Recon: Moderna sees immune response in Phase 1 study; GSK says monthly injection tops Truvada in HIV prevention trial

• Early data show Moderna Covid-19 vaccine generates immune response (STAT) (NYTimes) (Reuters)
• Gilead to end coronavirus drug trials, adding to access worry: researchers (Reuters)
• Trump Vows Vaccine by End of Year, and Mobilizes Military to Help (NYTimes) (STAT)
• US to stockpile vaccine candidates as trials continue: health secretary (Reuters)
• Trump says considering making vaccine available free of charge (Reuters)
• GSK's long-acting injection beats Truvada in HIV prevention trial (Reuters) (Bloomberg)
• FDA Clears Another Coronavirus Testing Kit for Use at Home (NYTimes) (FDA)
• FDA suspends Gates-backed at-home COVID-19 testing program (Reuters)
• A Drug Company Wagers the US Won’t Dare Charge It With Crimes (NYTimes)
• US probes PerkinElmer's role in massive Medicare fraud – sources (Reuters)
• FDA approves Bristol-Myers combo therapy for lung cancer (Reuters) (FDA)
• FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors (FDA)
• Clovis Oncology's Rubraca gets FDA approval for prostate cancer (Reuters) (Endpoints) (FDA)
• Trump says he is considering restoring some funding to WHO, no decision made (Reuters)

• EMA urged to release full clinical trial data upon authorizing Covid-19 treatments (STAT)
• Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 (EMA)
• WHO and Costa Rica preview technology pooling initiative to ensure access to COVID-19 health products for all (WHO)
• AstraZeneca Aims for 30 Million UK Vaccine Doses by September (Bloomberg)
• Israel's Teva gets China approval for Huntington's treatment (Reuters)
• Thermo Fisher launches 39 euros/share bid for Qiagen (Reuters)
• Keenly-watched COVID-19 vaccine 'won't be expensive', developer says (Reuters)
• UK to invest up to 93 million pounds in new coronavirus vaccine centre (Reuters)
• India’s pharma and chemicals groups jostle to take business from China (Financial Times)
• Unprecedented World Health Assembly Convenes Online As Pandemic Rages (NPR)
• WHO chief promises review of coronavirus response, China defends performance (Reuters) (CNBC)
• New evidence in race to find France's COVID-19 'patient zero' (NBC)
• Govt Won't Require Fujifilm-Sponsored Trial Data to Approve Avigan for COVID-19: Abe (PharmaJapan)
• US assails WHO 'failure' in pandemic, saying it cost 'many lives' (Reuters)

• COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products (FDA)
• JetBlue’s Founder Helped Fund A Stanford Study That Said The Coronavirus Wasn’t That Deadly (BuzzFeed)
• Statins may help older coronavirus patients avoid symptoms; COVID-19 more than respiratory illness (Reuters)
• New Evidence Suggests COVID-19 Patients On Ventilators Usually Survive (NPR)
• Coronavirus (COVID-19) Update: Daily Roundup May 15, 2020 (FDA)

• Drugmakers get hooked on data (Financial Times)
• Gene-editing pipeline takes off (Nature)
• Drugmakers Tout COVID-19 Vaccines To Refurbish Their Public Image (KHN)
• Impact of COVID-19 on oncology clinical trials (Nature)
• 7 Japan Major Drug Makers See Limited Impact from COVID-19: FY2019 Earnings (PharmaJapan)
• J&J posts a solid round of positive early data for their BCMA/CD3 bispecific teclistamab, highlighting blockbuster expectations (Endpoints)
• AstraZeneca nabs speedy review, as $7B ADC races to blockbuster status (Endpoints)
• AZ, Daiichi Sankyo’s Enhertu fast-tracked in US for NSCLC (PMLive)
• SEC backs Sinovac's case against activist investor who tried to take over; Bluebird pencils in $400M raise (Endpoints)
• Sweden's Calliditas seeks $75M IPO haul to bring its oral steroid to patients with an orphan kidney disease (Endpoints)
• Obliterated by Alzheimer's failure, Neurotrope relinquishes its Nasdaq spot in reverse merger (Endpoints)
• Bob Langer-founded cell therapy player loads up $65M to fund Roche-partnered cancer work while expanding into vaccines for infectious diseases (Endpoints)

• Fitbit to develop emergency COVID-19 ventilator: CNBC (Fierce)
• Medtronic offers 10-year data, pivotal trial update on transcatheter pulmonary valves (MedtechDive)
• FDA aims to thwart infusion pump shortage with new industrywide emergency use authorization (MedtechDive) (Fierce)
• Edwards lands CE Mark for Pascal transcatheter valve repair system (MassDevice)

• FDA Nonacquiescence Strategy Fails In Evergreening Case (Drug & Device Law)
• HHS Says Gilead Can't Allege Misconduct In HIV Drug IP Suit (Law360)
• Europe Authority Bans Patents On Plants And Animals (Law360)
• Report: 3M settles respirator price-gouging case (MassDevice)
• Regulatory status of equipment being used to help prevent coronavirus (COVID-19) (MHRA)
• Summary of the E6(3) Stakeholder Engagement Approach available now on the ICH website (ICH)