rf-fullcolor.png

 

January 7, 2025
by Jason Scott

Recon: J&J reports lung cancer therapy significantly prolonged survival in study; Stryker to buy Inari Medical for $4.9B

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Generic GLP-1 drugs could help Medicare drive a harder bargain for Ozempic and Wegovy (STAT)
  • Wegovy and Zepbound tipped to fuel $20B boom in heart failure market (Fierce Pharma)
  • Johnson & Johnson says its lung cancer drug significantly extended survival (STAT) (Reuters)
  • These common medications could be releasing ‘forever chemicals’ into the environment (The Washington Post)
  • Google’s secretive anti-aging company Calico finally released data. Its drug failed (STAT)
  • After tough year, Moderna CEO confronts challenges for RSV, COVID businesses in shareholder letter (Fierce Pharma)
  • Device maker Stryker strikes $4.9 billion deal for Inari Medical (Reuters)
  • AbbVie cuts 2024 profit forecast on acquisition expenses (Reuters)
In Focus: International                                                                                                       
  • Anthem Biosciences eyes $397M public offering in India (Endpoints)
  • France identifies first case of new mpox variant, AFP reports (Reuters)
  • Medtechs Ponder Significance Of UK’s Elective Reform Plan (MedTech Insight)
  • China Greenlights First Stem Cell Therapy On Mixed Clinical Findings (Pink Sheet)
  • Japan’s 2025 ‘Off-Year’ Price Cut Stirs Deeper Concerns (Pink Sheet)
  • Spanish Health Ministry Targets Efficiency With New Medicine Pricing Rules (Pink Sheet)
  • Big Pharma Rushes to China for Deal Prospecting Despite Regulatory Uncertainty (BioSpace)
  • Bird flu risk remains low after first US death, WHO says (Reuters)
Pharma & Biotech
  • Can an epilepsy drug do more than reduce seizures? (STAT)
  • Four years after AlphaFold’s AI ‘solved’ protein structure, a fierce competition lives on (STAT)
  • Metsera’s long-acting GLP-1 looks competitive in Phase 2 obesity study (Endpoints)
  • Immuneering touts positive pancreatic cancer data for MEK inhibitor (Endpoints)
  • Vertex signs in vivo gene editing delivery pact for sickle cell and thalassemia as it looks beyond Casgevy (Endpoints)
  • BWX Technologies to buy Canadian isotope maker for $525M (Endpoints)
  • Pfizer extends AI drug discovery pact with PostEra, adding ADCs to deal (Endpoints)
  • Forbion-backed cardio biotech rebrands to RyCarma with Phase 2 plans (Endpoints)
  • Avenzo picks up another ADC, this time with multi-partnered DualityBio (Endpoints)
  • XyloCor raises $67.5M Series B, updates pivotal gene therapy trial plans (Endpoints)
  • Bausch + Lomb re-ups 'Faces of Glaucoma' campaign to raise awareness of the eye disease (Fierce Pharma)
  • With phase 3 trial win, PharmaEssentia plots label expansion for rare blood cancer treatment Besremi (Fierce Pharma)
  • Klick Health swoops in to acquire life sci market access agency Peregrine (Fierce Pharma)
Medtech
  • Wearable maker ActiGraph acquires assets from Biofourmis to boost clinical trial offerings (STAT)
  • Philips sells small chipmaking subsidiary, Telegraaf reports (Reuters)
  • Outset Medical to pay down debt after raising nearly $300M (MedTech Dive)
Government, Regulatory & Legal
  • The long history of distrust for American insurance companies (STAT)
  • AI Adoption In Pathology Is Lagging: Funding And Clinical Standardization Needed (MedTech Insight)
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.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.