Drug development, clinical trials and industry dynamics. What changes timelines, risk and competitive positioning.
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Aug 21, 2026The approval covers Pasatru, also known as garetosmab and REGN2477 during development, to reduce new heterotopic ossification lesions and clinician-assessed flare-ups in adults with FOP. The launch changes the structure of a market that had only one approved drug, with Mirum Pharmaceuticals also approaching an FDA decision on zilurgisertib by Sept. 26.
Emily Carter
Aug 19, 2026A full commercial quarter after Eli Lilly’s April approval of Foundayo, early sales show Novo Nordisk ahead in the oral obesity market. The sources point to a familiar obesity rivalry taking a different shape in pills: Novo holds the early edge on brand recognition and reported weight-loss data, while Lilly’s simpler dosing and lower-cost small-molecule manufacturing could matter more as the market broadens.
Michael Torres
Aug 18, 2026The collaboration gives Sandoz ex-China rights to an initial group of biosimilars, with Henlius responsible for development and manufacturing. For Sandoz, the deal ties near-term pipeline expansion to a business line that grew 22% in the second quarter while its larger generics unit was flat.
Dr. Alex Morgan
Aug 18, 2026China’s National Medical Products Administration approved ivonescimab with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer last Wednesday. At the same time, updated HARMONi-6 data posted to the label showed degradation in progression free survival, complicating the case for Summit Therapeutics as it tries to translate Chinese momentum into a U.S. approval strategy.
Dr. Alex Morgan
Aug 17, 2026AbelZeta said rights to prizlon-cel were returned in July, ending J&J’s hold on a large B cell lymphoma asset it had licensed for $245 million upfront through its former Janssen subsidiary. The strategic signal is not about the quality of a single early dataset so much as how large pharmas are pruning external cell therapy bets while adding capital to newer priorities such as in vivo CAR T.
Dr. Alex Morgan
Aug 14, 2026Zenbexus is approved for patients with multiple myeloma who have undergone at least one prior line of treatment, and STAT reported the clearance marks the debut of a new class of medicine for the blood cancer. For Bristol Myers Squibb, the approval arrives as older myeloma products continue to erode, making execution on pricing, uptake and confirmatory evidence commercially important.
Daniel Cho
Aug 14, 2026BioSpace reports that manufacturers including Australia’s BLS Pharmaceuticals and Canada’s Optimi Health are preparing to supply MDMA and psilocybin products into the U.S. as policy support grows. Their opportunity depends not just on clinical progress, but on whether companies can satisfy FDA manufacturing standards and the Drug Enforcement Administration’s shipment-by-shipment controls for Schedule I substances.
Dr. Priya Nandakumar
Aug 12, 2026A newly approved treatment that brought long-awaited hope to Prader-Willi syndrome patients is now under sharper scrutiny after physicians flagged deaths and serious complications reported after launch. The episode shifts attention from approval-era efficacy to whether post-marketing surveillance changes prescribing behavior, uptake, or regulatory oversight.
Sophia Reynolds
Aug 12, 2026The transaction centers on alvelestat, an investigational oral neutrophil elastase inhibitor for alpha-1 antitrypsin deficiency-associated lung disease. For Sentynl, the option structure creates a staged bet on a rare disease asset; for Mereo, it brings a commercial partner candidate and financing tied to getting the program to a new drug application submission.
Dr. Priya Nandakumar
Aug 12, 2026New research published in the Lancet Healthy Longevity suggests that stopping statins at age 75 may be a reasonable option for some healthy older adults with no history of cardiovascular disease. The study’s signal is about flexibility and patient choice in a specific population, not proof that discontinuation is superior or broadly applicable.
Sophia Reynolds
Aug 11, 2026ITM Isotope said the FDA is unable to approve the NDA for 177Lu-edotreotide in its present form because of CMC- and third-party commercial facility-related items. The company said the agency did not identify clinical safety or efficacy issues and that it plans to resubmit the application.
Jonathan Blake
Aug 11, 2026The acquisition continues a deal-driven expansion in epilepsy for Jazz, whose neuroscience franchise is anchored by Epidiolex. Strategically, the transaction adds a potential first-in-class precision medicine in a niche indication where limited treatment options and a registrational path could support a differentiated rare disease play.
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