rf-fullcolor.png

 

November 27, 2023
by Jason Scott

Recon: Novo Nordisk pays $2.4B to build French plant for GLP-1 drugs production; UK names synthetic opioids to its banned drugs list

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

In Focus: US
  • Biden to invoke Cold War-era law to boost medical supplies (Reuters)
  • FDA withdraws from Global Harmonization Working Party (MedTech Dive)
  • FDA to SCOTUS: Setting the mifepristone regulations clock back to 2016 is 'unjustified' (Endpoints)
 
In Focus: International
  • Most clinical trials run in Canada failed to take basic steps toward transparency, analysis finds (STAT)
  • Britain adds new synthetic opioids to its banned drug list (Reuters)
  • Pandemic-related immunity gap in kids explains surge of respiratory infections in children in China, says WHO (STAT)
  • Canadian drugmaker Xenon Pharma's depression drug fails to meet main study goal (Reuters)
  • Japan panel recommends approval of updated Daiichi Sankyo COVID shot- Kyodo (Reuters)
Pharma & Biotech
  • Novo Nordisk invests $2.4B in French facility to address booming GLP-1 demand (Endpoints)
  • With new trial data, a blockbuster therapy from Sanofi, Regeneron could find an even bigger market (STAT)
  • A new algorithm unveils CRISPR ‘treasure trove’ (STAT)
  • With biotech in a slump, the industry’s job market is upside down (STAT)
  • GSK's blood cancer drug meets primary goal in late-stage trial (Reuters)
  • Roivant Sciences' lupus drug fails to reduce symptoms in mid-stage study (Reuters)
  • Feng Zhang's latest gene editing trawl reels in 188 new CRISPR systems (Endpoints)
  • Arvinas gets $350M boost from investors to extend runway into 2027 (Endpoints)
  • Despite failing its PhII test, Xenon sees future for major depression drug (Endpoints)
  • AstraZeneca's KRAS deal with Yusen Jianheng; Abeona gets a PDUFA date (Endpoints)
  • Sosei Heptares to take back GPCR agonist after GSK changes course (Endpoints)
  • Tang’s Concentra faces off with Foresite, OrbiMed in buyout battle for struggling biotech Theseus (Endpoints)
  • Exclusive: Aeglea rebrands to Spyre, names new CEO in IBD race against TL1A drugs at Merck, Roche and Sanofi (Endpoints)
  • 2023's Fiercest Women in Life Sciences (Fierce Pharma)
  • NS Pharma launches ‘Duchenne Heroes’ campaign to help families navigate the Duchenne journey (Fierce Pharma)
Medtech
  • Roundup: Top medtech companies cut jobs in 2023 (MedTech Dive)
  • Smith & Nephew inks $180M CartiHeal buyout, capitalizing on Bioventus turmoil to land knee implant (MedTech Dive)
  • LivaNova warns cybersecurity incident disrupts systems, takes steps to limit impact (MedTech Dive)
Government, Regulatory & Legal
  • BGOV OnPoint: Congress Returns to Looming Deadlines (Bloomberg)
  • Novartis Urges Court to Hand It Quick Win in Drug Price Battle (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.

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.