Recon: Trump says he may block FDA vaccine EUA guidance; Gilead to pay $97M to settle kickback claims

• Top adviser steps aside from FDA COVID-19 vaccine reviews over potential conflict (Reuters)
• Trump says he might reject stricter FDA vaccine guidelines (Politico) (Reuters) (Endpoints)
• Azar falls in line under Trump again. Experts say he's reinforcing a dark signal sent to the FDA (Endpoints)
• AstraZeneca still waiting for FDA go-ahead to resume US trial (Reuters)
• Gilead to pay $97 million for allegedly using a charity to pay kickbacks to Medicare patients (STAT) (DOJ)
• HHS criticizes Lilly for seeking to curtail discounts for safety-net hospitals (STAT)
• These Secret Safety Panels Will Pick the COVID Vaccine Winners (KHN)
• US appeals court rejects novel opioid settlement framework (Reuters)
• Becton Dickinson reaches $60 million settlement over pelvic mesh devices (Reuters)
• FDA grants EUA to first point-of-care COVID-19 antibody test (MedtechDive) (FDA)

• China's Sinovac expects interim final-stage trial data on coronavirus vaccine this year (Reuters)
• SoftBank offers $19 COVID-19 tests to companies, governments (Reuters)
• Pfizer partner BioNTech sees no role for its vaccine in UK challenge trial (Reuters)
• Russia to supply 17 more countries with COVID-19 drug Avifavir (Reuters)
• Pharmacies in England pause online flu jab bookings as demand soars (The Guardian)
• TimesUS warns Turkey over failure to pay foreign healthcare debts (FT)
• Eradicating dracunculiasis: human cases and animal infections decline as Angola becomes endemic (WHO)

• Covid-19 Vaccines Could End Up With Bias Built Right In (Wired)
• Here come the tortoises: In the race for a Covid-19 vaccine, slow starters could still win out (STAT)
• Trump’s Vaccine Czar Refuses to Give Up Stock in Drug Company Involved in His Government Role (ProPublica)
• Drugmakers still haven't started testing their coronavirus vaccines in children, putting kids at the end of the line for a potential shot (BI)
• Trump Administration Plans Crackdown On Hospitals Failing To Report COVID-19 Data (NPR)
• With a $4M federal grant, Lumen jumps into the Covid-19 treatment race (Endpoints)
• Australia's drug regulator TGA approves Covid tests that deliver results in 15 minutes (The Guardian)
• Coronavirus (COVID-19) Update: Daily Roundup September 23, 2020 (FDA)

• GoodRx IPO: drugstore disrupter (FT)
• New research finds unapproved drugs in brain-boosting supplements (STAT)
• Assessing the Safety of Glucose-Lowering Drugs — A New Focus for the FDA (NEJM)
• US data shows sharp drop in childhood vaccinations, preventative care during pandemic (The Hill)
• With US elections nearing, European pharma giants brace for potential pricing action: analysts (Fierce)
• UK To Diverge On Biosimilar Data Requirements (Pink Sheet)
• EMA fast-tracks review of bluebird bio’s LentiGlobin for sickle cell disease (PMLive)
• FDA and EMA accept regulatory submissions for UCB’s bimekizumab (PharmaTimes)
• Verona Pharma launches late-stage COPD trial programme (PharmaTimes)
• Following a hefty Series B, Silverback Therapeutics quickly pulls in $85 million for 'an important growth phase' (Endpoints)
• ‘March In’ Plan Unveiled By Democratic Think Tank: A Battle Biopharma Would Welcome? (Pink Sheet)
• Only five months after a Series A launch, Taysha goes public with $157M IPO (Endpoints)
• Remdesivir’s Path To Orphan Designation Could Be Exploited By Others, Experts Warn (Pink Sheet)
• Centre does a U-turn, says no plans to make pharmaceutical marketing code mandatory (Economic Times)
• PMDA to Continue Remote GCP/Compliance Inspections through End of March 2021 (PharmaJapan)
• Monte Rosa rakes in $96M Series B as it prepares 'molecular glue' platform for IND-enabling studies (Endpoints)

• Patient sentiment improving on elective procedures despite ongoing pandemic, survey suggests (MedtechDive)
• National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown (NatPSA/2020/007/MHRA) (MHRA)

• Federal Property: Formal Policies Could Enhance FDA's Property Management Efforts (GAO)
• Not by the numbers: Former Aceto controller is charged with insider trading (STAT)
• Health insurer sues Indivior over 'profit protection scheme' (BioPharmaDive)
• Drug Distributors Seek Out Of W.Va. Opioid Bellwether (Law360)
• Boehringer Escapes Suit Over Underfilled Inhalers (Law360)