Regulatory Recon: FDA Approves Takeda's Alunbrig as Second Line Lung Cancer Treatment Neurotrope Alzheimer's Drug Data Disappoints (1 May 2017)

Posted 01 May 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Takeda's Alunbrig as Second Line Lung Cancer Treatment Neurotrope Alzheimer's Drug Data Disappoints (1 May 2017)

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

In Focus: US

  • White House wants Obamacare vote this week (Politico) (Reuters) (NYTimes)
  • Kaiser Health Tracking Poll - Late April 2017: The Future of the ACA and Health Care & the Budget (KFF)
  • Government Spending Bill Would Boost FDA Funds by Almost $40M (Focus) (Science)
  • FDA approves Takeda's lung cancer drug as second-line treatment (Reuters) (Endpoints) (MedPage) (Press)
  • FDA approves Radius Health's osteoporosis drug Tymlos (Reuters)
  • Most Americans still want Washington to do something about drug costs (STAT)
  • Your guide to a (relatively) big week for biotech IPOs (STAT)
  • Neurotrope Alzheimer's drug data fails to impress; shares plunge (Reuters) (Fierce)
  • Trial of Transplantation of HCV-Infected Kidneys into Uninfected Recipients (NEJM)
  • Those TV Drug Ads Distract Us From The Medical Care We Need (NPR)
  • Hitting a Medical Wall, and Turning to Unproven Treatments (NYTimes)
  • Should the U.S. Import Drugs to Drive Down Costs? (NYTimes)
  • Cancer pill costs soar as drug companies retain pricing power (Financial Times)
  • Biotech and big pharma reap rewards from partnerships (Financial Times)
  • 6 FDA Events to Watch Out for in May 2017 (Yahoo)
  • Quest Diagnostics to Pay $6 Million to Settle Allegations of Kickbacks and Unnecessary Testing (DoJ)

In Focus: International

  • China Pushes Ahead With Human Gene-Editing Trials (WSJ)
  • Decision on EU agencies’ relocation from UK likely in October (Politico)
  • EMA Plots Workload Shift Ahead of UK Experts' Departures in 2019 (Focus)
  • Mexican Congress approves use of medical marijuana (Reuters)
  • Reform of the Orphan Drug Program - Transition arrangements (TGA)
  • Global medical-tech firms, India locked in tussle after stent price sting (Economic Times)
  • Canada Introduces World First 48-Hour Reporting Requirement (Pink Sheet-$)
  • EMA And Brexit: Rental Liabilities Could Add €350m To Relocation Costs (Pink Sheet-$)
  • Will UK's Unloved Cancer Drugs Fund Become An Election Issue? (Pink Sheet-$)
  • New Sanitary Licensing Regulations for Brazilian Companies in Effect (Emergo)

US: Pharmaceuticals & Biotechnology

  • Waiting and watching with ‘Stage 0’ breast cancer put to nationwide test (Washington Post)
  • A biotech billionaire tops the list of the 15 highest paid R&D execs in biopharma (Endpoints)
  • Zika virus persists in the central nervous system and lymph nodes of Rhesus monkeys (NIH)
  • FDA Issues Form 483 for Lupin's Goa Facility (Focus)
  • S. yellow fever vaccine supply will be gone by this summer, but CDC has a plan (Washington Post)
  • Ex-Merck R&D exec Robert Plenge jumps ship to Celgene (Fierce)
  • FDA Wants More Safety Info on Psych Drug, Intra-Cellular Shares Drop (Xconomy) (Endpoints)
  • Death Rate For Opioid Addicts 10 Times Higher In General Healthcare Settings (Forbes)
  • 21st Century Cures: The future of product innovation and approval (Pink Sheet-$)
  • FDA GMP Warning Letters Review: Compounding Pharmacies Drew The Most Letters In 2016 (Pink Sheet-$)
  • NIH Study Aims To Unravel The Illness Known As 'Chronic Fatigue Syndrome' (NPR)
  • Malaria, wiped out in U.S., still plagues American travelers (Reuters)

