Recon: FDA issues EUA for convalescent plasma; Takeda to sell $2.3B consumer health unit to Blackstone

• FDA authorizes plasma treatment despite scientists' objections (Politico) (STAT) (Endpoints) (Reuters) (NYTimes) (FDA)
• Trump wants FDA to ‘feel the heat,’ chief of staff says (Politico)
• Straight talk on the FDA’s tumultuous weekend — and new questions about its independence (STAT)
• Is convalescent plasma safe and effective? We answer the major questions about the Covid-19 treatment (STAT)
• Trump considers fast-tracking UK Covid-19 vaccine before US election (FT)
• AstraZeneca denies it is in discussions to fast-track US approval of its COVID-19 vaccine (Fortune) (The Guardian)
• Moderna says more than 40% of participants enrolled for COVID-19 vaccine trial (Reuters)
• Novavax starts enrollment for phase two of COVID-19 vaccine trial (Reuters)
• PhRMA scrambles to respond to Trump’s drug pricing ultimatum, as Monday deadline looms (STAT)
• Bristol Myers to buy Forbius in hunt for Opdivo-enhancing drugs (Fierce) (Press)

• WHO says 172 countries engaging with global COVID-19 vaccine plan (Reuters)
• WHO cautious on COVID-19 plasma as US issues emergency authorization (Reuters)
• Moderna, EU conclude advanced talks to supply COVID-19 vaccine candidate (Reuters)
• Novartis CEO says COVID-19 makes valuing takeover targets tougher (Reuters)
• Novartis immuno-oncology drug candidate fails skin cancer trial (Reuters) (Endpoints)
• Takeda to sell Japan consumer health unit valued at $2.3 billion to Blackstone (Reuters) (Press)
• China has been using Covid-19 vaccine candidate on key workers since July, health official says (SCMP) (Reuters)
• Teva, on the heels of major reorg, plans to cut 350 more manufacturing jobs in Israel (Fierce)
• Stephen Lightfoot Appointed New Chair Of UK MHRA (Pink Sheet)
• Vertex’s triple combination CF therapy to become available on the NHS (PMLive)
• New Ebola outbreak in Congo raises alarm (The Hill)

• Nearly a fifth of enrollees in Pfizer, BioNTech COVID-19 vaccine study are Black or Latino (Reuters)
• Factbox: China's coronavirus vaccine development efforts (Reuters)
• Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes — But There’s a Hitch (KHN)
• COVID-19 treatments: What's taking the clinical trials so long? (NBC)
• For Quick Coronavirus Testing, Israel Turns to a Clever Algorithm (NYTimes)
• In the race for a Covid-19 vaccine, Pfizer turns to a scientist with a history of defying skeptics — and getting results (STAT)
• Catalent to make drug substance for AstraZeneca's COVID-19 vaccine candidate (Reuters)
• China approves human testing for coronavirus vaccine grown in insect cells (Reuters)
• First Covid-19 reinfection documented in Hong Kong, researchers say (STAT)
• Cold War law invoked for BD, Quidel to prioritize antigen test contracts (MedtechDive)

• FDA commissioner needs to push back and tell Trump the agency is not part of the ‘deep state’ (STAT)
• Drug makers rebut Trump tweet that FDA ‘deep state’ is delaying Covid-19 vaccines and drugs (STAT)
• FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma (FDA)
• MHLW OKs Label Expansions for Keytruda, Imfinzi, Kadcyla (PharmaJapan)
• 4 years on, promised mandatory pharma ethics code elusive (Economic Times)
• Relay Therapeutics set out to change how drugs are designed. Can it continue what Vertex began? (BioPharmaDive)
• Odonate announces 'positive' results but faces investor backlash; Aslan is once again recruiting clinical trial participants after months-long wait amid the pandemic (Endpoints)
• Which big biopharma player should gamble $34B on a ripe rare-disease M&A target? An action-hungry top analyst fills in the blanks (Endpoints)
• Vir enlists Covid-19 antibody rival for cancer, infectious disease discovery work (Endpoints)
• Driving to the $278M mark on raises, a legendary R&D expert sets his sights on another pivotal goal line (Endpoints)
• Onconova reports PhIII flop, putting high-risk MDS program on the chopping block (Endpoints)
• Tony Coles takes second neuroscience startup public as Yumanity reverse merges (Endpoints)
• Ten years of vaccinovigilance in Italy: an overview of the pharmacovigilance data from 2008 to 2017 (Nature)

• Inside the Race to Build a Better $500 Emergency Ventilator (KHN)
• German Industry Warns EU Over MDR: Don’t Waste The Extra Time For Compliance (MedtechInsight)
• US Lawmaker Demands Briefing From HHS Chief On LDT Loophole (MedtechInsight)
• Japan Approves CureApp’s Smoking Cessation Apps (PharmaJapan)

• Pharma Giants Tee Up Biologics Innovation Fight At Fed. Circ. (Law360)
• SEC Says There's 'No Dispute' Biotech Brass Broke Law (Law360)
• AmerisourceBergen Board Looks To Ax Opioid Derivative Suit (Law360)
• Ferring Gets Rival's Patents Scrapped In Zoom Trial Win (Law360)
• Alcon Claims Lens.com Led It On 'Antitrust Wild Goose Chase' (Law360)