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Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.
AstraZeneca and Ionis Pharmaceuticals’ data drop divulging more details from its highly watched Phase 3 transthyretin silencer trial “further confuses the picture” for Wainua when combined with the standard of care for ATTR-CM, analysts say.
Teva Pharmaceuticals is the ‘stalking horse bidder’ to kick off the auction process for BioXcel Therapeutics’ AI-derived assets as the biotech files for Chapter 11 bankruptcy.
With the approval, Eli Lilly’s Mounjaro becomes the first dual GIP/GLP-1 receptor agonist indicated to lower the risk of heart attack, stroke or cardiovascular death in adults with type 2 diabetes.
Through its DualityBio deal, Roche’s Genentech hopes to create antibody-drug conjugates with payloads that can circumvent growing cancer drug resistance.
Lisraya carries a boxed warning typical of JAK inhibitors, but otherwise has a broad label that allows use in all adults with the rare autoimmune disease, setting up the drug for blockbuster status in a few years, according to Leerink.
Even without specific Phase 3 data yet revealed, analysts see AstraZeneca and Amgen’s Tezspire as a potential threat for Dupixent in eosinophilic esophagitis.
Manufacturers are being pushed beyond mAb‑era platforms into a new design model built around molecular engineering, complex analytics and amplified upstream and downstream processing.
Thanks in part to the revolution cell therapy brought to treating blood cancers, the modality is now showing promise in some autoimmune applications. This expansion is poised to yield even wider benefits.
Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
PRESS RELEASES
New Group Chief Commercial Officer to support next phase of international growth
The petition requests that the FDA broaden the scientific principles supporting generics and biosimilars to encompass all eligible FDA-approved drugs and biological products. The initiatives has the potential to foster competition for some of the most expensive therapies globally once patent and exclusivity protections expire, thereby eliminating barriers to market entry.