With rezpegaldesleukin (rezpeg) phase IIb data in alopecia areata holding strong over time, backers of Nektar Therapeutics Inc. are hopeful that the biologic can do for the hair loss market what Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) did in atopic dermatitis. Read More
Arriving a week ahead of April 28 PDUFA date, the U.S. FDA approval of Merck & Co. Inc.’s Idvynso (doravirine/islatravir) brings a new treatment option to adults with HIV-1 infection who are virologically suppressed. The approval is for those with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. Read More
Xeltis BV has secured CE mark approval for Axess, its restorative vascular access conduit for hemodialysis. The company also released 12-month data from its EU pivotal trial on the technology, which showed strong durability outcomes, including 79% secondary patency and a very low patency‑related reintervention rate of 1.3 per patient-year, as well as a substantial reduction in infection burden. Read More
Tortugas Neuroscience Inc. came out of its shell to announce the raising of $106 million between its seed and series A financing rounds. “We like the symbolism of the sea turtle – long-lived, persistent, very determined,” Tortugas CEO Jeff Jonas said of the company’s name. Read More
Shanghai Junshi Biosciences Co. Ltd reported early clinical signals across its next-generation immuno-oncology pipeline, including response rates of up to 71% in metastatic colorectal cancer and 45.5% in hepatocellular carcinoma, at the American Association for Cancer Research meeting in San Diego. Read More
Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga. Read More
Ever since Teva Pharmaceutical Industries Ltd. sued Eli Lilly and Co. several years ago, claiming Lilly’s migraine drug, Emgality (galcanezumab), infringed its headache treatment patents, the two companies have been on a litigation rollercoaster. Read More
When a tumor migrates and colonizes another tissue or organ, it can be identified as a metastasis, but its origin is not always clear. Now, a study based on machine learning has identified DNA-methylation patterns that reveal the type of tissue a cancer comes from when the primary tumor cannot be found. This technique could help guide more specific treatments for patients with cancers of unknown primary, who today often receive broad, nontargeted chemotherapy. Read More
Another biopharma acquisition is at the heart of one of the U.S. SEC’s latest insider trading settlements. This time, the trading centered on Jazz Pharmaceuticals plc’s $935 million purchase of Chimerix Inc. last year. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Alamar, Amanat, Marvel, Mobia, Modular, Odyssey, Prelude, Revolution, Screenpoint, Sharp. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Abbott, Agenus, Astrazeneca, Briacell, Clearmind, Greenwich, Intodna, Kyverna, Mink, Nektar, Nested, Novo Nordisk, Passage Bio, Revolution, Salubris, Sanofi, Sapience, Taurx, Xenon. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Abbvie, Aicuris, Anaptys, Asahi Kasei, Cathworks, First Tracks, GSK, H. Lundbeck, Insphero, Lex, Medtronic, Novartis, Nxera, Quidelortho, Vanda. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Astellas, Bracco, Conavi, Debiopharma, GSK, Orion, Pasithea, Specialised. Read More
