Recon: Gilead licenses remdesivir for distribution to 127 countries; FDA refuses BMS, Bluebird cell therapy application

• French Drug Giant to Give U.S. Preference on Covid Vaccine (Bloomberg)
• Moderna CEO says no single drugmaker can produce enough coronavirus vaccine doses for the planet (CNBC)
• FDA refuses application for cell therapy from BMS, Bluebird, dealing both a major setback (STAT) (Endpoints) (Press)
• Top Science and Health Officials Offer Sobering View of Reopening Readiness (NYTimes) (STAT)
• Testing czar predicts U.S. can conduct up to 50M coronavirus tests per month by fall (Politico)
• Colleagues paint a mixed picture of ousted vaccine chief (Politico)
• Gilead’s Remdesivir Tested With Other Drugs to Fight Covid-19 (WSJ)
• Thermo Fisher to invest $180M in new gene therapy plant (BioPharmaDive)
• Russian ventilators implicated in deadly fires not used in US: FEMA (Reuters)
• Despite Early Warnings, U.S. Took Months To Expand Swab Production For COVID-19 Test (NPR)

• Gilead signs licenses for generic companies to make and sell remdesivir in 127 countries (STAT) (Reuters)
• Fearing shortages, EU may deploy emergency funds in COVID-19 vaccine race (Reuters)
• A tale of two Japanese drugs in tests to fight COVID-19 (Reuters)
• Russia suspends use of ventilator type sent to US after fatal fires (Reuters)
• Russia claims promising signs in early trials of antiviral drug favipiravir (Reuters)
• With Castro-era biotech, Cuba seeks to compete in coronavirus treatment race (Reuters)
• Chinese coronavirus vaccine could be tested, manufactured in Canada (Reuters)
• Japan Regulators Upped Zolgensma Price after Novartis Complaints: Chuikyo Paper (PharmaJapan)
• NICE backs Roche’s Gazyvaro, Pfizer’s Lorviqua in new guidance (PMLive)
• Takeda touts blockbuster hopefuls, dials up cost-saving target from Shire deal (Fierce)
• MMS Australia fined $151,200 for alleged unlawful advertising (TGA)

• Coronavirus drugs trials must get bigger and more collaborative (Nature)
• We need to prioritize outpatient clinical trials of drugs against the coronavirus (SF Chronicle)
• Unveiling ‘Warp Speed,’ the White House’s America-first push for a coronavirus vaccine (Science)
• Can ‘Team Science’ Yield a Covid-19 Treatment? (NYTimes)
• Pfizer wants to expand human trials of coronavirus vaccine to thousands of people by September, CEO says (CNBC)
• Researchers look to blood antibodies as weapons in virus fight (Financial Times)
• LabCorp expands availability of at-home sample collection kit for COVID-19 test (Reuters)
• 23andMe study to recruit sickest Covid-19 patients in bid to unravel role of genetics in disease (STAT)
• Critically Ill COVID-19 Patients Recover Following Heart Cell Therapy (GEN)
• UNODC, WHO, UNAIDS and OHCHR joint statement on COVID-19 in prisons and other closed settings (WHO)
• Coronavirus (COVID-19) Update: Daily Roundup May 12, 2020 (FDA)
• UK's COVID-19 death toll tops 40,000, worst in Europe (Reuters)
• UK coronavirus outbreak kills at least 20,000 in care homes - Reuters calculation (Reuters)
• Slowly but steadily, China strives to make widespread virus testing the new normal (Reuters)
• Putin's spokesman becomes fifth senior Russian official to get coronavirus (Reuters)

• Big Pharma remains bullish in the face of Covid-19 (Evaluate)
• Activist investor Elliott pushes Alexion Pharma to sell itself (Reuters) (Endpoints)
• Deluge of genome editing therapies end research drought for sickle cell disease (STAT)
• Oxford Biomedica bags MHRA nod for two manufacturing suites (PharmaTimes)
• There Is a Lack of Evidence, Transparency About Ingredients to Support Use of Compounded Topical Pain Creams, Says New Report (NAS)
• How To Improve Post-Approval Evidence Generation (Pink Sheet)
• The new CEO at troubled AMAG begins his battle against an array of threats by axing staff and slashing costs (Endpoints)
• Boehringer Ingelheim sharpens retinal strategy, scooping up dry AMD drug from a Swiss team behind Novartis' Beovu (Endpoints)
• Precision therapy approach secures small biotech $42M haul to combat disease that inspired the Ice Bucket Challenge (Endpoints)
• One year on, Capricor's stem cell therapy appears to help DMD patients in small study, but investors balk at the data (Endpoints)
• Merck pours $400M into flea drugs for Fido; Avrobio shows durability; Rhythm gets priority review (Endpoints)
• Sun Pharma Raids Covid-19 Antibody Outfit for General Counsel (Bloomberg Law)
• Takeda Accelerates Transformation: Solid FY2019 Results, Confidence in FY2020 Growth Momentum (Press)

• FDA flags 2nd high-risk recall of embolectomy catheters in recent weeks (MedtechDive) (FDA)
• Eko algorithm gets FDA nod for cardiac screening of COVID-19 patients (MedtechDive)
• Abiomed faces familiar reimbursement fluctuation in CMS proposal (MedtechDive)
• Philips lands 510(k) to market ultrasound systems for COVID-19 (MassDevice)

• Pandemic Revives Calls To Ban Lawmakers From Bunking In Their Offices (NPR)
• Trump administration proposes a dramatic payment boost for CAR-T treatments under Medicare (STAT)
• Democrats Punt on Drug-Pricing Overhaul in Virus Relief Measure (Bloomberg Law)
• Zantac Makers Say Drug Has No Cancer Link As MDL Opens (Law360)
• Conn. Asks Justices To Pass On Drug Price-Fixing Discovery (Law360)
• Veeva Escapes IQVIA's Suit Over Noncompetes (Law360)
• Idorsia Pharmaceuticals, Ltd. v. Iancu (Fed. Cir. 2020) (Patent Docs)
• Gresham Man Charged with Smuggling and Importing Misbranded Chloroquine from China for Attempted Resale (FDA)
• Pair Sentenced for Conspiring to Defraud the Food and Drug Administration (FDA)
• End of pre-approval process for ads in specified media (TGA 1, 2)