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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)