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July 20, 2020
by Michael Mezher

Recon: Oxford, CanSino coronavirus vaccines trigger immune response; GSK buys 10% stake in CureVac

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • White House seeks to block funds for coronavirus testing and tracing in relief bill (CNBC)
  • Mistrust of a Coronavirus Vaccine Could Imperil Widespread Immunity (NYTimes)
  • Inside Johnson & Johnson’s nonstop hunt for a coronavirus vaccine (NYTimes)
  • More than 100,000 have signed up for coronavirus vaccine testing (The Hill)
  • Gene Therapy Shows Promise For Hemophilia, But Could Be Most Expensive U.S. Drug Ever (NPR)
  • Congress is back to hash out coronavirus relief (Politico)
  • How much will it cost? And 5 other questions Congress could push Covid-19 vaccine makers to answer (STAT)
  • Janssen/MeiraGTx sight loss gene therapy hits targets (PharmaTimes)
In Focus: International
  • Studies provide glimpse at efficacy of Covid-19 vaccines from Oxford-AstraZeneca and CanSino (STAT)
  • Oxford vaccine triggers immune response (BBC) (Endpoints) (The Lancet)
  • CanSino COVID-19 Vaccine Shows Immune Response in Human Trial (Reuters) (Endpoints) (The Lancet)
  • UK Orders 90 Million Covid-19 Vaccine Doses from Pfizer, Valneva (Bloomberg)
  • Sanofi forges ahead with active ingredients spin-off-sources (Reuters) (Endpoints)
  • GSK scoops up close to 10% of German vaccine producer CureVac (Financial Times) (Endpoints)
  • Pre-fab vaccine facilities aim to help fill production gap (Financial Times)
  • Tiny UK Company’s Stock Soars 552% as Drug Cuts Covid Risk (Bloomberg) (PMLive)
  • BeiGene expands pipeline and hops on board a quest to cure hep B, inking a $540M deal with a fellow upstart biotech (Endpoints)
  • Allergan Pulls EU Filing For Abicipar Pegol (Pink Sheet)
Coronavirus Pandemic
  • What Does It Mean to Say a New Drug ‘Works’? (Wired)
  • New studies clarify what drugs help, hurt for COVID-19 (NBC)
  • WHO reports record number of new coronavirus cases as death toll nears 600,000 (NBC)
  • Older Children Spread the Coronavirus Just as Much as Adults, Large Study Finds (NYTimes)
  • Immunosuppressant drug shows promise for Covid-19 patients (Financial Times)
  • Testing Backlogs May Cloud the True Spread of the Coronavirus (NYTimes)
  • For COVID Tests, the Question of Who Pays Comes Down to Interpretation (KHN)
  • Coronavirus vaccines: top shots (Financial Times)
  • Seven Indian pharmaceutical companies race to develop vaccine for deadly coronavirus (Economic Times)
  • Coronavirus (COVID-19) Update: Daily Roundup July 17, 2020 (FDA)
Pharma & Biotech
  • Art Krieg’s Checkmate executes a snappy 1-2 biotech gambit — big crossover followed by an instant IPO (Endpoints)
  • Small AI biotech BioXcel surges on positive PhIII results, setting up dementia and Alzheimer’s test (Endpoints)
  • USP Convention Meets Virtually in May 2020 to Review Upcoming Priorities, with Both 200-Year Legacy and Current Pandemic in Focus (IPQ)
  • Amplyx touts upbeat readout from a small PhII study for lead antifungal (Endpoints)
  • Ex-Sanofi Genzyme chief David Meeker hops to a new biotech CEO post, this time focusing on quick leap to commercialization (Endpoints)
  • FDA 'Consistency' Is Industry Watchword For Promoting Effective Drug Development (Pink Sheet)
  • Industry Calls For US FDA Transparency On Use Of Innovative Clinical Trial Designs (Pink Sheet)
  • US FDA's Postmarket Study Requirements: Industry Wants Standardization, Expert Input (Pink Sheet)
  • US FDA May Reconsider RMAT Requests If Resubmitted With Sufficient Clinical Data (Pink Sheet)
  • Leave a Ladder Down, Part Deux (LifeSciVC)
  • Over 158 applications for generic products pending with USFDA for approval: Lupin (Economic Times)
  • DCGI pulls up Glenmark for false claims, overpricing of coronavirus drug FabiFlu (Economic Times)
Medtech
  • Philips sees double-digit COVID-19 connected care bump amid Q2 sales dip (MedtechDive)
  • FDA says Verathon recall of GlideScope Core smart cable is Class I (MassDevice)
  • Orthofix wins FDA clearance for pediatric plating system (MassDevice)
Government & Regulatory
  • Substantial Obstacles after June Medical Services: ACOG v. FDA (Harvard Bill of Health)
  • Cipla settles case with Amgen Inc involving generic cinacalcet hydrochloride tablets (Economic Times)
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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