Regulatory Focus™ > News Articles > Regulatory Recon: A Surprising Day for FDA Advisory Committee Meetings (7 November 2014)

Regulatory Recon: A Surprising Day for FDA Advisory Committee Meetings (7 November 2014)

Posted 07 November 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: A Surprising Day for FDA Advisory Committee Meetings (7 November 2014)

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

In Focus: US

In Focus: International

  • Experimental Ebola drugs should not be withheld, WHO says (Guardian)
  • France asks Roche for data on use of cancer drug Avastin in eye (Reuters) (SCRIP-$)
  • UK Gov't urged to support Off-Patent Drugs Bill (PharmaTimes)
  • EU plans risk reduction steps for Servier, Amgen heart drug (Reuters) (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 November 2014 (EMA)
  • India to set up new drugs regulator for traditional medicines (Reuters)

US: Pharmaceuticals and Biotechnology

  • FDA advisers spurn Novartis' blood cancer drug, putting approval in doubt (Fierce) (Press) (Myeloma Beacon) (Tarius) (Medscape) (MedPage Today) (Press) (SCRIP-$) (BioCentury) (PharmaTimes) (PMLive)
  • Rockwell Dialysis Therapy Wins Panel Support But Final FDA Approval? Not So Fast. (Street) (SCRIP-$) (Pink Sheet-$) (Fierce)
  • Dr Reddy's gets FDA approval for generic of Roche's Valcyte (Reuters)
  • Ranbaxy Exclusivity Implosion on Nexium Remains ‘Very Hazy’ (Pink Sheet-$) (SCRIP-$) (FDA Law Blog)
  • Groups Sue FDA Over Livestock-Feed Additive (WSJ-$) (Press) (Reuters) (Food Safety News)
  • FDA unlikely to pull conventional opioids (BioCentury)
  • CSPI Wants to See FDA’s Findings on Drugs in Milk (Food Safety News)
  • FDA to Convene Secretive AdComm to Discuss "Further Clinical Development of an Existing Investigational Drug Products" (FDA)
  • FDA AdComm Weights in on Viral and Bacterial Shedding Guidance (Tarius)
  • Mind the Gap: Strengthening relations with the European Medicines Agency to the benefit of public health (FDA)
  • MAPP: Critical Path Innovation Meetings Policy and Procedures (FDA)
  • Industry Doesn’t Wait for FDA to Meet Track-and-Trace Pedigree Requirement (FDA News-$)
  • 'Low-T' Class Action Filed (Press)

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

  • Avanir says FDA approval in November for migraine treatment unlikely (Reuters) (Press)
  • Auspex Pharmaceuticals Receives FDA Orphan Drug Designation of SD-809 for Treatment of Huntington's Disease (Press)
  • Intercept Liver Drug Needs Safety Review, Researchers Say (Bloomberg)
  • 'BelPhen' Passes Early Safety Test (MedPage Today)
  • Danish Lundbeck’s Brexpiprazole Could Reach U.S. Market In 2015 (Pink Sheet-$)
  • BI Subgroup Analysis Shows Giotrif More Effective in Asian Patients (BI)

US: Pharmaceuticals and Biotechnology: General

  • Addressing The Threat Of Antibiotic Resistance: Policy Solutions To Fix A Broken Pipeline (HealthAffairs)
  • Flu Season Brings Stronger Vaccines And Revised Advice (NPR)

US: Medical Devices

  • FDA: Edap's Ablatherm prostate cancer device 'not approvable' (Mass Device)
  • Ipsen Announces FDA Approval of a New Delivery Device for Somatuline Depot (lanreotide) Injection (Press)

US: Dietary Supplements

  • Nature Made Supplement Buyers Near Cert. In False Ad Suit (Law 360-$)

US: Assorted And Government

  • Should FDA Monitor the Quality of Marijuana? (The Economist)
  • Head of the Office of the Federal Register Stepping Down (OFR)

Upcoming Meetings

Ebola Outbreak

  • Experimental Ebola drugs should not be withheld, WHO says (Guardian)
  • WHO welcomes approval of a second Ebola vaccine trial in Switzerland (WHO)
  • Ebola patient who used bio-filtration device reportedly free of virus (MM&M)
  • Tekmira to produce Ebola treatment for U.S. Dept of Defense (Reuters)
  • Innovative Medicines Initiative launches Ebola+ programme (IMI)

Europe

  • France asks Roche for data on use of cancer drug Avastin in eye (Reuters) (SCRIP-$)
  • Europe Mustering Its Scientific And Political Arsenal At Ebola And Beyond (Pink Sheet-$)
  • UK Gov't urged to support Off-Patent Drugs Bill (PharmaTimes)
  • EU plans risk reduction steps for Servier, Amgen heart drug (Reuters) (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 November 2014 (EMA)
  • EU accelerates medtech regs push-through as Italian Presidency, MEPs take action (Clinica-$)
  • Eisai "speechless" as G-BA denies price premium for Fycompa (PMLive)
  • EMA releases another update of the Pre-Authorisation Procedural Advice for CP users (Exalon)
  • Public consultation of the HTA Core Model version 2.1 (EUnetHTA)

India

  • India to set up new drugs regulator for traditional medicines (Reuters)
  • Dr BR Jagashetty to take over as National Advisor of drugs control & project-in charge CDSCO in mid-November (PharmaBiz)
  • NPPA extends date to register under IPDMS for companies by one month (PharmaBiz)

China

  • Watch out for China’s stricter clinical trial rules for hospitals, industry warned (Clinica-$)

Clinical Trials

  • Strong transparency proposals from US clinical trial funder (AllTrials)
  • Biotechs can increase valuation by implementing adaptive design. (GEN)

General Regulatory And Interesting Articles

  • Global Spending on Pharmaceuticals to Soon Surpass $1 Trillion (BBC)
  • BBC Puts Spotlight on High Pharma Profit Margins (BBC) (Fierce)

Regulatory Reconnaissance #436 – 7 November 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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