Regulatory Recon: Thermo Fisher to Buy Patheon for $7.2B EC Opens Formal Antitrust Investigation Into Aspen's Pricing Practices (15 May 2017)

Posted 15 May 2017 | By Michael Mezher 

Regulatory Recon: Thermo Fisher to Buy Patheon for $7.2B EC Opens Formal Antitrust Investigation Into Aspen's Pricing Practices (15 May 2017)

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

In Focus: US

  • Thermo Fisher Extends Binge With $7.2 Billion Patheon Deal (Bloomberg) (Financial Times) (Reuters) (Press)
  • How AstraZeneca cancer drug forecasts are set to rise (Reuters) (Financial Times)
  • AstraZeneca Shows That With Immune Cancer Drugs, No One Knows What's Next (Forbes)
  • How a Drug to Treat Crying Sent Sales Soaring (NYTimes)
  • New Gene Tests Pose a Threat to Insurers (NYTimes)
  • Trump Says He Knows About Health Care, But Some Of His Facts Seem Alternative (KHN)
  • White House Budget Director Dropped a Hint About How Trump Could Bring Drug Prices Down (Washington Post)
  • A Shocking Diagnosis: Breast Implants 'Gave Me Cancer' (NYTimes 1, 2)
  • Ionis says it gathered promising PhIII data for a top rare disease drug, but serious safety questions remain (Endpoints) (Xconomy)
  • The complete response letter: The mail no one wants to receive (C&EN)
  • Biosimilar Tentative Approvals Could Flow From US Supreme Court Case (Pink Sheet-$)
  • Taxing Drug Price Spikes: Assessing The Potential Impact (Health Affairs Blog)
  • Pharma's Not So Stingy With R&D After All (Forbes)
  • Conasgress Calls on HHS to Reverse Biosimilar Reimbursement Policy (Focus)
  • FDA Signs Off on New Device to Treat Esophageal Birth Defect in Babies (Focus)

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In Focus: International

  • CFDA Proposes Major Modernizations (BioCentury)
  • Aspen under EU antitrust spotlight over excessive cancer drug prices (Reuters) (European Commission)
  • French court orders TÜV to pay damages for faulty breast implants (Reuters)
  • WHO Officials Offer Opposition to Value-Based Drug Pricing (Focus)
  • Chief GSK breakup advocate Woodford, tired of being 'ignored,' pulls out (Fierce) (Reuters)
  • Brazil Declares an End to Its Zika Health Emergency (The Atlantic) (Pharmafile)
  • Novartis signs drug access deal with Pakistan government (Pharmafile)
  • NHS cyber-attack: No 'second spike' but disruption continues (BBC) (The Guardian) (NYTimes)
  • Hackers Hit Dozens of Countries Exploiting Stolen N.S.A. Tool (NYTimes 1, 2) (PharmaTimes)
  • Hackers Hit Dozens of Countries Exploiting Stolen N.S.A. Tool (CBS)
  • Winning in Nigeria: Pharma's next frontier (McKinsey)
  • Ebola vaccine could get first real-world test in emerging outbreak (Nature)
  • WHO confirms second Ebola case in Congo outbreak(Reuters)
  • Vaccine alliance says 300,000 doses of Merck's Ebola shot available for emergencies (Reuters)
  • WHO Regional Director for Africa, Dr Matshidiso Moeti travels to Kinshasa to discuss Ebola outbreak response (WHO)
  • Takeda establishes new drug discovery subsidiary (PharmaTimes)
  • Brazil's New Patent Agreement Is "Real and Concrete Threat" To IP (Pink Sheet-$)
  • How are anti-cancer drugs available without license: Court (Economic Times)

