Regulatory Focus™ > News Articles > Regulatory Recon: Big News for Hep C Treatments in UK, India and the EU (16 January 2015)

Regulatory Recon: Big News for Hep C Treatments in UK, India and the EU (16 January 2015)

Posted 16 January 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Big News for Hep C Treatments in UK, India and the EU (16 January 2015)

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

In Focus: US

  • FDA says one dead, many ill after receiving non-sterile solution (Reuters) (FDA) (NYTimes)
  • FDA Downplays 2014 Lull In Drug Promo Discipline (Law 360-$)
  • GDUFA Success Story: FDA Exceeds Hiring Goals (Pink Sheet-$)
  • Biotech Rivalry Gets Nasty in Mudslinging Battle Over Data (Bloomberg)
  • FDA’s Center for Veterinary Medicine Dramatically Decreases Application Review Time Using Question-Based Review (IPQ-$)
  • Opioid Guide Not Included On FDA Agenda, Despite Congressional Push (IHP-$)
  • Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Pegfilgrastim (Press)
  • LASIK: A Fight FDA Can’t Ethically Win (MDDI)
  • Fifth Circuit Holds That Product Development Protocol Has Same Preemptive Effect As Premarket Approval (Inside Medical Devices)
  • FDA To Open GUDID Accounts For Class III I/LS/LS Devices Jan. 26 (IHP-$)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • FDA says one dead, many ill after receiving non-sterile solution (Reuters) (FDA) (NYTimes)
  • FDA Downplays 2014 Lull In Drug Promo Discipline (Law 360-$)
  • GDUFA Success Story: FDA Exceeds Hiring Goals (Pink Sheet-$)
  • Biotech Rivalry Gets Nasty in Mudslinging Battle Over Data (Bloomberg)
  • FDA’s Center for Veterinary Medicine Dramatically Decreases Application Review Time Using Question-Based Review (IPQ-$)
  • Opioid Guide Not Included On FDA Agenda, Despite Congressional Push (IHP-$)
  • Social Media "Compassionate Use" Crusade Sets Unsettling Precedent (CTP Blog)
  • "Right-to-Try" Bill Introduced in Montana (Press)
  • Why the Actavis Product Switching Case may Transform Pharma (Pharmalot)
  • Antipsychotics-Associated Serious Adverse Events in Children: An Analysis of the FAERS Database (PubMed)

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

  • Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Pegfilgrastim (Press)
  • Treximet sNDA Accepted by FDA for Adolescent Migraine (MPR) (Press)
  • Auspex Pharmaceuticals Receives FDA Orphan Drug Designation for Tourette Syndrome Treatment (Press)
  • CorMedix Inc. Receives Fast Track Designation for Neutrolin (Press)

US: Pharmaceuticals and Biotechnology: General

  • Flu Vaccine Effective in Fewer Than 1 in 4 in U.S. (Bloomberg) (SCRIP-$)
  • Congress to Investigate Lack of Flu Vaccine Effectiveness (E&C)
  • Kite CEO plans to learn from Gilead's pricing playbook (Reuters)

US: Medical Devices

  • LASIK: A Fight FDA Can’t Ethically Win (MDDI)
  • Fifth Circuit Holds That Product Development Protocol Has Same Preemptive Effect As Premarket Approval (Inside Medical Devices)
  • FDA To Open GUDID Accounts For Class III I/LS/LS Devices Jan. 26 (IHP-$)
  • Q&A: Lawyer John Conley Counters Lab Industry Arguments against FDA Regulatory Authority over LDTs (Genome Web)
  • FDA Hosts Webinars on UDI and GUDID (Registrar Corp)
  • FDA warns Philips Respironics on malfunction reporting (Mass Device)
  • Realizing the Benefits of the Unique Device Identifier in Health Care (Pew)
  • Valorem Surgical announces FDA clearance and first clinical use of maxiMIS Spinal Fixation System (MNT)
  • Intelligent Implant Systems Gains FDA Approval for the Revolution Spinal System™ with Disposable Instrumentation Kit from ECA Medical Instruments (Press)
  • Cantel Medical Subsidiary Mar Cor Purification Given 510(k) Clearance For MINNCARE HD Disinfectant For Use In Water System Disinfection In Kidney Dialysis Applications (Press)
  • ECA Medical Instruments Develops First Disposable Spinal Instrument Fixation Kit to Gain FDA Approval with Intelligent Implant Systems (Press)

US: Dietary Supplements

  • USP Proposes New Probiotic Monographs, Introduces Guidance (NPI)

Upcoming Meetings

Ebola Outbreak

  • J&J Ebola vaccine gets 100 million euros to speed development (Reuters)
  • EFPIA and Innovative Medicines Initiative Announce New Ebola+ Projects to Further Collaborative Efforts Against Ebola (EFPIA) (EFPIA)
  • WHO defends Ebola actions, condemns world's failures (SCRIP-$)

Europe

  • AbbVie’s hepatitis C drug gets European approval for sale (WSJ) (Press)
  • Cameron Urges Lighter Regulation to Speed New Drug Development (Bloomberg)
  • Biosimilar Enbrel filed with EMA (SCRIP-$)
  • Should Direct-to-consumer genetic tests should come with a health warning? (PharmJournal)
  • Don't use generic Lyrica for pain, Pfizer warns U.K. providers--or else (Fierce)
  • NICE extends recommendations for Sovaldi, Olysio (BioCentury) (Pharmafile) (PharmaTimes) (SCRIP-$) (PMLive)
  • Janssen privy to new pricing scheme and see NICE nod (Pharmafile)

India

  • Gilead to challenge hepatitis C drug patent rejection decision (India Times) (PharmAsia-$) (SCRIP-$)
  • Regulator Sets Tough Tone At Indian Manufacturers’ Meeting (PharmAsia-$)
  • Health ministry reviewing industry proposal on withdrawing ban on PET bottles (PharmaBiz)

China

  • Chinese police net over 60,000 people in vast drug sweep (Reuters)

Other International

  • Heavy metal and drugs a health risk: ICH Q3D ready for implementation (In-Pharma)

Clinical Trials

  • Why is There a High Turnover Rate Among Principal Clinical Invesigators? (Pharmalot)

Regulatory Reconnaissance #473 – 16 January 2015

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 @AlecGaffney 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.


Categories: Recon, Regulatory News

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