Regulatory Focus™ > News Articles > Regulatory Recon: Gilead Prices Sovaldi in China at One Fifth US Cost; NICE Turns Down Early Use of

Regulatory Recon: Gilead Prices Sovaldi in China at One Fifth US Cost NICE Turns Down Early Use of Eisai's Halaven (28 November 2017)

Posted 28 November 2017 | By Michael Mezher 

Regulatory Recon: Gilead Prices Sovaldi in China at One Fifth US Cost NICE Turns Down Early Use of Eisai's Halaven (28 November 2017)

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

In Focus: US

  • Where the tax battle stands (Politico)
  • Drugmakers Hold Key to Puerto Rico's Future in Tax Overhaul (Bloomberg)
  • 7 questions for Alex Azar, Trump's health secretary nominee (STAT)
  • Express Scripts To Sell Drug Support Unit As PBM Industry Shifts Focus (Forbes)
  • Pfizer, Merck KGaA hit setback as Bavencio fails in PhIII gastric cancer study (Endpoints) (Reuters)
  • FDA Updates Orange Book With Patent Submission Dates (Focus) (FDA Law Blog)
  • FDA Issues Delayed DSCSA Grandfathering Guidance (Focus)
  • Pharma's contentious inter partes reviews come under Supreme Court scrutiny (Fierce) (Pink Sheet-$) (FDANews-$) (CNBC)
  • Pharma's broken business model: An industry on the brink of terminal decline (Endpoints) (In the Pipeline)
  • Priority Review Voucher Sales Prices Level Off In 2017 (Pink Sheet-$) (Endpoints)
  • FDA Boss Aims To Close EpiPen Loophole (Forbes) (CNBC)
  • Fresenius Kabi to invest $100M, add 445 jobs in North Carolina as US investments now top $5B (Fierce)
  • Lucentis biosimilar: Formycon eyes 2020 for US launch (BioPharmaReporter)
  • Heated And Deep-Pocketed Battle Erupts Over 340B Drug Discount Program (KHN)
  • How Opioids Started Killing Americans (Bloomberg)
  • 'Seminal' Allergan Cases Test Copycat Drug Limits (Law360-$)

RAPS Book Release: Fundamentals of EU Regulatory Affairs, Eighth Edition

  • Get the new, updated ultimate reference guide which includes the latest information on the new Medical Device and In Vitro Device Regulations, developments in implementation of the Clinical Trial Regulation and a number of new topics.
  • Learn more and shop now.

In Focus: International

  • NICE turns down earlier use of Eisai's Halaven (PharmaTimes)
  • Gilead prices hepatitis C giant Sovaldi in China at one-fifth the US price (Fierce)
  • UK gives Pfizer world's first over-the-counter Viagra approval (Reuters) (MHRA)
  • J&J Cold Feet Rumors About UK Innovation Site 'Unsubstantiated' (SCRIP-$)
  • Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate (Reuters) (Press)
  • Founder of Germany's failed Schlecker drugstores convicted, children jailed (Reuters)
  • Europe's HIV epidemic growing at alarming rate, WHO warns (Reuters)
  • British, Australian Regulators Recommends Vaginal Mesh Ban (MassDevice) (TGA)
  • European NBOG Designation Codes for Notified Bodies Officially Released (Emergo)
  • Report highlights pharma's key role in Scotland's economy (EPR) (ABPI) (Report)
  • Why this white paper on industrial strategy is good news (mostly) (The Guardian)
  • Industrial strategy is welcome, but good intentions are never enough (The Guardian)
  • Regulatory actions won't stop growth of emerging markets, says Sanofi EVP (Economic Times)
  • ViiV trials long-acting, two-drug HIV regimen (PharmaTimes)
  • Trio, including former Novartis exec, accused of bribery to the tune of over HK$1.5 million (Pharmafile)