US: Clinical Study Results, Filings & Designations

  • Atlantic starts rolling FDA submission for antisense drug (Fierce)
  • Medeor gets FDA OK to trial therapy that aims to do away with transplant drug (Fierce)
  • FDA Again Reviewing Kevzara (BioCentury) (Press)
  • Revance Provides Update on Phase 2 Program for RT002 Injectable in the Management of Plantar Fasciitis (Press)
  • Aeterna Zentaris Announces that ZoptEC Phase 3 Clinical Study of Zoptrex™ Did Not Achieve its Primary Endpoint (Press)
  • Kala Pharmaceuticals Announces Positive Results from Confirmatory Phase 3 Trial of KPI-121 1% Following Cataract Surgery (Press)

US: Medical Devices

  • FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD(TM) System Controllers and DC Adapters as Class I Recall (FDA)
  • Software Predicts Cognitive Decline Using Brain Images (MIT Technology Review)
  • Titan Medical spikes talks with Chinese distributor (MassDevice)
  • Quest Diagnostics CIO Harnesses Insights And Technology For Better Healthcare Results (Forbes)
  • 2017 Medical Design Excellence Awards Finalists: Vote for Your Favorite (MDDI)
  • Report: NAFTA renegotiations could spell trouble for US medtech industry (MassDevice)
  • Home blood pressure monitors may not be accurate enough (Reuters)
  • Allergan closes $2.48B Zeltiq acquisition (Drug Delivery) (Press)
  • FDA clears Roche high-volume immunoassay lab testing solution to support critical medical treatment decisions (Press)
  • TransEnterix files FDA 510(k) application for Senhance, prices $24.9m round (MassDevice)
  • Medtronic wins FDA nod for Resolute Onyx drug-eluting stent (Drug Delivery) (Press)
  • Artificial pancreas shows promise in pediatric study (Drug Delivery)

US: Assorted & Government

  • Feud erupted between CDC, Puerto Rico over reporting of Zika cases, document shows (STAT)
  • Trump appoints antiabortion champion to HHS post (Washington Post) (STAT)
  • The Other Supreme Court 4/25 Personal Jurisdiction Argument (Drug & Device Law)
  • Johnson & Johnson loses $20m verdict in 3rd pelvic mesh bellwether (MassDevice)
  • Florida Deal Would Reverse Key Part of Obama’s Medicaid Expansion (NYTimes)
  • With Obamacare in doubt, California asks insurers to double up on rate filings (Reuters)
  • Anthem-Cigna Deal Likely Dead After Appeals Court Rejection (Forbes) (MedCityNews)

Upcoming Meetings & Events


  • European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for Squamous Cell Cancer of the Head and Neck in Adults Progressing On or After Platinum-based Therapy (Press)
  • ‘Long-awaited’ NICE nod for Iclusig in England (PharmaLetter-$)
  • WP4 AC-B CA3 on "Antibacterial-coated Sutures Versus Non-Antibacterial-Coated Sutures for the Prevention of Abdominal, Superficial and Deep Incisional, Surgical Site Infection (SSI)" is now available. (EUnetHTA)


  • Daiichi Sankyo pumping $135m into antibody-drug conjugate production (BioPharmaReporter)
  • Venus Medtech wins Chinese FDA approval for Venus A-valve TAVR (MassDevice)


  • Doctors fear pharmacists will push for generic drugs that give max profit (Economic Times)
  • Branded drugs need to be phased out: Doctors' groups (Economic Times)
  • Stent makers want government to apply differential pricing for Drug-eluting stents (Economic Times)
  • Dr Reddy's gets 11 observations from USFDA for Hyderabad plant (Economic Times)
  • Cipla plea in High Court against change in price of asthma drugs (Economic Times)


  • Notice: Release of the Final Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements (Health Canada)


  • Medical Devices Safety Update, Volume 5, Number 3, May 2017 (TGA)
  • Hyland's Baby homeopathic teething tablets (TGA)

Other International

  • Is active surveillance safe for men with family history of prostate cancer? (Reuters)
  • Pharmaceutical employees arrested for illegally obtaining LE9 million in medicines (Egypt Independent)

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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