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

ReconRecon | 19 September 2022 | By

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you