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12th June 2020
by Michael Mezher

Recon: EU to spend up to $2.7B upfront on COVID-19 vaccines; FDA approves Viela’s NMOSD treatment

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Viela Bio’s Uplizna Therapy Gets FDA Approval (Bloomberg) (Endpoints) (FDA)
  • Hedge fund manager stands to profit on ‘flip’ of taxpayer-funded coronavirus drug (Washington Post)
  • New Long-Acting Insulin Drug Enters Market With FDA Approval (Bloomberg) (Pink Sheet)
  • Agios drug demonstrates strong response in patients with inherited blood disorder (STAT)
  • Apellis counters Alexion’s critique, clears up FDA questions as blockbuster decision looms (Endpoints)
In Focus: International
  • EU states back spending up to $2.7 billion upfront on COVID-19 vaccines (Reuters 1, 2) (Financial Times)
  • Brazil research institute in deal to help test, produce Chinese coronavirus vaccine (Reuters)
  • India's Zydus Cadila to make Gilead's potential COVID-19 drug remdesivir (Reuters)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (EMA)
  • Bottlenecks? Glass vial makers prepare for COVID-19 vaccine (Reuters)
  • Will Zolgensma Delay Spur Revision of Sakigake Designation System? (PharmaJapan)
Coronavirus Pandemic
  • Coronavirus Can Set Off a ‘Cytokine Storm.’ These Drugs May Calm It. (NYTimes)
  • Australian clot-busting drug holds hope for COVID-19 treatment (Reuters)
  • Coronavirus vaccine: US Chamber of Commerce calls for more transparency from big pharma over licensing deals (Independent)
  • Moderna burnishes its PhIII-ready Covid-19 vaccine with promising mouse data — which suggest one dose might be enough after all (Endpoints)
  • Coronavirus Vaccine Update, June 11 (In The Pipeline)
  • Coronavirus (COVID-19) Update: Daily Roundup June 11, 2020 (FDA)
  • South Korea to extend virus guidelines on prevention, sanitation (Reuters)
Pharma & Biotech
  • One of biotech’s biggest conferences grapples with how to talk about race and identity (STAT)
  • How a vaccine made of mosquito spit could help stop the next epidemic (Reuters)
  • Drug Sales Reps Stow the Sample Case and Turn to Zoom (Bloomberg)
  • LentiGlobin continues to deliver in latest sickle cell update as bluebird outlines path to accelerated approval, despite patient death (Endpoints)
  • Vertex and CRISPR spotlight another important gene editing advance in a march to a hoped-for cure (Endpoints) (STAT)
  • Another domino falls: MIT ends negotiations with Elsevier over research access dispute (STAT)
  • UPS expands healthcare footprint, shifting focus to vaccines (SupplyChainDive)
  • Sanofi and Regeneron outline Dupixent plans; Industry lobbying brings £30 million for UK's Biomedical Catalyst (Endpoints)
  • 'Rising star' CEO recounts path from pre-med to breakthrough meds; Dendreon taps Big Pharma vet Jason O'Neill as CEO (Endpoints)
  • The pandemic IPOs keep rolling, as Generation, Avidity, Vaxcyte each claim 200M+ (Endpoints)
Medtech
  • ADA 2020 kicks off with key data on Medtronic's 780G, Insulet's Horizon (MedtechDive)
  • Moody's cuts medtech outlook, pegs J&J, Zimmer among hardest hit by COVID-19 fallout (MedtechDive)
  • CMS to review at-home ventilation of COPD patients amid variability in device use (MedtechDive)
  • NCI develops viral antibody blood test to boost liver cancer screening (Fierce)
  • Class 1 Device Recall Ovation iX Abdominal Stent Graft System (FDA)
Government & Regulatory 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.