Recon: New FDA communications chief out after plasma debacle; WHO looks to win over more wealthy countries to COVAX facility

• Trump pledges a Covid-19 vaccine by end of 2020 — without acknowledging the scientific uncertainty (STAT) (Endpoints)
• Two PR Experts at FDA Have Been Ousted After Blood Plasma Fiasco (NYTimes)
• Employers are planning how to blunt the cost of gene therapies, pricey new specialty drugs (STAT)
• Trump administration to purchase 150 million Abbott COVID-19 tests for $750M (Reuters) (NYTimes)
• Trump skips RNC announcement of rapid Covid tests (Politico)
• CDC’s ‘Clarification’ on Coronavirus Testing Offers More Confusion (NYTimes)

• WHO sweetens terms to join struggling global COVAX vaccine facility (Reuters)
• New reckoning for WHO vaccine plan as governments go it alone (Reuters)
• UK to fast-track Covid-19 vaccine approval if sought before end of Brexit transition (FT)
• Sinovac's coronavirus vaccine candidate approved for emergency use in China- source (Reuters)
• J&J to start mid-stage coronavirus vaccine trials in three European countries (Reuters)
• EU working on further COVID-19 vaccine contracts: Merkel (Reuters)
• Japan, eyeing Olympics, lines up half-billion doses of COVID-19 vaccine (Reuters)
• Moderna in talks with Japan to supply 40 million doses of COVID-19 vaccine (Reuters)

• NIH awards $7.5 million grant to EcoHealth Alliance, months after uproar over political interference (STAT)
• Dr. Scott Gottlieb says the FDA appears to soften stance on a key requirement for home coronavirus tests (CNBC)
• Korea approves Celltrion’s Phase 1 trial of COVID-19 antiviral antibody treatment (Pharmafile)
• EU Urges Free Access To Publicly Funded COVID-19 Research Results (Pink Sheet)
• What A Nasal Spray Vaccine Against COVID-19 Might Do Even Better Than A Shot (NPR)
• Coronavirus (COVID-19) Update: Daily Roundup August 27, 2020 (FDA)

• New poll shows wide support for several Trump drug pricing reforms, but not rebate changes (STAT)
• Design-Based Development Paradigm for Cell/Gene Therapies Will Significantly Reduce Costs, Timelines and Regulatory Concerns, AGT CEO Galvin Affirms (IPQ)
• Macron renews calls for French sovereignty in healthcare and industry (Reuters)
• GSK’s Ionis-partnered hepatitis B drug hits the mark in phase 2 (PMLive) (Endpoints)
• MHLW Set to Address API, Coronavirus Vaccine Issues in FY2021 Budget (PharmaJapan)
• U.S. Efforts to Curb Antibiotic Resistance — Are We Saving Lives? (NEJM)
• The Greatest US FDA Advisory Committees: A Look Back At Tumult And Turning Points (Pink Sheet)
• GSK’s Trelegy Ellipta: US FDA Panel To Weigh Role Of Inhaled Corticosteroids On Mortality Results (Pink Sheet)
• Bayer aims for 40% more output at Beijing production site with new $59M plant (Fierce)
• Dermavant's psoriasis cream hits the mark in phase 3, teeing up FDA filing (Fierce)
• After Icon, PPD and Syneos, Pfizer pens updated Parexel deal, a clean sweep of re-upped CRO deals (Fierce)
• Emergent's next-gen nasal spray device snares shelf life extension for opioid overdose drug Narcan (Fierce)
• Athira, armed with data on 11 patients, plans $100M IPO to fund pivotal Alzheimer's trial (Fierce)
• Lupin, Mylan Launch Etanercept Biosimilar in Germany (Big Molecule Watch)
• Cadila Pharmaceuticals Announces Launch of Fourth Biosimilar in Two Months (Big Molecule Watch)
• Offers upped and upped again, CEO-to-CEO calls and perhaps a veiled walkout threat: Inside Sanofi CEO Paul Hudson's first big buyout (Endpoints)
• Fortress Biotech takes out $60M loan for debt purposes; Entasis pulls in $25M private placement for PhIII trial (Endpoints)
• Michael Varney comes out of brief Genentech 'retirement' for R&D gig at Erasca; Vivek Ramaswamy's Immunovant recruits J&J vet for CSO post (Endpoints)
• AbbVie and Harvard team up to find new drugs for the next new viruses (Endpoints)
• Cannabis research database shows how U.S. funding focuses on harms of the drug (Science)
• TGA Laboratories testing report: Seasonal influenza vaccines - Batch release 2020 (TGA)

• UK Medtech Gets A Role In Post-Brexit Trade Deal Negotiations (MedtechInsight)
• Insulin Pump Market Heats Up Among Rivals Medtronic, Insulet and Tandem (MedtechInsight)
• Clinical trial links hospital use of Dexcom G6 to improved glucose control (MedtechDive)
• Tandem's artificial pancreas improves glucose control in pediatric trial (MedtechDive)
• Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test (Press)

• TGA business plan 2020-21 (TGA)
• Danish Court Ruling Is Warning To Companies Not To ‘Screw Up Prices’ (Pink Sheet)
• French Anti-Gift Restrictions Set To Kick In (MedtechInsight)
• Opposition to Obamacare Becomes Political Liability for GOP Incumbents (KHN)
• Pa. Avoiding Discovery In Price-Fixing Case, Drugmakers Say (Law360)
• Baxalta's IP Suit Over Genentech Blood Drug Gets New Life (Law360)
• Shuttered Abbott Unit Beats Whistleblower's FCA Suit (Law360)