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      Deals:
      




      Novo Holdings’ $16.5 billion acquisition of Catalent is on track to close.
      




      Merck signed a deal worth up to $2 billion with Hansoh Pharma to develop and sell the Chinese biotech’s experimental oral GLP-1 drug.
      




      BioAge Labs secured a multiyear partnership with Novartis that could total nearly $550 million.
      




      Abundant Health Acquisition has partnered with Americaneagle.com and Sitecore to help healthcare clients of both companies modernize patient digital experiences. 
      




      NeuroMetrix to be acquired by ElectroCore.
      




      Bristol Myers Squibb said it’s giving BioArctic $100 million upfront to license two programs called BAN1503 and BAN2803. The drugmaker also ended collaborations with Immatics and Century Therapeutics.
      




      Novo Nordisk partnered with Broad Institute spinout Photys to explore a new class of small molecule drugs.
      




      CMI Media and Compas, a 2024 MM+M Agency 100 honoree, teamed up with Anoki AI.
      




      Gilead Sciences and Terray Therapeutics entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets.
      




      Silexion Therapeutics announced its ongoing collaboration with Evonik.
      




      Global private equity firms Blackstone and Bain Capital are among final bidders for Mitsubishi Tanabe Pharma, a unit of Japan’s Mitsubishi Chemical Group, in a deal that could value it at between $3 billion and $3.5 billion.
      




      BeiGene announced a $150 million deal to license a cancer candidate from fellow CSPC Zhongqi Pharmaceutical Technology.
      




      Certa Therapeutics bought OccuRx.
      




      Shuttle Pharma entered into a sponsored research agreement with the University of California, San Francisco to advance its PSMA development program.
      




      Sangamo Therapeutics agreed to an AAV partnership with Astellas Pharma.
      




      Curative Biotechnology engaged Golden Eagle Capital Advisors as the exclusive agent and strategic advisor to the company.
      




      FDA:
      




      The Food and Drug Administration said that a shortage of Eli Lilly’s obesity drug Zepbound has been resolved.
      




      The agency issued a Complete Response Letter for Zealand Pharma’s glepaglutide New Drug Application for the treatment of short bowel syndrome.
      




      The FDA approved Mesoblast’s Ryoncil (remestemcel-L-rknd), a mesenchymal stromal cell therapy to treat steroid-refractory acute graft-versus-host disease.
      




      The agency placed a black-box warning on Astellas’ menopause medication Veozah for risk of liver injury.
      




      The FDA declined to approve an injectable version of Johnson & Johnson’s drug Rybrevant for a type of lung cancer.
      




      The agency granted Breakthrough Therapy Designation to Gilead’s Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
      




      EyeDNA Therapeutics announced it received a Rare Pediatric Disease Designation (RPDD) by the FDA for HORA-PDE6b.
      




      Organon announced that the FDA approved Vtama (tapinarof) cream, 1% for an additional indication of the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
      




      Galderma received FDA approval for Nemluvio (nemolizumab) for patients with moderate-to-severe atopic dermatitis.
      




      Checkpoint Therapeutics won FDA approval of Unloxcyt (cosibelimab-ipdl).
      




      Neurocrine Biosciences won FDA approval for a drug to treat classic congenital adrenal hyperplasia.
      




      PTC Therapeutics announced the submission of the vatiquinone New Drug Application for the treatment of children and adults living with Friedreich ataxia to the FDA.
      




      Layoffs:
      




      Novartis said it will shutter MorphoSys sites in Munich and Boston, laying off around 330 employees.
      




      Funding rounds: 
      




      Ottimo Pharma raised $140 million in a Series A round.
      




      SiteOne Therapeutics raised $100 million in a Series B funding round.
      




      The Advanced Research Projects Agency for Health (ARPA-H) awarded TigaTx up to $33.5 million in funding.
      




      Tessera Therapeutics announced an investment of up to $50 million from the Bill and Melinda Gates Foundation for sickle cell disease treatment. 
      




      Startup Bluenote raised $10 million.
      




      Culina Health raised a $7.9 million Series A funding round.
      




