By James Waldron
Five years may not seem long to turn around a struggling biotech. But that’s the time frame that recently installed Galapagos CEO Paul Stoffels has given himself to reorient the company around his mantra of: “Let’s focus on the patient.”
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By Angus Liu
For Biogen’s ill-fated Alzheimer’s disease drug Aduhelm, a narrow Medicare reimbursement policy is taking a toll beyond sales. The company has pulled the plug on an observational clinical trial that was meant to collect real-world data on Aduhelm’s use in the U.S.
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By Andrea Park
The FDA handed down back-to-back Class I ratings to medical device recalls from Medtronic and Baxter after malfunctions led to three deaths.
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By Annalee Armstrong
Investors keenly awaiting one-year safety data from uniQure’s Huntington’s disease gene therapy have rewarded the company with a 20% share bump, as the data showed a clear safety profile.
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By Robert King
A Senate committee advanced legislation which grants the FTC more power to go after PBMs and install a series of reforms to the industry.
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By Andrea Park
BD has begun a voluntary recall of many of its intraosseous needle kits and delivery systems, the FDA reported Wednesday, citing a handful of potential safety issues with the devices.
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By Fraiser Kansteiner
Chronic hepatitis delta virus (HDV) infection patients are currently bereft of approved treatment options in the U.S., but that could soon change thanks in part to a positive readout from one of Gilead Sciences’ recently acquired liver disease prospects.
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By Paige Minemyer
LAS VEGAS—As the healthcare industry grapples with health inequities and disparities across the country, health insurers are well positioned to lead the charge, experts said Wednesday.
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By Annalee Armstrong
Just a couple months after showcasing a small data set, BioNTech’s solid tumor CAR-T cell therapy is ready for prime time. BNT211 has been granted a priority medicines, or PRIME, designation from the European Medicines Agency, giving the famed German biotech extra help during the regulatory process.
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By Kevin Dunleavy
After taking multiple myeloma drug Pepaxto off the market in the U.S., Swedish biotech Oncopeptides is advancing the drug in Europe. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the drug for full approval.
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By Conor Hale
Caption Health launched a mobile heart diagnostic service in partnership with Portamedic, which maintains a network of 4,000 medical technicians across 50 states.
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By Annalee Armstrong
There’s an urgent need to improve and extend the lives of patients with rare neurodegenerative diseases, and the FDA is hoping a new five-year action plan, which has a specific detailed blueprint for amyotrophic lateral sclerosis (ALS), can help accelerate new medicines.
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