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

• 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)