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Regulatory Focus™ > News Articles > 2020 > 6 > Recon: EU to use €2.4B emergency fund for coronavirus vaccines; Roche test for severe COVID-19 gets

Recon: EU to use €2.4B emergency fund for coronavirus vaccines; Roche test for severe COVID-19 gets EUA

Posted 04 June 2020 | By Michael Mezher 

Recon: EU to use €2.4B emergency fund for coronavirus vaccines; Roche test for severe COVID-19 gets EUA

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA struggles to remain independent amid race for virus cure (Politico)
  • Roche Test for Severe Covid-19 Gets Emergency FDA Approval (Bloomberg) (Reuters)
  • Trump Administration Selects Five Coronavirus Vaccine Candidates as Finalists (NYTimes) (Endpoints)
  • Malaria Drug Promoted by Trump Did Not Prevent Covid Infections, Study Finds (NYTimes)
  • Gilead bolsters its case for blockbuster hopeful filgotinib as FDA ponders its decision (Endpoints)
  • Moderna released scant Covid-19 data to prevent a leak, CEO says (STAT)
  • Watchdog group wants SEC to investigate coronavirus vaccine company Moderna (The Hill)
  • Amgen Drug Fraud Case Must Have Public Disclosure Review (Bloomberg) (Law360)
  • Inovio sues a key contract manufacturer as it races to develop a Covid-19 vaccine (STAT)
  • In a first for RNA-modifying drugs, AstraZeneca partners with startup Accent Therapeutics (STAT)
In Focus: International
  • EU to use $2.7 billion fund to buy promising COVID-19 vaccines (Reuters)
  • British PM Johnson hosts global vaccine summit, calls for funding (Reuters)
  • Europe May Race the U.S. for Early Vaccine Access With Deals (Bloomberg)
  • Australia to pledge $207 million for regional vaccine program (Reuters)
  • Vaccine group plans advance market agreement for COVID-19 vaccines (Reuters)
  • Tests for Coronavirus Vaccine Need This Ingredient: Horseshoe Crabs (NYTimes)
  • Brazil health regulator approves clinical trials of Oxford COVID-19 vaccine (Reuters)
  • Inovio plans human trials for potential COVID-19 vaccine in South Korea in June (Reuters)
  • UK drugs stockpile eroded by coronavirus ahead of Brexit (Financial Times)
  • Britain says nearly 30,000 COVID-19 tests sent to U.S. lab came back void (Reuters)
  • The coronavirus outbreak could make it quicker and easier to trial drugs (Nature)
  • Top supplier Malaysia sees no quick end to shortages in $8 billion gloves industry (Reuters)
  • Two more people infected with Ebola in new Congo outbreak, WHO says (Reuters)
Coronavirus Pandemic
  • WHO says coronavirus has not meaningfully mutated to a more lethal or contagious form (CNBC)
  • WHO set to resume hydroxychloroquine trial in battle against COVID-19 (Reuters) (Financial Times)
  • Sanofi to run consultations over restart of hydroxychloroquine trials (Reuters)
  • Genes May Leave Some People More Vulnerable to Severe Covid-19 (NYTimes)
  • Russia gets more US ventilators as coronavirus cases climb (Reuters)
  • African countries secure 90 million coronavirus test kits for next six months (Reuters)
  • Oxford, AstraZeneca Covid-19 deal reinforces ‘vaccine sovereignty.’ We need a people’s vaccine instead (STAT)
  • 3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic (MHRA)
  • CDER’s Work to Protect Public Health During the COVID-19 Public Health Emergency (FDA)
  • Coronavirus (COVID-19) Update: Daily Roundup June 3, 2020 (FDA)
  • Patients’ and healthcare professionals’ organisations updated on EMA’s response to COVID-19 (EMA)
Pharma & Biotech
  • The quest for a vaccine could restore faith in big pharma (The Economist)
  • Moderna names Amgen executive David Meline as CFO (Reuters) (Endpoints)
  • GSK's cell therapy R&D lead jumps ship to partner Immatics (BioPharmaDive) (Endpoints)
  • Tiny Denmark saved lots of money on biosimilar Humira, while Americans are still paying big bucks (STAT)
  • Biotech IPOs near last year's pace, despite COVID-19 pandemic (BioPharmaDive)
  • Florida offers drive-through Botox to quarantined residents (Reuters)
  • NICE publishes final guidance backing Teva's Ajovy for migraine (PharmaTimes)
  • Janssen's Tremfya shows skin clearance benefit for psoriatic arthritis patients in two Phase 3 studies (Pharmafile)
  • Recapping ASCO 2020, talking cancer therapy combinations, and looking to the future (STAT)
  • Private insurance might provide some shield from insulin price hikes — but the picture of costs is complicated (STAT)
  • New safety data expose potential weakness as Pfizer's abrocitinib takes on Dupixent in eczema (Endpoints)
  • US FDA Oncology AdComm's Pediatric Study Reviews Go Virtual (Pink Sheet)
  • Indian Drug pricing regulator fixes prices of 40 formulation drugs (Economic Times)
  • GSK presents case to expand use of its lupus drug in patients with kidney disease, but the field is evolving. How long will the monopoly last? (Endpoints)
  • FDA alerts health care professionals to the temporary absence of warning statement on the vial caps of two neuromuscular blocking agents (FDA)
  • José Baselga finds promise in new class of RNA-modifying cancer targets, locking in 3 preclinical programs with $55M (Endpoints)
  • Can a small biotech successfully tackle an Everest climb like Alzheimer’s? Athira has $85M and some influential backers ready to give it a shot (Endpoints)
Medtech
  • PMA major deficiency letters tick up, 510(k) asks for info flatline: MDUFA report (MedtechDive)
  • JAMA reanalysis goes against 5-year Abbott stent study findings, upping odds of death (MedtechDive)
  • Israeli medical device maker Alpha Tau raises $26 million to fund trials (Reuters)
  • Date of Entry into Force plus three years and a little bit (MedicalDevicesLegal)
  • Fitbit’s ventilator gets emergency FDA approval (The Verge)
  • Abbott issues urgent field safety notice over ablation catheter (MassDevice)
  • Haemonetics unveils back-to-back divestitures of blood supply assets (MedtechDive)
  • Health Canada adds private labels to scope of REP pilot program (Emergo)
Government & Regulatory
  • Top House, Senate lawmakers warn HHS over slow health provider aid payouts (Politico)
  • Committee for Advanced Therapies (CAT) Minutes of the meeting on 22-24 April 2020 (EMA)
  • EU Trade Commissioner Phil Hogan issues statement on European Union compulsory licensing in context of COVID-19, makes important statement about TRIPS Article 31bis (KEI)
  • Federal Circuit Hears Oral Argument in Bevacizumab Preliminary Injunction Appeal (Big Molecule Watch)
  • PTAB Issues Final Written Decisions Finding Most Claims of Sanofi’s Lantus Patents Invalid (Big Molecule Watch)
  • Federal Court Issues Temporary Restraining Order against Fort Davis Businessman Offering Fraudulent Coronavirus Cures/Treatments (FDA)
  • Meds2Go Express Pharmacy, Inc. Sentenced for Role in Drug Diversion Scheme (FDA)
  • Gilead Can't Shake New HIV Antitrust Complaint, Court Told (Law360)
  • Mylan Gets OK To Sell Generic Insomnia Drug During IP Fight (Law360)
  • Fla. Judge Recuses Himself In CR Bard Vein Filter Suit (Law360)
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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