Recon: FDA give thumbs-up to bluebird bio’s gene therapy treatment for rare neurological disorder; EMA OKs RSV preventive

• U.S. FDA approves bluebird bio's gene therapy for a rare neurological disorder (Reuters) (Biospace)
• Heron scores FDA go-ahead for Aponvie, an IV alternative to pills for postoperative nausea (Fierce)
• FDA Action Alert: Regeneron, Spectrum and More (Biospace)
• Amylyx’s ALS Pledge Vs. FDA’s Obscure Withdrawal Authority: Which Holds More Power? (Pink Sheet)
• Biden directive on screening foreign investments in US biotech not targeted at China, admin officials say (Endpoints)
• RWE By The Numbers: Breaking Down FDA's Use Over The Years (Pink Sheet)
• New report digs into top blockbusters and their reliance on patents to block competition (Endpoints) (FDAnews)
• Skyrocketing Prices Fuel Drive for Fresh Crackdown on Drug Costs (Bloomberg)
• F.D.A’s Drug Industry Fees Fuel Concerns Over Influence (NYT)
• Pfizer accused of running a fellowship program that discriminates on racial grounds (STAT)
• ‘I’m deeply concerned’: Francis Collins on trust in science, how Covid communications failed, and his current obsession (STAT)

• EMA OKs First Drug To Prevent RSV Infection In Babies (Pink Sheet) (Endpoints)
• After scoring hit in US study, Pfizer racks up EU infant win for 20-valent pnemococcal vaccine (Fierce)
• EU regulator backs wider use of AstraZeneca COVID therapy (Reuters)
• Moderna Gives WHO’s mRNA Hub Some Help, Pfizer Snubs Request (Bloomberg)
• Chinese Scientists Develop Mask That Detects Covid, Flu Exposure (Bloomberg)
• Lancet commission sharply critiques WHO and governments over their Covid response (Endpoints)
• Pharma Firms Keep A Close Eye On NICE's New HTA Approach In UK (Pink Sheet)
• Ghana declares end of Marburg virus disease outbreak (Reuters)

• AmerisourceBergen throws down nearly $1.3B cash for German life sciences company (Endpoints)
• Bristol Myers Squibb ad Abbvie to Cut 360 Jobs Across CA (Biospace)
• Moderna CEO looks to Japan for building new vaccine manufacturing site (Endpoints)
• Theravance declares independence from GSK, crafts $250M plan to buy back its own shares (Endpoints)
• Bryn advances anaphylaxis nasal spray after completing pivotal trial (Fierce)
• Genfit revs up liver failure strategy with $41M biotech buyout, bagging phase 2-ready candidate (Fierce)
• Fortress falls: Virious flunks fibromyalgia study but claims drug may work in the omicron era (Fierce)
• Presumed Clinical Benefits of TAVR Cerebral Protection Remain Unproven (Medpage Today)
• Intellia says CRISPR treatment safely corrects DNA of six patients with rare disease (STAT) (Fierce)

• FDA updates advice about Medtronic endotracheal tubes after Class I recall, patient death reports (MedTech Dive)

• FDA slaps Class I tag on Baxter recall of Clearlink chemotherapy delivery sets (Fierce) (MedTech Dive)
• Racial bias in pulse oximeters to be subject of FDA panel (MedTech Dive)
• Medical Devices Excluded From EU Cyber Resilience Act Proposals (MedTech Insight)
• Industry Needs Solid Regulations Now To Counterbalance Europe’s Tough Challenges (MedTech Insight)
• Boston Scientific’s TAVR safety net device misses study endpoint in reducing number of strokes (Fierce)
• Johnson & Johnson pours €100M into contact lends plant in Ireland (Fierce) (Endpoints)
• Private equity sees the billions in eye care as firms target high-profit procedures (Fierce)

• Teva expects to start paying U.S. opioid settlement in 2023 (Reuters) (Endpoints)
• Judge Axes 2 Anti-Seizure Drug Patents, Upholds 3 Others (Law360)
• A month after GSK's win in Zantac cancer case, plaintiffs file dozens more suits (Endpoints)
• J&J Talc Bankruptcy ‘Bad Faith’ Claims Go Before Third Circuit (Bloomberg)
• Liquidia Files Appeal of Ruling Lung Drug Infringes UTC’s Patent (Bloomberg)
• Zealand Pharma sued over misusing trade secrets (Medwatch)