Pharmaceuticals & Biotechnology

  • Viking hits primary endpoint in phase 2 hip fracture trial (Fierce)
  • Stakeholders Weigh FDA Proposal to Limit Risk Info in DTC Advertisements (Focus)
  • FDA Warns, Blocks Imports From Chinese API Manufacturer (Focus)
  • Administering the Hatch-Waxman Amendments: Industry, Academics and Senator Discuss Balance (Focus)
  • Full Implementation and Enforcement of Drug Compounding Law Will Save Lives (Pew)
  • A Q&A With a Survivor of Contaminated Compounded Drugs (Pew)
  • Final Guidance on Abuse-Deterrent Opioid Generic Drug Testing Arrives – High Burden of Proof! (Lachman Consultants)
  • After building a rep as an architect of experiments, RxCelerate plants its flag in America (Endpoints)
  • Bristol-Myers Squibb Awards "Golden Tickets" for LabCentral to Neutrolis, Remora Therapeutics (Press)
  • Biologics Industry Must Embrace Innovative Manufacturing Strategies to Keep Pace with a Changing Marketplace (Tufts)
  • Leveraging Platform Analytical Methods for Biopharma QbD (PharmaceuticalManufacturing)
  • Add Boehringer Ingelheim to HitGen's drug discovery collaboration list (Fierce)
  • UCL, Synpromics ally to develop Parkinson's gene therapy (Fierce)
  • Recipharm equips a further three facilities for US serialization (Pharmafile)
  • Compendium, compendia, compendial: Clearing up the mystery of these terms (USP)
  • FDA Cites Sterile Drugmaker Over Sanitation, Complaints and Product Discrepancies (FDANews-$)
  • RA backs Medeor's $57M round as researchers fast forward to PhIII (Endpoints)
  • Strike two: Auris shares crushed again as its second PhIII program fails to deliver (Endpoints) (Fierce)
  • As Advair struggles, GlaxoSmithKline seeks expanded label for blockbuster-to-be Trelegy (Fierce)
  • Novartis looks to poach Advair patients with positive Ultibro switching data (Fierce) (PharmaLetter)
  • Which trends will impact pharma marketers in 2018? InVentiv has a few ideas (Fierce)
  • Synthetic biology pioneer Synthorx recruits Cleave's Laura Shawver for top position (Endpoints)
  • Cryo-electron microscopy makes waves in pharma labs (Nature)
  • Cancer immunotherapy: Rewiring cancer cells (Nature)
  • Polypharmacology: Repurposing ceritinib (Nature)
  • Infectious disease: Fighting influenza B (Nature)
  • The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication (FDA)
  • Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority Review Designation of Mogamulizumab's Biologics License Application (Press)
  • Egalet Announces Positive Top-Line Results from Phase 3 Study Evaluating Efficacy and Safety of Egalet-002 in Patients with Moderate-to-Severe Chronic Low Back Pain (Press)
  • European Medicines Agency Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma (Press)
  • Enrollment Completed in Flex Pharma's Phase 2 Exploratory Spasticity Study in MS (Press)
  • Eyeing Phase 2 Study of CNS Drug, Promentis CEO Plots Path Forward (Xconomy)
  • Emmaus Life Sciences, Inc. to Present Results of Phase 3 Study of EndariTM (L-glutamine oral powder) at 59th American Society of Hematology Annual Meeting (Press)

Medical Devices

  • Pediatric Information for X-Ray Imaging Device Premarket Notifications (FDA)
  • What Are Your Medtech Career Questions? (MDDI)
  • What You Need to Know About the Internet of Things and Medical Devices (MDDI)
  • Can Mobile Scanners Expand Access to Ultrasound? (MDDI)
  • Repro-Med clears FDA warning letter, shuffles C-suite (Drug Delivery)
  • Siemens Healthineers, Materialise ink 3D printing deal (MassDevice)
  • Philips snaps up imaging workflow provider Analytical Informatics (MassDevice)
  • Philips is expanding its radiology offerings: Here's how (Medical Design & Outsourcing)
  • Hologic wins FDA 510k for Quantra 2.2, inks dev & distro deal with Clarius (MassDevice)
  • Masimo wins FDA nod for NomoLine capnography sampling lines (MassDevice)
  • Apollo Endosurgery Receives FDA Clearance for OverStitch Sx Endoscopic Suturing System (Press)
  • PAVmed Files 510(k) Submission with FDA for CarpX Device to Treat Carpal Tunnel Syndrome (Press)

US: Assorted & Government

  • Combined Effect of Tax Bill Sequestration and MIPS Payment Adjustments on Part B Drug Reimbursement (ADVI)
  • BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information (BIO)
  • Challenge to Original FDA Approved Warning Preempted (Drug & Device Law)
  • Pfizer Reaches $94M Settlement Over Celebrex Claims (Law360-$)
  • DOJ Closes J&J Witness Tampering Investigation (Law360-$)
  • Justices Decline To Review Removal Of Vascular Filter Suits (Law360-$)
  • Pfizer Wants Justices To Review Lipitor Antitrust Ruling (Law360-$)
  • Food Safety: FDA Continues to Evaluate and Respond to Business Concerns about the Produce Rule (GAO)

Upcoming Meetings & Events

Europe

  • Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017 (EMA)
  • Ferring's Rekovelle receives Swiss approval (PharmaLetter)
  • New rules on blood donation come into force (UK DoH)
  • HPRA states almost 600 life-saving defibrillators across 5 brands require urgent updates. (HPRA)
  • Spain reports atypical mad cow disease on farm: OIE (Reuters)
  • UK's National Health Service to tap "ethical hackers" in $27m cybersecurity push (MassDevice)
  • Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (EMA)
  • Guideline on the assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products (EMA)

Asia

  • AstraZeneca seeks to extend label for Tagrisso in Japan (PharmaLetter-$)
  • Kyowa Hakko Kirin to market tenapanor for cardiorenal diseases in Japan (PharmaLetter-$)
  • MSD and Astellas conclude co-promotion deal in Japan for type 2 diabetes combo drug (PharmaLetter-$)

India

  • How India can make cheap and quality medicines available to all (Economic Times)
  • Indian Pharma run rate slows down in Q2 2018 (BioSpectrum)
  • NPPA guidelines for examination of cases of launch of new drugs by cos without obtaining prior price approval (PharmaBiz)
  • US FDA inspection lands Glenmark with 483 with seven observations (InPharma) (Economic Times)

Australia

  • Australian State & Territory variations from Part 4 of the Poisons Standard (TGA)

Canada

  • Notice: Guidance on the Use of a Foreign-sourced Reference Product as a Canadian Reference Product (Health Canada)
  • Notice - Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format (Health Canada)

Other International

  • Madagascar's plague epidemic is slowing, but we must sustain the response (WHO)
  • WHO delivers medicines as diphtheria spreads in Yemen (WHO)
  • Research misconduct is common among Middle East scientists, survey says (C&EN)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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