Regulatory Focus™ > News Articles > Regulatory Recon: FDA Panel Gives OK to New Novo Nordisk Diet Drug (12 September 2014)

Regulatory Recon: FDA Panel Gives OK to New Novo Nordisk Diet Drug (12 September 2014)

Posted 12 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Panel Gives OK to New Novo Nordisk Diet Drug (12 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here, or check out some of the mostnews-worthy sessions here.

In Focus: US

  • FDA panel endorses Novo's liraglutide in weight loss (SCRIP-$) (Tarius) (Fierce) (Reuters) (MedPage Today) (PMLive) (BioCentury) (Pink Sheet-$)
  • Court Upends FDA’s Clinical Superiority Requirement for Granting Orphan Drug Exclusivity; Decision Leaves a Lot of Questions to Be Answered (FDA Law Blog)
  • No Wins for Polypills at FDA (MedPage Today)
  • FDA’s Woodcock Says Biomedical Research Infrastructure ‘Overbuilt’ In Some Areas (Pink Sheet-$)
  • Amarin Appeal of SPA Reversal Denied by FDA (Press)
  • UDI System Faces Major Test As Manufacturers Work To Meet FDA’s Class III Device Deadline (Silver Sheet-$) (Gray Sheet-$)
  • Silicon Valley Struggles to Speak FDA's Language (AP)

In Focus: International

  • Comparing How Germany and France Evaluate the Benefit of a Drug (Context Matters)
  • Europe Unveils New Health Commissioner And Restructuring For Growth (Pink Sheet-$)
  • Groups Express Concern About EMA's Move to DG Enterprise (HAI) (EUrActiv) (SCRIP-$)
  • More Than Half Hubei Pharma Manufacturers Non-GMP Compliant (PharmAsia-$)

US: Pharmaceuticals and Biotechnology

  • FDA panel endorses Novo's liraglutide in weight loss (SCRIP-$) (Tarius) (Fierce) (Reuters) (MedPage Today) (PMLive) (BioCentury) (Pink Sheet-$)
  • Court Upends FDA’s Clinical Superiority Requirement for Granting Orphan Drug Exclusivity; Decision Leaves a Lot of Questions to Be Answered (FDA Law Blog)
  • No Wins for Polypills at FDA (MedPage Today)
  • FDA’s Woodcock Says Biomedical Research Infrastructure ‘Overbuilt’ In Some Areas (Pink Sheet-$)
  • Mini-Sentinel Program Develops Routine Prospective Drug/Biologic Safety Surveillance Methedology (MS)
  • FDA could be source of innovation, Hamburg says (BizJournal)
  • FCA Whistleblowers Accuse Gilead Of Defective-Drug Fraud (Law 360-$)
  • Apotex recalls Paxil tainted at GSK plant (Fierce)
  • Hospira Issues a Voluntary Nationwide Recall of One Lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9% Sodium Chloride Injection, 500 mL, Due to Particulate Matter (FDA)
  • Taro Pharma Said To Order Warfarin Recall Over Quality Issues (PharmAsia-$) (Economic Times)
  • Health Policy Brief: Drug Shortages (Health Affairs)
  • Are Opioid Overdoes a "Public Health Emergency" Warranting the Challenge of FDA? (TIE)
  • Pharmacist Pleads Not Guilty in Tainted Steroid Case (AP) (Law 360-$) (Bloomberg)
  • J&J To Face Suit Over Allegedly Misleading Sunscreen Labels (Law 360-$)
  • Preclinical QT safety assessment: cross-species comparisons and human translation from an industry consortium (PubMed)

