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      Deals:
      




      Novartis returned to Monte Rosa Therapeutics for a deal worth more than $5.7 billion.
      




      Roche is spending $2.4 billion – and potentially up to $3.5 billion – to buy 89bio.
      




      Shape Therapeutics agreed to a major partnership with VectorY worth up to $1.2 billion.
      




      CSL and VarmX inked a $117 million deal.
      




      Biogen acquired Alcyone Therapeutics for an initial $85 million payment.
      




      OpenEvidence bought Amaro, an ad agency backed by Google Ventures and Greycroft.
      




      Bright Green Corporation merged with PharmAGRI Capital Partners, a federally aligned pharmaceutical infrastructure platform.
      




      Innovaccer acquired Story Health. 
      




      Infinitus and IBM Consulting partnered to bring agentic AI into healthcare entities at scale.
      




      FDA:
      




      The FDA launched a real-time adverse event reporting dashboard for cosmetic products.
      




      Regen BioPharma is preparing a response for FDA regarding its orphan drug application for HemaXellerate. 
      




      The agency approved Corstasis Therapeutics’ Enbumyst to treat the edema associated with congestive heart failure, chronic kidney disease and liver disease.
      




      Roivant Sciences said a candidate licensed from Pfizer for an autoimmune disease has passed a registrational test in dermatomyositis and will lead to an NDA filing with the FDA.
      




      Funding rounds:
      




      AI start­up Lila Sci­ences is clos­ing in on a Se­ries A round to raise $300 mil­lion or more.
      




      Oruka Therapeutics raised $180 million.
      




      Ollin Biosciences debuted with $100 million in funding.
      




      Michael Langer, son of Bob Langer, raised $78 million for T.Rx Capital, his new venture capital fund. 
      




      Dualitas Therapeutics raised $65 million in a Series A financing round.
      




      AllRock Bio announced a $50 million Series A financing round.
      




      Doctronic raised $20 million in funding.
      




      Synthesize Bio launched with $10 million in funding.
      




      Layoffs:
      




      X4 Pharmaceuticals is laying off 50% of its workforce
      




      Arsenal Bio laid off 50% of its staff.
      




      Innate Pharma is cutting 30% of its employees
      




      Industry news:
      




      Eli Lilly lost an appeal of a $183.7 million Medicaid fraud award.
      




      Lilly announces plans to build $5 billion manufacturing facility in Virginia
      




      Lilly’s oral obesity pill, orforglipron, was more effective in lowering blood sugar and weight than Novo Nordisk’s oral version of Ozempic known as Rybelsus, according to data from Lilly’s Phase 3 trial.
      




      Lilly said it had filed for approval of its diabetes drug Mounjaro in children after a Phase 3 trial.
      




      GSK said it will invest $30 billion into U.S. manufacturing and R&D over the next five years.
      




      Areteia Therapeutics said its experimental drug, a twice-daily pill called dexpramipexole, improved lung function in patients with a type of asthma driven by an increase of white blood cells.
      




      Genmab ceased development of an early-stage antibody-drug conjugate that it bought in its $1.8 billion acquisition of ProfoundBio.
      




      ATyr Pharma said its experimental drug efzofitimod failed to reduce the use of oral steroids compared to placebo in a Phase 3 study of pulmonary sarcoidosis.
      




      Exact Sciences debuted Cancerguard, a $689 liquid biopsy test that promises to detect signals from 50 cancers using DNA and protein markers.
      




      AstraZeneca said Fasenra did not succeed in a trial for treating chronic obstructive pulmonary disease.
      




      Simon Reid launched Graphene Medical Animation
      




      Corcept Therapeutics must face a Teva lawsuit over a mifepristone “monopoly” for a rare disorder.
      




      ACIP said health plans will continue to cover all ACIP-recommended immunizations that were recommended as of September 1 – including updated formulations of the COVID-19 and influenza vaccines – with no cost-sharing for patients through the end of 2026.
      




      Johnson & Johnson released data finding icotrokinra was more effective than Bristol Myers Squibb’s Sotyktu for psoriasis.
      




      Moderna said its updated COVID-19 vaccine against LP.8.1 variant generated a strong immune response in humans.
      




      States can now apply for a $50 billion fund for rural health providers through the Centers for Medicare and Medicaid – the application period closes on November 5.
      




      Arvinas said it is abandoning efforts to market a breast cancer drug that it had originally developed with Pfizer.
      




      Hims & Hers announced it will offer Kyzatrex (testosterone undecanoate), an FDA-approved oral testosterone replacement therapy from Marius Pharmaceuticals.
      




      Causaly launched its agentic AI platform built for life sciences research and development.
      




      Regeneron Pharmaceuticals said its treatment for an ultra-rare bone disease achieved the primary goal of a Phase 3 study.
      




      AllRock Bio launched.
      




      Sanofi announced one of its newer immunological drugs succeeded in a Phase 2a study for a chronic skin condition.
      




      Wisp expanded access to weight-loss drugs for cash-paying patients in the U.S.
      




      Pneumagen launched its NeumoBind technology platform.
      




      BrightFocus Foundation debuted a pair of national public service announcements, Stop AMD and Stop Glaucoma, to raise awareness of macular degeneration and glaucoma.
      




      To read last week’s edition of Rx Rundown, click here.