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Recon: Sanofi Stockpiling Drugs Ahead of Brexit; FDA Approves Shionogi Blood Disorder Drug

Posted 01 August 2018 | By Ana Mulero 

Recon: Sanofi Stockpiling Drugs Ahead of Brexit; FDA Approves Shionogi Blood Disorder Drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Letting Medicare negotiate drug prices could save nearly $3 billion: Democratic report (Washington Examiner) (STAT-$) (Fierce)
  • Kyoa, Ultragenyx sell priority review voucher for $80.6M (BioCentury)
  • With Millions At Stake, New Jersey Won't Accept Junk Science Against Pharma Companies (Forbes)
  • The data showing drug pricing games (Axios)
  • FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development (FDA)
  • NewLink cuts 30% of staff to continue indoximod development (BioPharma Dive) (FIerce)
  • FDA approves blood disorder drug made by Japan's Shionogi (Reuters) (Fierce) (Endpoints)
  • To Tame Prescription Prices, HHS Dips A Toe Into Drug Importation Stream (KHN)
  • Ancestry and 23andMe Agree to Rules on Providing DNA to Third Parties (Fortune)
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In Focus: International
  • Justice Dept. Investigating Claims That Drug Companies Funded Terrorism in Iraq (NYT)
  • Sanofi and Novartis are stockpiling drugs to prepare for Brexit (CNN) (Reuters) (Fierce) (WSJ)
  • Boehringer sales rise as Jardiance and Ofev thrive (PharmaTimes) (The Pharma Letter-$)
  • Asia’s first pre-profit biotech listing Ascletis Pharma ends unchanged in debut trade (South China Morning Post) (Reuters)
  • Novartis dispatches two more cancer drug castoffs to a partner in China (Endpoints) (Fierce)
  • ReViral raises $55M to run midphase RSV clinical trials (Fierce) (Endpoints)
  • New Ebola outbreak declared in DRC a week after earlier one declared over (STAT) (AP News)
  • Ugandan hospitals hit by shortages of drugs, other supplies (Reuters)
Pharmaceuticals & Biotechnology
  • Biosimilar Litigation Updates (Big Molecule Watch)
  • Amgen Wants High Court Review of Regeneron, Sanofi Patent Fight (Bloomberg-$)
  • Pfizer CEO on what happened after Trump tweeted (CNBC)
  • The top 5 vaccine companies by 2017 revenue (Fierce)
  • Game change: Pfizer doubles down on its late-stage pipeline as CEO Read disavows a long reliance on M&A deals (Endpoints)
  • Merck Says Vaccine Bundles Caused Low Prices, Not Harm (Law360-$)
  • Series of ethical stumbles tests NIH’s reliance on private sector for research funding (STAT)
  • Two Akcea drugs are about to hit the market — but are they already too late? (STAT-$)
  • The FDA commissioner has issued how many statements? (STAT-$)
  • Analysts not buying pharma promises to contain prices (The Detroit News)
  • AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material (FDA)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • As NDA talks loom, FDA hands Daiichi Sankyo a ‘breakthrough’ on its $410M AML drug quizartinib (Endpoints)
  • Scientists, using new method, coax bioengineered lungs to survive for prolonged period in pigs (STAT)
  • Discovery of unknown lung cell points to new target for cystic fibrosis medicines (STAT)
Medical Devices
  • Hologic drops $85m on Faxitron Bioptics (MassDevice)
  • LivaNova beats Q2 expectations (MassDevice)
  • FDA widens approval of Roche cobas HPV test to new sample media (Fierce)
  • US FDA Medical Device User Fees Tick Up Slightly for 2019 (Emergo Group)
  • Medtronic Announces Paurvi Bhatt as President of Medtronic Foundation (Press)
  • QIAGEN’s careHPV Test Wins WHO Prequalification Status for Cervical Cancer Screening (Press)
  • TherapeuticsMD Licenses Population Council’s Novel Segesterone Acetate/ Ethinyl Estradiol One-Year Vaginal Contraceptive System (Press)