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

  • Amarin Appeal of SPA Reversal Denied by FDA (Press)
  • AbbVie's Humira shines in skin disease with no competitors (SCRIP-$)
  • Sanofi produces more Lemtrada data ahead of second FDA approval decision (SCRIP-$)
  • FDA Designates Antifungal Agent Orphan Drug Status (MPR) (Press)
  • Detailed Results from Biogen Idec and AbbVie’s Pivotal Phase 3 Decide Study Further Define the Efficacy and Safety Profile of ZINBRYTA (Daclizumab High-Yield Process) (Press)
  • Oxygen Biotherapeutics Announces Halt of Oxycyte Phase IIb Traumatic Brain Injury Trial (Press) (BioCentury)
  • Lilly Announces CYRAMZA Phase III Second-Line Colorectal Cancer Trial Meets Primary Endpoint of Overall Survival (Press)
  • Merck KGaA scraps a controversial PhIII comeback attempt for cancer vaccine (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • Generic pharmaceutical savings reach highest-ever watermark of $239 billion in 2013, U.S. (MNT) (Pharmalot)
  • Glaxo’s Ebola Vaccine and the Rise of Tropical Disease R&D (Pharmalot)
  • Sticking Point: The Price of an Old Insulin Skyrockets (Pharmalot) (MedPage Today)
  • Novartis, Penn reveal CACT plans (BioCentury)
  • 2014 PhRMA Research and Hope Awards Celebrate Groundbreaking Achievements in HIV/AIDS, While Recognizing the Continued Work Needed for a Cure (Policy and Medicine)

US: Medical Devices

  • UDI System Faces Major Test As Manufacturers Work To Meet FDA’s Class III Device Deadline (Silver Sheet-$)
  • UDI Architect Jay Crowley Offers Device Manufacturers Last-Minute Advice (Gray Sheet-$)
  • Silicon Valley Struggles to Speak FDA's Language (AP)
  • 23andMe CEO navigates health regulation (AP)
  • LDTs Present a Test for FDA and Labs (GEN)
  • CivaTech Oncology Receives FDA Approval for CivaSheet Brachytherapy Device (Press)
  • FDA approves PleximmuneTM for personalized prediction of transplant rejection in children (Press)

US: Dietary Supplements

  • Rock Creek Pharmaceuticals Receives New Dietary Ingredient Notification Response (Press)

US: Assorted And Government

  • Deadline Passes on CMS Open Payments Data Corrections (Pharmalot)

Upcoming Meetings

Ebola Outbreak

  • Statement on the WHO Consultation on potential Ebola therapies and vaccines (WHO)
  • American Ebola Victim Receives Blood Transfusion from Former Ebola Victim (CBS)
  • Global response to Ebola marked by lack of coordination and leadership, experts say (WaPo)
  • Microsoft co-founder Allen to give $9 million for Ebola fight (Reuters)
  • Ebola survivor to testify before Congress (The Hill)

Europe

  • Comparing How Germany and France Evaluate the Benefit of a Drug (Context Matters)
  • Europe Unveils New Health Commissioner And Restructuring For Growth (Pink Sheet-$)
  • Groups Express Concern About EMA's Move to DG Enterprise (HAI) (EUrActiv) (SCRIP-$)
  • IQWiG: Olysio offers 'major' benefit vs. Incivek (BioCentury)
  • Highlights from the September PRAC Meeting (EMA)
  • EMA Strengthens Liver Injury Warnings on Antidepressants Valdozan and Thymanaz (EMA)
  • @MHRA: regulators could track #drug reactions via Twitter (In-Pharma)
  • Commission Expert Group on Rare Diseases (EC)
  • AcuFocus lands E.U. approval for next-gen eye implant (Mass Device) (Press)
  • Russia does not plan to ban drug imports from Western countries (Pharma Letter-$)
  • Ukraine takes measures to solve problem of drug shortages (Pharma Letter-$)

India

  • Blackberry to integrate medical devices in India (Fierce)
  • NPPA warns of penal action against cos failing to maintain production level of essential drugs (PharmaBiz) (SCRIP-$)

China

  • More Than Half Hubei Pharma Manufacturers Non-GMP Compliant (PharmAsia-$)

Japan

  • Japanese Research Scandal Involving Novartis Blood Pressure Drug Widens (Forbes)
  • First Nod For Edoxaban In Major Indications (PharmAsia-$)

Australia

  • TGA Releases Draft Monographs for four Drugs (TGA) (TGA) (TGA) (TGA)

General Regulatory And Interesting Articles

  • Vaginal Microbe Yields Novel Antibiotic (SciAm) (Press) (NYTimes)
  • Scientists 'reset' stem cells to study start of human development (Reuters)
  • The high price of antibiotic overuse (CBS)
  • Red Cross launches blood donation app (MobiHealthNews)

Regulatory Reconnaissance #398 – 12 September 2014

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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