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May 4, 2020
by Michael Mezher

Recon: Vir, Alnylam plan clinical trials for COVID-19 RNAi drug; EU pledges €1B for coronavirus vaccine development

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump contradicts top health officials with vaccine timeline, malaria drug claims (Politico)
  • Trump now says he hopes US coronavirus deaths less than 100,000 (Reuters)
  • Vir, Alnylam plan human trials by year-end for potential COVID-19 therapy (Reuters) (Endpoints)
  • US steers clear as global COVID-19 pledging conference begins (Reuters)
  • Health officials eyeing at least one of 14 potential coronavirus vaccines to fast-track (NBC)
  • Gilead Lobbying Rose As Interest In COVID-19 Treatment Climbed (NPR)
  • Roche wins US nod for COVID-19 antibody test, aims to boost output (Reuters) (CNBC)
  • Former FDA commissioner warns of new fall epidemic amid 'persistent spread' (Politico)
  • DHS report accuses China of hiding coronavirus info so it could hoard supplies (Politico)
In Focus: International
  • Profits and Pride at Stake, the Race for a Vaccine Intensifies (NYTimes)
  • UN calls for COVID vaccine, treatment available for all (Reuters)
  • Cost of vaccinating billions against Covid-19 put at more than $20bn (Financial Times)
  • China’s Coronavirus Vaccine Drive Empowers a Troubled Industry (NYTimes) (Financial Times)
  • EU warns against suspension of children vaccination amid coronavirus crisis (Reuters)
  • EU to provide one billion euros for global vaccine search: Von der Leyen (Reuters)
  • European Investment Bank joins WHO in pandemic help for Africa (Reuters)
  • The Coronavirus Still Is a Global Health Emergency, W.H.O. Warns (NYTimes) (Reuters)
  • Turkey eases export rules for medical devices used for virus (AP)
  • Canada giving AbCellera Biologics C$176 million for coronavirus research (Reuters)
  • Japan aims to fast-track review of anti-viral drug remdesivir (Reuters) (PharmaJapan)
  • Eli Lilly And Junshi Biosciences To Co-Develop Therapeutic Antibodies For Treatment Of Covid-19 (Reuters) (Press)
Coronavirus Pandemic
  • Blood-Pressure Drugs Don’t Increase Coronavirus Risk (WSJ) (NYTimes)
  • The Covid-19 Riddle: Why Does the Virus Wallop Some Places and Spare Others? (NYTimes)
  • Coronavirus gets a promising drug. MAGA world isn’t buying it. (Politico)
  • Amgen adds Otezla to the COVID-19 candidate list (PMLive)
  • Lawmakers ask HHS to ensure Gilead’s remdesivir is affordable if US taxpayers funded R&D (STAT)
  • With the pricing ball in Gilead’s court, ICER offers some parameters on how it can be played — analyst sees at least '$1B in theory' (Endpoints)
  • German study suggests infections are 10 times the number of confirmed cases (Reuters)
  • New Zealand reports no new coronavirus cases for first time since mid-March (Reuters)
  • Britain to trial new coronavirus tracing system (Reuters)
  • Coronavirus Sweeps Across Brazil, a Land Ill-Equipped to Fight It (WSJ)
  • Coronavirus (COVID-19) Update: Daily Roundup May 1, 2020 (FDA)
Pharma & Biotech
  • Why Are Clinical Trials So Complicated? (In The Pipeline)
  • With coronavirus pandemic, venture capitalists are taking extra precautions (STAT)
  • How Remdesivir, New Hope for Covid-19 Patients, Was Resurrected (NYTimes)
  • How an unproven drug became a bellwether for global stocks (Financial Times)
  • Belgian Body Welcomes Clawback Exemption For Generics/Biosimilars Amid Price Cuts (Pink Sheet)
  • BioMarin broadens its gene therapy horizons with a new R&D alliance in rare cardio cases (Endpoints)
  • Recent Study Examines the Influence of Institutional Incentives in Uptake of Biosimilars (Big Molecule Watch)
  • Precision Medicine Evidence Gaps Could Be Filled With Real-World Data, Central Repository (Pink Sheet)
  • Agios drops as COVID-19 takes a toll on drug studies (BioPharmaDive)
  • Newron's Merck KGaA-in licensed compound fails Rett Syndrome study, shares wilt (Endpoints)
  • DoP gives green signal to six manufacturers for export of 2,000 MT of paracetamol API (Pharmabiz)
  • Without showing any data, CytoDyn touts treatment for Covid-19 as winner — while its CEO sells stock (STAT)
  • New Darzalex formulation wins FDA approval; Israeli biotech plans $50M IPO (Endpoints) (FDA)
  • Menarini bags Stemline and a rare disease drug in $677M buyout. But will a better offer follow? (Endpoints)
Medtech
  • Stryker sees 50% of revenue vulnerable to elective procedure pullback (MedtechDive)
  • Coronavirus surge in critical care sales helps Hillrom beat Q2 guidance (MedtechDive)
  • Cerus gains FDA approval for blood plasma kit (MassDevice)
  • BioMerieux COVID testing product gets U.S. emergency use authorization (Reuters)
  • Routine cancer screenings have plummeted during the pandemic, medical records data show (STAT)
  • Some consumer wearables might accurately track sleep (Reuters)
  • Takuo Aoyagi, an Inventor of the Pulse Oximeter, Dies at 84 (NYTimes)
  • Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide (FDA)
Government & Regulatory
  • ‘It just had to do with luck’: Inside Biden’s struggle to contain the H1N1 virus (Politico)
  • CMS rolls back more Medicare, telehealth regs for providers working through pandemic (HealthcareDive)
  • Oklahoma AG Mike Hunter refiles lawsuits against 3 opioid distribution companies (The Oklahoman)
  • Doctor Who Promoted Malarial Drug Draws Scrutiny of Federal Prosectors (NYTimes)
  • Pharmacovigilance Inspection Program metrics report: Jan - Dec 2019 (TGA)
  • Update to Manufacturing Principles for medicines, APIs & sunscreens (TGA)
  • Former Naturopath Charged Criminally for Trafficking in Misbranded Drugs Claiming They Could Prevent COVID-19 (FDA)
  • Daiichi Told Cancer Drug Patent Fight Must Be Arbitrated (Law360)
  • Purdue Creditors Get OK For Sackler Bank Subpoenas (Law360)
  • Preemption and Second-Guessing FDA Classifications (Drug & Device Law)
  • Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir. 2020) (Patent Docs)
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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