Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA to convene second panel of outside experts to review Amylyx Pharma’s ALS treatment (STAT) (Endpoints) (Reuters)
- Novavax expects COVID vaccine targeting Omicron in fourth quarter (Reuters)
- Can Biogen’s backup plan for Alzheimer’s succeed? (Boston Globe)
- Another Duchenne clinical hold gets lifted, this time at Dyne Therapeutics (Endpoints)
- FDA Clears Vertex to Continue Dosing in Diabetes Cell Therapy Trial (Biospace)
- US government more than doubles the supply of monkeypox vaccine (Endpoints) (Fierce)
- Pfizer/BioNTech Vaccine Trial In Young Kids Marked By High Level Of Unblinding (The Pink Sheet)
- COVID Vaccines For 5 and Under: Pfizer Pivot To 3 Shots Leaves Meager Data Package Compared To Moderna (The Pink Sheet)
- Continuous Pharmaceutical Manufacturing Bill Hitches A Ride With US FDA User Fee Legislation (The Pink Sheet)
- ‘A slippery slope’: Pfizer sells a contraceptive and donated to political groups that could come after the company (STAT)
- A Clunky Mask May Be the Answer to Airborne Disease and N95 Waste (NYT)
- Little-Known Abortion Pill Maker Faces Scrutiny (WSJ)
- 'We strongly dissent': Women biotech execs pen letter to colleagues and politicians in Roe v. Wade aftermath (Endpoints)
- Left behind at the Covid vaccine starting line, CureVac files suit against BioNTech over megablockbuster IP claims (Endpoints) (Biopharma Dive) (Reuters)
- EMA Explains Process For Assessing Suitability of Biomarkers With Concerned Medicines a (The Pink Sheet)
- Payers Set Out Radical Wishlist For Changes To EU Pharma Legislation (The Pink Sheet)
- Biopharma Investment in China is Thriving Amid U.S. Downturn (Biospace)
- Wacker Chemie invests 100 million euros in mRNA factory (Reuters)
- Monkeypox: WHO Advises Antiviral Use In Trials Or Expanded Access Programs (The Pink Sheet)
- German health minister in move to boost use of COVID treatment Paxlovid (Reuters)
- Sanofi launches global health brand with non-profit treatments (Reuters)
- Novartis buys FDA priority review voucher from bankrupt Mallinckrodt for $100M (Fierce)
- Moderna COVID Vaccine’s Myocarditis Risk Has Improved With Time, US FDA Says (The Pink Sheet)
- Astra Agrees to Pay up to $1.3 Billion for Biotech TeneoTwo (Bloomberg) (Fierce) (BioSpace) (Scrip)
- Wuxi Biologics inspection raises prospects for getting off US ‘unverified list’ -- report (Endpoints)
- Lonza to invest $500M+ on fill-finish facility on its home turf (Endpoints)
- VC deals and valuations begin falling apart amid biotech’s stock shock (STAT)
- The top biotech hubs in 2022 (Fierce)
- Anebulo Pharma says study supports development of its pill as an antidote for cannabis intoxication (STAT)
- How antibiotics may shut down cancer metastasis (Fierce)
- Here At Last: EU’s Implementing Regulation On Common Specifications For Class D IVDs (MedTech Insight)
- Four Months And Ticking: No New Opinions From EU Medtech Expert Panels (MedTech Insight)
- Notified Body Process For Consulting EMA On Companion Diagnostics (MedTech Insight)
- FDA Approves Companion Diagnostic For Obesity Drug (MedTech Insight)
- LiveMetric’s blood-pressure ‘smartwatch’ device gets FDA clearance (MedTech Dive)
- Intuitive secures FDA clearance for lung biopsy robot featuring Siemens’ imaging tech (MedTech Dive)
- U.S. drug distributors prevail in $2.5 billion West Virginia opioid case (Reuters) (Bloomberg)
- Bausch + Lomb, Nicox Sue Gland Pharma to Block Generic Eye Drops (Bloomberg)
- Jury Hands Endo Win In Opana Pay-For-Delay Case (Law360)
- Bio-Rad, Danaher’s Cytiva Settle Protein Purifying Patent Suit (Bloomberg)
- Tossing of J&J Unit’s Bankruptcy Urged by Cancer Patients, DOJ (Bloomberg)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
