Regulatory Recon: Cures Bill a Top Priority for Lame-Duck Period Two Died in Boehringer Trial (30 September 2016)

Posted 30 September 2016 | By Zachary Brennan 

Regulatory Recon: Cures Bill a Top Priority for Lame-Duck Period Two Died in Boehringer Trial (30 September 2016)

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

In Focus: US                                      

  • FDA Acknowledges Decrease in Rx Promotion Violation Letters (BNA)
  • ICER Releases Evidence Report on Treatments for Non-Small Cell Lung Cancer (ICER)
  • ICER Releases Draft Evidence Report on Treatments for Plaque Psoriasis (ICER)
  • McConnell: Cures bill a 'top priority' in lame-duck (The Hill) (WSJ-$)
  • The man behind the curtain in drug price increases (The Hill)
  • ‘They killed her’: A potent painkiller — and a company’s drive to sell it — are faulted in a young woman’s death (Stat)
  • Biologists plan scoring system for antibodies (Nature News) (Nature Methods)
  • GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info (Focus)
  • PRV Fees to Decline in FY 2017 (Focus)
  • Are Golden Tickets That Speed Drugs Through FDA Worthwhile? (NPR)
  • Zika-related birth defects likely higher than anticipated: panel (Reuters)

In Focus: International

  • Boehringer Ingelheim returns development and commercial rights of olmutinib to Hanmi Pharmaceutical (Press) (Korea Herald) (Endpoints)
  • €10.2 billion lost every year across the EU due to fake medicines (Pharmafile)
  • Shelf life after opening to be listed on packaging of over-the-counter medicinal products in Netherlands (MEB)
  • Six candidates compete in WHO Director-General election (Lancet)
  • GE opens Korean tech training center (BioPharma-Reporter)
  • Becton Dickinson invests $40m in Irish plant expansion (Mass Device)
  • NICE rejects Lilly lung cancer drug, recommends Bayer’s Xofigo and Amgen’s Imlygic (Pharmafile)
  • UK bioethicists eye designer babies and CRISPR cows (Nature News)
  • Experts warn home 'gene editing' kits pose risk to society (Guardian) (Report)
  • Merck Congratulates Guatemala as Fourth Country in Latin America to Achieve WHO Verification of Elimination of River Blindness (Press)
  • Pregnant Women Should Consider Not Traveling To Southeast Asia (NPR) (New York Times)

US: Pharmaceuticals and Biotechnology

  • Cathepsin K: A Promising Target Fades Out (In the Pipeline)
  • Aligned With Roche, SQZ Bio Gets $16M to Push Cell Therapies to Clinic (Xconomy)
  • Swiss biotech giant to more than double footprint in Houston suburb (Houston Business Journal)
  • The Eteplirsen Approval: Former FDA Officials Weigh In On The Science (Pink Sheet-$)
  • Another Blow to the Discount Safe Harbor in Massachusetts District Court (FDA Law Blog)
  • Pharma’s response to viral threats and the trial landscape of Ebola, MERS, SARS, and Zika vaccines (Citeline)
  • Boehringer and Sarah Cannon team for immune-oncology venture (PharmaPhorum)
  • Former Puma Biotechnology exec is accused of making $1.2 million from insider trading (LA Times) (Focus)
  • Genentech to Develop Hanmi Cancer Candidate HM95573 (GEN) (PharmaTimes)
  • ImmunoGen Eliminates 17% of Workforce After Strategic Review (Press) (Boston Globe)
  • Novartis says migraine prevention drug clears phase III trial (PMLive)
  • Speed Is Everything In CGRP Race As Amgen/Novartis Reveal Phase III Data (Scrip-$)
  • Professor David Goldstein appointed as chief adviser for AstraZeneca’s genomics initiative (Press)
  • A Vision for 3D Printing in Pharma Manufacturing (PharmaTech)
  • Biotech Stock Mailbag: Dynavax, Puma, Ariad (TheStreet)
  • Charles River Acquisition of Agilux for $64M (Fierce)
  • Teva Announces Launch of Generic Epzicom Tablets in the US (Press)
  • Kite Pharma Names Christine Cassiano as Senior Vice President of Corporate Communications and Investor Relations (Press)

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

  • Regeneron: Phase 2 Study of Aflibercept and Rinucumab (anti-PDGFR-beta) Shows No Benefit Over Aflibercept Alone in Neovascular Age-Related Macular Degeneration (Press) (Reuters) (Endpoints)
  • Esmo preview – Novel checkpoints add to the Parp showdown (EP Vantage)
  • UCSF scientist rolls out a new blueprint for programming T cells, the 2.0 way (Endpoints)
  • Memorial Sloan Kettering Researchers Engineer “Micro-Pharmacies” in CAR T Cells to Treat B Cell Lymphomas (Press)

Medical Devices

  • US FDA Lists Reimbursers Interested in Attending Pre-Sub Meetings for Medical Devices (Emergo)
  • Boston Scientific lands $71m Defense Dept. contract (Mass Device)
  • Medtronic issues urgent field safety notice for select ICDs, CRTds (Mass Device)
  • DePuy Synthes recalls select medical power tool battery packs over explosion risk (Mass Device)

US: Assorted and Government

  • Murray, Alexander Committed to Getting a Result This Year on Legislation to Drive Medical Innovation, Support Precision Medicine and Cancer Moonshot (Press)
  • Federal Right to Try Bill Blocked in Senate (Stat)
  • GHTC Letter to OMB on Budget (GHTC)
  • Form 483 for Option Care (FDA)
  • Feds slam Mylan for misclassifying EpiPen, with ‘financial consequences’ to Medicaid (Stat)

Upcoming Meetings and Events             



  • Chiesi submits MAA in Europe for triple combo inhaler (PharmaLetter-$)
  • Cancer Research UK, MSD and Verastem Collaborate to Trial New Combination of Immunotherapy Drugs (Press)

General Health and Other Interesting Articles

  • When a Nobel Prize brings a shower of hype: the roller coaster ride of RNAi (Stat)
  • What's The Prognosis For $3 Billion Zuckerberg Health Plan? (NPR)
  • Reproducibility: Seek out stronger science (Nature)
  • CDC Urges Americans To Get A Flu Shot As Soon As Possible (NPR)
  • Prostate cancer treatment needs to get more personalized (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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