Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Jazz Drug for Rare Liver Disorder, GSK Says it Wont File Patents in L

Regulatory Recon: FDA Approves Jazz Drug for Rare Liver Disorder, GSK Says it Wont File Patents in Low-Income Countries (31 March 2016)

Posted 31 March 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Jazz Drug for Rare Liver Disorder, GSK Says it Wont File Patents in Low-Income Countries (31 March 2016)

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

  • FDA to Congress: GDUFA is Working (Focus)
  • Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products (FDA Law Blog)
  • Possible Drug Risks Buried in Delayed FDA 'Watch Lists' (Medscape)
  • Pfizer, Allergan get request for additional information from FTC (Reuters) (WSJ-$) (Bloomberg) (Press)
  • Decline in financial settlements with U.S. Big Pharma: report (Reuters) (Public Citizen)
  • Rare liver disorder drug from Jazz wins U.S. approval (Reuters) (SCRIP-$) (FDA) (Press)
  • FDA Hold-Up: Opko Scrambles To Fix Problems At Manufacturing Site (Pink Sheet-$) (SCRIP-$) (Press) (In-PharmaTechnologist)
  • Curing Cancer Is Within Reach (Bloomberg View)
  • FDA's Relationship with Marijuana: It's Complicated (Harvard Bill of Health)
  • Obama Task Force Director On The Cancer 'Moonshot' Initiative (NPR)
  • FDA Authorizes Use of Investigational Test to Screen Blood Donors for Zika (Focus) (NYTimes) (FDA)
  • Priorities – Teamwork to Achieve Common Goals (FDA)

In Focus: International

  • The Zika Challenge (NEJM)
  • Zika Virus Mosquitoes May Spread Farther North Than Thought (WSJ-$)
  • GSK plans graduated approach to drug patents to help poor (Reuters)
  • Exclusive: Japan Pharma entering a new era (PharmaLetter-$)
  • Zika Attacked a Baby's Brain as Doctors Watched (MIT Technology Review) (Reuters)
  • Biomet Still Under Scrutiny For Overseas Bribery (Gray Sheet-$)
  • EU GMP Guidance For Advanced Therapies Expected This Year (Pink Sheet-$)
  • Turkish ministry says investigating drugmaker over bribe allegations (Reuters) (
  • French regulators report GMP failings at Anuh Pharma API processing plant (In-PharmaTechnologist)

US: Pharmaceuticals & Biotechnology

  • Pragmatic Trials for Noncommunicable Diseases: Relieving Constraints (PLOS)
  • Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies (NEJM)
  • Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders (NEJM)
  • New Method For Discovering Chemical Reactions Could Speed Product Development (Forbes)
  • Long-term antibiotic therapy ineffective for persistent Lyme symptoms (Reuters) (Forbes)
  • 'Remember Me:' The Real-Life Impact of Q&R (MIT Technology Review)
  • Real-world biosimilar data driving physician acceptance, says Celltrion (BioPharma-Reporter)
  • Biotech investor Steve Burrill to pay $6m, banned from trading (MassDevice)
  • An Infographic: Comparing Drugs And Devices Trials (imarc)
  • Valeant Asks Its Lenders for Some Slack (WSJ-$)
  • Follow-up more than six weeks after heart attack linked to reduced medication adherence (Pharmaceutical Journal)
  • Sanofi Pasteur: Strategy for 2nd-Gen Influenza Vaccine (DD&D)
  • FDA Approves New Label for Lower Dose of Abortion Drug (NYTimes) (Focus)
  • HELP to discuss limited population antibiotic pathway (BioCentury)
  • Extrapolation Applies To Interchangeability, Not Just Biosimilarity, Sandoz Says (Pink Sheet-$) (SCRIP-$)
  • HIMSS, AMDIS comment on Precision Medicine Initiative security plans (Fierce)
  • Teva Goes Absurd in Latest Opioid Addiction Videos (Fierce)
  • "Raw Potential" And Three Other Takeaways from NY's Life Science Disruptors (Xconomy)
  • Autism Research Lacks Cultural And Ethnic Diversity (Forbes)
  • AI solution redacts 'hundreds of studies per day,' Synchrogenix President (Outsourcing-Pharma)

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

  • Tokai Announces Dosing of First Patient in Phase 2 Expansion Study of Galeterone in Enzalutamide-Refractory mCRPC Patients (Press)
  • Phase 3 Study Findings Demonstrate Treatment with Baricitinib Results in Significant Improvements for Patients with Rheumatoid Arthritis Who Had Inadequate Response to Biologics (Press)
  • Genmab's Darzalex passes Phase III MM test (BioCentury)
  • Radius Health files for approval of osteoporosis drug to rival Forteo (Boston Biz Journal)

