Regulatory Focus™ > News Articles > Regulatory Reconnaissance (3 September 2013)

Regulatory Reconnaissance (3 September 2013)

Posted 03 September 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

  • FDA Flexible With Accelerated Approval Evidence, Analysis Finds (Pink Sheet)
  • CDER Policy Council Urged To Address Manufacturer/Payer Communications (Pink Sheet)
  • Teva drops Nuvigil for depression (BioCentury) (Reuters) (PMLive) (SCRIP)
  • More legal trouble for Fresenius as GranuFlo Faces Class Action Lawsuit Status (Mass Device) (Reuters)
  • Calif. County's Drug Disposal Mandate Found Constitutional (Law 360)
  • FDA Calls Out "Egregious" Novartis Petition; Firm Asks Agency To Be Nicer (Pink Sheet) (FDA News)
  • mHealth coalition urges FDA to work with ONC, FCC (Gov Health IT)

In Focus: International

  • Lundbeck Files Appeal to Reduce or Annul $123.7M EU Commission Pay-for-Delay Fine (Reuters) (Pharma News) (SCRIP)
  • One Month Left to Send Comments to EMA on its Open Access to Clinical Trials Data Draft Policy (EMA)
  • European public health group gets behind tighter device controls (Fierce)
  • German HTA to help patients deconstruct trial data (SCRIP)
  • Indian Health Ministry plans to amend rules to increase period of retaining seized documents, samples (PharmaBiz)
  • Ethical questions linger in cervical-cancer study (SCRIP) (USA Today)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Flexible With Accelerated Approval Evidence, Analysis Finds (Pink Sheet)
  • CDER Policy Council Urged To Address Manufacturer/Payer Communications (Pink Sheet)
  • Teva drops Nuvigil for depression (BioCentury) (Reuters) (PMLive) (SCRIP)
  • More legal trouble for Fresenius as GranuFlo Faces Class Action Lawsuit Status (Mass Device) (Reuters)
  • FDA Calls Out "Egregious" Novartis Petition; Firm Asks Agency To Be Nicer (Pink Sheet) (FDA News)
  • FDA "Available Therapy" Determination Is A Moving Target, Industry Groups Say (Pink Sheet)
  • Biomarkers For Rare Diseases Get Scaled-Back Plea In New White Paper (Pink Sheet)
  • PhRMA Urges Fed. Circ. To Rethink Novo Patent Obviousness (Law 360)
  • Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Aminosyn™ II 10%, Sulfite-Free, Due To Foreign Particulate Matter (FDA)
  • Genzyme, Sanofi Take Aim At Generic Cancer Drug (Law 360)
  • Esperion's drug lowers blood fat in mid-stage study (Reuters)
European Society of Cardiology Meeting
  • Amgen drug misses endpoint in acute heart failure trial (PMLive) (The Street) (Reuters) (SCRIP)
  • More data backs Novartis' serelaxin in heart failure (PMLive) (Reuters)
  • EXAMINE confirms CV safety of alogliptin in high risk patients (SCRIP) (Pink Sheet)
  • The Cardiovascular Safety of Diabetes Drugs - Insights from the Rosiglitazone Experience (NEJM)
  • Boehringer presents Pradaxa data confirming heart valve contraindication (SCRIP)
  • Lack of cancer signal one less worry for DPP-IVs (EP Vantage)
  • New Diabetes Drugs Don't Raise Heart-Attack Risk, but Could be Linked to Heart Failure (WSJ) (Reuters)
  • Analysis: Doctors worry as heart drug research loses steam (Reuters)
  • Positive Results for New Anticoagulant From Daiichi Sankyo (Forbes) (Pharma Times)
Pharmaceuticals: General
  • Calif. County's Drug Disposal Mandate Found Constitutional (Law 360)
  • Meningitis deaths may be undercounted in Tennessee After Compounding Fiasco (USA Today)
  • How a Cabal Keeps Generics Scarce (NYTimes)
  • AstraZeneca Pulls Twitter Ads, Showing Risks Of Expansive Social Media Platforms (Pink Sheet)
  • Big steps by small firms to battle multiple-drug resistant bacteria (Boston Herald)
Medical Devices
  • mHealth coalition urges FDA to work with ONC, FCC (Gov Health IT)
  • FDA Role, Safety Oversight Addressed In Health IT Framework Comments (Gray Sheet)
  • FDA clears 3D-printed skull fillers by Tissue Regeneration Systems (Mass Device)
  • Considering Women's Needs in Developing Medical Devices: Here's 'HoW' (FDA)
  • Advamed Calls CDRH 'Inconsistent with ISO' in New Guidance (MDDI)
Assorted And Government
  • Advisory Council on Blood Stem Cell Transplantation; Request for Nominations for Voting Members (HRSA)
  • SCRIP Capitol Capsule (SCRIP)
Upcoming Meetings And Events
  • 2-5 September 2013: Pharmacovigilance Risk Assessment Committee (EMA)
  • 5-6 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 5 September 2013: ENVI Meeting on Medicines and Innovation (ENVI)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Lundbeck Files Appeal to Reduce or Annul $123.7M EU Commission Pay-for-Delay Fine (Reuters) (Pharma News) (SCRIP)
  • One Month Left to Send Comments to EMA on its Open Access to Clinical Trials Data Draft Policy (EMA)
  • European public health group gets behind tighter device controls (Fierce)
  • German HTA to help patients deconstruct trial data (SCRIP)
  • Agenda: Pharmacovigilance Risk Assessment Committee Meeting of 2-5 September (EMA)
  • EU approval for Ilaris in active systemic juvenile idiopathic arthritis (Reuters) (Pharma Letter) (RTT)
  • Roche wins EU approval for injectable Herceptin (PMLive) (Reuters) (Roche) (Pharma Times) (SCRIP)
  • Sanofi's Aubagio gets European approval for MS (BioCentury) (Pharma Letter)
  • EC approves Stivarga for mCRC (BioCentury) (Fierce) (Fierce) (Pharma Times)
  • GSK melanoma therapy Tafinlar cleared in EU (PMLive) (GSK) (Pharma Times) (SCRIP)
  • British cost watchdog recommends Thrombogenics eye drug (Reuters)
  • INTERVIEW: UK stamps its identity as EU regulators consider device/IVD Regulations (Clinica)
  • MHRA issues warning over tanning injections and nasal sprays (PJ Online)
  • The EMA should continue its new openness policy despite current lawsuits (Cochrane)
  • Swiss regulators deny Apricus ED drug (Fierce) (Pharma Letter)

Asia

  • Indian Health Ministry plans to amend rules to increase period of retaining seized documents, samples (PharmaBiz)
  • Ethical questions linger in cervical-cancer study (SCRIP) (USA Today)
  • Wockhardt makes leadership changes to solve crisis after FDA finds dire problems (BioSpectrum)
  • JAMS: Japanese Clinical Research Is In Crisis (PharmAsia)
  • Japanese government budgets plan for creating NIH (Pharma Letter)
  • Bribery by GSK China was coordinated at company level: Xinhua (Reuters)

General Regulatory And Interesting Articles

  • Of Mice and Men: Problems with Animal Studies Highlighted in a New Light (MedPage Today)
  • Opioids without Addiction: Nektar Therapeutics developing painkiller that may enter the brain too slowly to be abused (MIT TR)
  • Psychiatric drugs may not increase death risk: study (Reuters)

Regulatory Reconnaissance #144  - 3 September 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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