Recon: FDA Approves Bluebird Bio’s Gene Therapy Treatment for Rare Neurological Disorders; E


| September 19, 2022 | By Joanne S. Eglovitch

Welcome to Regulatory Reconnaissance, your daily update on regulatory news and intelligence.

In brief: United States

  • US FDA approves bluebird bio’s gene therapy for rare neurological disorder (Reuters) (Biospace)
  • Heron gets FDA green light for Aponvie, an intravenous alternative to pills for post-surgery nausea (Fierce)
  • FDA Action Alert: Regeneron, Spectrum and more (Biospace)
  • Amylyx’s commitment against ALS. FDA’s Obscure Withdrawal Authority: Which Holds the Most Power? (pink sheet)
  • Biden directive on screening foreign investment in US biotech does not target China, administrative officials say (Endpoints)
  • RWE in numbers: analysis of FDA use over the years (pink sheet)
  • New report examines top blockbusters and their use of patents to block competition (Endpoints) (FDAnews)
  • Soaring prices fuel campaign for new drug cost crackdown (Bloomberg)
  • FDA pharma fees fuel influence concerns (NYT)
  • Pfizer accused of running racially discriminatory scholarship program (STAT)
  • ‘I am deeply worried’: Francis Collins on trust in science, Covid communications failure and his current obsession (STAT)

Focus: International

  • EMA approves first drug to prevent RSV infection in babies (pink sheet) (endpoints)
  • After scoring success in US study, Pfizer wins EU infant victory for 20-valent pneumococcal vaccine (Fierce)
  • EU regulator backs wider use of AstraZeneca COVID therapy (Reuters)
  • Moderna helps WHO mRNA hub, Pfizer snubs Request (Bloomberg)
  • Chinese scientists develop mask that detects Covid and flu exposure (Bloomberg)
  • Lancet commission slams WHO and governments over their Covid response (Endpoints)
  • Pharmaceutical companies are closely watching NICE’s new HTA approach in the UK (pink sheet)
  • Ghana declares an end to the Marburg virus disease outbreak (Reuters)

Pharmaceuticals and biotechnology

  • AmerisourceBergen throws nearly $1.3 billion in cash for German life sciences company (Endpoints)
  • Bristol Myers Squibb and Abbvie to cut 360 jobs across California (Biospace)
  • Moderna CEO looks to Japan to build new vaccine manufacturing site (Endpoints)
  • Theravance declares independence from GSK and develops $250 million plan to buy back its own shares (Endpoints)
  • Bryn advances anaphylaxis nasal spray after completing pivotal trial (Fierce)
  • Genfit Accelerates Liver Failure Strategy with $41M Biotech Buyout and Phase 2-Ready Candidate (Fierce)
  • Fortress Falls: Virious misses fibromyalgia study, but claims drug could work in omicron era (Fierce)
  • The alleged clinical benefits of TAVR brain protection remain unproven (Medpage Today)
  • Intellia says CRISPR treatment safely fixes DNA in six patients with rare disease (STAT) (Fierce)

medical technology

  • FDA Updates Advice on Medtronic Endotracheal Tubes After Class I Recall, Patient Death Reports (MedTech Dive)
  • FDA places Class I label on Baxter’s recall of Clearlink (Fierce) Chemotherapy Administration Sets (MedTech Dive)
  • Racial bias in pulse oximeters will be the subject of an FDA panel (MedTech Dive)
  • Medical Devices Excluded from EU Cyber ​​Resilience Bills (MedTech Insight)
  • Industry needs strong regulations now to counter Europe’s tough challenges (MedTech Insight)
  • Boston Scientific’s TAVR safety net device misses study endpoint in stroke reduction (Fierce)
  • Johnson & Johnson pours 100 million euros into a contact loan factory in Ireland (Fierce) (Endpoints)
  • Private equity sees billions in eye care as companies target high-profit procedures (Fierce)

Government, regulation and legal

  • Teva plans to start paying for US opioid settlement in 2023 (Reuters) (Endpoints)
  • Judge Axes 2 patents for anti-epileptic drugs, confirms 3 others (Law360)
  • A month after GSK’s victory in Zantac cancer case, plaintiffs file dozens more lawsuits (Endpoints)
  • J&J Talc Bankruptcy ‘Bad faith’ claims go ahead of Third Circuit (Bloomberg)
  • Liquidia appeals lung drug ruling infringing UTC’s patent (Bloomberg)
  • Zealand Pharma sued for misuse of trade secrets (Medwatch)

Regulatory Recon is our daily intelligence briefing for regulatory affairs, bringing you top regulatory, biopharma and medtech news from around the world.
Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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