Here's why some VC investors say an economic downturn can be good for digital health In first M&A strike, Paul Stoffels lays out 5-year plan to turn Galapagos around Biogen terminates an Aduhelm study no thanks to restricted Medicare coverage Medtronic, Baxter face FDA Class I labels for separate recalls of heart pumps, ventilators uniQure shares spike as investors see bright spot in 12-month Huntington's gene therapy data PBM reform bill that boosts FTC powers inches closer to passage in Senate BD recalls two years’ worth of bone marrow needle kits after 37 complaints Gilead trumpets win for the chronic hepatitis delta prospect it acquired in $1B+ buyout AHIP 2022: How payers could lead the charge in addressing health equity BioNTech's solid tumor CAR-T hits prime time with EU regulatory tag Rising from the ashes, Oncopeptides gains CHMP endorsement for multiple myeloma drug Caption Health launches AI-guided, at-home heart ultrasound service FDA unveils 5-year action plan for neurodegenerative drugs, with focus on ALS Featured Story | By Heather Landi TORONTO—IIn just the past six months, there have been dramatic shifts in the startup environment. Current trends indicate a market correction is underway. But some venture capital investors say they are excited about this market “reset,” as it represents an opportunity for mission-driven founders to thrive. read more |
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| | L.E.K.’s Looking Ahead 2022 series of Executive Insights looks at how accelerated innovation has brought both unprecedented achievement and enduring challenges for companies throughout the healthcare ecosystem. Click to read more. |
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Top Stories 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.” read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more |
