Recon: FDA approves Novartis’ Kesimpta for MS; Bayer to pay $1.6B to resolve US Essure claims

• Top FDA official says would resign if agency rubber-stamps an unproven COVID-19 vaccine (Reuters)
• Pfizer, BioNTech shares gain as more data backs vaccine candidate (Reuters)
• Bayer to pay $1.6 billion to resolve U.S. claims for Essure birth-control device (Reuters)
• Senators open investigation into prescription delays through Postal Service (The Hill)
• Novartis wins FDA approval to repurpose leukaemia drug against multiple sclerosis (Reuters)
• Drug makers seek to curtail discounts paid to hospitals as part of a controversial federal program (STAT)
• US expand use of Janssen's Darzalex (PharmaTimes) (Endpoints)
• Third patient dies in halted study of Audentes gene therapy (BioPharmaDive)
• How big is the 2020 biotech IPO boom? More than $11 billion big among the year's four dozen entrants (Endpoints)

• Russia vaccine roll-out plan prompts virus mutation worries (Reuters)
• Russia's Vektor COVID-19 vaccine to complete clinical trial in September: RIA (Reuters)
• Lilly Asia Ventures leads AstraZeneca spinout's $100M push into China's growing R&D hub in Wuxi (Endpoints)
• Russia approves trial of AstraZeneca COVID-19 vaccine: registry filing (Reuters)
• AstraZeneca scores Japanese approval for Imfinzi combo in extensive-stage small cell lung cancer (Pharmafile)
• Europe Stands Firm On Nitrosamine Assessment Deadline For APIs (Pink Sheet)
• Global Biosimilars Approval and Launch Updates (Big Molecule Watch)
• GlaxoSmithKline could cut up to 60 workers at UK site as it ends production of antibiotic chemical (Fierce)

• Biden’s pandemic challenge: A unified plan for a divided country (Politico)
• Drug Pitched to Trump for Covid-19 Comes From a Deadly Plant (NYTimes)
• U.S. will have third act of coronavirus and it will likely be ‘more pervasive,’ Dr. Scott Gottlieb says (CNBC)
• COVID-19 era highlights U.S. 'black hole' compensation fund for pandemic vaccine injuries (Reuters)
• Japan Plans to Provide Indemnity to Coronavirus Vaccine Suppliers (PharmaJapan)
• Coronavirus (COVID-19) Update: Daily Roundup August 20, 2020 (FDA)

• Do surprise drug rejections signal a more conservative FDA? Don’t bet on it (STAT)
• Wary hemophilia patients say they’re willing to wait longer for a safe gene therapy (STAT)
• FY 2019 Drug Development Drives FY 2021 User Fees Lower (Pink Sheet)
• Bayshore Pharmaceuticals voluntarily recalls metformin hydrochloride ER tables (FDA)
• Virtual FDA AdComm for Alkermes' ALKS 3831 adds new focus on drug-drug interactions (Fierce)
• When Prescribing Isn’t Enough — Pharmacy-Level Barriers to Buprenorphine Access (NEJM)
• A Good Place to Start — Low-Threshold Buprenorphine Initiation (NEJM)
• ICH To Add Guidance On Impurities, Viral Safety, Risk Management And Quality Overall Summary (Pink Sheet)
• Massachusetts requires most students to get flu vaccine to ease burden on health system during pandemic (CNBC)
• Pharma giants back a leader in virtual clinical trials as Covid-19 blights sites (Endpoints)
• Kymera, raising $173M+, becomes the 48th biotech IPO of the year as 2020 surpasses 2019 (Endpoints)
• BioMarin submits NDA for controversial achondroplasia drug; Cell and gene therapy boom sparks €49M buyout (Endpoints)
• That new biotech compound Arie Belldegrun & Co. have been building in Seaport? It turns out one fast-growing developer took the whole thing (Endpoints)
• MD Anderson's Patrick Hwu to helm Moffitt Cancer Center; After Rockwell Medical ouster, Robert Chioini gets another chance to lead (Endpoints)
• Revocation of the Test for Mycoplasma (FDA)

• Medtronic hopes for renewed spotlight on dialysis access device with NEJM publication (MedtechDive) (NEJM)
• Intuitive robot may up survival in mouth and throat, though not other cancers: study (MedtechDive)
• 3 serious incidents related to BD Alaris recall (MassDevice)

• Hatch-Waxman Complaints Down Sharply During Pandemic (Law360)
• Shkreli's Prison Comms Get Partial Protection From FTC (Law360)
• Pharmacy Board Asks 6th Circ. To Block Opioid Rx Info (Law360)
• DEA Proposes Rule For Regulating Hemp-Derived CBD (Law360)
• Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020) (Patent Docs)
• Prescription Drug Wholesalers: Don’t Overlook Non-Resident State License Requirements (FDA Law Blog)