Swiss drugmaker Roche Holding’s new immunotherapy Tecentriq won approval from U.S. health regulators as a second-line lung cancer treatment, a decision seen likely to erode Bristol-Myers Squibb’s position in this hotly contested market.
St. Jude Medical Inc. warned that some of its implanted heart devices were at risk of premature battery depletion, a condition it said had been linked to two deaths.
Tesaro Inc. data showed the oral, once-daily PARP inhibitor niraparib could benefit 70% of all ovarian cancer patients who received previous chemo treatments.
Amgen’s multiple myeloma drug did not fare better than Takeda’s older therapy Velcade in a study involving patients who had not yet been treated for the disease.
Pfizer, which was considering a split into two companies for more than two years, said it would not do so because the move would not create any shareholder value.
The U.S. Food and Drug Administration approved Amgen’s biosimilar version of AbbVie’s top-selling arthritis drug Humira.
Novartis’ Zykadia drug performed well against a rare form of lung cancer, citing a study the Swiss company hopes will help it win expanded regulatory approval.
Sarepta Therapeutics Inc.’s Duchenne muscular dystrophy drug won approval from the U.S. FDA, capping months of regulatory uncertainty.
Shares of Novavax plummeted more than 82 percent after the company released data that its Phase III trial for its RSV F Vaccine for older adults did not meet its goals, failing to demonstrate “vaccine efficacy.”