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  4. Recon: Moderna says COVID vaccine more than 94% effective; Drugmakers offer C$1B to fend off new Canadian pricing rules

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Recon
16 November 2020
by Michael Mezher

Recon: Moderna says COVID vaccine more than 94% effective; Drugmakers offer C$1B to fend off new Canadian pricing rules

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna says coronavirus vaccine more than 94 percent effective (Politico) (STAT) (NYTimes)
  • J&J starts two-dose trial of its COVID-19 vaccine candidate (Reuters 1, 2)
  • J&J supply chain exec: ‘I lose sleep’ over sending Covid-19 vaccine to lower-income countries (STAT)
  • Azar says FDA will move ‘as quickly as possible’ to clear Moderna, Pfizer’s Covid vaccines (CNBC)
  • Inovio to begin mid-stage study of COVID-19 vaccine candidate (Reuters)
  • Fauci warns that White House transition delays could slow vaccine rollout (Politico)
  • States Vow Extra Scrutiny of Coronavirus Vaccine (NYTimes)
  • Missing From State Plans to Distribute the Coronavirus Vaccine: Money to Do It (NYTimes)
  • Cytokinetics heart failure drug succeeds but slightly higher death rate seen (Reuters)
  • Federal authorities issue strong warning to pharma over speaker programs and kickbacks (STAT) (Law360)
In Focus: International
  • EU eyes COVID vaccine deal with Moderna at less than $25 per dose, says source (Reuters)
  • CureVac deal takes EU's COVID vaccine supplies close to 2 billion (Reuters)
  • Britain expects to roll out Pfizer's COVID-19 vaccine before Christmas (Reuters)
  • UK in talks to access Moderna vaccine from spring 2021 at the earliest (Reuters)
  • Lonza aims to make ingredients for 400 million doses of Moderna's COVID vaccine annually (Reuters)
  • Drugmakers offer Canada C$1 billion to scrap some pending pricing rules (Reuters)
  • First ever vaccine listed under WHO emergency use (WHO)
  • Covid-19 Vaccine Makers Face Russian, North Korean Cyberattacks, Microsoft Says (WSJ)
Coronavirus Pandemic
  • As the Pandemic Surges, CDC Issues Increasingly Assertive Advice (NYTimes)
  • Doctors Are Calling It Quits Under Stress of the Pandemic (NYTimes)
  • WHO reports 65 staff infections since pandemic began (Reuters)
  • Russia focuses on freeze-dried vaccine doses as transport fix (Reuters)
  • Indian drugmaker Biological E. starts human trials of COVID-19 vaccine candidate (Reuters)
  • MHLW to Continue Follow-Up on Veklury’s Safety/Efficacy Info: Official (PharmaJapan)
  • MHLW Weighs COVID-19 Vaccinations outside Medical Institutions (PharmaJapan)
Pharma & Biotech
  • Big study supports cheap combo pill to lower heart risks (STAT)
  • Failed study spawns fresh debate about fish-oil-derived drugs for heart disease (STAT)
  • With Consensus on 13 Topics Delayed by COVID-19, ICH Expected to Restrict Selection of New Topics at Virtual Assembly (PharmaJapan)
  • PMDA Reviewing New Safety Risks for Soliris, Venclexta/Noxafil (PharmaJapan)
  • Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation (IPQ)
  • Improving target assessment in biomedical research: the GOT-IT recommendations (Nature)
  • Sanofi's hopes for rare blood disease candidate sutimlimab on hold after FDA blasts 3rd-party manufacturer (Fierce)
  • Merck's Keytruda steps up to face Roche's Tecentriq with FDA OK in triple-negative breast cancer (Fierce) (FDA)
  • Biogen’s Aducanumab: Why Accelerated Approval Might, And Might Not, Be An Option For US FDA (Pink Sheet)
  • Brexit: New Rules Will Hit Parallel Trade From UK to EU (Pink Sheet)
  • Sleep disorder drug modafinil linked to increased risk of birth defects and also to reduced effectiveness of contraception (MHRA)
Medtech
  • DHS Flags Becton Medical Pump For Cybersecurity Issues (Law360)
  • Medtronic closes Medicrea buyout, seeking spinal surgery boost (MedtechDive)
  • EU regulators provide 7 rules for classifying diagnostics under IVDR (MedtechDive)
  • Making The Leap From EU MDD To MDR Clinical Evidence (Part 3): Critical Questions Answered (MedtechInsight)
  • AHA: Digital monitoring study finds high rates of hidden atrial fibrillation after heart surgery (Fierce)
  • Glympse Bio clears first-in-human safety study of its injectable biosensors (Fierce)
Government, Regulatory & Legal
  • Where $40 Million Might Go for FY 21 (Alliance for a Stronger FDA)
  • C R Bard Inc. v. AngioDynamics, Inc. (Fed. Cir. 2020) (Patent Docs)
  • We’re Not in the MDL Anymore: Mesh Complaint Fails to Satisfy Twiqbal in the District of Arizona (Drug & Device Law)
  • Genentech Sues Centus Over Proposed Bevacizumab Biosimilar (Big Molecule Watch)
  • Insulin Pen Buyers Say Sanofi Antitrust Suit Not Overly Broad (Law360)
  • FDA Must Address Lannett's Lies On Cocaine Drug, Suit Says (Law360)
  • FDA, DEA Experts Cleared To Testify In NY AG's Opioid Case (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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