Recon: FDA authorizes Pfizer’s RSV vaccine for pregnant women; Teva to shell out $225M to resolve US price-fixing case
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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