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

• 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)

• 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)

• 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)

• 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)

• 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)