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.
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