Recon: WHO okays J&J vaccine for emergency use listing; Sanofi, Translate Bio launch trial of mRNA COVID vaccine

| 12 March 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden: All US adults to be eligible for vaccines by May, some normalcy coming by summer (Reuters)
  • Pharma Giants Get Their Pennies Pinched on Drug Pricing (WSJ)
  • The top drugs that could be impacted by an obscure provision in the pandemic relief law (BioPharmaDive)
  • To Extract More Doses per Vial, Vaccinators Put Squeeze on FDA to Relax Handling Advice (KHN)
  • Lonza to commission Houston suite to supply Altimmune's COVID-19 vaccine candidate (Reuters)
  • Pfizer vaccine production on the rise as pandemic hits one-year mark (Reuters)
  • Sacklers boost opioid settlement offer to $4.3 billion: sources (Reuters)
  • J&J to make up to three billion COVID-19 vaccines in 2022: chief scientist (Reuters)
  • Fauci’s star rises as relationship with Biden deepens (Politico)
In Focus: International
  • As vaccine nationalism deepens, governments pay to bring production home (Reuters)
  • WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19 (WHO)
  • Sanofi, Translate Bio launch human trial of mRNA COVID-19 vaccine (Reuters)
  • Australia considers funding vaccine maker to curb reliance on imports (FT)
  • Novavax vaccine 96% effective against original coronavirus, 86% vs British variant in UK trial (Reuters)
  • AstraZeneca cuts EU vaccine supply again; health bodies dismiss safety fears (Reuters)
  • EU told to expect no AstraZeneca vaccines from US in near future (Reuters)
  • WHO says its advisory committee looking at AstraZeneca vaccine issues (Reuters)
  • WHO's Aylward hopes to have J&J vaccine in COVAX scheme by at least July (Reuters)
  • WTO Fails To Reach Deal On COVID IP Waiver Proposal, Again (Law360)
  • ACT-Accelerator releases prioritised strategy and budget for 2021 to change the course of the evolving COVID-19 pandemic (WHO)
Coronavirus Pandemic
  • The US Is Sitting on Tens of Millions of Vaccine Doses the World Needs (NYTimes)
  • Boehringer drops development of a COVID-19 candidate (PharmaLetter) (Press)
  • Brazil gives final approval for AstraZeneca vaccine, sees domestic manufacture (Reuters)
  • South Africa could get 20 million more J&J vaccine doses, minister says (Reuters)
  • South Africa's drugs regulator to start assessing Sinovac COVID-19 vaccine (Reuters)
  • Daiichi Sankyo says it has begun producing AstraZeneca's COVID-19 vaccine in Japan (Reuters)
  • Japan vaccine chief says to use six-dose syringes from mid-April (Reuters)
  • Doses of Russia's Sputnik V, made in Italy, to go on sale no sooner than late 2021: TASS (Reuters)
  • Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers (FDA)
Pharma & Biotech
  • Prometheus and Longboard make the leap to Nasdaq with 9-figure offerings and are joined by a Falcon Edge-backed SPAC (Endpoints)
  • Albert Bourla bagged $21M in year marked by generics spinoff, colossal R&D effort for Covid-19 vaccine (Endpoints)
  • The Food and Drug Administration approved revisions to the TRIUMEQ (abacavir/dolutegravir/lamivudine) and DOVATO (dolutegravir/lamivudine) labels (FDA)
  • EMA Management Board – highlights of March 2021 meeting (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021 (EMA)
  • How Rocket Pharma quietly became one of gene therapy's high flyers (BioPharmaDive)
  • Astellas Seeks Japan Nod for Padcev in Japan (PharmaJapan)
  • Benefits of ifosfamide solutions continue to outweigh risks EMA’s safety committee (PRAC) has concluded that the benefits of ifosfamide solutions for infusion (EMA)
  • Mitochondrial biotech Minovia Therapeutics nabs biopharma veteran Alan Jacobs as new chief medical officer (Fierce)
  • UCSD spinout pursues gene therapy for chronic pain following positive data in mice (Fierce)
  • Turalio – Why The EU Said No To The US-Approved Drug (Pink Sheet)
  • GSK, Novo and Roche meds hit pandemic potholes while Dupixent, Humira stood strong: analysts (Fierce)
  • Lilly disses Amgen and Mirati as it debuts new KRAS molecule (Endpoints)
  • BARDA bets $86M on ContraFect's PhIII bid against drug-resistant Staph (Endpoints)
  • Monte Rosa pulls in $95M to test its 'molecular glues,' and the first target is GSPT1 (Endpoints)
  • Withdrawal of Approval of Five Abbreviated New Drug Applications for Bacitracin for Injection (FDA)
  • Sagent pulls 3 lots of phenylephrine after customer finds a loosely sealed vial (Fierce)
  • Medtronic, Farapulse Advance Pulsed Field Ablation With US Trials (MedtechInsight)
  • FDA clears Baxter’s connected, in-center dialysis machine (Fierce)
  • How will doctors talk to patients about contraception apps like Natural Cycles and Clue? (STAT)
  • Why The Humble Swab Could Be A Seriously Disruptive Element In The MDR And IVDR (MedtechInsight)
  • Member States Vote On Critical Medtech Standards Request: Will It Be Accepted This Time? (MedtechInsight)
  • NHS trials edible capsule cameras to detect colon cancer (mobihealthnews)
  • Hospitals lift curtain on prices, revealing giant swings for hips, knees and more (MedtechDive)
  • Cardinal Health sells troubled Cordis unit to private equity firm for $1B (MedtechDive)
  • New Taiwanese medical device regulations set for May 2021 (Emergo)
  • Thailand Issues New Medtech Regulations – Industry Guidelines To Follow (MedtechInsight)
  • Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers (FDA)
Government, Regulatory & Legal
  • NJ Court Revokes Pelvic Mesh Verdicts, Says 510(k) Evidence Should Be Allowed (MedtechInsight)
  • Ohio attorney general sues a health plan over its PBM contracts and Medicaid costs (STAT)
  • Senate OKs Drug Exclusivity Change To Boost Generics (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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