Regulatory Recon: Pfizer to Sell NYC Headquarters and Infusion Business 25% of EU Patients with Advanced Melanoma Lack Access to New Drugs (7 October 2016)

Posted 07 October 2016 | By Zachary Brennan 

Regulatory Recon: Pfizer to Sell NYC Headquarters and Infusion Business 25% of EU Patients with Advanced Melanoma Lack Access to New Drugs (7 October 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US

  • Whether it’s Trump or Clinton, biotech is in for ‘a moment of change’ (Stat)
  • Pfizer to sell infusion business to ICU Medical for $1B, take stake (Reuters) (Law360-$) (PharmaTimes)
  • Pfizer to Sell New York City Headquarters By End of Next Year (WSJ-$) (Reuters)
  • Inflectra Launch Prep Continues Post-Deadline, Pfizer Says (Pink Sheet-$)
  • Medical Device User Fee Amendments; Public Meeting; Request for Comments (FDA)
  • Exclusive: U.S. lawmakers to investigate funding of WHO cancer agency (Reuters)
  • Novartis to pay $35 million to settle charges of illegally promoting a drug for infants (Stat)
  • Ending Obama plan to overhaul Medicare Part B would cost $395 million (Stat)
  • Alphabet’s Latest Project Is Birth Control for Mosquitoes (MIT Tech Review) (FastCompany)
  • How Ariad Pharma Used a Safety Problem to Jack Up a Cancer Drug's Price (TheStreet)
  • FDA Final Rule on Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (FDA)

In Focus: International

  • NICE recommends AZ’s Forxiga in triple therapy (PharmaPhorum)
  • Thousands of European melanoma patients lack access to new drugs (Reuters)
  • European biopharma funding is down 43% so far this year (BioWorld)
  • Could Gilead face early Sovaldi generics in Europe? (PMLive)
  • India’s Drug Regulator May Scrap Need to Renew Licenses and Approval (Economic Times)
  • APIC Concerned About API Import Rules (InPharma-Technologist)
  • Patient Safety: Single European Code and EU Web Platform improve traceability of donated tissue and cells (EC)
  • Foreign and domestic drugmakers oppose new rules for drug labeling in Russia (PharmaLetter-$)
  • South Africa plans health study to track half a million people (Nature News)
  • Venezuela doctors sound alarm on reported return of diphtheria (Reuters)
  • Mexican authorities report cases of Zika linked Guillain-Barre syndrome (Reuters)

US: Pharmaceuticals & Biotechnology

  • As a stealthy liver disease becomes more common, the search for treatments accelerates (Stat)
  • AstraZeneca to divest certain Rhinocort Aqua rights to Johnson & Johnson unit for $330 million (FirstWord Pharma)
  • Bill Gates on What Life Sci Innovations Governments Should Invest in (Gates)
  • Single Use Tech and the Bio-CMO Space (BioPharma-Reporter)
  • Pfizer Wins Dismissal Of Zoloft Developmental Delay Suit (Law360-$)
  • Guidance on Insanitary Conditions at Compounding Facilities Gets Mixed Reviews (FDANews-$) (BIO)
  • Astellas Filed Lawsuit against Patent Infringement of Myrbetriq in the United States (Press)
  • Families Blast GSK's New Zofran Label Submission In MDL (Law360-$)
  • Indiana Biosciences Research Institute Hires Chief Scientific Officer (Xconomy)
  • Seattle Genetics on a building, hiring frenzy (BioPharmaDive)
  • An unlikely trio award $75M to battle heart disease, set new research paradigm (MedCity News)
  • Report: Drug device market to reach $1.8B by 2024 (Drug Delivery)
  • Beyond Imatinib: Expert Explores Next Frontier in GIST (OncLive)
  • Daratumumab Combo Data Published as FDA Considers New Myeloma Indication (OncLive)

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

  • Immunotherapy Trials Score Poorly in Adverse Event Reporting, According to Study (FDANews-$)
  • LDL-Lowering Genetic Variants Linked to Diabetes Risk (CardioBrief)
  • Doctors warn of dangers of complementary medicine for children (BMJ)
  • J&J Drug Outperformed Humira (Big Molecule Watch Blog)
  • No Benefit Observed From Combined Irradiation in Intermediate-Risk Prostate Cancer (OncLive)
  • Additional Phase 1 Data from ECHO-202 Reinforce Durability of Response in Patients with Treatment-naive Advanced or Metastatic Melanoma Treated with Epacadostat in Combination with Keytruda (Press)
  • Exelixis Announces Phase 1 Trial Results for Cabozantinib in Combination with Nivolumab in Advanced Genitourinary Tumors (Press)

US: Medical Devices

  • Theranos: Implosion Of A Unicorn (Forbes Video)
  • Minn. Supreme Court to hear investors suit over Medtronic inversion (Mass Device)
  • BTG’s U.S. Biocompatibles business to pay $36m to settle Justice Dept. beef (Mass Device)
  • Eccrine Systems raises $6m for sweat-sensing wearable (Mass Device)
  • St. Jude Neurostimulation Products Get US Thumbs Up (MedTech Insight)
  • Clinical Corner: New Data From Xeltis Bioabsorbable Heart Repair Devices Headlines Trial News (MedTech Insight)

US: Assorted & Government

  • Wyden, Pallone Confirm EpiPen Makers Overcharged Medicaid for Two Decades (Senate Committee on Finance)
  • EpiPen Price Increases: How Regulatory Barriers Inhibit Pharmaceutical Competition (Senate HELP)
  • CDC funds 34 innovative projects to combat antibiotic resistance (CDC)
  • BARDA Awards $37.6 million Contract to Sanofi to Supply Leukine (sargramostim) for Potential Public Health Emergency (Press)
  • DOJ Pummels Medical Supplier's Kickback Defenses (Law360-$)

Upcoming Meetings & Events


  • Brexit government’s anti-immigration stance spooks UK scientists (Nature News)
  • Genfit sinks after raising EUR 33.9M (BioCentury)
  • Ra Medical wins dual CE Marks for atherectomy catheter, dermal excimer laser (Mass Device)
  • The ethics of genome editing - what does it mean for the pharmaceutical industry? (ABPI)
  • EFPIA Statement on the ENVI Committee’s Draft Report on EU Options for Improving Access to Medicines (Press)
  • Dodgy dental equipment could come back to bite you (MHRA)
  • GSK partner shows progress in cancer epigenetics (PharmPhorum)


  • Essential drugs can't be stopped suddenly (Times of India)
  • Indian pharma to become a $55 billion market by 2020: IBEF (MoneyControl)


  • Got Zika? For Pregnant Women, Lab Constraints Mean It’s Often Hard To Know (Kaiser Health News)

General Health & Other Interesting Articles

  • As DNA reveals its secrets, scientists are assembling a new picture of humanity (Stat)
  • Do You Need Extra Screening For Breast Cancer? The Picture Is Blurry (NPR)
  • For cancer patients, newest treatments force the ultimate decision, with no room for error (Stat)
  • Robot surgeons and artificial life: the promise of tiny machines (BBC News)

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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