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January 29, 2024
by Jason Scott

Recon: Philips no longer selling sleep apnea devices in US after FDA consent decree; BMS’ Opdivo posts disappointing post-kidney cancer trial results

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

In Focus: US
  • Vaccines save lives and generate profits. Why is investment lagging? (STAT)
  • Merck, Johnson & Johnson CEOs agree to testify in Congress on high drug prices, avoiding Bernie Sanders’ subpoena (STAT)
  • First-ever RNA editing trial in US gets clearance, pitting ‘exon editing’ technology against vision loss (Endpoints)
  • Philips' US sales of sleep apnea devices face years-long halt after FDA deal (Reuters)
  • Top 10 most anticipated drug launches of 2024 (Fierce Pharma)
  • Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month (Fierce Pharma)
In Focus: International
  • Which country has the best health care? That’s the wrong question (STAT)
  • Exclusive: UK biotech raises $33.1M to test CF drug that could work on top of standard of care (Endpoints)
  • UK government to ban disposable vapes to prevent use by children (Reuters)
  • Britain's disposable vape ban hits stocks, divides experts (Reuters)
  • Zimbabwe launches door-to-door cholera vaccination campaign (Reuters)
  • Lilly in talks with Germany over weight-loss drug coverage -Spiegel (Reuters)
  • WuXi Biologics plays defense after US bill brands certain Chinese biopharmas as security threats (Fierce Pharma)
Pharma & Biotech
  • Another step toward new drugs for Parkinson’s (STAT)
  • Cognito raises $35 million for Alzheimer’s treatment device, touts benefits compared to drugs (STAT)
  • Mid-stage CNS biotech Alto Neuroscience plots $89M IPO (Endpoints)
  • Roche ends KRAS deal with Hookipa Pharma, as biotech lays off 30% of staff (Endpoints)
  • Ascendis spins out ophthalmology company; Gamida Cell eyes strategic options (Endpoints)
  • Sanofi partners with Synthekine in immunology race (Endpoints)
  • Bristol Myers' Opdivo fails part two of post-kidney cancer surgery test as competitor Merck touts new survival data (Endpoints)
  • Fractyl has the GUTS: Obesity and diabetes biotech charts $99M IPO (Endpoints)
  • Sanofi's $1.7B rare disease gambit; CAR-T boxed warning saga; New biotechs on Nasdaq; A seller's market for M&A?; and more (Endpoints)
  • Less corporate, more human: How Sanofi is using the Olympics to change public perceptions (Fierce Pharma)
Medtech
  • Eli Lilly overtakes Tesla in market value (STAT)
  • Decentralized trials company Science 37 to go private in deal with diagnostics startup eMed (Endpoints)
  • What to watch for as Stryker, Boston Scientific and BD post earnings this week (MedTech Dive)
  • Absolutions receives FDA breakthrough designation for abdominal wall closure device (MedTech Dive)
  • Globus lays off Nuvasive employees after merger (MedTech Dive)
  • How Masimo forced Apple to redesign its smartwatches (MedTech Dive)
  • Cook Medical sells ear, nose and throat devices to C2Dx (MedTech Dive)
Government, Regulatory & Legal
  • 23andMe breach targeted Chinese, Jewish populations (STAT)
  • Pricey sickle cell treatments raise daunting new challenges for Medicaid programs (STAT)
  • From a small town in Wales, a scientific sleuth has shaken Dana-Farber — and elevated the issue of research integrity (STAT)
  • Bayer shares fall nearly 6% on court order to pay $2.25 bln in damages (Reuters)
  • Outlining the Legal Arguments Against FDA’s Proposed Rule Regulating LDTs (FDA Law Blog)
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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