US: Assorted & Government
  • U.S. insurers grilled on exposure to $4.7 billion J&J talc verdict (Reuters)
  • FDA previews veterinary stewardship plan (University of Minnesota)
  • In shift, IBM is adding regional treatment advice and real patient data to cancer product (STAT)
  • Google is here. Now the rest of healthcare has to keep up (Modern Healthcare)
  • Anthem Taps Artificial Intelligence Space With Allergy Research Trial (Forbes)
  • Janssen Loses Remicade Patent Case To Pfizer, Celltrion (Law360-$)
  • Insurers Get Green Light To Sell ACA-Skirting Policies (Law360-$)
  • How drugmakers sway states to profit off of Medicaid (The Center for Public Integrity)
  • Healthcare Admin Costs Can Be Tamed, Senators Told (MedPage Today)
  • Trump Administration Delivers on Promise of More Affordable Health Insurance Options (CMS)
  • Short-Term Health Plans Backed by Trump Are Cheap for a Reason (Bloomberg)
  • Specialty Pharmacies Want In on Medicare Drug Coverage (Bloomberg-$)
  • H.R.6641 - To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to prohibit health insurance issuers, group health plans, Medicare Advantage organizations, and prescription drug plan sponsors from limiting drug price information a pharmacy may give to a consumer. (
  • H.R.6642 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs. (
Upcoming Meetings & Events Europe
  • Brexit deal ‘backstop for Ireland? Pharma pushes for undisrupted, cross-border supply (in-PharmaTechnologist)
  • First treatment for lipodystrophy approved in Europe (PharmaTimes)
  • Pfizer's Xeljanz cleared for ulcerative colitis in Europe (PharmaTimes)
  • CAR-T player Cell Medica names Kite’s European chief as CEO (Fierce)
  • Baxter Announces CE Mark and Regulatory Approval of New Evo IQ Infusion System for the United Kingdom, Ireland, Australia and New Zealand (Press)
  • Fears of bad vaccines drive Chinese to seek care far from home (Nikkei Asian Review)
  • Ascentage Pharma Secures US$150 Million In Series C Funding (Asian Scientist Magazine)
  • Daiichi Sankyo splits to offload old assets and focus on oncology ambition (The Pharma Letter-$)
  • ‘Roche Korea’s Alecensa effective against central nervous system disease risk’ (Korea Biomedical Review)
  • QIAGEN Creates Collaboration with Japan’s Largest Clinical Laboratory Testing Company, SRL, to Accelerate Launch of Companion Diagnostics (Press)
India Australia
  • My Health Record: Greg Hunt promises to redraft legislation after public outcry (The Guardian)
  • Fycompa added to Australia's Pharmaceutical Benefits Scheme (The Pharma Letter-$)
  • TGA eyes tougher regulation for smartphone health apps (Pharmacy News)
  • Durex Real Feel condoms, 6 pack: Recall - single batch does not pass shelf life durability tests (TGA)
  • Imprimis Announces Multi-Center Clinical Trial for Dropless TriMoxi (Triamcinolone Acetonide-Moxifloxacin for injection) Formulation in Canada (Press)
  • Intellis, the Next Generation Medtronic Spinal Cord Stimulator for Long-Term Management of Chronic Pain, Now Licensed in Canada (Press)
  • Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018 (Emergo Group)
  • Patent backlog in Brazil: slow, but welcome, progress (Lexology-$)
  • Launched Guide to Measuring Administrative Burden (Anvisa)
  • Generic unprecedented approved for the treatment of cancer (Anvisa)
General Health & Other Interesting Articles
  • The Rise Of Concierge Medical Practices (Forbes)
  • Naked Labs’ 3-D body scanner shows you the naked truth (Wired)
  • Gender inequality still plagues the health care industry. Women are fed up (STAT)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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