Recon: US federal judges question FDA’s authority on abortion pill; FDA advisers supportive of Pfizer’s maternal RSV shot ahead of meeting

• 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)

• 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)

• 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)

• 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)

• 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)