Recon: Pfizer publishes promising RSV data ahead of FDA decision; DOJ charges 3 former Magellan execs with selling defective lead tests

• US FDA withdraws approval for Covis Pharma’s preterm birth prevention drug (Reuters) (Bloomberg) (STAT)
• Pfizer RSV data set up $10B showdown with GSK and Moderna for the next big vaccine market (Endpoints) (Reuters) (BioSpace) (BioPharma Dive)
• Uptick in FDA adcomms coming in 2023 as CDER hiring picks up, Cavazzoni says (Endpoints)
• ‘Like salmon swimming upstream’: FDA’s Peter Marks lays out plan to boost gene therapy approvals (Fierce)
• Where is the White House’s new pandemic response office? (STAT)
• Warning Letters Special Report: Where Investigations By Prescription Drug Product Firms Fell Short (Pink Sheet)
• The US Patent Office Examination Needs Revamping. Here’s How. (Bloomberg)
• Analysis: Texas abortion pill ruling could disrupt U.S. drug oversight (Reuters)
• ‘War on drugs’ déjà vu: Fentanyl overdoses spur states to seek tougher laws (Washington Post)
• Research misconduct allegations put Stanford’s president — and science — under an uncomfortable spotlight (STAT)
• Air Pollution Linked to Higher Dementia Risk in Harvard Analysis (Bloomberg) (MedPage Today)

• WHO chief thinks COVID-19 emergency will be lifted this year (Reuters)
• Europe at Risk of Dengue and Zika Summer Outbreaks, WHO Says (Bloomberg)
• New EU Approvals (Pink Sheet)
• UK to offer COVID-19 vaccines for young children with medical conditions (Reuters)
• Russian Clinical Trials Plunge To Lowest Point In 19 Years Following Ukraine War (Pink Sheet)
• English Funding OK For Lynparza Follows Complex Pricing Negotiations (Pink Sheet)
• Japan Plans New Incentives As it Tackles Antibiotic Resistance Issues (Pink Sheet)
• Korean Govt’s Role To Boost Biopharma Should Sync With Maturity (Pink Sheet)

• Canaan lands $650M for latest VC fund aimed at tech and drug development (Endpoints)
• Thermo Fisher Scientific pulls plug on New Jersey biologics site, lays off 113 (Fierce)
• Incyte taps Biotheryx for $360M in 2^nd molecular glue degrader deal of the day (Fierce)
• Amgen's denosumab shows promise in small, NIH-funded rare bone disease study (Endpoints)
• AstraZeneca's Lynparza-Imfinzi combo clears PhIII trial in ovarian cancer (Endpoints)
• Sanofi breaks ground on BARDA-backed, $160M vaccine manufacturing site in Pennsylvania (Endpoints)
• TPG-Backed Inova Said in Talks to Buy Mundipharma OTC Assets (Bloomberg)
• Manufacturing supplies maker Meissner plots hiring spree at new $250M US plant (Fierce)
• In listening mode, new Bayer CEO keeps ‘open mind’ on company split (Reuters)
• Alzheimer’s Drug Discovery Foundation gets $200M from family of Estee Lauder (Fierce)
• Ginkgo snaps up gene therapy vector assets from StrideBio (Endpoints)
• To make immunotherapy safe for brain tumors, researchers will have to tackle new risks (STAT)

• Who’s Who As Commission’s Devices Unit Focuses On Complex International Convergence (MedTech Insight)
• FDA Slaps Olympus With Another Endoscope Warning (MedTech Insight)
• Total Recall: Datascope/Getinge Gets Another Class I Recall For Its Aortic Balloon Pumps (MedTech Insight)
• Amid CE mark suspension, Getinge cardiac balloon pumps hit with 2^nd Class I recall this year (Fierce)
• Icahn ramps up rhetoric on Illumina after FTC orders Grail sale (MedTech Dive)

• DOJ charges 3 former Magellan execs with fraud over faulty lead tests (Fierce) (MedTech Dive) (STAT)
• GSK will have to pay additional royalties to AstraZeneca on cancer drug Zejula (Fierce)
• Viatris Lauds New York Win Over EpiPen Claims (Generics Bulletin)
• Illumina Challenges “Unconstitutional” FTC Order on Grail Deal (Bloomberg)
• US Prevails in Suit Alleging Medicare Home Care Is Deficient (Bloomberg)