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January 27, 2021
by Michael Mezher

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.
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