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April 23, 2020
by Michael Mezher

Recon: AZ to test Farxiga against COVID-19; EU approves Mylan, Upjohn merger with conditions

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • House to pass $484 billion coronavirus aid package (Politico) (WSJ)
  • Health Chief’s Early Missteps Set Back Coronavirus Response (WSJ)
  • Special Report: Former Labradoodle breeder was tapped to lead US pandemic task force (Reuters)
  • Vaccine Chief Says He Was Removed After Questioning Drug Trump Promoted (NYTimes) (Politico) (CNBC) (In the Pipeline) (Reuters) (STAT)
  • Inside America’s unending testing snafu (Politico)
  • US says review of WHO to assess if the body is run in 'the way it should be' (Reuters)
  • More US states make plans to reopen; California holds firm (Reuters)
  • Trump disagrees with Georgia's push to re-open economy (Reuters)
  • Hahn: States could increase coronavirus testing this week with at-home kits (Washington Post)
  • Vaccine Rates Drop Dangerously as Parents Avoid Doctor’s Visits (NYTimes)
  • Lilly beats Q1 expectations, driven by prescriptions amid coronavirus pandemic (FoxBusiness) (Press)
  • FDA grants accelerated approval for Immunomedics' breast cancer therapy (Reuters) (Endpoints) (FDA)
In Focus: International
  • European firms step up COVID-19 vaccines work, UK team starts human trials (Reuters)
  • EMA warns against malaria drugs' side effects in COVID-19 use (Reuters)
  • Chinese cancer drug developer Akeso banks on pharma tie-up in race with rivals amid record-setting Hong Kong IPO (SCMP)
  • Sanofi MS drug reduced brain lesions in preliminary study (STAT) (Fierce) (Endpoints) (Press)
  • AstraZeneca pilots diabetes drug as potential COVID-19 treatment (Reuters)
  • Pivotal data cement use of Incyte, Novartis' ruxolitinib in difficult-to-treat graft-versus-host disease (Endpoints) (Fierce) (Press) (NEJM)
  • EU Clears Mylan, Pfizer Unit Deal With Generics Spin Off (Law360) (European Commission)
  • Hard fought gains in immunization coverage at risk without critical health services (WHO)
  • WHO warns that malaria deaths in Africa could double this year (Reuters)
  • ‘Instead of Coronavirus, the Hunger Will Kill Us.’ A Global Food Crisis Looms. (NYTimes)
Coronavirus Pandemic
  • Opinion: A Coronavirus Vaccine: Faster, Please (WSJ)
  • As Leaders Urge Face Masks, Their Behavior Muffles the Message (NYTimes)
  • As virus advances, doctors rethink rush to ventilate (Reuters)
  • In New York’s largest hospital system, 88 percent of coronavirus patients on ventilators didn’t make it (Washington Post)
  • Blood-pressure drugs are in the crosshairs of COVID-19 research (Reuters)
  • UK to test prevalence of COVID-19 in general population (Reuters)
  • Italy's Triboo starts selling Chinese COVID-19 antibody tests (Reuters)
  • California governor orders autopsies back to December to find out how long coronavirus has been in the state (The Hill)
  • The Untold Story of the Birth of Social Distancing (NYTimes)
  • Covid-19 Arrived in Seattle. Where It Went From There Stunned the Scientists. (NYTimes)
  • China coronavirus cases may have been four times official figure, says study (The Guardian)
  • Itochu to recall masks after reports of defects in Japanese handout (Reuters)
  • Most kids with coronavirus usually recover within two weeks, JAMA study finds (CNBC)
  • Pfizer, Teva running short on antibiotic azithromycin amid COVID-19 therapy hunt (Fierce)
  • EU Industry Wants End To Isolated National Measures On Coronavirus (Pink Sheet)
  • Revive Therapeutics Announces US FDA Recommendation to Proceed Directly Into A Phase 3 Confirmatory Clinical Trial (Press)
  • Coronavirus (COVID-19) Update: Daily Roundup April 22, 2020 (FDA)
Pharma & Biotech
  • The coronavirus pandemic could shrink some biotech startup valuations (STAT)
  • Three Ways to Make Coronavirus Drugs In a Hurry (Scientific American)
  • A Decade of FDA Advancing Health Equity (FDA Voices)
  • Biogen’s top executive crew has a big credibility issue. And they seem determined to make it worse (Endpoints)
  • Analysis shows Swiss biotech index outshines Nasdaq counterpart, but coronavirus challenges are universal (Endpoints)
  • Venrock joins the biotech VC fundraising game, tossing $447M into a $4.3B pot of new money (Endpoints)
  • It's not developing drugs that bind to RNA, or morphing RNA into a therapeutic — this Cambridge startup has scored $63M to work on RNA-modifying proteins (Endpoints)
  • Why $120M for Affinivax may reflect a new view of vaccine makers (BioPharmaDive)
  • World’s 1st Topical JAK Inhibitor to Hit Shelves on June 24: JT/Torii (PharmaJapan)
  • Pfizer Japan Further Extends Work-from-Home through May-End (PharmaJapan)
  • States Take Unusual Actions To Control On-Label Drug Supply Amidst COVID-19 Shortages (Pink Sheet)
  • DOJ OKs Supply Chain 'Control Tower' Collaboration Against COVID-19 Drug Shortages (Pink Sheet)
  • If Drug Distributors Can Coordinate Without Anti-Trust Concerns During The Coronavirus Pandemic, What About Generic Manufacturers? (Pink Sheet)
Medtech
  • AdvaMed says 25m COVID-19 tests in the pipeline (MassDevice)
  • FDA to Harmonize COVID-19 Data with New Terminology Codes (GenomeWeb)
  • Medtronic sees US business fall 60% amid pandemic response (MedtechDive)
  • Quest Diagnostics testing volumes plunge due to coronavirus (MedtechDive)              
  • Thermo Fisher and Roche enjoy COVID-19 diagnostic tailwinds, but warn of routine testing declines (MedtechDive)
  • LivaNova cardiopulmonary devices can be used longer under FDA coronavirus guidance (MassDevice)
  • Conformis furloughed employees returning to active employment (MassDevice)
  • Programmable VT detection in cardiac resynchronisation therapy defibrillator (CRT-D) devices (TGA)
Government & Regulatory
  • Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 27 April and on 1 May 2020 (EMA)
  • Juul, Rival E-Cigarette Makers Get More Time Before FDA Review Due to Coronavirus (WSJ)
  • Bausch Execs Try To Nix Derivative Suit Over Fraud Scheme (Law360)
  • How AI-Related Life Sciences Patents Are Examined In Japan (Law360)
  • FTC Inks $38M Settlement Over Supplement False Ad Claims (Law360)
  • ITC Bans Cholesterol Test Strip Imports From Chinese Co. (Law360)
  • McKesson Settles Derivative Suit Over DOJ Fine For $175M (Law360)
  • HHS Broadly Interprets PREP Act Immunity: Reasonable Belief is Good Enough (FDA Law Blog)
  • Post-Albrecht Preemption Pummels Pradaxa Plaintiffs (Drug & Device Law)
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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