Recon: Philips to cut 4,000 jobs worldwide amid slipping sales, legal action; Sumitovant Pharma purchases Myovant for $2.9B

ReconRecon | 24 October 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • AstraZeneca’s Imjudo finally snags first approval-only in an ever-crowded liver cancer field (Fierce) (Endpoints)
  • Bristol Myers lines up a date with the FDA to expand the footprint of its $13B heart drug (Endpoints)
  • Hikma, Teva, Sandoz Report Short Supply of Amoxicillin in US (Bloomberg)
  • FDA’s vaccines chief sees possibility of more Covid boosters — sooner than he’d like (STAT)
  • As Vaccines Pipeline Gushes, Complex Communication Challenges Loom (Pink Sheet)
  • Pfizer Gains on Plan to Charge as Much as $130 Per Covid Shot (Bloomberg)
  • As government funding dries up, Pfizer expects to charge private payers $110+ for Covid-19 vaccine (Endpoints) (Reuters)
  • Roche issues voluntary recall for Susvimo over manufacturing issue (Endpoints)
  • Biden Administration Offers Plan to Get Addiction-Fighting Medicine to Pregnant Women (NYT)
  • Hospitals are worried about child RSV this year. Here’s what to know. (Washington Post)
  • Medicare Urged To Create Clear Path For Ending Coverage With Evidence Development Restrictions (Pink Sheet)
  • A ‘Tripledemic’? Flu and Other Infections Return as Covid Cases Rise (NYT)
In Focus: International
  • New EU Filings Include First Self-Administered Treatment For Myasthenia Gravis (Pink Sheet)
  • New Omicron Subvariant Is Expected to Drive Covid Wave in Europe (Bloomberg)
  • New industry report suggests UK clinical trial research recruitment is in massive decline (Endpoints)
  • Australian Industry Gets Price Rises To Offset Cost Of New Anti-Shortage Rules (Pink Sheet)
  • History Echoes When China Places Politics Over Economy (Pink Sheet)
  • Indonesia may seek prosecution of pharma firms as child AKI deaths rise (Reuters)
  • Uganda says 9 more Ebola cases confirmed in Kampala, urges vigilance (Reuters)
  • COVID disrupted measles vaccinations in Africa and now cases are surging (Reuters)
Pharma & Biotech
  • Weeks after Rejecting First Offer, Myovant Agrees to Acquisition by Sumitomo (Biospace) (Reuters) (Endpoints) (Fierce)
  • J&J plans to cut 64 jobs at New York plant in new year (Endpoints)
  • CD28 kills again? Mitch Gold’s plan to make cell therapy 2.0 history crashes after another patient dies of cardiogenic shock (Endpoints)
  • Gilead presses forward with next-gen CAR-T, inking deal with small synthetic biology startup (Endpoints)
  • Novartis, eyeing $3B market, beats AstraZeneca blood disorder in phase 3 (Fierce) (Endpoints)
  • Rise 'til we fall: Pharma ad spending still on the way up, even as most other categories drop (Endpoints)
  • Gene therapy biotech AGTC jumps on Syncona $23.5M bid to escape ‘challenging’ funding landscape (Fierce)
  • Tricida’s shares plunge as phase 3 fail seals fate of FDA-rejected kidney disease drugs (Fierce)
  • Altamira finds buyer for Zilentin inner ear unit so Swiss biotech can go all-in on RNA (Fierce)
  • Philips to cut 4,000 jobs worldwide after hit from legal action (Financial Times) (Fierce) (Bloomberg)
  • New Philips CEO Jakobs apologizes for handling of sleep apnea device recall (MedTech Dive)
  • Medtronic to spin off 2 businesses as part of restructuring process (Reuters) (Fierce) (Bloomberg)
  • Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say, (MedPage Today) (MedTech Insight)
  • MedTech Europe Urges EU To Support European Health Data Space Proposal (MedTech Insight)
  • Avoid EU Mistakes And Cast Regulatory Net Wide Globally, UK Told (MedTech Insight)
  • MHRA Grants Extra Year For CE-Marked Devices To Access UK Market (MedTech Insight)
  • Medtronic scores FDA approval for pacemaker hardware that taps into heart’s natural electrical signals (Fierce)
  • FDA clears Philips AI for making CT-like images from head and neck MRI scans (Fierce)
  • FDA clears Intelligent Ultrasound’s AI for real-time guidance in nerve block injections (Fierce)
Government, Regulatory & Legal
  • Sun Advances Claims Allergan Misused Info to Prosecute Patents (Bloomberg)
  • Will feds reclassify 'magic mushroom' therapies? Seattle doctor ramps up court battle (Endpoints)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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