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)
- 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)
- 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)
- BGOV OnPoint: Congress Returns to Looming Deadlines (Bloomberg)
- Novartis Urges Court to Hand It Quick Win in Drug Price Battle (Bloomberg)
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