Recon: FDA reviewing remdesivir data at ‘lightning speed’; Oxford, AstraZeneca team up on coronavirus vaccine

• FDA Moving at ‘Lightning Speed’ on Gilead Drug, Commissioner Says (Bloomberg) (WSJ) (CNBC)
• Gilead CEO: We’re going to make sure that access is not an issue with remdesivir (STAT)
• Fauci says leak concerns fueled his White House revelation of Gilead drug results (Reuters)
• Trump’s ‘Operation Warp Speed’ Aims to Rush Coronavirus Vaccine (Bloomberg) (Reuters)
• FDA gives broader approval to GSK's Zejula for ovarian cancer (Reuters) (Endpoints) (Press) (FDA)
• Watchdog scolds HHS for lacking a big-picture plan to incentivize antibiotic development (STAT) (Endpoints)
• NIH announces $1.5 billion, ‘Shark Tank’-like initiative to accelerate Covid-19 testing (STAT) (GEN)
• Pfizer aims for 10-20 million doses of coronavirus vaccine by end-2020 for emergency use (Reuters)
• Coronavirus was 'not manmade or genetically modified': US spy agency (Reuters)

• Oxford University, AstraZeneca Join Forces for Coronavirus Vaccine (WSJ) (Financial Times) (Reuters)
• COVID-19 complication seen in children is 'rare', WHO says (Reuters)
• Japan Can’t Give “Special Approval” for Avigan under Current Law: Abe (PharmaJapan)
• Japan to Utilize “Special Approval” Scheme for Remdesivir after It’s OK’ed Overseas (PharmaJapan)
• In reversal, Chile says coronavirus release certificates will not prove immunity (Reuters)
• British doctors warn some Chinese ventilators could kill if used in hospitals (NBC)
• Glenmark to conduct trials in India for potential COVID-19 drug (Reuters)
• India exports 50 million hydroxychloroquine tablets to US for COVID-19 fight: source (Reuters)
• WHO says very concerned at community spread of coronavirus in West Africa (Reuters)
• Covid-19 could mark a deadly turn in Ghana's fight against fake drugs (The Guardian)

• Old Drugs May Find a New Purpose: Fighting the Coronavirus (NYTimes) (Financial Times)
• Gilead’s remdesivir has seen success against the coronavirus. Now the company has to make enough to supply the world (STAT)
• As Coronavirus Strikes, Crucial Data In Electronic Health Records Hard To Harvest (KHN)
• Hologic launches second COVID-19 test to help reach more Americans (Reuters)
• Los Angeles becomes the first major city in the US to offer free coronavirus testing for all residents, Mayor Eric Garcetti says (CNBC)
• US cracks down on ethanol-based hand sanitizer, hitting supply as demand soars (Reuters)
• Britain has Europe's second highest COVID-19 death toll, new figures show (Reuters)
• Russia's coronavirus case tally surges past the 100,000 mark after record daily rise (Reuters)
• South Korea: no new domestic coronavirus cases, no transmission from election (Reuters)
• Bosnia reports sharp rise in coronavirus cases after relaxing lockdown (Reuters)
• Yemen records multiple coronavirus cases for first time; UN fears more (Reuters)
• India has 1,000 coronavirus deaths but expert says no exponential rise (Reuters)
• Coronavirus (COVID-19) Update: Daily Roundup April 29, 2020 (FDA)

• Cancer research offers faster ways to ID new Covid-19 treatments (STAT)
• Big Pharma could boost its reputation with a solid response to Covid-19 (STAT)
• Biogen’s blockbuster rare disease drug could be in trouble (STAT)
• Virtual Advisory Committees: Who Will Be First In Line To Test On-Line Meetings? (Pink Sheet)
• Sponsors Seeing Subtle Differences With US FDA Meetings In Coronavirus Era (Pink Sheet)
• Pfizer looks to right sterile injectable woes with modernized manufacturing (Fierce)
• Amid Covid-19 hunt, Pfizer adds Lyme disease vaccine in $308M deal with Valneva (Endpoints)
• Vertex, even amid pandemic, raises sales projections thanks to gangbusters start for Trikafta (Fierce)
• FDA/FTC Joint Workshop on a Competitive Marketplace for Biosimilars – Comments from Stakeholders (Big Molecule Watch)
• Decisive Action Called For On EU Drug Shortages (Pink Sheet)
• EMA Considers Fast-Tracking Rhythm’s Insatiable Hunger & Obesity Disorders Drug (Pink Sheet)
• Novartis Faces The Music Over EU Piqray Review (Pink Sheet)
• Takeda’s Mobocertinib Bags FDA Breakthrough Therapy Status for EGFR Exon 20 Mutant NSCLC (PharmaJapan)
• A novel vaccine target for malaria (Nature)
• Fujifilm sets aside manufacturing space for a possible Gates-funded COVID-19 therapy (Fierce)
• What does a post-pandemic IPO filing look like? Hong Kong biotech application offers clues (Endpoints)
• Kelly Martin skips to a new CEO suite as his last biotech team raises the white flag (Endpoints)
• Ordinary People Achieving The Extraordinary: Lessons In Leadership From The Court To The C-suite (LifeSciVC)
• Vertex lavishes $80M cash to expand gene therapy tool kit; Supernus bags a $300M CNS portfolio (Endpoints)

• FDA Grants Marketing of New Device for Continuous Dialysis Therapy for use in Pediatric Patients with Certain Kidney Conditions (FDA)
• GE reducing healthcare headcount in $700M cost-cutting drive (MedtechDive)
• Boston Scientific sees April sales cut in half amid coronavirus (MedtechDive)
• Dexcom's hospital strategy accelerates, but next-gen iCGM path slows (MedtechDive)
• LabCorp pulls 2020 guidance as testing demand plunges due to COVID-19 (MedtechDive)
• Baxter Reports First-Quarter 2020 Results (Press)
• AdvaMed pushes US to lift tariffs on Chinese imports of COVID-19 devices (MedtechDive)
• Mind-controlled prosthetic arm enables patients to feel the objects they grip (STAT)
• Pear rolls out digital therapeutic for schizophrenia, after FDA loosens regulations in COVID-19 response (MobiHealthNews)
• COFEPRIS releases guidelines on priority devices amidst partial COVID-19 shutdown (Emergo)
• CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets (FDA)

• Cures 2.0 May Get Fast Tracked Due To COVID-19 (Pink Sheet)
• Situation Normal, All-Federal Questioned Up (Drug & Device Law)
• Biogen Int'l v. Banner Life Sciences LLC (Fed. Cir. 2020) (Patent Docs)
• Therapeutic Goods Advertising Consultative Committee, 20 February 2020 (TGA)
• TGA publishes more information about medicine formulations (TGA)