Eli Lilly and Co. anticipates shipping newly approved Foundayo (orforglipron) within the next week, as the drug becomes the second oral weight-loss glucagon-like peptide-1 (GLP-1) receptor agonist to enter the U.S. market following December’s approval of Novo Nordisk A/S’ Wegovy (semaglutide) pill. Read More
Just over a month after emerging from stealth and disclosing a $150 million series A, Korsana Biosciences Inc. is making the leap to the public market via a merger with Cyclerion Therapeutics Inc. The agreement, which is backed by a $370 million private placement from Korsana’s investors, solidly positions the newly merged company as it heads toward the clinic with KRSA-028, a next-generation shuttled antibody targeting amyloid beta for the treatment of Alzheimer’s disease, and builds out a pipeline of neurodegenerative disease candidates. Read More
Once again, Amgen Inc.’s Tavneos (avacopan) is under U.S. FDA scrutiny, as the agency alerted patients and doctors March 31 about 76 cases of drug-induced liver injury, including eight deaths, with “reasonable evidence of a causal association” with the drug. Read More
Phase II data disclosed March 31 by Pepgen Inc. in myotonic dystrophy type 1 (DM1) hobbled the stock but might have been much different if not for one outlier in the 5-mg/kg multiple ascending dose cohort of the ongoing phase II Freedom2-DM1 trial – and Wall Street is pondering what the hitch means for the Boston-based firm as well as the competitive space. Read More
With cases of peripheral artery disease (PAD) rising across the U.K., and lower limb amputations continuing to increase, med-tech companies joined forces with parliamentarians and health care professionals to push for urgent reform of the vascular sector. Read More
Deep molecular advances are enabling precision medicine for the field of hematology, Wyndham Wilson said during a plenary session at the 2026 Korean Society of Hematology International Conference March 26. Read More
Wegovy (semaglutide) has passed the notoriously strict cost-effectiveness scrutiny of the U.K. health technology assessment body and will now be reimbursed for the prevention of further serious cardiovascular events in people who have had a heart attack or stroke, or are diagnosed with peripheral arterial disease. Read More
On top of prison sentences, loss of assets and a $2.6 million restitution order issued several years ago, Li Chen and Yu Zhou had their naturalized U.S. citizenship revoked March 30 as a consequence of stealing exosome-related trade secrets from Nationwide Children's Hospital's Research Institute in Ohio – the hospital that had sponsored them when they first came to the U.S. from China on H-1B Specialty Occupation visas. Read More
Seeking to increase their understanding of the opportunities and challenges of using digital health technologies (DHTs) in drug trials, the U.S. FDA’s CBER and CDER are requesting public feedback to help inform new guidance as the technologies continue to advance. Read More
New hires and promotions in the biopharma and med-tech industries, including: Immunic, Inogen, Kalohexis, Onconetix, Proxygen, Reset Health, Science Corp., Stryker, Telo Genomics. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Ambrosia, Diagens, Guided, Immunitybio, Scynexis, Soundable Health, Sub-Q Bionics, Tippingpoint, Volitionrx. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Astrazeneca, Concept, Merck, Natera, Oric, Palisade, Pepgen. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Cytovale, Fortress, Infinimmune, Leo, Lipella, Merck & Co., Mindmaze, Novo, Poxel, Scynexis, Takeda, Vibra. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Agios, Ascendis, Elevar, Haemonetics, Medibeacon, Oculis, Polypid, Praxis, Sanofi, Scholar Rock. Read More