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January 30, 2024
by Jason Scott

Recon: Vertex non-opioid pain reliever succeeds in late-stage trials; Neuralink implants brain chip in first human patient

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

In Focus: US
  • Can Wegovy treat depression as well as obesity? New research looks to GLP-1 drugs for mental illnesses (STAT)
  • Vertex’s closely watched pain relief drug succeeds in late-stage trials — with a catch (STAT) (Reuters)
  • The academic-entrepreneur model built companies and minted millionaires. What happens when one of its earliest advocates quits?  (Endpoints)
  • Exclusive: Eli Lilly supplied schizophrenia drug to uncertified healthcare providers, Form 483 shows (Endpoints)
  • Pfizer posts surprise 4th quarter profit, but key products miss on sales (Reuters) (Endpoints)
  • Philips' US sales of sleep apnea devices face years-long halt after FDA deal (Reuters) (MedTech Insight)
    Elon Musk's Neuralink implants brain chip in first human (Reuters)
In Focus: International
  • Spanish pharma services company Suanfarma rebrands under unified umbrella (Fierce Pharma)
  • Singapore’s Genetic Design and Manufacturing reels in $21M in series A funding (Fierce Pharma)
  • New EU AI Innovation Package Launched, With AI Office (MedTech Insight)
  • Rise in reports of fake weight-loss drugs linked to shortage of real thing, WHO says (Reuters)
Pharma & Biotech
  • Here are the new hotspots for Boston-area biotech (STAT)
  • How an immunological Trojan horse could treat disease (STAT)
  • Cour Pharmaceuticals, a biotech taking aim at autoimmune diseases, raises $105 million (STAT)
  • Ultima Genomics launching high-end DNA sequencers that can read genome for $100 (STAT)
  • Avrobio makes way for GPCR biotech Tectonic Therapeutic in reverse merger (Endpoints)
  • Kura’s stock jumps on PhIb readout; FDA lifts hold on INmune Bio program; Nanobiotix’s $20M milestone (Endpoints)
  • Amid strategic pivot, 2seventy bio plots comeback for BMS-partnered CAR-T Abecma (Fierce Pharma)
  • MarketingRx roundup: Astellas menopause drug led NFL TV spending; A podcast's deep dive into Novo's history (Endpoints)
  • Hims CEO says he'd rather go after rivals' customers than buy their businesses (Endpoints)
  • Gilead, Kite shorten Yescarta manufacturing by two days in 'incremental' improvement (Endpoints)
  • Creative AI gains steam among pharma marketers including Sanofi, Novartis, although concerns abound (Endpoints)
  • CAR NK biotech Catamaran Bio to wind down, will seek partners for cell therapies (Endpoints)
  • Chicago-area autoimmune biotech gets pharma backing in $105M round for two PhII trials (Endpoints)
  • Scientists document first-ever transmitted Alzheimer's cases, tied to no-longer-used medical procedure (STAT)
Medtech
  • Tasso Launches At-Home Blood Draw Platform For Trial Pre-Screening (MedTech Insight)
  • FDA Sends Final Report On Device Pilot Projects To Lawmakers (MedTech Insight)
  • 4 heart device trends shaping the medtech sector in 2024 (MedTech Dive)
  • Vicarious Surgical hires former Olympus leader as president (MedTech Dive)
Government, Regulatory & Legal
  • Sanofi’s Olympic role brings perks and pride to engage workforce (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.
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