The Medicines Co. (NASDAQ: MDCO) announced last week that its cholesterol-lowering medicine inclisiran, meant to be taken just twice a year, had passed a key test but offered no details. Some of those details arrived this morning. At a medical meeting in Paris, a presentation from the test, a 1,617-patient Phase 3 study called ORION-11, […]

Three patents that extend the exclusivity of Alexion Pharmaceuticals’ franchise rare disease drug will now face a patent challenge from Amgen. On Friday, a court within the US Patent and Trademark Office agreed to a review of Amgen’s claims that three Alexion (NASDAQ: ALXN) patents covering its drug, eculizumab (Soliris), were anticipated or obvious, and […]

AbbVie has officially waved the white flag on the cancer drug that triggered its $5.8 billion buyout of Stemcentrx a few years ago. North Chicago, IL-based AbbVie (NYSE: ABBV) said that rovalpituzumab tesirine, or Rova-T, failed another clinical trial—this time a Phase 3 study, MERU, testing the drug as a maintenance therapy in patients with […]

Scholar Rock (NASDAQ: SRRK) announced that Rhonda Chicko, the company’s chief financial officer, is leaving to “pursue other opportunities.” The Cambridge, MA-based drug developer gave no other details about Chicko’s plans other than to say that she will stay on the job through Sept. 30 to help with the transition of her responsibilities. A search […]

Infections caused by the hepatitis B virus, which attacks the liver, are typically treated with drugs that keep the virus from making ever more copies of itself. However, because those treatments reduce but don’t eliminate the virus, patients have to take the drugs indefinitely, according to the World Health Organization. Ionis Pharmaceuticals (NASDAQ: IONS) has […]

Thomas Neff, the founder, CEO, and chairman of FibroGen (NASDAQ: FGEN), has passed away. The San Francisco-based biotech did not disclose any details other than to say Neff’s death over the weekend was unexpected. Board member James Schoeneck has been named interim CEO while the company searches for Neff’s permanent successor. Neff founded FibroGen in […]

An experimental GlaxoSmithKline treatment for multiple myeloma has achieved the main goal of a key study, and the drug maker plans to file for regulatory approval by the end of this year. GlaxoSmithKline (NYSE: GSK) said Friday that treatment with its drug, belantamab mafodotin, showed a “clinically meaningful overall response rate” in the study. The […]

John Halamka thinks the digital health industry is still “emerging.” But it has come a long way and is starting to deliver after years of hype. Halamka, a Boston-based physician and healthcare technology expert, says that’s thanks to several coalescing factors: improved technology, more favorable financial incentives for using digital products in healthcare, and growing […]

Elanco Animal Health, the veterinary sector’s fourth-largest company measured by revenue, is poised to leap to number two through a $7.6 billion cash and stock deal for Bayer’s animal health unit. The acquisition will help Elanco boost its business selling products for farm animals. But Elanco (NYSE: ELAN) notes that Bayer, which sells the popular […]

Sarepta Therapeutics won one of the most dramatic and controversial drug approvals in the history of the FDA a few years ago. It didn’t have the same luck the second time around. The FDA late Monday rejected golodirsen (Vyondys 53), which was widely expected to become the second approved Duchenne muscular dystrophy drug from Sarepta […]

The dog days of summer are here and IPO activity has slowed, but that hasn’t stopped some biotech companies from securing a place in the line leading to Wall Street. Late Friday, SpringWorks Therapeutics and Satsuma Pharmaceuticals filed paperwork to go public. SpringWorks spun out of Pfizer (NYSE: PFE) nearly two years ago, aiming to […]