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Regulatory Focus™ > News Articles > 2020 > 9 > Recon: US trials blood thinners in COVID patients; Pharma’s campaign against ICER

Recon: US trials blood thinners in COVID patients; Pharma’s campaign against ICER

Posted 11 September 2020 | By Michael Mezher 

Recon: US trials blood thinners in COVID patients; Pharma’s campaign against ICER

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Marks: Prepare for 'EUA-plus' for Covid vaccines (Politico) (Pink Sheet)
  • FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision (CNBC)
  • Covid vaccine becomes divisive issue in US election campaign (FT)
  • FDA Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure (NYTimes)
  • Big Pharma wages stealth war on drug price watchdog (Reuters)
  • Covid’s Deadly Clotting Spurs US Trials of Blood Thinners (Bloomberg)
  • Sarepta CEO pins gene therapy delay on Covid-burdened FDA (Endpoints)
  • Drugmaker AbbVie pressures reluctant employees to return to work, raising safety questions (CNBC)
In Focus: International
  • From Asia to Africa, China Promotes Its Vaccines to Win Friends (NYTimes)
  • China Injects Hundreds of Thousands With Experimental Covid-19 Vaccines (WSJ)
  • China starts testing nasal spray coronavirus vaccine (The Hill)
  • Statement from the first ACT-Accelerator Facilitation Council meeting (WHO)
  • The UK’s Future As Innovator In A Post-Brexit, Post-Coronavirus World (Pink Sheet)
  • NICE U-turns to approve AstraZeneca's Tagrisso in two new lung cancer indications (Pharmafile)
  • NICE backs Portola's Ondexxya (PharmaTimes)
Coronavirus Pandemic
  • Verily nets FDA authorization for pooled COVID-19 testing (Fierce)
  • The ethics of pausing a vaccine trial in the midst of a pandemic: a conversation with Ruth Faden (STAT)
  • Missed Vaccines, Skipped Colonoscopies: Preventive Care Plummets (NYTimes)
  • Celltrion passes early safety trial for anti-COVID-19 antibody as key tests await (Fierce)
  • MHLW Erases Hydroxychloroquine, 4 Other Drugs from COVID-19 Treatment Guide (PharmaJapan)
Pharma & Biotech
  • Drug Repurposing: How Often Does It Work? (In the Pipeline)
  • FDA clarifies compounding policies (FDA)
  • Catalent to invest $130M in gene therapy plant near Baltimore airport (BioPharmaDive)
  • Trispecific antibodies take to the clinic (Nature)
  • Real-time gene sequencing can help control — and may someday prevent — pandemics (STAT)
  • A year out from FDA approval, Vertex looks to expand top-selling CF drug to pediatrics (Endpoints)
  • A 'breakthrough' PD-1? From China? FDA says why not for rare cancer (Endpoints)
  • Phase 3 migraine flop squashes Satsuma's stock price (Fierce)
  • Brent Saunders pivots from Allergan sale to a $460M SPAC, making him an overnight player in one of the hottest money-raising gambits in biotech (Endpoints)
  • An old Vertex drug gets new life as an Alzheimer's treatment, but human studies still far off (Endpoints)
  • Opdivo trial offers new insights into how immuno-oncology drugs could be enhanced (Fierce)
  • After Novartis left, Boehringer bets up to $500M on the field of prescription smartphone apps (Endpoints)
  • Fasenra shows positive PhIII topline data for nasal polyps, tightening race with GSK's Nucala (Endpoints)
  • Sanofi's hemophilia drug comes into focus as delays hit a key competitor (BioPharmaDive)
  • Savara's long-reigning duo both resign in the wake of CF bust (Endpoints)
  • GSK and J&J alum Vijay Reddy to take control of R&D at Tmunity; Andrew Hirsch exits Agios for CEO job at C4 Therapeutics (Endpoints)
  • REYVOW™ (lasmiditan) C-V Demonstrated Pain Freedom from Migraine Attacks At 60 Minutes and Up to 48 Hours in New Phase 3 Study (Press)
  • Daiichi Sankyo Submits Supplemental Application in Japan for Approval of Partial Changes in Usage or Dosage for Anticoagulant Edoxaban (Press)
  • FDA advisers support down-classing bone growth stimulators, in face of industry and lawmaker pushback (MedtechDive)
  • Thermo Fisher hikes growth forecast, expects COVID-19 sales to top $3B in late 2020 (MedtechDive)
  • Quest raises 2020 revenue outlook to beat pre-coronavirus goal by 10% (MedtechDive)
  • BD says its antigen test on par with Quidel's in head-to-head preprint study (MedtechDive)
  • Bill Advances Mandating Private Insurance Coverage Of Devices To Correct Birth Defects (MedtechInsight)
Government, Regulatory & Legal
  • Pfizer successful in getting insurer to pay for litigation (legalnewsline)
  • State AGs Say Drugmakers Want To Delay Price-Fixing Trials (Law360)
  • US FDA Contracting Update: From Rating Site Quality Maturity To Blocking COVID-19 Scams (Pink Sheet)
  • Publication of notified medicine shortages: Updated protocol (TGA)
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.

Tags: US, worldwide

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