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Regulatory Focus™ > News Articles > 2020 > 5 > Recon: US secures 300M doses of potential AZ-Oxford vaccine; Beximco launches generic remdesivir

Recon: US secures 300M doses of potential AZ-Oxford vaccine; Beximco launches generic remdesivir

Posted 21 May 2020 | By Michael Mezher 

Recon: US secures 300M doses of potential AZ-Oxford vaccine; Beximco launches generic remdesivir

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US gives up to $1.2 billion to AstraZeneca for Covid-19 vaccine (STAT) (Reuters) (FT)
  • Trump’s Vaccine Chief Has Vast Ties to Drug Industry, Posing Possible Conflicts (NYTimes)
  • Biosimilars got the cold shoulder from health plans when it came to preferred coverage (STAT)
  • GSK ties up with gene editing start-up Mammoth for COVID-19 test (Reuters)
  • Higher dose of Gilead-Galapagos drug meets ulcerative colitis study goals (Reuters)
  • Grassley says Trump pushing for drug pricing action after Senate lunch (The Hill)
  • HHS watchdog who reported medical shortages to testify before House panel next week (The Hill)
In Focus: International
  • WHO reports most coronavirus cases in a day as cases approach five million (Reuters)
  • UK healthcare workers begin COVID-19 hydroxychloroquine trial (Reuters)
  • Britain agrees deal to provide free antibody tests (Reuters)
  • First copies of remdesivir to start selling in Bangladesh (Bloomberg) (BioPharmaDive) (Reuters)
  • Avigan Interim Analysis Not Intended to Determine Efficacy, Research Sponsor Says on Reports (PharmaJapan)
  • US pharma firm Gilead Sciences likely to seek nod to market anti-viral drug remdesivir in India (Economic Times)
  • Denmark to send back inaccurate antibody tests from China's Livzon (Reuters)
  • Strides Pharma to conduct trials in India for potential COVID-19 drug (Reuters)
  • Early-stage trials for coronavirus vaccine developed in Singapore could start next month, says professor (CNBC)
  • US-Based Merck Banned From Using 'Merck' Trademark In UK (Law360)
Coronavirus Pandemic
  • U.S. Could Have Saved 36,000 Lives If Social Distancing Started 1 Week Earlier: Study (NPR)
  • How to Discover Antiviral Drugs Quickly (NEJM)
  • ‘How Could the CDC Make That Mistake?’ (The Atlantic)
  • Apple-Google contact tracing tech draws interest in 23 countries, some hedge bets (Reuters)
  • Top HIV scientist says he wouldn't count on a vaccine for coronavirus soon (Reuters)
  • Analysis: Get Ready For The Vaccine — They’re Never Simple (KHN)
  • What to Expect When a Coronavirus Vaccine Finally Arrives (NYTimes)
  • A New Entry in the Race for a Coronavirus Vaccine: Hope (NYTimes)
  • Octapharma cleared to start phase 3 trial of Octagam in COVID-19 (PMLive)
  • ‘It’s something I have never seen’: How the Covid-19 virus hijacks cells (STAT)
  • UK's COVID-19 tracking system under fire amid warning of second spike (Reuters)
  • A secret coup and a ‘poison pill’ have frozen shares of a biotech in the race for a Covid-19 vaccine (STAT)
  • Peru coronavirus cases surpass 100,000 as demand sends drug prices soaring (Reuters)
  • Swedish antibody study shows long road to immunity as COVID-19 toll mounts (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup May 20, 2020 (FDA)
Pharma & Biotech
  • Startup Spotlight: Aiming to speed precision cancer therapies to children (STAT)
  • Compliance Tips For Running Clinical Trials During COVID-19 (Law360)
  • Revance Therapeutics, Mylan, and Formycon Announce Updates to Their Biosimilar Plans (Big Molecule Watch)
  • Why Do CVS And Express Scripts Rely on Secretive Private Companies to Run Their Copay Maximizer Programs? (Drug Channels)
  • The Business Of Science (LifeSciVC)
  • A Considerable Setback For Cancer Trials Because Of COVID-19, IQVIA/CRI Survey Finds (Scrip)
  • Once valued at $4B, an embattled Akorn — nursing a market cap of roughly $37M — files for bankruptcy (Endpoints)
  • Chiesi Group Receives FDA Approval for Ferriprox® (deferiprone) twice-a-day tablets (Press)
  • Stakeholder Engagement on ICH E6: Guideline for Good Clinical Practice 4-5 June 2020 (FDA)
  • Kadmon to seek FDA approval of drug targeting graft-versus-host disease following positive study outcome (STAT) (Endpoints)
  • European regulators accept FibroGen's anemia drug for review; Passage Bio's lead gene therapy gets more love from the FDA (Endpoints)
  • Bezos, Paul Allen funds, a16z put up $100M to build an Illumina of human proteins (Endpoints)
  • As CEO bounces back from Covid-19, Apellis says FDA meeting clears path to file for an OK on Soliris rival (Endpoints)
  • HotSpot announces $65M Series B, as Nimbus pioneers look to keep up in a crowding field (Endpoints)
  • Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval (FDA)
  • Immunomodulatory drugs: temporary pregnancy prevention guidance during coronavirus (COVID-19) (MHRA)
  • Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19) (MHRA)
Medtech
  • Medtronic misses mark in Q4 as sales decline 26% (MassDevice)
  • Health Canada authorizes Abbott COVID-19 antibody test (MassDevice)
  • Hospitals push FEMA to form broad supply pact with medtech (MedtechDive)
  • Labs welcome CMS rate for coronavirus antibody testing (MedtechDive)
  • Trump administration paying huge premium for mask-cleaning machines. Which don't do the job. (NBC)
Government & Regulatory
  • Small Biotech Companies Could Get Faster USPTO Review Of COVID-19 Patent Applications (Pink Sheet)
  • Drug overdose deaths drop in U.S. as other deaths of despair rise, report finds (NBC)
  • New Info Could Boost Allergan ERISA Suit, 3rd Circ. Told (Law360)
  • AbbVie Says Recent Antitrust Ruling Irrelevant In Humira Case (Law360)
  • States Join Bid For Virus Delay In Purdue Pharma Bankruptcy (Law360)
  • Doctor fined $37,800 for alleged advertising breaches including references to COVID-19 (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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