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Regulatory Focus™ > News Articles > 2020 > 7 > Recon: Gilead claims remdesivir reduced mortality in Phase 3 study; FDA staff flag ocular toxicities

Recon: Gilead claims remdesivir reduced mortality in Phase 3 study; FDA staff flag ocular toxicities ahead of GSK myeloma drug panel

Posted 10 July 2020 | By Michael Mezher 

Recon: Gilead claims remdesivir reduced mortality in Phase 3 study; FDA staff flag ocular toxicities ahead of GSK myeloma drug panel

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Special Report: How the Trump administration secured a secret supply of execution drugs (Reuters)
  • Trump will sign three executive orders on lowering drug prices: chief of staff (Reuters)
  • Gilead says remdesivir data show reduced risk of death (Financial Times) (Endpoints) (Reuters) (Press)
  • FDA Says to Review Side Effect of GSK's Multiple Myeloma Drug (Reuters) (BioPharmaDive) (Endpoints)
  • Blackstone hits $4.6B fundraising goal, teeing up big bets on late-phase R&D (Fierce) (Endpoints)
  • Relay Therapeutics, focused on solid tumors, seeks to raise $250M in IPO (STAT)
  • Despite the pandemic, prices for many drugs keep rising (STAT)
In Focus: International
  • German Biotech Sees Its Coronavirus Vaccine Ready for Approval by December (WSJ)
  • Fujifilm's Avigan inconclusive in COVID-19 patients in Japan trial (Reuters)
  • UK turns down EU coronavirus vaccine scheme (The Telegraph)
  • NICE backing for Takeda's Adcetris for rare lymphoma (PharmaTimes)
  • EU Pharmaceutical Strategy Roadmap Seen As Weak On Innovation (Pink Sheet)
  • Australia approves Gilead's remdesivir for COVID-19 treatment (Reuters) (TGA)
Coronavirus Pandemic
  • The Coronavirus Can Be Airborne Indoors, W.H.O. Says (NYTimes)
  • Trump’s health officials find ways to contradict his message downplaying virus risks (Politico)
  • These Scientists Raced to Find a Covid-19 Drug. Then the Virus Found Them. (NYTimes)
  • Hepatitis C drugs help combat Covid-19 in trials (Financial Times)
  • Fetal coronavirus infection is possible, small study suggests (NBC)
  • Siemens COVID-19 antibody test beats rivals in head-to-head study (MedtechDive)
  • Coronavirus (COVID-19) Update: Daily Roundup July 9, 2020 (FDA)
Pharma & Biotech
  • FDA new drug approvals in Q2 2020 (Nature)
  • EU Checks Pharma’s Appetite To Share Market Launch Intentions (Pink Sheet)
  • GSK's Shingrix supply recovers thanks to drop in vaccinations, uninterrupted production (Fierce)
  • Top biotech analyst projects a gloomy outlook for Pfizer's JAK portfolio (Endpoints)
  • Ophthalmic drugs, cancer cell therapies attract $340M+ on two HKEX biotech debuts (Endpoints)
  • Another four biotechs scratch out the first number and ask for more as IPO boom continues (Endpoints)
  • Bayer's finerenone hits targets in diabetes/kidney disease trial (PharmaTimes)
  • Allergan Declines To Confirm Abicipar Pegol Fate (Pink Sheet)
  • UK’s CMA Issues Fines Over Fludrocortisone (Pink Sheet)
  • Harbour BioMed nabs meaty C round as cancer, COVID-19 work draws investors (Fierce)
  • AstraZeneca signs computational drug discovery collaboration; J&J-partnered Fate cleared for the clinic (Endpoints)
  • Bob Goeltz bolts Unity Biotechnology to become CFO at Arcus Biosciences; John Johnson tapped for his latest CEO gig (Endpoints)
  • A new venture fund amid a pandemic? In the Nordics? Eir Ventures brings it on with €76M first close (Endpoints)
  • FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity (Press)
  • EU Industry Wants IVDR Delay, Grace Period For More Products And Phased Implementation (MedtechInsight)
  • Interim FDA-Mandated Postmarket Study Finds Essure Has Significantly Higher Rates Of Adverse Events (MedtechInsight)
  • Malaysia's MDA publishes post-market surveillance guidance documents (Emergo)
  • Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020) (MHRA)
Government & Regulatory
  • Office of Women's Health Strategic Priorities; Establishment of a Public Docket; Request for Comments (FDA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (EMA)
  • Full Fed. Circ. Won't Consider Standing In Novartis Drug Case (Law360)
  • Feds Indict 4 In Alleged $34M Pharma Kickback Scheme (Law360)
  • 1st Circ. Affirms Pharmacists' Guilt In Meningitis Outbreak (Law360)
  • NuVasive Spinal Fusion Patents Largely Survive PTAB Review (Law360)
  • A Look At CMS' Proposed Medicaid Drug Rebate Changes (Law360)
  • Father and Sons Charged in Miami Federal Court with Selling Toxic Bleach as Fake “Miracle” Cure for Covid-19 and Violating Court Orders (FDA)
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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