rf-fullcolor.png

 

November 28, 2023
by Jason Scott

Recon: FDA approves SpringWorks’ Ogsiveo for treating desmoid tumors; Pfizer sues Poland over missed COVID-19 vaccine payments

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

In Focus: US
  • SpringWorks wins FDA approval for drug to treat desmoid tumors (STAT)
  • SpringWorks' non-cancerous tumor drug to be priced at $29,000 per month in US (Reuters)
  • White House urges RSV vaccine makers to meet demand (Reuters)
  • Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy (Pink Sheet)
  • Merck stokes pneumococcal rivalry with Pfizer, revealing updated 21-valent vaccine data (Endpoints)
  • Unomedical recall of infusion sets tagged as Class I by FDA (MedTech Dive)
  • Accelerated Approval Drugs’ Fate Rests Heavily On Current Therapeutic Landscape When Confirmatory Trials Are Overdue (Pink Sheet)
 
In Focus: International
  • Pfizer takes Poland to court over alleged missed COVID-19 vaccine payments (Fierce Pharma)
  • Hospital chain Aster DM to sell majority stake in Gulf business for $1 bln (Reuters)
  • WHO authorizes emergency use of Novavax’s updated COVID shot (Reuters)
  • Suspected fraud on UK COVID loans climbs 7% in value -govt data (Reuters)
  • El Salvador Sets Up New Regulatory Body To Oversee Medicines & Devices (MedTech Insight)
  • EU Aims To Foster Innovation Through Streamlined Uptake Of Clinical Trial Methodologies (Pink Sheet)
  • ACCESS Consortium Expands Focus To ATMPs And ‘Urgently Needed’ Medicines (Pink Sheet)
  • The Opportunities & Challenges Of Local mRNA Vaccine Production In Africa (Pink Sheet)  
Pharma & Biotech
  • Argenx antibody fails study in platelet-destroying autoimmune disorder, derailing expansion plans (STAT)
  • Manufacturers need to be more open about a dangerous Alzheimer’s drug side effect (STAT)
  • How to spot when drug companies spin clinical trial results (STAT)
  • Nippon Life to buy Nichii Holdings for about $1.41 bln (Reuters)
  • Novartis execs highlight progress of slimmer pipeline after Sandoz spinoff (Endpoints)
  • Takeda aligns with leading rare disease group for calls to action around health equity diagnoses (Endpoints)
  • Early-stage healthcare startups are facing a funding cliff (Endpoints)
  • Novocure to lay off 200 workers, narrow pipeline for electric fields cancer therapy (Endpoints)
  • Immunovant takes on argenx, J&J with plans to test FcRn inhibitor in multiple parallel trials after PhI win (Endpoints)
  • Acelyrin says CRO Fortrea made errors in trial of lead immunology drug izokibep (Endpoints)
  • Aro raises $41M; Candel’s layoffs; Lilly to expand its accelerator to San Diego (Endpoints)
  • Coherus prices China-made PD-1 drug Loqtorzi at 20% discount to Merck's Keytruda (Fierce Pharma)
 
Medtech
  • Shattered Glass Or Broken Ladder: Is the Medtech Industry Becoming More Equal For Women? (MedTech Insight)
  • Why medical device companies are worried about the EPA’s planned sterilization regs (MedTech Dive)
  • News We’re Watching: Boston Scientific Closes Relievant, Medtronic's PFA Earns CE Mark, And More (MedTech Insight)
  • Medtronic to chase Boston Scientific, Abbott in left atrial appendage closure market (MedTech Dive)
 
Government, Regulatory & Legal
  • The push to get estrogen FDA-approved for gender-affirming care (STAT)
  • A growing number of U.S. states, cities, and counties are suing insulin makers and PBMs (STAT)
  • Who cares about pharma ESG efforts? Patients and patient groups do — and they want more, survey finds (Endpoints)
  • Teva drops patent case against Lilly after two Ajovy patents deemed invalid (Fierce Pharma)
  • GSK’s consumer wing nears settlement of ‘non-drowsy’ marketing lawsuit (Fierce Pharma)
 
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.
 

Related topics

×

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.