Regulatory Focus™ > News Articles > 2020 > 8 > Recon: FDA approves Novartis’ Kesimpta for MS; Bayer to pay $1.6B to resolve US Essure claims

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

Posted 21 August 2020 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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