Recon: FDA authorizes Pfizer’s RSV vaccine for pregnant women; Teva to shell out $225M to resolve US price-fixing case

• FDA approves Pfizer’s RSV vaccine designed to protect newborns by immunizing parent (STAT) (FDA)
• Teva Agrees to Pay $225 Million to Settle U.S. Price-Fixing Charges (The Wall Street Journal) (Justice Department)
• FDA advisory panel to debate contentious data on Medtronic’s high blood pressure device (STAT)
• Medtronic says surgeries back at pre-pandemic levels, shares rise (Reuters)
• Novavax's updated COVID shot shows immune response against subvariant Eris (Reuters)

• UK pumps £13M into wide-ranging group of manufacturing projects (Fierce Pharma)
• Canada Builds On RWE Guidance (Pink Sheet)
• Keytruda: English Funding First For Data Based On Immunotherapy Basket Trial (Pink Sheet)
• Swiss New Drug Approval Times On A Par With EMA, But Longer Than US FDA (Pink Sheet)
• Off-Patent Industry Group Welcomes ‘Differentiated’ Approach To UK Statutory Scheme (Pink Sheet)
• NICE recommends Amryt’s Filsuvez for rare skin disorder (Pharma Times)
• LEO receives marketing authorisation application for delgocitinib (Pharma Times)

• Blue blood of horseshoe crabs puts pharma groups under scrutiny (Financial Times)
• Inversago was working toward a potential 2024 IPO, but Novo’s interest won out. CB1 biotechs hope to ride the wave (Endpoints)
• Fulcrum’s sickle cell hold resolved, and trial will now focus on more severe patients (Endpoints)
• Aravive warns of possible liquidation as it axes all clinical work, lays off 70% of employees (Endpoints)
• Lava Therapeutics makes cuts to its headcount (Endpoints)
• Inovio spinout plans pivotal study for cancer vaccine as it touts alternative take on PhIb/IIa liver cancer data (Endpoints)
• What infeasible trial? Lilly shows Roche how it's done with positive Retevmo readout in thyroid cancer (Fierce Pharma)
• Agilent to wind down Resolution Bioscience liquid biopsy unit (MedTech Dive)
• Advertising Untitled Letter For Exeltis Slynd Social Media Spot Renews Attention To Online Risk Disclosure (Pink Sheet)
• Sun Pharma Seeks Recall Of Unapproved Phenobarbital Following Approval Of Its Product (Pink Sheet)
• Research shows new technique could cut time to detect polio in half (Pharma Times)
• Alligator Bioscience gains orphan designation for mitazalimab (Pharma Times)

• Axonics appoints Kari Keese to CFO post as Dan Dearen retires (MedTech Dive)
• More but slower medtech approvals (MedTech Insight)
• 3M names Bryan Hanson as CEO of its health care business (Reuters)
• Men with enlarged prostates offered robotic treatment by fourth University Hospital (Pharma Times)

• Eli Lilly CEO donates big to Mike Pence presidential super PAC (STAT)
• Republicans love RFK Jr. What does that tell us about their health platforms in 2024? (STAT)
• Indivior to pay $30 million to settle health plans' Suboxone claims (Reuters)
• SpringWorks fixes 'minor data handling error' after March Form 483 for trial site linked to upcoming PDUFA (Endpoints)
• Supreme Court Decision Makes Partnerships With International Manufacturers More Crucial For US Firms (MedTech Insight)
• Push To Create Ultra-Rare Orphan Drug Designation Finds Resistance At US FDA (Pink Sheet)
• New Collaborative Initiative To Deliver Tailored Support For RCTs In Low Resource Settings (Pink Sheet)
• Cancer Drug ‘Strategic Reserve’ May Be Shortage Solution, US FDA’s Pazdur Says (Pink Sheet)
• Pharmacies Selling PSE: Remember to Train Employees and Self-Certify (FDA Law Blog)