You are here:
Homepage
News & Insights Search
Recon: Biden administration to order 200M more COVID vaccine doses; AstraZeneca, EU spar over vaccine supplies
Recon: Biden administration to order 200M more COVID vaccine doses; AstraZeneca, EU spar over vaccine supplies
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Biden administration to buy 200 million more doses of Covid vaccine (Politico )
U.S. CDC sees lower rates of allergic reaction after Pfizer vaccine (Reuters )
Moderna in talks with US to sell 100 million more COVID-19 vaccine doses (Reuters )
Eli Lilly, Regeneron's COVID-19 treatments may be weaker against South Africa variant (Reuters )
Remdesivir, Given to Half of Hospitalized Covid Patients in US, Is Big Win for Gilead — Boosted by Taxpayers (KHN )
Biden Pledges to Speed Flow of Vaccines to the States (NYTimes )
WATCH: Biden's Coronavirus Team Gives First Briefing (NPR )
Millions earmarked for public health emergencies were used to pay for unrelated projects, says inspector general (Washington Post ) (Letter )
Johnson & Johnson confident of rebound as vaccines offer boost for healthcare (FT ) (MedtechDive )
Biden Administration Criticized For Delay In Tackling Opioid Crisis (NPR )
Senate rules could pose hurdles for vaccine funds (STAT )
Court orders Rochester General to give experimental COVID treatment to patient (Democrat & Chronicle )
In Focus: International
Global COVID-19 cases surpass 100 million as nations tackle vaccine shortages (Reuters )
EU pushes for access to AstraZeneca COVID vaccines from UK plants (Reuters ) (FT ) (NYTimes )
EU asks AstraZeneca to publish vaccine contract after CEO's disclosures (Reuters )
Sanofi confirms its will supply over 125 million Pfizer-BioNTech doses to the EU (Reuters )
AstraZeneca UK vaccine partner says suspicious package made safe, production schedule unaffected (Reuters )
AstraZeneca to ask Japan's JCR Pharmaceutical to produce COVID-19 vaccine (Reuters )
Vaccines should be able to be adapted fast to address COVID-19 variants - WHO's Ryan (Reuters )
COVAX to supply 355 million vaccine doses for Eastern Med this year - WHO official (Reuters )
Lonza sees months before Swiss COVID-19 vaccine plants hit 'cruising speed' (Reuters )
With Expensive U.S. COVID-19 Vaccines, Many Countries Look Elsewhere (NPR )
Coronavirus Pandemic
World surpasses 100M coronavirus cases (The Hill )
US considering mandatory COVID-19 tests for domestic flyers, CDC official says (The Hill )
China, India's COVID-19 vaccinations to stretch to late 2022: study (Reuters )
India's COVAXIN likely effective against UK variant – study (Reuters )
TimesBrazilian companies discuss seeking direct vaccine supplies (Financial Times )
3M CEO expects Covid demand for the company’s N95 masks to be strong throughout 2021 (CNBC )
Abbott's Panbio antigen test obtains new European approvals for mass COVID-19 screening (Fierce )
BD study suggests its COVID-19 antigen test better than PCR at detecting infectious individuals (MedtechDive )
France Rejects Advice To Delay Second Dose Of Pfizer Vaccine (Pink Sheet )
At-home Covid-19 tests offer promises — and questions (NBC )
Why N95 Masks Are Still In Short Supply In The U.S. (NPR )
Eli Lilly teams up with pharma rival GSK and partner Vir for COVID-19 antibody cocktail test (Fierce )
Some European Countries Move To Require Medical-Grade Masks In Public (NPR )
Chinese cities using anal swabs to screen COVID-19 infections (Reuters )
India's Dr.Reddy's ends study of COVID-19 drug Avigan in Kuwait (Reuters )
Mexico may approve Russian COVID-19 vaccine within days, health official says (Reuters )
South Africa approves AstraZeneca vaccine for emergency use (Reuters )
Morocco gets half million doses of Sinopharm Covid-19 vaccine (Reuters )
Spanish regions cap COVID-19 vaccinations due to slowing supply (Reuters )
UNICEF signs up Dubai's DP World to help distribute COVID-19 vaccines (Reuters )
Chile health regulator approves AstraZeneca COVID-19 vaccine for emergency use (Reuters )
Uganda conducting clinical trials of possible drug against COVID-19 infections – statement (Reuters )
Pharma & Biotech
With All Eyes on Covid-19, Drug-Resistant Infections Crept In (NYTimes )
Novartis hit by ‘COVID-19-related lockdowns’ in Q4 (PMLive )
For Biosimilars, A Mid-Review Cycle Product Quality Discussion Appears To Be A Bad Omen (Pink Sheet )
AstraZeneca scores new goal on the pipeline front, adding its first AI-generated target to the portfolio (Endpoints )
Can Biosimilar Orphans Increase Health System Sustainability In The UK? (Pink Sheet )
NICE recommends Celgene's REVLIMID for multiple myeloma (Pharmafile )
EU Crunch Time For Two Drugs That Lost Their Fast-Track Status (Pink Sheet )
Horizon Therapeutics Sets Sights on Blockbuster Sales, Broader Pipeline (GEN )
Agios readies FDA filing as anemia drug clears another phase 3 (Fierce )
Sanofi joins fellow French firms in venture to boost digital health solutions (Fierce )
CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence (Pink Sheet )
Safety finding weighs on Pfizer's inflammation drug, and could spell trouble for others (BioPharmaDive ) (Endpoints )
Ex-MD Anderson chief DePinho is helping launch another biotech — and he's sticking with familiar ground (Endpoints )
As targeted therapies get ever more precise, Deerfield unveils $50M bet on an Harvard professor's chemistry insights (Endpoints )
Foresite returns to the SPAC well, as investors wonder how long the run can last (Endpoints )
Leaps by Bayer backs a protein engineering startup taking on Aimmune — and Nestlé — in peanut allergy (Endpoints )
AstraZeneca CEO Pascal Soriot severs an unusual board connection, steering clear of conflicts while retaining important alliances (Endpoints )
Vir stock soars on blinded, 8-subject hepatitis B analysis (Fierce )
GSK transfers malaria vaccine production to India's Bharat Biotech (Economic Times )
Medtech
Ventilators, imaging drive GE healthcare profits up 27% as procedures even out (MedtechDive )
Surmodics drug-coated balloon on par with Medtronic's in study (MedtechDive )
Delayed NHS MedTech funding mandate policy to launch in April (mobihealthnews )
Samsung says smartwatch ECG, blood pressure measurement will go live in 31 more countries (mobihealthnews )
HFE for over-the-counter medical devices and combination products: Nice to have or necessary? (Emergo )
Government, Regulatory & Legal
‘Use that money wisely’: Coalition urges governments to spend opioid settlement funds on evidence-based efforts (STAT )
CMS puases three Trump-era proposed rules (Modern Healthcare )
Judge Doubts Walmart's Preemptive Opioid Suit Can Prevail (Law360 )
Fresenius Asks 3rd Circ. For Partial Redo Of Generics Opinion (Law360 )
Eli Lilly Says HHS Drug Discount Rule Will Cost It Billions (Law360 )
Full Fed. Circ. Won't Take Up Hatch-Waxman Act Venue Limits (Law360 )
Opioid MDL Judge Takes Senior Status, Setting Up Biden Pick (Law360 )
NJ Court Lends Support To FDA Evidence In Mesh Cases (Law360 )
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.