Recon: COVID vaccine makers see EU liability shield; BMS lands FDA priority review for ide-cel CAR-T therapy

• Decision Time Looms for Biotech’s Riskiest Bet (WSJ)
• After bruising rejection, bluebird and Bristol Myers Squibb land ide-cel priority review. But will it matter for the CVR? (Endpoints) (Press)
• Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization (WSJ)
• CDC Advisory Panel to Delay Vote on Initial Covid-19 Vaccine Roll-Out (WSJ) (Reuters)
• CDC backtracks on warning that coronavirus is airborne (Politico) (NYTimes)
• A Covid-19 Vaccine for Children May Not Arrive Before Fall 2021 (NYTimes)
• NIH official departs after anonymous posts attacking health leaders (NYTimes) (The Daily Beast)
• Government watchdog finds supply shortages are harming US coronavirus response (The Hill) (GAO)
• It’s Not Just Insulin: Lawmakers Focus on Price of One Drug, While Others Rise Too (KHN)

• COVID-19 vaccine makers see EU shield against side-effect claims (Reuters)
• Chinese state-backed firm expects coronavirus vaccine approval for public use within months (Reuters)
• Exclusive: 'We're confident' - Russia to share legal risks of COVID-19 vaccine (Reuters)
• India trials for Russia's 'Sputnik-V' vaccine could start in next few weeks: exec (Reuters)
• Industry says $6 to $18 per dose is reasonable price for COVID-19 vaccine (Reuters)
• Mexico to sign up to WHO's coronavirus COVAX vaccine plan this week: foreign minister (Reuters)
• South Korea suspends flu shots in setback for winter COVID-19 preparations (Reuters)
• Legend Biotech CEO detained in China as part of investigation (STAT)
• Samsung Biologics nets $330M+ deal from AstraZeneca ahead of 'Super Plant' construction (Endpoints)
• Zai Lab hauls in $761M from Hong Kong IPO to push Zejula, more budding candidates in China (Endpoints)

• US surpasses grim milestone of 200,000 COVID-19 deaths (Reuters)
• Signs of an ‘October Vaccine Surprise’ Alarm Career Scientists (KHN)
• The Vaccine Protocols (In The Pipeline)
• To get approval in India, vaccines must work in at least 50% cases (Economic Times)
• Valneva says in very advanced talks on second COVID-19 vaccine deal (Reuters)
• The world is racing toward Covid-19 drugs. In normal times, it takes years to get new antivirals out the door (STAT)
• Coronavirus (COVID-19) Update: Daily Roundup September 21, 2020 (FDA)
• NIH to fund 7 digital health projects aimed at COVID-19 (Fierce)

• China hikes prices of key drug ingredients (Economic Times)
• Remarks by Commissioner Hahn to the Compounding Quality Center of Excellence Conference (FDA)
• Coming for the king: Keytruda dominates the immunotherapy market, but challengers are lining up (STAT)
• #ESMO20: Bristol Myers marks Opdivo's second adjuvant win — eyeing a standard of care gap (Endpoints)
• Can a magnetic cell therapy replace corneal transplantation? As eight-year journey leads to the clinic, two brothers unveil bold vision (Endpoints)
• #ESMO20: Seattle Genetics eyes 4th approval with new data in a crowded field (Endpoints)
• Emmecell exits stealth mode as FDA greenlights clinical trials of cornea cell therapy (Fierce)
• #ESMO20: Pushing into frontline, Merck and Bristol Myers duke it out with new slate of GI cancer data (Endpoints)
• Medicxi's David Grainger and Francesco De Rubertis pump €200M into six companies and what they say is a first-of-its kind fund (Endpoints)
• Israeli biotech raises $57M to go where current BRAF inhibitors can't, with backing from Novartis, SR One (Endpoints)
• Flagship's merged biotech Repertoire nets ex-Pfizer CSO Anthony Coyle as R&D chief (Endpoints)
• Tiny Vaccinex's drug flops in PhII Huntington's trial, stock craters; Siolta nabs $30M Series B to develop microbiome drug (Endpoints)
• FDA Alerts of Perrigo's voluntary albuterol inhaler recall (FDA)
• New WHO Public Inspection Reports (WHOPIRs) published (WHO)

• Labs, diagnostics, dialysis sectors predicted to recover by year-end, but S&P cautious on device outlook (MedtechDive)
• FDA De Novo OKs outpace 2019 with Spineology device, two others (MedtechDive)
• Novartis, Siemens to develop blood tests for multiple sclerosis (Fierce)
• BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Error (FDA)
• Trump admin unveils final kidney care payment model (MedtechDive)
• Teva’s two new digital inhalers complete Digihaler product line (MobiHealthNews)
• House Passes Bill Allowing FDA To Seize Counterfeits (Law360)

• If the Supreme Court Ends Obamacare, Here’s What It Would Mean (NYTimes)
• Ruth Bader Ginsburg’s Impact On Pharma, From Patents To The First Amendment (Pink Sheet)
• Trump administration shakes up HHS personnel office after tumultuous hires (Politico)
• Senators urge bankruptcy judge to prevent Purdue from paying its CEO a $3.5 million bonus (STAT)
• Scripps reaches $10M settlement with government over allegations NIH grants weren't properly accounted for (Endpoints)
• New Early Scientific Advice service to support medicine registrations (TGA)