Recon: Sanofi to Buy Ablynx for €3.9B, FDA Rejects Aradigm's Inhaled Antibiotic Linhaliq

Posted 29 January 2018 | By Michael Mezher 

Recon: Sanofi to Buy Ablynx for €3.9B, FDA Rejects Aradigm's Inhaled Antibiotic Linhaliq

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

In Focus: US

  • Drugmaker emerges as big winner from Trump tax bill (Financial Times)
  • AbbVie raises 2018 forecast, quarterly profit beats on strong Humira sales (CNBC) (EPVantage) (Financial Times)
  • Aradigm Receives Complete Response Letter from the FDA for Linhaliq NDA (Press) (Endpoints) (Drug Delivery)
  • Gilead is accused of an 'unethical' access policy for an HIV prevention drug (STAT)
  • US SEC files suit over possible insider trading on Bioverativ (Reuters) (Endpoints) (SEC)
  • AbbVie wins US trial in lawsuit over AndroGel's risks (Reuters)
  • Takeda's Zika Vaccine Gets FDA 'Fast Track' Status (Reuters) (Press)
  • Roche wins FDA's breakthrough therapy label for autism drug (Reuters) (Endpoints)
  • Zimmer Biomet moves Puerto Rican workers to Indiana (MassDevice)
  • State of the Union: Voters want to hear Trump on health care (Politico)
  • Scientists are now rushing to develop a universal flu vaccine (CNBC)
  • Leader of Fraudulent Medical Device Scheme Pleads Guilty (DoJ)
  • In Utah, an unlikely crusader fights the generic-drug industry with his own free-market approach (STAT)
  • Lawmakers in three states push bills to allow off-label promotion (STAT)
  • Medical Miracles From FDA Inefficiency (WSJ)

In Focus: International

  • Sanofi beats Novo Nordisk with €3.9bn Ablynx deal (Financial Times 1, 2) (WSJ) (Endpoints) (EPVantage)
  • EMA Chief Rasi Says Temporary Amsterdam Housing 'Not Optimal' (Reuters) (EMA)
  • Brexit: Council (Article 50) adopts negotiating directives on the transition period (European Council)
  • Hong Kong Seeks to Cash In on Frenzy for Chinese Drug Stocks (Bloomberg)
  • High levels of antibiotic resistance found worldwide, new data shows (WHO)
  • Santhera's Raxone rejected in Europe for Duchenne muscular dystrophy (Pharmafile)
  • Apotex CEO Jeremy Desai resigns (Reuters)
  • How Sanofi's setback could lead to better dengue vaccines (Reuters)
  • Brexit Health Alliance warns of UK at back of the medicine queue (Pharmafile) (PharmaTimes)
  • Cloning breakthrough heralds China's scientific rise (Financial Times)
  • Roche follows Shire to Europe with hemophilia approval for Hemlibra (Fierce)
  • Rare Disease Finds Fertile Ground In Rohingya Refugee Camps (NPR)

Pharmaceuticals & Biotechnology

  • Roche hemophilia drug lowers costs despite high price: ICER (Reuters)
  • Pharma-Funded Charities v. Health and Human Services (Health Law & Policy Brief)
  • Merck spinout grabs some assets and launches a quest for the Holy Grail in antibiotics R&D (Endpoints)
  • The Novel Off-Label Use For Gabapentin You Never Heard Of (Unless You Happen To Be A Veterinarian) (Forbes)
  • FDA To Review Its Pediatric Exclusivity Decision For Amgen's Sensipar (BioCentury)
  • An MCEM Framework for Drug Safety Signal Detection and Combination from Heterogeneous Real World Evidence (Nature)
  • UCSF-led clinical trial model may present a better way to test new breast cancer drugs (MedCityNews)
  • Molecular secrets revealed: antipsychotic docked in its receptor (NIH)
  • Interleukin-10 Directly Inhibits CD8+ T Cell Function by Enhancing N-Glycan Branching to Decrease Antigen Sensitivity (Cell)
  • Blockchain Will Not Be Used For DSCSA Data Exchange (RxTrace)
  • The market for chimeric antigen receptor T cell therapies (Nature)
  • Post-exposure treatments for Ebola and Marburg virus infections (Nature)
  • Innovation comes in many forms, including new and expanded uses of existing medicines (PhRMA)
  • Sofosbuvir found to be effective against Zika virus (EPR)
  • Entrepreneurship In Reproductive Medicine 2: Why We Need More Tech In High Tech Reproduction (Forbes)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Cipla gets USFDA approval for HIV drug (Economic Times)
  • Ensysce Biosciences Inc. Receives Fast Track Designation for PF614, BIO-MD Abuse Deterrent Extended Release Oxycodone Prodrug (Press)
  • Prometic's PBI-4050: Phase 3 Pivotal Clinical Trial Design For Idiopathic Pulmonary Fibrosis (IPF) Finalized (Press)
  • Antibe Therapeutics Announces Enrollment of Final Subjects in Phase 2B Gastrointestinal Safety Study of Lead Pain Drug, ATB-346 (Press)
  • Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease (Press)

