Recon: US federal judges question FDA’s authority on abortion pill; FDA advisers supportive of Pfizer’s maternal RSV shot ahead of meeting
In Focus: US- US appeals judges express support for opponents of abortion pill (Reuters) (BioSpace) (STAT)
- US Challenge to Amgen Deal Threatens Big Pharma Business Model (Bloomberg) (STAT) (Reuters) (Endpoints)
- FDA Shows Confidence in Pfizer’s Maternal RSV Shot Ahead of Panel (BioSpace) (Reuters)
- Amgen agrees not to seek quick close to Horizon acquisition (Reuters)
- US FDA staff flag 'serious' safety risks for Intercept's fatty-liver disease treatment (Reuters)
- Teva Plans Cuts to Generic Drug Production Amid Shortages (Bloomberg)
- FDA approves Allergan's newest hyaluronic acid injectable — with a new delivery system (Endpoints)
- Intercept's NASH hopeful gets preliminary thumbs down in FDA briefing docs (Endpoints)
- New Biden science agency ARPA-H launches first program, targeting bone regrowth (STAT)
- FDA's Peter Marks talks reimbursement of gene therapies that win accelerated approval (Endpoints)
- Ex-FDA neuro chief Billy Dunn is taking a spin through the revolving door with biopharma — and that's a problem (Endpoints)
In Focus: International
- WHO recommends new COVID shots should target only XBB variants (Reuters)
- Exclusive: India considers policy change after cough syrup deaths (Reuters)
- EU Regulator Urges Firms To Up Their Game On Drug Shortages (Pink Sheet) (Endpoints)
- Updated EU CTIS Guide Offers Workaround To Protect ‘Commercially Confidential’ Dosing Data (Pink Sheet)
- After string of setbacks, FibroGen and AstraZeneca’s anemia drug Evrenzo finally chalks up a win (Fierce)
Pharma & Biotech
- AstraZeneca beefs up cell therapy tool kit with gene editing deal (Endpoints)
- Gilead woos Cindy Perettie from Roche to lead Kite after Christi Shaw departs (Endpoints)
- Avidity says partial hold on lead muscle wasting disorder asset has been ‘eased’ but not lifted (Fierce)
- Teva Pharm CEO sees $2.5 billion in revenue for Austedo drug by 2027 (Reuters)
- PTC, chasing BioMarin, posts phase 3 rare disease win but fails to silence skeptics (Fierce)
- New biotech Siren calls for gene therapy and cancer to ‘get into the weeds together’ (Fierce)
- Mustang bucks some partnered cell and gene therapy work (Fierce)
- Fierce Biotech Layoff Tracker 2023: Athenex lets go of 123 employees amid bankruptcy; Novavax lays off hundreds (Fierce)
- In Belgium, a native son returns to resurrect the drugmaker Galapagos — and ‘to get the trust back’ (STAT)
Medtech
- Abbott’s spinal cord stimulators score FDA approval to treat nonsurgical back pain (Fierce) (MedTech Dive)
- Waxing Moon: Surgical tech maker pulls $55M and robotics maven Fred Moll into its orbit (Fierce)
- Philips says recalled CPAP, BIPAP machines show low risk of harm in completed safety tests (Fierce)
- Clinical trials showcase potential roles for ultrasound in treating cancer, inflammatory disease (MedTech Dive)
Government, Regulatory & Legal
- J&J beats back Viatris’ generic challenge to schizophrenia med Invega Trinza (Fierce)
- Theranos’ Elizabeth Holmes ordered to report to prison amid appeal, fined $452M in restitution alongside Sunny Balwani (Fierce)
- Walgreens to pay record $230 million to San Francisco over opioid crisis (Washington Post)
- Genetic deletion: Agilent loses 2 CRISPR patents after Synthego wins IP cases (Fierce)
- Former Immunomedics CFO pleads guilty to insider trading (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.
