Recon: Pfizer to seek FDA approval for RSV vaccine; Novartis spins off Sandoz unit

ReconRecon | 25 August 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Chasing GSK, Pfizer races to regulators after RSV vaccine paints positive impression in RENOIR phase 3 (Fierce) (Reuters) (Endpoints) (STAT)
  • Moderna seeks FDA nod for booster shot aimed at Omicron BA.4, BA.5 (Reuters)
  • BioMarin to resubmit Hemophilia A gene therapy to FDA after EU approval (Biospace)
  • AbbVie, J&J’s Imbruvica wins pediatric nod. This one for chronic graft-versus-host disease (Fierce) (Bloomberg)
  • House investigates Trump’s ‘inappropriate’ pressure on FDA during the pandemic (Endpoints) (STAT)
  • ALS ‘Urgency’, US FDA Regulatory Environment Justify Filing NurOwn, BrainStorm Says (Pink Sheet)
  • Interchangeability without switching studies: FDA explains why a new Lucentis biosimilar may be a game-changer (Endpoints)
  • US FDA Plans Education Efforts As Humira Biosimilars Launch (Pink Sheet)
  • Drug Negotiations Will Drive Biosimilars as Patent Tactics Shift (Bloomberg)
  • US considers use of expired monkeypox vaccines amid rising demand for doses (Endpoints)
  • Senate Health Committee Plans Hearings on Monkeypox Response (Bloomberg)
  • The FDA stands by as the vaping industry flouts its orders (STAT)
In Focus: International
  • BioMarin nets conditional approval for valrox in Europe, marking the first hemophilia gene therapy (Endpoints) (Fierce)
  • Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA? (Pink Sheet)
  • WHO reports 21% decline in monkeypox cases globally (Reuters)
  • Bavarian Nordic vows to boost monkeypox vaccine supply to combat shortfall (Reuters)
  • German health minister expects renewed coronavirus wave in autumn (Reuters)
  • Thai king's medical firm reports record profit after vaccine deal with AstraZeneca (Reuters)
  • ‘Status Quo' Interim Pricing Guidance Now In Force In Canada (Pink Sheet)
  • Ebola vaccinations in east Congo to start on Thursday after new case (Reuters)
Pharma & Biotech
  • It’s a spinoff: Novartis parts ways with Sandoz just as its generics biz shows signs of recovery (Fierce) (Endpoints) (Reuters) (Biospace)
  • Novartis suspends dosing in phase 2b Huntington’s trial after side effects reported (Fierce) (Endpoints)
  • Thermo Fisher opens its second site in a week, this time closer to its Massachusetts headquarters (Endpoints)
  • Resilience partners with the California Institute for Regenerative Medicine to help cell therapy startups (Endpoints)
  • Pfizer's Paxlovid only helped seniors avoid hospitalization and death, new NEJM study finds (Endpoints)
  • NEJM Study: Omicron Blunts Pfizer’s Paxlovid in Younger Adults (Biospace)
  • Aktis makes waves with $84M extension as big pharmas channel funds to radiopharmaceutical pipeline Fierce)
  • Aeglea culls workers, shifts pipeline focus after knockback by FDA (Fierce)
  • Biosensors International Wins FDA Approval For Drug-Eluting Coronary Stent (MedTech Insight)
  • Abbott’s Next-Generation Spinal Cord Stimulator Gets FDA Nod (MedTech Insight) (MedTech Dive)
  • FDA clears Point Robotics’ hand-held spinal surgery system (Fierce)
  • Brain Scientific’s EEG headset caps off regulatory push with European approval (Fierce)
  • US FDA Issues Alert For MS Patients Using Autoinjector Devices (MedTech Insight)
  • Getinge’s recall of 11,000 ventilators labeled Class I event by FDA (MedTech Dive)
  • Integra pulls intracranial pressure monitors for inaccurate readings (MedTech Dive)
  • French Medtech Reimbursement - How Added Value And Clinical Benefit Sway Decisions (MedTech Insight)
  • MIT researchers track Parkinson’s patients using radar as they sleep (Fierce)
  • A Test Before An Approved Therapy: Inbiomotion MAFTEST Is Tackling Breast Cancer Metastases (MedTech Insight)
Government, Regulatory & Legal
  • What ever happened to DOJ’s baby powder probe into J&J? Lawmakers are pressing for answers (Fierce)
  • Inovio agrees to shell out $44M to settle Covid-19 vaccine lawsuit (Endpoints)
  • Ex-Kadmon consultant faces up to 20 years in prison following guilty plea over insider trading (Endpoints)
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.


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