Regulatory Recon: Merck's Lead Alzheimer's Candidate Fails in Late Stage Study EU Ready for First Cancer Biosimilars (15 February 2017)

Posted 15 February 2017 | By Michael Mezher 

Regulatory Recon: Merck's Lead Alzheimer's Candidate Fails in Late Stage Study EU Ready for First Cancer Biosimilars (15 February 2017)

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

In Focus: US

  • Pharma industry shuns Trump push for radical shift at FDA (Reuters)
  • Panel Foresees Changes at FDA, Action on Drug Prices and Obamacare (GEN)
  • Biotech Execs Bullish About 2017, Fret About Pricing and FDA Under Trump (Endpoints)
  • Uninsured rate hits new low (Politico) (CDC)
  • Merck Alzheimer's Drug Study Halted Early for Futility (The Street) (Endpoints) (WSJ) (Reuters) (Forbes) (Press)
  • Endo, Bayer Secure Win in Testosterone Drug Fight (Bloomberg)
  • CEO Under Fire for $89,000 Drug Has a History of Steep Price Hikes (Bloomberg)               
  • Merck & Co's HIV drug meets Phase III trial endpoint (PharmaLetter-$) (Press)
  • ViiV study shows efficacy of two-drug HIV regimen (PharmaTimes) (PharmaLetter-$)
  • PBMs launch attack on drug companies (BioCentury)
  • Pfizer, GSK targeted for vaccine pricing in MSF Twitter spree (Fierce)
  • FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition (Focus)
  • CDRH and CDER Send Warning Letters to Six Asian Companies (Focus)
  • S&P: Medtech outlook stable, even after downgrades (MassDevice)
  • Medical device's biggest players doled out $895m to docs in 2015 (MassDevice)
  • Integra offers to buy J&J's Codman business for $1.05 billion (Reuters) (MassDevice)
  • Hologic Expands Into Medical Aesthetics With $1.4B Cynosure Deal (Xconomy) (Reuters)
  • Bill & Melinda Gates Outline Successes, Impact of Warren Buffett's $30B Gift to Foundation (KFF) (Gatesnotes)
  • Disabled, Shunned and Silenced in Trump's America (NYTimes)
  • Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike (Focus)
  • Why people should be able to buy drugs approved in other countries (Washington Post)
  • Ex-Medtronic CEO George: Trump's anti-trade talk risks 'crony capitalism' (MassDevice)
  • US science advisers outline path to genetically modified babies (Nature)
  • BIO Statement on National Academies' Consensus Study on Human Gene Editing (BIO)

In Focus: International

  • Europe ready to embrace first copies of biotech cancer drugs (Reuters)
  • CETA: EU parliament backs free trade deal with Canada (BBC) (EP) (EFPIA)
  • EMA Reviews Safety of PAH Medicine Following 5 Deaths in France (Focus)
  • China introducing drug pricing reforms (BioCentury)
  • CFDA Amends Medical Device Recall Rules (Ropes & Gray)
  • Clinical applicability and cost of a 46-gene panel for genomic analysis of solid tumours: Retrospective validation and prospective audit in the UK National Health Service (PLOS)
  • EMA Clarifies Approach to Pharmacovigilance Fees in Revised Q&A Guidance (FDANews-$)
  • Hep C patents challenged in India and Argentina (PharmaLetter-$) (PharmaBiz)
  • NICE rejects Alexion's rare disease therapy Kanuma (PharmaTimes)
  • Six new medicines accepted for NHS use in Scotland (PharmaTimes)
  • Asia Regulatory Roundup: India Asks China to Expedite GMP Inspections (Focus)

US: Pharmaceuticals & Biotechnology

  • Podcast: Former FDA Commissioner On "Smarter Regulation" (Pink Sheet-$)
  • FDA Pulls Truvada from Pediatric Advisory Committee Meeting Agenda (FDA)
  • Field Alert Reports – A Brief Overview (FDA Law Blog)
  • Nativity and ethnicity may influence quality of breast cancer care (Reuters)
  • Barer among investors acquiring NexImmune (BioCentury)
  • Association for Accessible Medicines -  What is This? (Lachman Consultants)
  • AstraZeneca/Chi-Med Set For 'Selective' Pivotal Renal Cell Cancer Trial (SCRIP-$)
  • Ionis gets $75M milestone in Bayer anticoagulant deal (BioCentury)
  • Shire's Sales, R&D Heads Shed Light On The Post-Baxalta Road Ahead (SCRIP-$)
  • If copies of Teva's Copaxone hit, oral MS rivals could be the real threat (Fierce)
  • Defending Sarepta Against Blowback From the Marathon Pharma Steroid Price Gouging Scandal (The Street)
  • Versant's Jecure Therapeutics debuts with a focus on NASH, fibrosis (Fierce)
  • Triple Immunotherapy Combos Enter The Ovarian Cancer Fight (SCRIP-$)
  • How Kaleo Pharma Prices Its EpiPen Competitor (The Street)
  • New cancer drug could give hope to non-responsive patients (Pharmafile)
  • MS Drug Prices Far Exceed Value Thresholds, Even At Current Discounts – ICER Report (Pink Sheet-$)
  • Driving business value from pharmaceutical serialization (EPR)
  • GSK looks for another OTC allergy crossover hit in newly launched Flonase Sensimist (Fierce)
  • MS Patient Treatment Preferences Diverge From Payers, Physicians (Pink Sheet-$)
  • Synergy Rx Pharmacy Issues Voluntary Nationwide Recall of All Lots of HCG (Human Chorionic Gonadotropin)Freeze Dried Vials Due to a Lack of Sterility Assurance (FDA)

