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As the U.S. Food and Drug Administration begins to take aim at updating its 40-year-old draft guidance on drugs that treat major depressive disorder (MDD), three drugmakers with key business in that space are raising some concerns.
The U.S. Food and Drug Administration (FDA) granted Merck & Co.’s Keytruda another approval, this one in combination with Alimta (pemetrexed) and platinum chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
Beyond developing novel therapies for serious and rare diseases including FCS, Akcea is also dedicated to supporting the broader needs of the communities they serve.
Two weeks ago during its quarterly report, Novo Nordisk pointed to positive results in four of 10 Phase IIIa trials with oral semaglutide. This morning, the company revealed that the drug hit the mark in the reduction of blood sugar levels and weight in adults with type 2 diabetes.
This past week’s roundup of Movers and Shakers in the biotech industry started with a surprise. Gilead Science’s new(ish) chief medical officer was leaving the company six months after taking over the position.
Sensyne Health, a London-based healthcare artificial intelligence (AI) company founded by biotech entrepreneur Paul Drayson, recently launched an initial public offering (IPO) on the London AIM market. Drayson’s plan is to raise $78 million. It’s just one of many companies that are exploiting advances in computing, data science and AI to help identify and develop potential new drugs.
Copenhagen, Denmark-based Novo Nordisk acquired Bristol, UK-based Ziylo in a deal that could exceed $800 million.
Yet another company is launched to focus on longevity and diseases of aging. The Buck Institute for Research on Aging, Insilico Medicine, an artificial intelligence (AI) company with offices and resources in the U.S., Belgium, Russia, the UK, Taiwan and Korea, and Juvenescence, also a human longevity company, founded Napa Therapeutics to develop drugs against a novel aging-related target.
BioNTech, headquartered in Mainz, Germany, and Pfizer, based in New York City, signed a multi-year research-and-development deal to develop mRNA-based flu vaccines.
Regeneron’s fasinumab hit the mark in a late-stage study assessing patients with chronic pain from osteoarthritis (OA) of the knee or hip. At 16 weeks patients experienced significantly less pain and also showed significantly improved functional ability from baseline.
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