Recon: NIH launches late-stage study of remdesivir and convalescent plasma; China joins COVAX scheme

• Gilead's remdesivir shaved five days off COVID-19 recovery time, reduced risk of death in some (Reuters)
• Late-stage study of COVID-19 convalescent-plasma treatment with remdesivir starts (Reuters)
• Fauci says 'reasonably good chance' Regeneron antibody therapy helped Trump (Reuters)
• Pfizer's breast cancer drug Ibrance fails late-stage study (Reuters) (Press)
• FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases (FDA)
• Trump’s Covid Treatments Were Tested in Cells Derived From Fetal Tissue (NYTimes) (FT)
• As Trump Touts His ‘Great’ COVID Drugs, the Pharma Cash Flows to Biden, Not Him (KHN)
• Health officials scrambling to produce Trump's ‘last-minute’ drug cards by Election Day (Politico)

• Russia expected to register second COVID-19 vaccine on October 15: developer (Reuters)
• China joins WHO-backed vaccine programme COVAX rejected by Trump (Reuters)
• Takeda-led COVID-19 plasma treatment enters clinical trial with first patient (Reuters)
• Pharmaceutical companies say they are stockpiling medicines for Brexit because they have no idea how the Northern Ireland border will work (BI)
• Launch of Ethics & Vector-borne Diseases: WHO Guidance (WHO)

• Report - Lessons From COVID-19 (Council on Foreign Relations)
• FDA grants emergency clearance for GenMark test that screens for the flu, coronavirus and other viruses (CNBC)
• The 'evidence is clear': Hydroxychloroquine doesn't help Covid-19 patients (NBC)
• What President Trump’s ‘compassionate use’ of a Covid-19 drug means — and doesn’t mean (STAT)
• Taxpayers are subsidizing 80 percent of Regeneron’s COVID-19 treatment’s R&D costs (KEI)
• It's not just the antibodies: Eli Lilly burnishes its second EUA in play with new Covid-19 data on Olumiant plus remdesivir (Endpoints) (Press)
• Top CDRH Officials Tell EUA Holders: Don’t Procrastinate In Getting Products FDA-Approved (MedtechInsight)

• Covid drives historic demand for life sciences real estate and these REITs, report says (CNBC)
• Corbus to ax half of staff after back-to-back trial failures (Fierce)
• U.K. manufacturer Abzena pumps $60M into new biologics facility in San Diego (Fierce)
• Complex Generics: Pre-Competitive Research Collaborations To Get US FDA Funding Boost (Pink Sheet)
• PDUFA And Gene Therapy: Bring ‘Fully Baked’ Ideas And ‘Don’t Be Stingy,’ Grogan Tells Developers (Pink Sheet)
• Sensei Biotherapeutics rakes in $28.5M to give cancer immunotherapies a push (Endpoints)
• Seattle Genetics shortens name to Seagen, dropping local connection as it goes global (Fierce) (Endpoints)
• Three more biotechs go public Friday as nothing seems able to slow down the 2020 train (Endpoints)
• What are the right ingredients for a blockbuster unicorn IPO? Norbert Bischofberger has some thoughts on that (Endpoints)
• Notice of Concern (NOC) for Panexcell Clinical Lab Pvt Ltd published (WHO)
• Novartis received European Medicines Agency (EMA) PRIME designation for iptacopan (LNP) in C3 glomerulopathy (C3G) (Press)
• Lilly's OVERCOME Study Reveals Nearly 80% of People Reported Improvement in Their Migraine Since Starting a CGRP Monoclonal Antibody for Preventive Treatment (Press)

• Medtronic shares early data TAVR works in low-risk bicuspid patients (MedtechDive)
• Getting On The IVDR Bandwagon: Becton Dickinson Explains The Benefits And Hurdles (MedtechInsight)
• ‘MDD+’ For The UK, As Future Devices Regulation Will Be A ‘Living Document’ (MedtechInsight)
• Fresenius outlines plans to expand extracorporeal care portfolio to hearts, lungs (Fierce)
• Steris to acquire Key Surgical for $850M (MassDevice)
• Olympus gains 510(k) clearance for colonoscopes (MassDevice)

• What To Know About FDA's 'Intended Use' Proposed Rule (Law360)
• High Court Punts FDA Bid To Revive Abortion Pill Restriction (Law360)
• FDA Requests Comment on Labeling of Cell-Derived Seafood Products Except… Wait For It… Catfish (FDA Law Blog)
• Takeda Asks 2nd Circ. To Flip Actos Rulings (Law360)
• Stryker's Trial Win Over Surgery Death Upheld On Appeal (Law360)
• New transparency measures for prescription medicines (TGA)
• Submissions received and TGA response: Transparency measures for prescription medicines (TGA)