Recon: FDA lifts hold on bluebird bio’s sickle cell gene therapy; AstraZeneca wins EU approval for heart failure drug

ReconRecon | 19 December 2022 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • New Covid Booster Shots Cut Risk of Hospitalization by Half, C.D.C. Reports (NYTimes)
  • Siemens Healthineers, GE Healthcare Eye Medtronic Units (Bloomberg)
  • U.S. FDA lifts hold on Bluebird's sickle cell disease therapy (Reuters)
  • Eli Lilly diabetes drug Mounjaro in short supply, FDA says (STAT)
  • Probe of Musk's Neuralink to scrutinize long-criticized U.S animal welfare regulator (Reuters)
  • US faces lab monkey shortage amid Cambodia smuggling scandal (FT)
  • DEA alleges Cerebral’s pharmacy, Truepill, wrongly filled prescriptions for ADHD medication (PoliticoPro)
  • FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19 (FDA)
In Focus: International
  • Sanofi expands on Innate tumor collab with fresh $1.44B deal for more NK engagers (Fierce)
  • AstraZeneca wins EU backing for heart drug, but suffers lung cancer setback (Reuters)
  • Medical device makers drop products as EU law sows chaos (Reuters)
  • EU regulator backs gene therapy to treat rare bleeding disorder (Reuters)
  • Drugmakers ask regulators to change standards on new Covid antibody drugs for most vulnerable (STAT)
  • China's capital Beijing to speed up imports of COVID drugs – official (Reuters)
  • Industry Breathes Sigh Of Relief Over UK Batch Release Move (Pink Sheet)
  • EMA Management Board: highlights of December 2022 meeting (EMA)
  • Consultation on proposed agile regulations and guidance for licensing drugs and medical devices (Health Canada)
Pharma & Biotech
  • US health agency accused of bowing to drug industry with new opioid guidance (The Guardian)
  • They Created a Drug for Susannah. What About Millions of Other Patients? (NYTimes)
  • We finally have new drugs for sickle cell disease. Why are so few patients taking them? (STAT)
  • Even with gene therapy on the horizon, drugmakers join hunt for new sickle cell drugs (STAT)
  • FDA approves imaging drug to help identify lung cancer lesions (FDA)
  • AstraZeneca's Imfinzi fails in lung cancer trial as a monotherapy to improve OS (Endpoints)
  • Dr. Reddy's subsidiary hits the pause button on drug development for psoriasis (Endpoints)
  • Madrigal experimental drug delivers strong results in fatty liver disease known as NASH (STAT)
  • U.S. FDA approves Ferring Pharma's first gene therapy for bladder cancer (Reuters) (FDA)
  • With another FDA nod, Eagle's Pemfexy gets up to speed with Lilly's Alimta (Fierce)
  • Lilly Pulls EU Approval Application For Olumiant In COVID-19 (Pink Sheet)
  • Lilly partners with Sosei to develop drugs aimed at a key family of proteins (BioPharmaDive)
  • Synaptogenix's Alzheimer's prospect flops in NIH-sponsored study, sinking stock (Fierce)
  • Pregnant? Here’s What You Need to Know About NIPTs (ProPublica)
  • No one’s quite sure how to fix pulse oximeters. The FDA asked this lab to find answers (STAT)
  • Gates, Bezos invest in Synchron’s brain computer interface (MedtechDive)
  • Pfizer to partner with Mayo Clinic spinoff on early cardiac amyloidosis detection (MedtechDive)
  • Moon Surgical sets up robotic assistant launch with FDA clearance, first-in-human study (Fierce)
  • Click wins FDA breakthrough designation for prescription digital migraine therapy (MedtechDive)
  • Cancer researchers question antitrust arguments against Illumina-Grail deal (Reuters)
Government, Regulatory & Legal
  • Apple Vs. AliveCor: EEG Patent Battle Headed To Import Ban Decision (MedtechInsight)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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