Recon: FDA gives thumbs-up to GSK measles vaccine; FDA committee set to review Novavax COVID vaccine EUA on Tuesday

ReconRecon | 06 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • GSK measles vaccine gets FDA approval (Reuters) (Endpoints) (Biospace)
  • FDA scientists say Novavax’s Covid-19 vaccine is effective, but also raise concerns (STAT) (Endpoints) (InsideHealthPolicy)
  • Bristol Myers pulls plug on Reblozyl program for rare blood disorder, months after missed PDUFA date (Endpoints)
  • 21 Americans Infected With Monkeypox, CDC Reports (NYT) (STAT)
  • CDC treats first monkeypox patient with SIGA's smallpox antiviral via expanded access (Endpoints)
  • Pfizer to spend $120 mln to boost US COVID pill manufacturing (Reuters)
  • The FDA’s Pazdur on accelerated approval, single-arm studies, and his own future (STAT)
  • US FDA’s Fast Track Designation Policy Faces Unusual Legal Challenge (The Pink Sheet)
  • Vid Desai On How US FDA’s Modernization Will Improve Inspections And Drug Reviews (The Pink Sheet)
  • US FDA Poses Next-Level GMP Challenges For Aurobindo's Polepally Site (The Pink Sheet) (Endpoints)
  • If Roe is overturned, the ripples could affect IVF and genetic testing of embryos, experts warn (STAT)
  • Abbott Says It’s Restarting Baby Formula Production in Michigan (Bloomberg)
In Focus: International
  • UK MHRA To Have Its Say Again In ICH Activities (The Pink Sheet)
  • Novartis drug combo shows promise in childhood brain cancer (Reuters)
  • New data sets stage for broader use of AstraZeneca breast cancer drug (Reuters) (Biospace)
  • China's mRNA Shot Shows Benefits Over Older COVID Vaccines (Scrip)
  • Korean Firms Hunt For Overseas Biologics Manufacturers To Support Growth (Scrip)
  • Global Cancer Coalition Seeks To Increase Access To Medicines In LLMICs (Generics Bulletin)
  • India Physician Conduct Rules Want Them Off Pharma-Sponsored Symposia (The Pink Sheet)
Pharma & Biotech
  • BioNTech’s mRNA Therapy for Pancreatic Cancer Inspires Early Optimism (Biospace) (Endpoints) (Fierce)
  • Contract manufacturer Emergent says J&J breached vaccine contract (Reuters)
  • Mirati drug helps some patients whose lung cancer spread to the brain, study says (Reuters)
  • In yet another stinging setback, Pfizer’s blockbuster CDK 4/6 fails its latest test on survival. But can Novartis and Eli Lilly benefit? (Endpoints)
  • Adicet ‘gamma-delta’ T cell therapy shows complete remissions in early study of lymphoma patients (STAT)
  • Promising results reported for new generation of CAR-T immunotherapy for myeloma (STAT)
  • Neoantigen Cancer Vaccine Helps BioNTech Advance Oncology Ambitions (Scrip)
  • Amarin to slash jobs as generic rivals dull U.S. prospects of heart drug (Reuters)
  • In study, Gilead’s Trodelvy shows modest benefit in breast cancer patients (STAT)
  • Roche’s Tigit troubles escalate, sparking more debate about the closely tracked cancer immunotherapy target (STAT)
  • Praxis’ novel antidepressant fails make-or-break trial (STAT)
Medtech
  • EU Now Boasts Of 30 Notified Bodies Under The Medical Device Regulation (MedTech Insight)
  • Axogen Seeks FDA Approval For Avance Nerve Graft (MedTech Insight)
  • Becton Dickinson to acquire Parata Systems for over $1 billion (Reuters)
  • Illumina sequencing devices vulnerable to critical hacking risks, FDA warns (Fierce)
  • Baxter warns of possible oxygen level drops linked to Hillrom lung-expansion therapy (Fierce)
  • Philips updates latest ventilator recall following report of patient death, 4 injuries (Fierce)
  • Can wearables help Parkinson's patients? Verily publishes new data from virtual exams (Endpoints)
  • Hot Flash! Menopause May Not Be Sexy, But Investors Are Warming To Digital Health Solutions (MedTech Insight)
  • ADA: Twin Health’s AI tech leads to Type 2 diabetes remissions, study finds (Fierce)
Government, Regulatory & Legal
  • Roche’s Genentech Sues Tanvex to Block Cancer Drug Biosimilar (Bloomberg)
  • Avion, Balchem Unit Sue Lupin to Block Birth-Control Pill Copies (Bloomberg)
  • How long covid could change the way we think about disability (Washington Post)
  • Indiana Supreme Court Rules for Governor in Pandemic Powers Suit (Bloomberg)
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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