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

  • First Patient Enrolled in Novocure's Phase 3 Pivotal LUNAR Trial Testing Tumor Treating Fields for the Treatment of Advanced Non-Small Cell Lung Cancer After Failing Platinum-Based Therapy (Press)
  • Cepheid Announces FDA Clearance Of Xpert® Xpress Flu And Xpert Xpress Flu/RSV (Press)
  • The FDA has Approved Tirosint-SOL, Levothyroxine in Liquid Solution for the American Market, IBSA Patent (Press)
  • Ardelyx Announces Successful Phase 3 Trial of Tenapanor for Hyperphosphatemia in Patients with End-Stage Renal Disease (Press)

US: Medical Devices

  • Are clinical vendor audits important? (MassDevice)
  • Scalp-Cooling Caps Help Prevent Hair Loss in Chemo (NYTimes)
  • FDA Exempts Evoke from Requirement for Human Factor Validation Study (Press)
  • Companies Plan Tests of "Optogenetic Goggles" to Restore Sight (MIT Technology Review)
  • How to Test Materials for Chemical Resistance (MDDI)
  • Starting a Medtech Company? Try Skipping Venture Capital, VCs Say (Xconomy)
  • Medtronic's OsteoCool(TM) RF Ablation System Receives Expanded Indication for Palliative Treatment of Metastatic Bone Tumors (Press)
  • FlowAid Receives FDA US Market Clearance for the FA100 SCCD (Press)

US: Assorted & Government

  • Briefing Complete In Appeal In Amgen V. Apotex (Big Molecule Watch)
  • Shire Development LLC v. Watson Pharmaceuticals Inc. (Fed. Cir. 2017) (Patent Docs)
  • Influence Of GOP Doctors Caucus Grows As Congress Looks To Replace Health Law (KHN)
  • Individual Insurance Primer: Long Troubled Market At Center Of Drive For Repeal (KHN)
  • CMS Issues Proposed Rule for Individual and Small Group Market Stabilization (CMS)
  • Mylan Wins Court Block on Aurobindo's Dye for Cancer Test (Bloomberg)
  • Obamacare significantly expanded insurance for people with HIV (Reuters)
  • Anthem sues Cigna to block deal termination (Reuters)
  • Humana Plans to Pull Out of Obamacare's Insurance Exchanges (NYTimes)
  • Antitrust Rulings Put Chill on Health-Insurance Mergers (WSJ)
  • Cybersecurity: Actions Needed to Strengthen US Capabilities (GAO)
  • Valeant, Ackman agree to split costs in shareholders class action (Drug Delivery)
  • Health Savings Accounts' Dirty Secret And How The GOP Can Fix It (Forbes)

Upcoming Meetings & Events


  • Marketing authorisations granted in January 2017 (MHRA)
  • Parallel import licences granted in January 2017 (MHRA)
  • CBG-MEB to Release Notifications of Medicine Shortages and Defects in English (CBG-MEB)
  • Novasep's €27m viral vector plant to create up to 100 Belgian jobs (BioPharmaReporter)
  • 100-plus companies link to Germany's securPharm (Securing Industry)
  • Actelion reports income, revenue growth in FY2016 (Drug Delivery)


  • China bird flu deaths surge in what could be the worst season ever (Reuters)


  • Sun Pharma's R&D focus a good sign (Economic Times)
  • Dr Reddy's, Aurobindo recall drugs from US market (Economic Times)
  • Gujarat records more than 10 % increase in WHO-GMP units last year (PharmaBiz)
  • Indian & MNC pharma cos scout for qualified pharmacy graduates & post graduates to work in regulatory depts (PharmaBiz)
  • AiMeD wants govt to mandate 'Buy in India' for devices with 50 % price benefit for Indian products (PharmaBiz)
  • Heart of the matter: Coronary stents get cheaper by up to 85% (Economic Times)


  • Consultation: Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS) (TGA)
  • Bill to cut red tape for new meds in Australia stalled by delay (PharmaLetter-$)

Other International

  • Yellow fever vaccination recommendations for International Travelers related to current situation in Brazil (WHO)

General Health & Other Interesting Articles

  • Int'l Experts Call Sodium Guidelines Far Too Restrictive (Medpage)

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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