Recon: Thermo Fisher to buy CorEvitas for $913M; Moderna inks deal to make mRNA vaccines in China

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• Poseida Therapeutics Gains; FDA Clears Lymphoma Treatment Trial (Bloomberg)
• Amneal Slides as FDA Asks for Data on Parkinson’s Treatment (Bloomberg) (Endpoints)
• FDA says Ipca Labs failed to address quality issues with bad API batches (Endpoints)
• Artificial Intelligence Legislative Activity To Start In Fall; Sen. Schumer Lays Out Principles, Process (Pink Sheet)
• Bernie Sanders wants to add price caps to therapies developed with BARDA, CDC funds (Endpoints)
• Defense Department enlists Evotec to make new antibody treatments for Mpox and other poxes (Endpoints) (Fierce)
• Mark Cuban's online pharmacy set to launch Humira biosimilar (Reuters)
• NIH halts funding for Colombian research facilities accused of abusing animals (STAT)
• First pediatric study to test neutralizing antibodies against HIV shows promise (STAT)

• Moderna pens deal with China to make mRNA medicines that 'will not be exported' (Endpoints) (Bloomberg)
• ICH Takes First Step In Bid To Align RWE Use Globally (Pink Sheet)
• Moderna files RSV vaccine for older adults in US and Europe (Endpoints)
• EU agency sees no major reason to block glyphosate (Reuters)
• ‘Faster Global Drug Approval’ Possible Under EMA’s Extended Reliance Framework (Pink Sheet)
• EMA and FDA Compared – The Case Of Minoryx’s Leriglitazone (Pink Sheet)
• England’s NICE Consults On Health Technology Evaluations Guide Incorporating Proportionate Approach (Pink Sheet)
• China approves BCMA CAR-T therapy for multiple myeloma, with Innovent beating Legend in race to be first (Endpoints)
• HTA changes at EU level could slow the uptake of new cell and gene therapies, industry group warns (Endpoints)
• Australia reclassifies psychedelics to facilitate medical use, as advocates push for similar move in US (Endpoints)
• Sanofi inks deal to help Saudi Arabia manufacture vaccines locally (Endpoints)

• Thermo Fisher fronts over $900M for data intelligence company as M&A strategy takes shape  (Fierce) (Reuters) (BioSpace)
• Revive Therapeutics' experimental COVID treatment fails in late-stage study (Reuters)
• Teva Said to Mull Sale of $2 Billion Active Ingredients Unit (Bloomberg) (Endpoints)
• Bausch + Lomb Buys J&J’s Dry Eye Drops for $106.5M in Expansion of OTC Business (BioSpace) (Fierce) (Reuters)
• Takeda adds another F-Star collab to constellation, this time for $1B in biobucks (Fierce) (BioSpace)
• Pfizer, Samsung Biologics build on biosimilar deals now worth $897M (Endpoints) (Fierce)
• Pfizer pours $25M investment into Caribou’s cell therapies (Fierce)
• Sumitomo Cuts 62 Jobs in NYC Due to Company Consolidation (BioSpace)
• Aslan hopes fewer side effects can catapult atopic dermatitis med over Dupixent after mixed readout (Fierce)
• J&J leads pharma companies in brand rankings, topping Roche, Bayer and Pfizer amid overall industry decline (Endpoints) (BioSpace)
• Novo Nordisk bought prescribers over 450,000 meals and snacks to promote drugs like Ozempic (STAT)
• Brii hands VBI a lifeline, stumping up $15M for global rights to hepatitis B program and more  (Fierce)
• Protagonist, J&J oral psoriasis drug falls short of injectables but gets close enough to spur phase 3  (Fierce)
• With savvy bets, a dynamic duo makes Eli Lilly one of pharma’s biggest success stories (STAT)
• AbbVie sends SHP2 deal back to port, following Big Pharma peer in retreating from target (Fierce)

• What Changes To The AI Act Would Medtech Benefit Most? (MedTech Insight)
• Harmonizing EPA And Industry Needs: EtO Emissions (MedTech Insight)
• Abbott reels in FDA approval for dual-chamber leadless pacemaker (Fierce) (Bloomberg)
• llumina’s ‘inevitable’ split from Grail likely by mid-2024, analysts say (MedTech Dive)
• ResMed acquires sleep and respiratory diagnostics software maker Somnoware (Fierce)
• Medtronic finds hacking risk in heart device data management system (Fierce)

• Amgen and Horizon call FTC's attempt to block $28B merger unconstitutional in counterclaims (Endpoints)
• Drugmakers Ask Supreme Court to Throw Out Terror Support Ruling (Bloomberg)
• Merck Argues Fosamax Bone Fracture Suits Were Rightly Dismissed (Bloomberg)
• InnoMed Accuses UCLA of Infringing Bell’s Palsy Care Patent (Bloomberg)

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
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