Recon: Pfizer plans Phase III study for DMD gene therapy; FDA rejects Blueprint cancer drug

• Pfizer says efficacy of its Duchenne gene therapy outweighs side effects (STAT) (Endpoints) (Reuters)
• After a PhIII failure, the FDA delivers Blueprint an expected CRL (Endpoints) (Reuters)
• Trump Weighs Made-in-US Order for Vital Drugs, Devices (Bloomberg)
• Trump administration to expand strategic stockpile for pandemic needs (Politico)
• Convalescent Plasma Is Safe to Treat Covid-19, National Study Shows (WSJ) (medRxiv)
• FDA says Abbott’s 5-minute Covid-19 test may miss infected patients (STAT) (NPR) (NBC) (Reuters)
• U.S. health secretary expresses confidence in Abbott's fast COVID-19 test (Reuters)
• Why Big Investors Aren’t Betting It All on a Coronavirus Cure (WSJ)
• Trump administration aims to nab 300M N95 masks in 90 days -official (Reuters)
• South Korean coronavirus test maker Osang ready to ship 100 million kits to US (Reuters)
• U.S. CDC issues guidelines on how to reopen schools, transit and workplaces (Reuters)
• How Rick Bright grabbed the spotlight and angered the Trump administration (Politico)

• More companies in talks for Remdesivir licence (EconomicTimes)
• Pakistan's Ferozsons to begin producing COVID-19 drug remdesivir (Reuters)
• Dutch researchers: in talks to develop antibody treatment for coronavirus (Reuters)
• Oxford coronavirus vaccine found protective in small monkey study (Reuters)
• Novartis CEO says any new coronavirus vaccine will take two years: newspaper (Reuters)
• Russia's ChemRar says in second-, third-phase testing of coronavirus drug favipiravir (Reuters)
• Europe pins hopes on antibody tests to avoid second virus wave (Reuters)
• Britain approves Abbott's COVID-19 antibody test (Reuters)
• UK spent £20m buying up stocks of HIV and malaria drugs (The Guardian)

• Global coronavirus death toll exceeds 300,000: Reuters tally (Reuters)
• Chasing The Elusive Dream Of A COVID Cure (KHN)
• COVID patients given malaria drug didn't see significant improvements: studies (Reuters)
• New Data Shows That Patients On Ventilators Are Likely To Survive (NPR)
• Talking Can Generate Coronavirus Droplets That Linger Up to 14 Minutes (NYTimes)
• Under an ‘America First’ president, will the US corner the market on Covid-19 vaccine? (STAT)
• Less than a movie ticket or ‘impossible to overpay’? Experts name their price for remdesivir (STAT)
• Hologic's latest COVID-19 test gets FDA approval for emergency use (Reuters)
• Moscow rolls out mass coronavirus antibody testing programme (Reuters)
• China's Wuhan says tested almost a third of residents for coronavirus since April (Reuters)
• Coronavirus (COVID-19) Update: Daily Roundup May 14, 2020 (FDA)

• Biotechs harness AI in battle against Covid-19 (Financial Times)
• Will COVID-19 change how Big Pharma does clinical trials? (Fortune)
• Women and Black patients are poorly represented in clinical trials, analysis finds (STAT)
• Monoclonal Antibodies and Vaccines: Q and A (In the Pipeline)
• Cancer biotech stocks shift on glimpse of ASCO data (BioPharmaDive)
• Bristol Myers’ Pomalyst Approved by FDA for Kaposi Sarcoma (Bloomberg) (Press)
• Japan’s First Humira Biosimilar Could Hit Market as Early as November (PharmaJapan)
• MHLW Urging Novartis to Ensure Speedy Zolgensma Supplies: Sr. Vice Minister (PharmaJapan)
• Study Says that Conversion of Intermediate-Risk FN Patients to Pegfilgrastim Biosimilar Likely to Have Large Budget Impact (Big molecule watch)
• ADC steams back to virtual Wall Street — and this time the team scores a $233M IPO haul (Endpoints)
• J&J jumps into gamma delta field with Lava collaboration; Myokardia guns for $605M raise (Endpoints)
• Rare disease drugmaker Ultragenyx builds case for its gene therapy franchise with fresh trial updates (Endpoints)
• Cherry Thomas joins Caribou as SVP of clinical development; Artax locks in Joseph Lobacki as CEO (Endpoints)
• Stanford, Parker Institute scientists team up with two young engineers in $20M AI play with an immunology focus (Endpoints)

• Consumer COVID-19 fears, coverage concerns could stymie medtech rebound: Wall Street surveys (MedtechDive)
• Philips, startups look to deploy new ultrasound tech amid coronavirus (MedtechDive)
• Latest International Clinical Investigations Standard Ready By June But EU Must Play Catch-Up (MedtechInsight)

• No Firings, No Furloughs: FDA Staff Weathering COVID-19 Pandemic (MedtechInsight)
• Sanders rekindles Democrats' health coverage feud before key House vote (Politico)
• The State of Cannabis Research Legislation in 2020 (NEJM)
• Biogen Thwarts 'Brazen' Drug Copycat With IP Settlement (Law360)
• Setting The Protocol For The Ex Parte Party (Drug & Device Law)