Medical Devices

  • FDA puts MedyMatch image analysis software on fast track (Fierce) (Press)
  • Breast implants tied to increased risk of rare blood cancer (Reuters)
  • Bright light therapy may help fatigued cancer survivors sleep better (Reuters)
  • Twice as many in half the time: the FDA speeds up 2017 device approvals (EPVantage)
  • Stryker touts post-market Wingspan stent trial results (MassDevice)
  • Will Intuitive Stay Ahead of the Robot Competition? (MDDI) (MassDevice)
  • Masimo Announces FDA Clearance of Next Generation SedLine Brain Function Monitoring (Press)
  • J&J's Cerenovus launches Galaxy G3 mini embolic coil, touts Arise II Embotrap study data (MassDevice)
  • LimFlow Completes Enrollment In US Feasibility Study and Receives Breakthrough Device Status from FDA for Its Percutaneous Deep Vein Arterialization (pDVA) System (Press)
  • Meso Scale Diagnostics Receives First FDA Clearance for IVD Assay (Press)
  • Pixium Vision touts 1st use of Prima bionic vision system (MassDevice)
  • Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures (FDA)
  • Medical Devices; General and Plastic Surgery Devices; Classification of the Surgical Smoke Precipitator (FDA)

US: Assorted & Government

  • Amicus Briefs Filed in Mohawk Tribe's Motion to Dismiss IPRs (Patent Docs)
  • Arizona governor signs opioid crackdown legislation (Reuters)
  • Avalere Says Hospitals Will Benefit Overall Under New 340b Rule (BioCentury)
  • Drug Discount Program Strays from Patient Health to Hospital Wealth (BIO)

Upcoming Meetings & Events


  • Working to launch its shingles vaccine in the US, GlaxoSmithKline nabs Shingrix recommendation in Europe (Fierce)
  • Assessing the impact of medical technologies: apply for funding (MHRA)


  • Taiwan drugmakers embrace China's speedy approval policies (PharmaLetter-$)
  • Shanghai Pharma reveals aggressive expansion plan (PharmaLetter-$)


  • Billionaire Singh brothers accused in lawsuit of siphoning money (Economic Times)
  • Healthcare: Remove price capping, encourage innovation (Economic Times)
  • Consultation For Revisnig Ceiling Price of Coronary Stents (NPPA)


  • What We Heard Report: A Summary of Feedback from the Consultation: Toward a Strengthened Assisted Human Reproduction Act (Health Canada)


  • More Rigorous Assessments Ahead Under Australia's Program For Subsidizing Rare Disease Drugs (Pink Sheet-$)
  • Prescription medicines and biologicals: TGA annual summary 2017 (TGA)

General Health & Other Interesting Articles

  • Children Who Survive Congenital Heart Defects Can Face New Problems As Adults (NPR)
  • Preventive Care Saves Money? Sorry, It's Too Good to Be True (NYTimes)
  • Scientists Discover a Bone-Deep Risk for Heart Disease (NYTimes)
  • This scientist is creating tiny versions of one of neuroscience's most notorious opponents (STAT)
  • Storing data in DNA is a lot easier than getting it back out (MIT Technology Review)
  • Virus looks like flu, acts like flu, but it's not influenza (NBC)
  • A Prick A Day Won't Keep Your Blood Sugar Away (Forbes)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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