Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition

ReconRecon | 05 July 2022 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
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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