Regulatory Focus™ > News Articles > Regulatory Recon: FDA Warns of Liver Risk with AbbVie Hep C Drugs (23 October 2015)

Regulatory Recon: FDA Warns of Liver Risk with AbbVie Hep C Drugs (23 October 2015)

Posted 23 October 2015 | By Michael Mezher 

Regulatory Recon: FDA Warns of Liver Risk with AbbVie Hep C Drugs (23 October 2015)

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

In Focus: US

  • Rx Price Debate Could Kill Senate FDA-Reform Legislation (InsideHealthPolicy)
  • FDA warns of serious liver injury risk with AbbVie hep C drugs (Reuters) (WSJ-$) (Washington Post) (FDA)
  • Spectrum says FDA declines to approve Evomela for injection (Press) (Reuters)
  • FDA clears Merrimack's pancreatic cancer drug with warning (Reuters) (FDA) (SCRIP-$) (Press)
  • Theranos heavily rebuts the WSJ – but do we buy it? (MedCityNews) (Theranos)
  • Roche's Kadcyla Fails Phase II/III Trial for Gastric Cancer (GEN) (PMLive) (Roche)
  • FDA approves new therapy for certain types of advanced soft tissue sarcoma (FDA)

In Focus: International

  • UK and China start global fund to tackle drug resistant infections (GOV.UK)
  • Fighting Poor Quality Medicines in Guatemala (USP)
  • Amgen wins EU green light for first virus-based cancer drug (Reuters) (EMA)
  • IP Australia consults on High Court decision (PharmaLetter-$) (National Law Review)
  • CFDA Minister Bi Jingquan meets CEO of the Bill & Melinda Gates Foundation (CFDA)

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  • Incorporate current FDA thinking and data into the regulatory strategy

US: Pharmaceuticals and Biotechnology

  • How We Can Get New Antibiotics to Patients With Resistant Infections (Pew)
  • When Antibiotics Fail (Pew)
  • Priority Review Voucher Plan's Looming Sunset Shouldn't Dissuade Sponsors – FDA (Pink Sheet-$)
  • Antibiotic resistance breakers: can repurposed drugs fill the antibiotic discovery void? (Nature-$)
  • FDA Asks for Drug Interaction Studies on Kayexalate (MedScape) (FDA)
  • Cyber security in pharmaceuticals (EuropeanPharmaceuticalReview)
  • Industry Weighs in on Improving Inactive Ingredient Database (FDANews-$)
  • GSK to profile new class of antibiotic at Nov. 3 investor day (Reuters)
  • How Generic Drugs Can Cost Small Pharmacies Big Bucks (NPR)
  • Lilly CEO Lechleiter On Drug Pricing: ''The Facts Tell Us A Different Story'' (SCRIP-$)
  • How to decide if a cancer drug is worth the cost NCCN’s Carlson explains (Pharmalot)
  • Animal Experiments Don't Use Safeguards Against Bias, Says Study (DD&D) (PLoS)
  • Martin Shkreli may get competition for his pricey drug, after all (BioCentury) (Pharmalot) (CBS)
  • Doctors, Not Parents, Are The Biggest Obstacle To The HPV Vaccine (NPR)

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

  • Zafgen closes beloranib trials (BioCentury) (FierceBiotech) (Press)
  • ADHD generic receives US FDA approval (GaBI)
  • FDA Approves Post-Gemcitabine Therapy For Patients With Metastatic Pancreatic Cancer (Press)
  • Ipsen Presents Additional Results from a Phase III Clinical Trial of the Investigational Use of Dysport® in Children with Spastic Equinus Foot Deformity Due to Cerebral Palsy (Press)
  • Ocular TherapeutixTM Reports on Topline Results of Phase 2b Glaucoma Clinical Trial (Press)
  • Ocular Therapeutix™ Announces Topline Results of Phase 3 Clinical Trial for DEXTENZA™ for the Treatment of Allergic Conjunctivitis (Press)
  • Iroko Pharmaceuticals Receives FDA Approval for VIVLODEX™ - First Low Dose SoluMatrix® Meloxicam for Osteoarthritis Pain (Press)

US: Medical Devices

  • Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable (FDA)
  • Elbit Imaging Ltd. Announces That Insightec Has Submited Pre Market Application (PMA) for FDA Approval of Exablate Neuro for Treatment of Essential Tremor (Press)
  • Regulatory Divisions Pressured by More Demands and Cost Cuts (MDDI)
  • Insightec files PMA for Exablate Neuro (MassDevice)
  • Edwards SAPIEN XT Heart Valve Now FDA Approved for Valve-in-Valve Procedures (medGadget)
  • Transcend Medical finalizes PMA bid for CyPass glaucoma stent (MassDevice)
  • Shining Light on Ebola Virus for Faster Diagnosis (NIH)

US: Assorted and Government

  • 'What Else Don't We Know?' May Spread Beyond Valeant (SCRIP-$)
  • FDA Approved 'Sham' Label For Cancer Drug, DC Circ. Told (Law360-$)
  • 8 Regulatory Considerations For Digital Health Care Cos. (Law360-$)
  • How Much Do Boston-Area Pharma Companies Spend on R&D? (BioSpace)
  • Biosimilars substitution bill become law in California (GaBI)
  • SEC closes InVivo Therapeutics probe (MassDevice)
  • DEA Considering Rulemaking on Suspicious Order Reporting (FDA Law Blog)
  • Valeant faces PhRMA attack, will discuss fraud allegation (BioCentury) (PhRMA)
  • Oregon Sues GNC, Alleging Supplements Contained Illegal Ingredients (WSJ-$)

Upcoming Meetings and Events              


  • EMA to Drugmakers: Document Supply Chain Back to Starting Materials (FDANews-$)
  • Good, But Could Go Further: Industry On EMA's planned Priority Medicines Scheme (SCRIP-$)
  • Diligence And Janitors Needed To Keep Europe Innovating, Says Orphan Approval Pioneer (SCRIP-$)
  • Biosimilars use in Italy increasing (GaBI)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 2015 (EMA)
  • Medicines licence submissions: compulsory use of electronic application forms (eAFs) (MHRA)
  • MHRA seizes $1.5m worth of unlicensed ED drugs (In-Pharma Reporter) (MHRA)
  • C2 Therapeutics Coldplay cryoballoon wins CE Mark (MassDevice)
  • Clinical trials: how NHS trusts and health boards can maintain compliant electronic health record systems (MHRA)


  • TN drugs control director puts up major proposal at DCC meet for strengthening regulatory machinery (PharmaBiz)
  • Around 5000 drug samples collected from 9 ports for national drugs survey (PharmaBiz)


  • Submissions received: Medicine labelling (TGA)
  • Updates to Orphan Drugs List (TGA)

Other International

  • Onivyde gets U.S., Taiwan approval (BioCentury) (Press)
  • Turkey Regulatory Update: New Health Loans, Vaccine Compensation (PharmAsiaNews)
  • Puerto Rico looks to organ transplants to help cure ailing economy (Reuters)

General Health and Other Interesting Articles

  • Could a Drug Engineered From Bananas Fight Many Deadly Viruses? New Results Show Promise (ICT)
  • Sleep Apnea Is Tied to Gout (NYTimes)
  • Ask Well: A Cure for Macular Degeneration? (NYTimes)

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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