US: Pharmaceuticals & Biotechnology

  • PhRMA Pitches Pricing Ideas To Price (BioCentury)
  • FDA Advisory Committee Votes Against Compounding Of Coated Modified Release Drugs (Pink Sheet-$)
  • Dendreon eyes real-world data boost for lagging prostate cancer med Provenge (Fierce) (Press)
  • GlaxoSmithKline aims for the whole consumer-health shebang with $10.3B Novartis JV buyout (Fierce)
  • ADHD treatment tied to lower car crash risk (Washington Post)
  • When will pharma move from experimenting with digital health tools to adopting them? (MedCityNews)
  • Life after Pfizer: A decade later, Michigan pharmaceutical companies have found paths to growth (Crain's)
  • Prescription drug monitoring program fails in Missouri (ABC)
  • Expedited Review Pathways: Three More Breakthroughs, Third RMAT Awarded (Pink Sheet-$)
  • Surgeons plan to use hepatitis-infected hearts to slash wait for a transplant (STAT)
  • Intellia moves closer to clinic with CRISPR tech (Fierce)
  • Post-Marketing Drug Safety and Pharmacovigilance Is Now More Important Than Ever (Advera Health)
  • Roche to showcase 20-medicines at ASCO 2017 (PharmaLetter-$)
  • Alzheimer's experts call for changes in FDA drug approval standards (EPR)
  • Henri Termeer, key biotech leader who built Genzyme into an industry giant, dead at 71 (Boston Globe) (Xconomy)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Ardelyx reports positive phase 3 data, but shares fall hard premarket (Fierce)
  • Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration (Press)
  • FDA Breakthrough status for Rhythm's setmelanotide (PharmaLetter-$)
  • Imara Receives Rare Pediatric Disease Designation from FDA for Lead Product Candidate IMR-687 for Sickle Cell Disease (Press)
  • Aerie Pharmaceuticals Announces FDA Acceptance of NDA Submission for Rhopressa™ (netarsudil ophthalmic solution) 0.02% (Press)
  • Advaxis Provides Phase 1 Data of Higher Dose Axalimogene Filolisbac (Press)
  • Glenmark Pharmaceuticals to Initiate Clinical Study for GBR 1342, Second Investigational New Drug from Immuno-Oncology Portfolio (Press)
  • Teleflex (TFX) Announces Commencement of Phase I Clinical Study (FDP-1) of RePlas Freeze-Dried Plasma (Press)
  • Syros Announces First Patient Dosed in Phase 1 Clinical Trial of SY-1365, Its First-in-Class Selective CDK7 Inhibitor, in Patients with Advanced Solid Tumors (Press)
  • Resverlogix Receives Approval From The FDA Cardiovascular and Renal Division To Proceed With A Requested Apabetalone Clinical Trial (Press)

US: Medical Devices

  • Smarter Rehab with Robotics and Machine Learning (MDDI)
  • Class 1 Device Recall NC Trek RX Coronary Dilatation Catheter (FDA 1, 2, 3)
  • New Study Shows Medtronic Insertable Cardiac Monitors Detect High Rate of Atrial Fibrillation in Previously Undiagnosed High-Risk Patients (Press)
  • First Patient Transfused in Cerus' Phase III RedeS Study Evaluating Safety and Efficacy of the INTERCEPT Red Blood Cell System (Press)

US: Assorted & Government

  • Oversight Hearing - Advances in Biomedical Research  (House Appropriations)
  • HHS Solicits Nominations for Antimicrobial Resistance Council (HHS)
  • Why Some Can't Wait for a Repeal of Obamacare (NYTimes)
  • Addiction specialists blast Tom Price for opioids comments (Politico)
  • LDTs: The Saga Continues (FDA Law Blog)
  • Discovery – Requestor Pays, Part of the Way, Anyway (Drug & Device Law)
  • Webinar on Antitrust Issues in ANDA Patent Litigation (Patent Docs)

Upcoming Meetings & Events


  • Sanofi to start insulin supplies to EU market from Russian plant (PharmaLetter-$)
  • Russian watchdog slams cartels in domestic drug market (PharmaLetter-$)
  • British scientists survey infectious bacteria by having people walk outside in socks (Washington Post)


  • FiercePharmaAsia—Wockhardt's growing loss, Takeda's new deal, Mitsubishi's ALS med (Fierce)
  • China threatens prison time and death penalty to fight fraudulent trial data (Pharmafile)
  • China loosens grip on clinical trials, improves IP protection to boost innovation (PharmaLetter-$)
  • China regulators formalize procedures for medical device expert panel meetings (MassDevice)


  • India to immunise five million using Pfizer pneumococcal disease vaccine (Pharmafile) (Economic Times)
  • Alembic Pharma's cholesterol drug gets US FDA nod (Economic Times)
  • Malaria to be eliminated from 15 states by 2020: Government (Economic Times)
  • Health ministry plans to cap charges of lab tests & surgeries (PharmaBiz)
  • India makes strategic shift from manufacture of chemicals to biological drugs: Peter Salazar (PharmaBiz)
  • Govt identifies 40 ADR centres to expand PvPI at hospitals for ADR information (PharmaBiz)
  • Seventy pharma units shut down in Telangana with tightened pollution and licensing norms (PharmaBiz)
  • Union govt is likely to bring new law to empower pharmacists to substitute brands with generics versions (PharmaBiz)


  • Advertising cosmetic services that include schedule 4 substances (TGA)
  • Past conference participation by the TGA (TGA)

Other International

  • Cholera strikes Yemen's Sanaa; state of emergency called (Reuters)
  • Venezuela replaces health minister after data shows crisis worsening (Reuters)
  • New Zealand government acts to reduce reimbursement waiting list (PharmaLetter-$)

General Health & Other Interesting Articles

  • How a tiny clinic turned into the biggest US babymaker (Washington Post)
  • Lifetime risk of hand arthritis may be over 40 percent (Reuters)
  • Women using long-acting contraception less likely to use condoms (Reuters)

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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