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May 14, 2020
by Michael Mezher

Recon: Sanofi CEO promises access to COVID-19 vaccine after French backlash; Japan says remdesivir in use at hospitals

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump Taps Ex-Glaxo Official and General to Lead Vaccine Race (Bloomberg) (Reuters) (Politico)
  • Trump mobilizing US military to deliver coronavirus vaccine (Reuters)
  • Trump administration fires back at ousted vaccine expert as he testifies on his role in US coronavirus response (STAT) (WSJ)
  • Ousted vaccine chief: 'Our window of opportunity is closing' (Politico 1, 2)
  • A Trump Official Tried to Fast-Track Funding for His Friend’s Unproven COVID-19 “Treatment,” Whistleblower Says (ProPublica)
  • Accuracy of rapid coronavirus test called into question by NYU study (Politico) (Reuters) (NYTimes)
  • US to tell doctors to report cases of COVID-19 inflammatory syndrome in kids (Reuters 1, 2)
  • Sanofi gets priority FDA review for sutimlimab product (Reuters)
  • Amgen’s KRAS-blocking drug shows small improvement in colon cancer response (STAT) (Endpoints)
Sponsored Content: Clinical and regulatory challenges for cell and gene therapies
 
In Focus: International
  • 'This virus may never go away,' WHO says (Reuters)
  • Sanofi CEO pledges virus vaccine for all after French backlash (Reuters) (Financial Times) (Endpoints)
  • Why vaccine ‘nationalism’ could slow coronavirus fight (Financial Times)
  • China calls US accusation of hacking in COVID-19 research "slander" (Reuters)
  • Japan says drugmaker Gilead's COVID-19 treatment remdesivir now in use in hospitals (Reuters)
  • Health groups ask India to rescind Gilead's patents for COVID-19 drug remdesivir (Reuters)
  • CureVac's coronavirus vaccine candidate triggered immune response in animal tests (Reuters)
  • MHLW to Accept Applications for COVID-19 Treatments Without Clinical Trial Data; Avigan, Alvesco, Futhan Might Be Eligible (PharmaJapan)
  • Takeda says coronavirus treatment trial using recovered patients' blood could start in July (Reuters)
  • UK follows EU, US to approve Roche COVID-19 antibody tests (Reuters)
  • DiaSorin gets Canada's approval for sale of COVID-19 antibody tests (Reuters)
  • Roche’s novel checkpoint inhibitor delivers mixed results in new lung cancer study (STAT) (BioPharmaDive) (Endpoints)
  • Novo Nordisk’s first semaglutide obesity trial hits the mark (PMLive)
  • Boehringer Ingelheim Acquires Northern Biologics’ Preclinical Pipeline (Xconomy) (Press)
  • Israel approves medical cannabis exports (Reuters)
Coronavirus Pandemic
  • World Health Assembly draft resolution boosts access to Covid-19 medicines (STAT)
  • Abivax to Begin Testing Experimental Colitis Drug for Covid-19 (Bloomberg)
  • Dozens of coronavirus drugs are in development — what happens next? (Nature)
  • Gilead should ditch remdesivir and focus on its simpler and safer ancestor (STAT)
  • Sitting in a freezer for years, potential SARS vaccine now ready for coronavirus trial (USA Today)
  • Coronavirus surveillance program in King County put on hold because of FDA concerns (Seattle Times)
  • Trucks used to store bodies amid pandemic can haul food again, FDA says (Miami Herald)
  • Eisai Resurrects Eritoran as Potential COVID-19 Treatment, Eyes Trial Launch Next Month (PharmaJapan)
  • India to test four drugs as part of WHO trial (Economic Times)
  • LabCorp to make COVID-19 testing services available at workplaces (Reuters)
  • Remote digital monitoring in clinical trials in the time of COVID-19 (Nature)
  • BMJ, Nature warn against 'sabotaging' COVID-19 response with poor and 'chaotic' trials (Fierce)
