FDA approved garetosmab on 19 August as the first FOP drug shown, in a placebo-controlled trial, to cut both new heterotopic-ossification lesions (by ≥90%) and clinician-assessed flare-ups.
On 18 August the D.C. Circuit let Teva’s challenge to CMS’s “bona fide marketing” generic test go forward, while upholding CMS’s decision to treat Austedo and Austedo XR as one drug. That is not a repeal. It is a seam.
Amylyx’s Phase 3 LUCIDITY hit on 18 August: avexitide cut Level 2/3 hypoglycemia 55% versus placebo in post-bariatric hypoglycemia , a first-in-class blocker of the same receptor the industry has spent years agonizing.
Multibillion-dollar factory expansions by Eli Lilly and Novo Nordisk are narrowing official FDA shortage lists, threatening telehealth compounding models built on unapproved peptide copies.
Coupling topoisomerase inhibitors and microtubule disruptors onto a single antibody scaffold exerts simultaneous multi-pathway cytotoxic pressure to block emergent drug resistance.
Jazz agreed on 10 August to buy Actio Biosciences for $820 million cash plus $500 million in milestones, spinning out everything that is not ABS-1230, to bolt a precision ion-channel drug onto Epidiolex.
With over $200 billion in branded biologic revenues losing exclusivity by 2030, originator drugmakers are navigating secondary patent litigation under aggressive FTC antitrust scrutiny.
Two earnings prints in 48 hours showed the obesity market splitting: Lilly raised the ceiling; Novo raised guidance into a decline.
mFLUSIVA is licensed for adults 50 and older as of 5 August, but the committee that usually turns a license into coverage has not met all year , and flu season is weeks away.
The European Medicines Agency recommended approval for the first-in-class THR-beta agonist for MASH with fibrosis, setting up commercial execution against encroaching GLP-1 combinations.
Engineered methyltransferases achieve durable transcriptional repression across multiple cell divisions without inducing double-strand chromosomal breaks or genomic translocations.
Aiming to diversify oncology revenues ahead of Keytruda's patent expiry, Merck licensed a topoisomerase ADC platform to develop targeted solid-tumor conjugates.