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Roche’s lung cancer drug wins U.S. approval

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.

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St. Jude warns of heart-device battery issue

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.

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Tesaro Jumps on PARP Ovarian Cancer Win

Tesaro Inc. data showed the oral, once-daily PARP inhibitor niraparib could benefit 70% of all ovarian cancer patients who received previous chemo treatments.

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Amgen’s Kyprolis falls short in study

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.

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Pfizer abandons plan to split into two companies

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.

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FDA approves Amgen’s copy of AbbVie arthritis drug Humira

The U.S. Food and Drug Administration approved Amgen’s biosimilar version of AbbVie’s top-selling arthritis drug Humira.

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Novartis’ Zykadia gets positive results

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.

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Sarepta’s DMD drug wins FDA approval

Sarepta Therapeutics Inc.’s Duchenne muscular dystrophy drug won approval from the U.S. FDA, capping months of regulatory uncertainty.

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Novavax Stayin’ Alive After Shares Crater on Flunked Phase III

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.”

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Roche says new MS drug works better than Rebif

Roche said its Ocrevus multiple sclerosis drug controlled the most common form of the disease better than a rival’s medicine and worked against another form of MS for which there is no approved treatment.

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