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March 4, 2024
by Jason Scott

Recon: Perrigo launches over-the-counter birth control pill in the US; Drugmakers make counteroffers in first round of Medicare price negotiations

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Massachusetts lawmakers consider $1 billion proposal to bolster region’s life science leadership (STAT)
  • Perrigo's over-the-counter birth control launch takes flight in the US (Fierce Pharma)
  • US court to weigh Obamacare mandate to cover HIV drug, cancer screenings (Reuters)
  • Drugmakers submit counteroffers as part of first round of drug price negotiations (Endpoints) (Reuters)
  • Federal regulators, scrambling to keep up with AI in health care, team up with industry to set standards (STAT)
  • Pfizer to 'wind down construction' of Seagen's $350M manufacturing site (Endpoints)
  • Pfizer stops buildout of $350M Seagen plant, leaving 120 workers' roles in question (Fierce Pharma)
  • FDA pushes back decision on Zevra’s drug; Revance to raise $100M (Endpoints)
  • RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds (Fierce Pharma)
In Focus: International
  • India's Serum boosts supply of cervical cancer shots ahead of government's mass drive (Reuters)
  • Spain's Catalonia hands out free reusable menstruation products (Reuters)
  • Three Major Regulators Launch Pilot To Reduce Duplication Of GMP Inspections (Pink Sheet)
  • Teva slammed for breaching drug promotion code in earned media article (Fierce Pharma)
  • GSK's new HIV drug formula could support longer dosing intervals (Reuters)
Pharma & Biotech
  • He’s 19 months old and has one of the world’s rarest diseases. His parents are determined to find a cure (STAT)
  • Longer treatment gave better liver outcomes for MASH patients, Akero drug study shows (STAT)
  • Q&A: Stem cell biologist predicts human embryo models could pave the way to organ transplants (STAT)
  • In a first, fetal cell organoids generated from amniotic fluid, new study reports (STAT)
  • Sanofi’s CEO on the consumer divestiture, a future in weight loss, antitrust and AI’s secrecy wave: Q&A (Endpoints)
  • Merck KGaA bags another molecular glue deal for $16M upfront, this time with C4 (Endpoints)
  • Exclusive: Nocion raises $62M for different approach to chronic cough than Merck, GSK (Endpoints)
  • Ally Bridge beefs up 'new generation' as investment firm passes 10-year mark (Endpoints)
  • Cormorant nears the close of fifth private healthcare fund as biotech industry sees greener pastures (Endpoints)
  • Akero's fatty liver disease drug lessens scarring in mid-stage trial (Reuters)
  • Lilly CEO: Affordable Generics And IP Support 'Not Incompatible Ideas' (Pink Sheet)
  • With Takeda out of the picture, J&J’s Rybrevant moves into first line in lung cancer subtype (Fierce Pharma)
Medtech
  • Medicare is a tricky market for telehealth companies. Why is Talkspace betting on it? (STAT)
  • One Step Closer to Final: The LDT Rule Arrives at OMB, Making A Lawsuit More Likely (FDA Law Blog)
  • Baxter considers selling kidney care unit to private equity (MedTech Dive)
  • Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices (MedTech Dive)
  • GE Healthcare recalls incubators due to risk of newborns falling (MedTech Dive)
Government, Regulatory & Legal
  • Explaining Change Healthcare and the gravity of its cyberattack (STAT)
  • Missing data is making it difficult for the pharmaceutical industry to help LGBTQ+ people (STAT)
  • Too many donor organs go to waste. Here’s how to get them into the patients who need them (STAT)
  • Walgreens CEO says no plans to sell specialty pharmacy unit (Reuters
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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