  • China's BGI gets Australian foothold through mass coronavirus test delivery (Reuters)
  • Italy launches blood tests to investigate who has had COVID-19 (Reuters)
  • Spanish antibody study points to 5% of population affected by coronavirus (Reuters)
  • Only 4.4% of French population infected by coronavirus: Pasteur institute (Reuters)
  • Brazil passes France in coronavirus cases to become 6th worst-hit country (Reuters)
  • Moscow says it ascribed over 60% of coronavirus deaths in April to other causes (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup May 13, 2020 (FDA)
Pharma & Biotech
  • BIO gets a new chief lobbyist to face off against the growing ranks of critics in Congress (Endpoints)
  • Reprogrammed skin cells inserted in brain help Parkinson's patient regain function: study (Reuters) (STAT)
  • J&J myeloma data heat up cell therapy battle (BioPharmaDive)
  • ASCO: Off-the-shelf CAR-T pioneer Allogene shows early hints of efficacy in lymphoma (Fierce) (BioPharmaDive) (Endpoints)
  • Bristol Myers Squibb spells out OS benefit of Opdivo/Yervoy combo plus 'limited' chemotherapy — is it enough to change practice? (Endpoints) (Fierce)
  • BCMA rival to bluebird, Bristol Myers files for $100M IPO as the frontrunners stumble in a race to the finish line (Endpoints)
  • Days after rapid FDA approval, Lilly and Blueprint go head-to-head again at ASCO (Endpoints)
  • MacroGenics chief Scott Koenig details the upbeat cancer drug data from 2 programs that drove a big spike in their share price (Endpoints)
  • ASCO: Pfizer, Astellas show Xtandi helps early prostate cancer patients live longer (Fierce)
  • ASCO: Arvinas unveils first-in-human data for novel protein degrader in prostate cancer (Fierce)
  • ASCO: Is the PD-1 target behind Keytruda's small-cell miss? Merck exec says no (Fierce)
  • Avrobio posts 22-month update on Fabry gene therapy trial (Fierce)
  • ‘Good’ bacteria could help fight a common vaginal infection, new data show (STAT)
  • European Commission Approves Adcetris For Treatment Of Systemic Anaplastic Large Cell Lymphoma (Reuters) (Press)
  • How the pandemic helped secure a rare cancer drug for Menarini (Endpoints)
  • Amazon, Berkshire Hathaway and J.P. Morgan’s joint venture to revamp health care loses its CEO (CNBC)
  • Continuous Manufacturing Back In Second Act (Pink Sheet)
  • Gedeon Richter Chief Makes Biosimilars Prophecy (Pink Sheet)
  • Back To Normal? US FDA Schedules In-Person Meeting But Pauses Non-COVID Guidance Development (Pink Sheet)
Medtech
  • To screen COVID-19 patients for heart problems, FDA clears several ultrasound, AI devices from Philips, Eko, Caption Health (Fierce)
  • EFTA countries and Russia introduce COVID-19 policy changes (Emergo)
  • Hims & Hers, Vault Health now sell FDA-authorized home COVID-19 tests via telehealth (MobiHealthNews)
  • Smiths Medical acquires Access Scientific (MassDevice)
  • FDA clears ophthalmic camera from Optina Diagnostics (MassDevice)
  • Nevro Senza Omnia SCS wins CE Mark (MassDevice)
Government & Regulatory
  • State Supreme Court Overturns The Stay-At-Home Order In Wisconsin (NPR)
  • COVID-19 Underscores Diagnostic Patent Eligibility Problems (Law360)
  • Natera, Illumina Ink Deal To End Row Over DNA Testing IP (Law360)
  • CVS Unit To Pay $15M Over 'Improper' Opioid Dispensing (Law360) (STAT)
  • Don't Bet On Aug. Trial In CVS Drug-Pricing Suit, Judge Says (Law360)
  • MDL Won't Stop PTAB From Reviewing Merck Diabetes Patent (Law360)
  • How to manage temporary GDP process changes and risks through the COVID-19 pandemic (MHRA)
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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