adults with type 1 and type 2 diabetes. Read More