      Havas is now officially an independent, publicly traded business following a successful spin-off from parent company Vivendi.
      




      Industry news:
      




      Luigi Mangione was indicted on charges including first-degree murder after the killing of UnitedHealthCare CEO Brian Thompson earlier this month.
      




      Gov. Gavin Newsom declared a state of emergency for bird flu in California.
      




      SkinSpirit named 5WPR as its agency of record.
      




      Aurion Biotech said its cell therapy for treating the cornea improved vision at the highest dose, encouraging it to embark on a Phase 3 trial.
      




      Just over a third of U.S. psychologists say they don’t accept any type of health insurance, according to the American Psychological Association’s latest annual provider survey. 
      




      Tenaya Therapeutics’ clinical data readout for TN-201 showed promise in treating heart disease but the results were underwhelming and sent the stock tumbling.
      




      Insitro discovered a new ALS drug target.
      




      Edgewise Therapeutics shares rose after its muscular dystrophy drug, Sevasemtem, succeeded in Phase 2 trial.
      




      Roche has officially discontinued a Phase 3 hemophilia A gene therapy from its Spark Therapeutics unit.
      




      Roche’s Parkinson drug failed in second mid-stage trial
      




      The Supreme Court said it will consider South Carolina’s move to cut off Medicaid funding to Planned Parenthood.
      




      Teva Pharmaceuticals and Sanofi said a study of duvakitug, a drug to treat ulcerative colitis and Crohn’s disease, showed it had met primary goals.
      




      U.S. digital advertising spending will surpass $300 billion for the first time in 2024, reaching $309.3 billion, a 15.1% increase over 2023, according to data from eMarketer.
      




      Sandoz entered into a settlement agreement with the end payer plaintiffs’ class for $275 million, which is expected to be paid before the end of the year.
      




      Eton Pharmaceuticals announced compelling results from a clinical trial evaluating PKU GOLIKE for treating phenylketonuria (PKU) during prolonged fasting periods. 
      




      Merck announced it will discontinue the development of two cancer assets, vibostolimab and favezelimab.
      




      Merck revealed topline results from two pivotal Phase 3 trials of a two-drug regimen of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection, which met the primary endpoints.
      




      Regeneron announced successful results from the Phase 3 QUASAR trial of EYLEA HD (aflibercept) Injection 8 mg for treating macular edema following retinal vein occlusion.
      




      Regeneron said it will start a Phase 3 program next year for its two factor XI antibodies, following mixed open-label Phase 2 results.
      




      Regeneron also settled a patent lawsuit with Allele Biotechnology over its COVID-19 antibody. 
      




      Vertex Pharmaceuticals shares tumbled after its experimental non-opioid drug showed little difference versus the placebo in reducing pain.
      




      OSE Immunotherapeutics announced positive clinical progress for its late-stage proprietary cancer vaccine Tedopi.
      




      Boundless Bio said it will not advance BBI-825 into the Part 2 portion of the STARMAP clinical trial.
      




      Viridian Therapeutics said its experimental treatment achieved the goals of a second Phase 3 trial for chronic thyroid eye disease.
      




      Edgewise Therapeutics said an experimental drug designed to prevent muscle damage achieved the primary goal of a study involving participants with Duchenne muscular dystrophy, a rare neuromuscular disorder.
      




      The Securities and Exchange Commission reopened an investigation into Elon Musk’s brain-chip startup Neuralink, according to a letter shared by Musk on X. 
      




      Novavax achieved its first $50 milestone payment from Sanofi.
      




      Sanofi sued the Department of Health and Human Services over payment terms for 340B hospitals. 
      




      The Department of Justice issued a lawsuit against CVS Health, stating that it contributed to the opioid crisis epidemic.
      




      Bain Capital was sued for allegations that it exploited inside information and bought shares worth $140 million from Cerevel Therapeutics before its sale to AbbVie.
      




      AbbVie bought Nimble Therapeutics for $200 million.
      




      McKinsey & Co. agreed to pay $650 million for helping Purdue Pharma boost sales of its opioid OxyContin.
      




      See last week’s edition of Rx Rundown.