US: Medical Devices

  • FDA: Cook Medical central venous cath recall is Class I (MassDevice) (FDA)
  • Precision Biopsy asks FDA to OK new ClariCore trial (MassDevice)
  • New genetic testing for childhood cancers (OnMedica)
  • A World of Potential in Clinical Research Apps (geeks talk clinical)
  • Xtant Medical wins FDA nod for spinal laminoplasty system (MassDevice)
  • TSO3 Receives FDA Clearance for Universal Design of STERIZONE VP4 Sterilizer (ICT)
  • FDA clears LED Dental's Tuxedo dental radiography device (MassDevice)

US: Assorted & Government

  • Johnson & Johnson Has a Baby Powder Problem (Bloomberg)
  • US environmental groups sue to overturn GMO salmon approval (Reuters)
  • Patient-Centered Outcomes Research Institute: Review of the Audit of the Financial Statements for Fiscal Year 2015 (GAO)
  • Congressmen Slam FDA's Handling of Investigation Into Tainted Chinese Heparin (Focus)
  • Clean, Safe Places For Heroin Addicts To Shoot Up: Coming To A City Near You? (Forbes)
  • House Panel Issues Subpoenas in Fetal Tissue Research Inquiry (NYTimes)
  • Massachusetts Passes Drug Stewardship Program Law (Porzio)
  • Patent Challenges For Apopharma's Ferriprox And Akorn's Zioptan (24 Insight)
  • FTC, States Settle Claims Against Two Entities Claiming to Be Cancer Charities; Orders Require Entities to Be Dissolved and Ban Leader from Working for Non-Profits (FTC) (Washington Post)

Upcoming Meetings & Events


  • Reflection paper on poorly extractable and/or non-radiolabelled Substances (EMA)
  • Will You Need A New Notified Body And Authorized Representative? (Clinica-$)
  • Janssen's Rezolsta HIV combination to be funded in England (PharmaPhorum)
  • Bio Products Laboratory gets European approval for bleeding disorder treatment (Pharmafile)
  • NICE proposes new guidance for treating multimorbidities (PharmaTimes)
  • Bid to ease burden of heavy periods steps up with new UK drug trial (MNT)
  • Opdivo edges closer to first haematological cancer indication (PMLive) (Press)



  • India's DCGI Attempts To Eliminate Clinical Trial Backlog (24 Insight)
  • Delhi HC seeks government view on validity of drug companies' licences (Economic Times)
  • Pneumonia vaccine: the new battleground for Indian drug makers (Live Mint)
  • India: PET OK in packaging, but phthalate excipient use should be minimized (In-PharmaTechnologist)
  • Aurobindo Pharma gets final USFDA nod for gastro reflux drug (Economic Times)
  • Cadila Healthcare confirms WHO notice of concern in BSE filing (In-PharmaTechnologist)
  • Zydus group firm Nesher Pharmaceuticals gets USFDA nod for a drug (Economic Times)


  • ACSS public statement, 30-31 October 2015 (TGA)


  • Fighting the Zika virus - A lesson for defending against emerging pathogens (PhRMA)
  • Team of Rival Scientists Comes Together to Fight Zika (NYTimes)
  • World Health Organization launches Zika app for healthcare workers (mobihealthnews)

Other International

  • Biocad ships Herceptin biosimilar to Sri Lanka (BioPharma-Reporter)
  • The Community As the Patient in Malaria-Endemic Areas: Preempting Drug Resistance with Multiple First-Line Therapies (PLOS)
  • Performance of the GeneXpert Ebola Assay for Diagnosis of Ebola Virus Disease in Sierra Leone: A Field Evaluation Study (PLOS)
  • Increased Duration of Paid Maternity Leave Lowers Infant Mortality in Low- and Middle-Income Countries: A Quasi-Experimental Study (PLOS)

General Health & Other Interesting Articles

  • Everything you thought you knew about the shape of DNA is wrong (STAT)
  • Shaping Health Policy for Millions, and Still Treating Some on the Side (NYTimes)
  • Even when women aren't obese, PCOS can mean pregnancy problems (Reuters)
  • Black patients may do better at hospitals with more racial diversity (Reuters)
  • Early age of type 2 diabetes diagnosis tied to poorer health (Reuters)
  • Diabetes link to sitting largely due to obesity and lack of exercise (Reuters)

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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