You are here:
Homepage
News & Insights Search
Recon: Sanofi CEO promises access to COVID-19 vaccine after French backlash; Japan says remdesivir in use at hospitals
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.