Recon: FDA expected to authorize second COVID booster for 50 and older; UCB drug nabs FDA approval for Lennox-Gastaut Syndrome

• 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)