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