Recon: FDA expected to authorize second COVID booster for 50 and older; UCB drug nabs FDA approval for Lennox-Gastaut Syndrome
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA expected to authorize second coronavirus booster for 50 and older (Washington Post) (Bloomberg)
- FDA approves UCB's drug for rare childhood epilepsy (Reuters)
- Officials limit an antibody therapy, saying it’s ineffective against BA.2 variant of Omicron (STAT) (Endpoints)
- President Biden's 2023 budget plan would offer a massive boost for FDA's coffers (Endpoints)
- Congressman asks FDA for information on oversight of Medtronic's troubled HVAD (MedTech Dive)
- Intarcia may finally get its post-CRL review, although FDA points to Covid and another hearing as taking priority (Endpoints)
- Cancer drug prices rise in the US despite an increasingly competitive market — report (Endpoints)
- New EU Body To Deal With COVID-19 Vaccine Strategy & Procurement (The Pink Sheet)
- EMA OKs two new drugs — J&J's BCMA CAR-T for multiple myeloma, AstraZeneca's Evusheld — plus 5 label expansions (Endpoints)
- As War Rages On, Kyiv Drugmaker Inks Deal for Pfizer Covid Pill (Bloomberg)
- Stryker, Zimmer don't expect near-term titanium supply impact from Russia-Ukraine war (MedTech Dive)
- Public Health Catastrophe Looms in Ukraine, Experts Warn (NYT)
- Japan approves iron deficiency drug from Pharmacosmos (MedWatch)
- Vertex strikes agreement with Australia for cystic fibrosis pill, ending high-profile standoff (Endpoints)
- UK study to test Pfizer's COVID pill in hospitalised patients (Reuters)
- Germany speaks out against COVID-19 vaccine patent waiver (Reuters)
- Covid vaccinations – including boosters – fall to lowest levels since 2020 (Washington Post)
- Second COVID vaccine booster significantly lowers death rate, Israeli study shows (Reuters)
- Lilly, after making $1B bet, posts ‘compelling’ late-phase data on Dupixent trial (Fierce)
- ‘Stay alive’: Wave of layoffs crashes into biotech startup inferno (Fierce)
- Bristol Myers' hope for a third Reblozyl OK delayed by three months (Endpoints)
- Novo Nordisk’s acquisition journey is driven by price pressure and a hunger for innovation (MedWatch)
- Big Pharma has skirted long Covid, but a pipeline of small biotechs is testing treatments for lingering symptoms (Endpoints) (Reuters)
- Foreign Firms Not Fatigued In India, Game For 'New Things' (Scrip)
- A biotech developing a synthetic biology Covid-19 vaccine comes up short in first data readout — and investors are fleeing (Endpoints)
- Big Pharma Pacts Benefit From Reduced HBV Biologics Competition (Scrip)
- As CAR-T Therapies Move Into Earlier Lines, Best Uses Begin To Come Into Focus (Scrip)
- As Gilead’s stock price gets blitzed after a series of pratfalls, why is Dan O’Day getting a small raise? (Endpoints)
- MDR updates safety, clinical performance requirement for high-risk devices (MedTech Dive)
- Google launches new search tool for provider appointments, seeks FDA approval for Fitbit feature (MedTech Dive)
- Abbott awarded $1B US Army contract for COVID-19 antigen tests (MedTech Dive)
- Medtronic kicks off pivotal study of tibial neuromodulation implant for overactive bladder (Fierce)
- Roche, Bristol Myers partner to develop digital pathology AI to analyze clinical trial assays (Fierce)
- Merck finally free from fracture lawsuits over Fosamax label (Endpoints)
- GSK’s ViiV, Shionogi Settle Lupin Patent Suit on Juluca HIV Drug (Bloomberg)
- GSK Zofran Birth Defect Suits Should be Reinstated (Bloomberg)
- ImmunoGen Patent Application Suit Sent Back to Court (Bloomberg)
- Sacklers Say New Ch. 11 Plan Boasts ‘Extraordinary’ Support (Law 360)
- Hospitals’ Challenge to Medicare Payment Formula Tossed by Court (Bloomberg)
- AbbVie, Endo hit with subpoenas amid Texas AG's attempts to limit medical care for trans youth (Endpoints)
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