Recon: Philips to cut 4,000 jobs worldwide amid slipping sales, legal action; Sumitovant Pharma purchases Myovant for $2.9B
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)
- 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)
- 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)
- Sun Advances Claims Allergan Misused Info to Prosecute Patents (Bloomberg)
- Will feds reclassify 'magic mushroom' therapies? Seattle doctor ramps up court battle (Endpoints)
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