Recon: Kodak $765M loan on hold; Gilead submits NDA for remdesivir

• FDA Chief is Caught Between Scientists and the President (NYTimes)
• FDA’s reopening plan will keep biologics labs shuttered far longer than other government labs (STAT)
• Eastman Kodak's $765 million US loan agreement on hold after recent allegations (Reuters) (Politico)
• Gilead files US marketing application for remdesivir (Reuters)
• FDA approves first oral treatment for a rare muscle-destroying disease (STAT) (Endpoints)
• FDA approves Trevena’s Olinvyk for clinical controlled settings (BioWorld) (FDA)
• One in Three Americans Would Not Get COVID-19 Vaccine (Gallup)
• CureVac aims to raise up to $245 million in U.S. IPO (Reuters)
• Pharma is showering Congress with cash, even as drug makers race to fight the coronavirus (STAT)
• Shortages threaten Trump’s plan for rapid coronavirus tests (Politico)

• WHO decries 'vast global gap' in funds needed to fight coronavirus (Reuters)
• Roche 'disappointed' with trial results for colitis drug (Reuters) (Endpoints)
• Industry Body Calls Russian Covid-19 Vaccine a Pandora’s Box (Bloomberg) (NBC)
• China's Sinopharm starts Phase III trial of COVID-19 vaccine in Bahrain, Saudi Arabia (Reuters 1, 2)
• Australia experiencing critical shortage of antidepressants, contraceptives and HRT (The Guardian)
• 73rd World Health Assembly Decisions (WHO)

• U.S. Hits More Than 5 Million Confirmed Cases Of Coronavirus (NPR)
• Nearly 100,000 children tested positive for coronavirus over two weeks last month (The Hill)
• This Company Boasted to Trump About Its Covid-19 Vaccine. Experts Are Skeptical. (NYTimes)
• Seizing on India’s lax standards for Covid-19 drugs, critics push for an overhaul on transparency (STAT)
• Inside the Chinese lab central to the search for the coronavirus' origin (NBC)
• Omeros' COVID-19 treatment shows promise, shares jump (Reuters)
• GigaGen’s polyclonal antibody against COVID-19 outperforms plasma in lab tests (Fierce)
• NIH to fund new diagnostic tests for the emerging, severe childhood illness linked to COVID-19 (Fierce)
• AI invents new ‘recipes’ for potential COVID-19 drugs (Science)
• Up to 750,000 UK Covid test kits recalled due to safety concerns (The Guardian)
• MHRA Releases Synthetic Datasets To Speed COVID-19 & Cardiovascular Device Development (MedtechInsight)
• Coronavirus (COVID-19) Update: Daily Roundup August 7, 2020 (FDA)

• Seres announces positive late-stage results for its microbe-based drug (STAT)
• US FDA, Sponsors Eye Best Practices For Virtual AdComms (Pink Sheet)
• Vida Ventures co-leads Dyne's $115M megaround for next-gen oligo therapies aimed squarely at muscles (Endpoints)
• Eli Lilly teams with Pieris on HER2+ tumors; Opdivo + Yervoy best chemo in mesothelioma (Endpoints)
• AnaptysBio's etokimab provides more disappointing results, raising questions about compound's future (Endpoints)
• Innovent and Eli Lilly challenge Merck's mega-blockbuster Keytruda in non-small cell lung cancer field (Endpoints)
• The duvelisib hot potato is tossed to a new owner as Verastem looks to reorganize around the pipeline (Endpoints)
• Spark Therapeutics nabs new CMO from Genentech, filling a major post-merger departure (Endpoints)
• RFID Tags Found To Improve Drug Supply Chain Tracking In Recent DSCSA Pilot (Pink Sheet)
• GAO Report on Over-the-Counter Drugs (FDA Law Blog)
• Lupin, Sun Pharma recall Lisinopril and Clonazepam respectively in the US market (Economic Times)

• Genomic sequencing to screen newborns raises more false alarms than routine blood tests, study finds (STAT)
• FDA Approves Guardant’s Guardant360 CDX Comprehensive Genomic Profile (MedtechInsight) (MedtechDive)
• FDA clears Siemens’ wheeled, bedside CT scanner (Fierce)
• US FDA launches pilot program for RFD and Pre-RFD electronic submissions process (Emergo)
• Pandemic Hampers Reopening of Joint Replacement Gold Mine (KHN)
• Coronavirus Q&A: Hogan Lovells' Medical Devices Director (Law360)

• Major Questions Remain in Wake of Trump Drug Pricing Executive Orders (Drug & Device Law)
• Chinese Scientist Wins Covid-19 Release in Drug Secret Suit (Bloomberg)
• Drug Companies Face Lawsuits From Opioid Crisis As They Respond To The Pandemic (NPR)
• Citrus Flavoring Is Weaponized Against Insect-Borne Diseases (NYTimes)
• Bayer, Merck Can't Be Pulled Back In Leg Amputation Suit (Law360)
• JPML Consolidates Profemur Hip Implant Suits In Ark. (Law360)
• Independent review of the reforms to the therapeutic goods advertising framework complete (TGA)