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      Deals:
      




      BioNTech agreed to acquire CureVac for about $1.25 billion in an all-stock deal.
      




      RayzeBio, the radiopharmaceutical unit of Bristol Myers Squibb, licensed an experimental drug and diagnostic agent for prostate cancer from Philochem AG for a $350 million upfront payment. Philochem is eligible for another $1 billion in contingency payments.
      




      Deep Apple Therapeutics reached an agreement with Novo Nordisk to develop and commercialize oral small molecule treatments for obesity.
      




      Concentra is set to acquire Elevation Oncology.
      




      Citius Oncology entered into a distribution services agreement with Cardinal Health to support its upcoming U.S. commercial launch of Lymphir (denileukin diftitox-cxdl or E7777).
      




      Boehringer Ingelheim and Eko Health entered into a digital health collaboration to improve heart murmur detection in dogs.
      




      OBI Pharma entered into an ADC collaboration with TegMine Therapeutics.
      




      Kiora Pharmaceuticals and Senju Pharmaceutical are set to collaborate on KIO-301 for ophthalmic diseases in Asia.
      




      MaxCyte and Ori Biotech announced a strategic collaboration.
      




      Chiesi Group announced a licensing deal with Swedish biotech Key2Brain to develop blood-brain barrier-crossing enzyme replacement therapies for lysosomal storage disorders.
      




      Swedish CDMO Recipharm and the University of Oxford expanded their collaboration to include additional manufacturing duties.
      




      Biofrontera Inc. confirmed a disclosure by the management board of Biofrontera AG that the two companies are in negotiations regarding a possible combination of the two companies or an adjustment of the license and supply agreement between them.
      




      MilliporeSigma and Simtra BioPharma Solutions announced a partnership.
      




      Lumeris announced a partnership with Google Cloud to target the primary care shortage in the U.S.
      




      The American Society of Echocardiography and the Cardiovascular Research Foundation launched an educational collaboration.
      




      FDA:
      




      Officials at the FDA say they want to speed up approvals for new drugs and devices using tech like the new “Elsa” AI system.
      




      The agency approved Merck’s Enflonsia for prevention of RSV in infants born during or entering their first RSV season.
      




      Nuvation Bio won FDA approval for its first commercial drug for non-small cell lung cancer.
      




      George Medicines announced that the FDA approved Widaplik (telmisartan, amlodipine and indapamide) for hypertension in adults, including initial treatment.
      




      FDA moved to restrict the use of Merck’s and Bristol Myers Squibb’s immunotherapies in patients with stomach cancer.
      




      The agency approved Incyte’s Zynyz for anal cancer.
      




      The FDA has cleared Capsida Biotherapeutics to test its gene therapy for Parkinson’s disease linked to GBA mutations.
      




      FDA approved Azurity Pharmaceuticals’ Xifyrm for moderate-to-severe pain management.
      




      The FDA approved an expanded indication for AbbVie‘s Mavyret (glecaprevir/pibrentasvir) to treat acute hepatitis C.
      




      Avidity Biosciences reached an agreement with the FDA to seek accelerated approval of its treatment for an inherited muscle-weakening disease
      




      Monte Rosa Therapeutics announced FDA clearance of its investigational new drug application for MRT-8102.
      




      Funding rounds:
      




      Gene therapy biotech SpliceBio raised $135 million.
      




      ADC Therapeutics launched a $100 million PIPE.
      




      The National Institutes of Health is soliciting proposals for Health and Human Services Secretary Robert F. Kennedy Jr.’s autism data project, pledging an initial $50 million for efforts to help identify causes of the neurological condition, per a funding opportunity posted to the agency’s website.
      




      Parallel Bio raised $21 million in Series A funding.
      




      Citius Pharmaceuticals announced a registered direct offering of up to $15.8 million.
      




      Angelini Ventures invested in a €11.25 million seed round for Elkedonia.
      




      Aytu BioPharma closed an upsized at the market public offering of common stock.
      




      CERO Therapeutics Holdings, Inc. announced a reverse stock split.
      




      Immunology biotech Odyssey Therapeutics has withdrawn its plans to go public via an IPO.
      




      Layoffs:
      




      National Resilience, a startup that promised to transform drug manufacturing, said that it would “wind down” many of its facilities.
      




      Recursion Pharmaceuticals said it was laying off 20% of its employees
      




      HHS Secretary Kennedy has taken the extraordinary step of firing the CDC’s vaccine advisory panel, saying that “a clean sweep” is needed to restore faith in vaccines.
      




      Genentech laid off 143 employees in South San Francisco.
      




      Vertex Pharmaceuticals is laying off 125 employees in Rhode Island.
      




      ADC Therapeutics revealed layoffs.
      




      Industry news:
      




      Sanofi said it plans to deliver its AstraZeneca-partnered RSV product, Beyfortus, “well ahead” of the disease season that starts in November.
      




      Novartis announced positive results from a Phase 3b study evaluating the efficacy and safety of twice-daily oral Fabhalta in patients switching from anti-C5 PNH therapies.
      




      A monthly treatment from Otsuka Pharmaceutical reduced by more than half the levels of a toxic protein in the urine of patients with an autoimmune kidney disease.
      




      Metsera shared its first clinical data as a publicly-traded company.
      




      A recent report found that taurine — an amino acid abundant in plants, animals and energy drinks — was found to be an unreliable biomarker for aging.
      




      Insmed said its once-daily, inhaled formulation of treprostinil achieved the primary goal of a Phase 2 study in patients with pulmonary arterial hypertension.
      




      Danforth Advisors established the Danforth Market Access Division.
      




      The Pharmaceutical Care Management Association, the trade group representing pharmacy benefit managers, sued to overturn a first-in-the-nation state law that prevents them from owning pharmacies in Arkansas.
      




      Oak Street Communications started working with MaxCyte as its PR agency of record.
      




      Johnson & Johnson announced findings from a Phase 3b study showing that Tremfya (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis and inhibited progression of joint structural damage at 24 weeks compared to placebo.
      




      Eversana was named U.S. commercialization partner for OS Therapies.
      




      Weber Shandwick Collective agencies Current Group and DNA Communications launched CurrentWell, a consumer health offering supporting brands across wellness, health tech and behavior change campaigns.
      




      Medtronic announced MiniMed as the name for its planned diabetes company.
      




      See last week’s edition of Rx Rundown.