Recon: FDA approves Eyenovia’s pupil-dilating spray; Baxter to sell biopharma business for $4.25B

• US FDA approves Eyenovia's pupil-dilating spray (Reuters) (Fierce)
• Ahead Of Sarepta Advisory Committee, FDA Feels Congressional Pressure About Public Participation (Pink Sheet)
• The luckiest of the unlucky’: A Duchenne gene therapy brings hope to families — and tests the FDA (BioPharma Dive)
• FDA Action Alert: Sarepta, Protalix, Otsuka/Lundbeck and More (BioSpace)
• FDA Final Guidance Details PDUFA VII Fee Program, Assessment Changes (FDAnews)
• Long-Term Postmarket Studies For Gene Therapies May Need To Be Combined, Standardized (Pink Sheet)
• Emerging Gene Therapy Concern: A Child Joins A Clinical Trial, But Must Be Followed Into Adulthood (Pink Sheet)
• CDC Overhaul Plans Questioned by House Republicans (Bloomberg)
• CDC Director Announces Surprise Exit as Covid Emergency Ends (Bloomberg) (Reuters)
• Medicare No. 2 Says Drug Price Setting Can Help Pharma Business (Bloomberg)
• Does the end of Covid emergency declarations mean the pandemic is over? (STAT) (Endpoints)
• NIH contributes billions to new drug development. GAO says patents don't tell the full story (Endpoints)
• U.S. backs study of safe injection sites, overdose prevention (STAT)

• WHO declares end to COVID global health emergency (Reuters)
• EU’s Proposed Emergency Approval Route For Crisis-Related Products – Would It Work? (Pink Sheet)
• CTIS: EMA Consults On Transparency Rules & Simplifications For Clinical Trials Portal (Pink Sheet)
• EU needs tiered drug pricing to improve patient access, Bayer exec says (Reuters)
• 'Still Bad Out There' - Drug Makers In APAC Prepare For Worst Before It Gets Better (Scrip)

• Baxter to divest biopharma business for $4.25 billion (Reuters) (MedTech Dive)
• Busy dealmakers Ginkgo, Boehringer Ingelheim sign one together with $406M for undruggable targets (Fierce) (BioSpace)
• BMS Cuts Jobs in New Jersey, Cites ‘Constantly Evolving’ Business Model (BioSpace)
• After weight loss, Alzheimer's may be next frontier for drugs like Ozempic (Reuters)
• Enher-tu, Eisai? Japanese drugmaker inks Bliss ADC deal to tee up challenge to AstraZeneca blockbuster (Fierce)
• Catalent shares tank on warning of $400 mln cut to annual revenue forecast (Reuters)
• Amgen, Entera ax $270M oral biologic pact ‘out of mutual convenience’ (Fierce)
• BioNTech Looks to Expand into Other Markets as COVID-19 Revenues Dwindle (BioSpace)
• Helene von Roeder to become new CFO of Germany's Merck (Reuters)
• Spain's Grifols names current chairman as CEO, ending family leadership (Reuters)
• Bayer opens cell, gene therapy incubator in Cambridge (Endpoints)
• Boehringer Ingelheim to surf with Melbourne-based biotech in $181M neuropsychiatric therapy deal (Fierce)
• Selecta lays off 25% as unpartnered gene therapies rake a back seat (Fierce)
• So you think you can go public? Few biotechs dance with Wall Street  (Fierce)

• 12 Member States Weigh In On Support Needed To Implement EU Health Data Sharing Initiative (MedTech Insight)
• Tempus clocks FDA approval for 648-gene cancer test (Fierce)
• Insulet shuffles C-suite after another quarter of record Omnipod revenue growth (Fierce)
• Illumina defends its board, calls Icahn campaign ‘character assassination’ (MedTech Dive)
• ZimVie will lay off 5% of staff in bid to reduce costs, streamline business
• (MedTech Dive) (Fierce)
• Friday Q&A: Boston Scientific’s De Rosa on the rise of an AFib ‘game changer’ (MedTech Dive)

• Boston Scientific gets DOJ subpoena for documents related to heart monitoring (MedTech Dive)
• Guardant Cancer Test Patent Claims Revived by Federal Circuit (Bloomberg)
• iRhythm says it received DOJ subpoena regarding company’s ‘products and services’ (MedTech Dive)