The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
Roche AG has become the latest pharmaceutical company to respond to the Trump administration’s threat to impose tariffs, saying it will invest $50 billion in drug and diagnostics manufacturing in the U.S. over the next five years. That figure matches a similar commitment by its Basel, Switzerland-based neighbor, Novartis AG, which on April 11 said it would be investing almost $50 billion in the U.S., also over the next five years.
New and positive data for Maia Biotechnology Inc.’s lead candidate for a particularly deadly and advanced lung cancer propelled the stock modestly higher on Feb. 4. The pivotal phase II THIO-101 study of Thio, a telomere-targeting agent sequenced with Regeneron Inc.’s immune checkpoint inhibitor, Libtayo (cemiplimab), as a third-line treatment for advanced non-small-cell lung cancer (NSCLC) showed median overall survival of 16.9 months for the 22 NSCLC patients who received at least one dose of Thio in parts A and B.
Positive top-line data from Eyepoint Pharmaceuticals Inc.’s phase II study of EYP-1901 and the selective tyrosine kinase inhibitor vorolanib for treating wet age-related macular degeneration (AMD) is challenging Regeneron Pharmaceuticals Inc.’s recently approved Eylea (aflibercept).
Blueprint Medicines Corp.’s cancer drug Ayvakyt (avapritinib) looks set to gain an expanded label in Europe, amid a flurry of decisions from the European Medicines Agency’s CHMP scientific committee. Late last week the CHMP gave a positive opinion for Ayvakyt for treatment of adults with advanced systemic mastocytosis, meaning the drug is likely to gain a further European indication in the coming weeks.
Once again, the U.S. FDA giveth and it taketh away. Just a few days after expanding its approval for Gilead Sciences Inc.’s Veklury (remdesivir) to provide access to more people infected with COVID-19, the FDA essentially shut down the use of two monoclonal antibody (mAb) treatments Jan. 24 that had been authorized to treat mild-to-moderate COVID-19 infections – Regeneron Inc.’s Regen-Cov (Ronapreve in Europe), an antibody cocktail of casirivimab and imdevimab, and Eli Lilly and Co.’s bamlanivimab and etesevimab that are administered together.
Cambridge, U.K.-based Astrazeneca plc has new data from its long-acting COVID-19 antibody combination, AZD-7442, which aims to provide longer protection, potentially for up to a year. Latest data show the intramuscularly injected drug achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild to moderate symptomatic disease.
LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.
LONDON – The U.K. is to make treatment with interleukin-6 (IL-6) inhibitors standard of care for critically ill COVID-19 patients after a randomized trial found the arthritis drugs significantly improve survival.
The biotech industry's rapid response to COVID-19, a pivot of global scope, is driving a broad array of approaches to tackling the infection. On Monday, the first day of BIO's virtual convention, the trade group gathered some of the effort's leading voices to take stock of how those efforts are shaping up.
