With half-year industry financings down 59% from last year, and a U.S. administration supportive of cryptocurrencies, biopharma companies are building treasuries of digital assets to secure future R&D efforts and operational runways. Companies such as Artelo Biosciences Inc., MEI Pharma Inc., Windtree Therapeutics Inc. and 180 Life Sciences Corp. and have entered crypto deals in recent weeks, with the latter noting the potential to “unlock value outside traditional biotech milestones.”
Starlight Therapeutics Inc., a wholly owned subsidiary of Lantern Pharma Inc., announced that the FDA has cleared STAR-001 (LP-184) in combination with spironolactone for patients with glioblastoma multiforme (GBM) at first progression.
The U.S. FDA has staked out a position on the use of per- and polyfluoroalkyl substances in medical devices, declaring that the evidence offers no reason to restrict their continued use in med-tech products.
Jazz Pharmaceuticals plc is prepped and ready for launch following U.S. FDA accelerated approval of dordaviprone as the first systemic therapy for H3 K27M-mutant diffuse glioma. Branded Modeyso, the orally administered first-in-class imipridone was acquired via Jazz’s acquisition earlier this year of Chimerix Inc. in a deal valued at about $935 million.
Cancel culture continues at the U.S. Department of Health and Human Services (HHS) as it observes National Immunization Awareness Month with another strike against vaccines. This time, a $500 million strike specifically targets 22 mRNA vaccine R&D programs at the Biomedical Advanced Research and Development Authority (BARDA), marking the beginning of the end of BARDA’s funding for mRNA vaccines.
The U.S. Centers for Medicare & Medicaid Services adopted several significant policy changes in the Medicare inpatient final rule for fiscal 2026, which includes a larger rate bump for hospitals than seen in the draft.
Olympus Corp.’s “active investment” in endoluminal robotics has materialized in a new joint venture med-tech called Swan Endosurgical Inc., with Revival Healthcare Capital LLC.
The U.K. National Institute for Health and Care Excellence updated its guidance for the use of single-procedure insertion of scaffolds for knee cartilage repairs, specifying that only qualified surgeons should perform the procedure.
After shutting down manufacturers’ efforts last year to offer the mandated 340B discounts on outpatient prescription drugs as a rebate rather than an up-front price, the U.S. Health Resources and Services Administration (HRSA) is now inching the rebate door open for drugs that were selected for the first round of Medicare price negotiations.
Agios Pharmaceuticals Inc. said the patients’ deaths tied to anemia therapy Pyrukynd (mitapivat) that were announced in a securities analyst’s Aug. 4 note to investors hasn’t changed the drug’s already established benefit-risk profile on the drug’s U.S. prescribing information.
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