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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)