Regulatory Focus™ > News Articles > Regulatory Reconnaissance (12 September 2013)

Regulatory Reconnaissance (12 September 2013)

Posted 12 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 exceeds FY2013 GDUFA hiring goals (DSN) (IHP)
  • In Rare Move, Sanofi to Withdraw NDA for Diabetes Treatment to Wait for Additional Study Data (Reuters) (SCRIP) (Pharma Letter) (Pharma Times) (Bloomberg)
  • Johnson & Johnson recalls schizophrenia drug after discovering mold (Reuters) (WSJ)
  • FDA approves Botox Cosmetic to improve the appearance of crow's feet lines (FDA) (Allergan) (SCRIP) (Fierce) (CBS)
  • Friends of Cancer Research proposing breakthrough companion diagnostics (BioCentury)
  • Rep. Lance to reintroduce MODDERN Cures Act (BioCentury)
  • Massachusetts Legislature Schedules Meeting to Define What a "Modest" Meal or Refreshment is in Prescriber Educational Settings and to Limit "Undue Influence" (Scout) (Scout) (Scout)

In Focus: International

  • EMA hears views from stakeholders on its conflicts of interests policy for scientific  experts (EMA)
  • Celltrion seeking Japanese approval of Remicade biosimilar (BioCentury)
  • After FDA Warning Letter, Wockhardt Restructures Quality Control Team (BioSpectrum)
  • India's Compulsory License Threat Haunts BMS' Sprycel (PharmAsia) (SCRIP) (PMLive)
  • Pharma companies, research bodies face confidentiality test in India (Economic Times)
  • South Africa Releases Proposal To Overhaul Pharma Patents (Pharmalot) (Pharma Times)

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

US

Pharmaceuticals/Biotechnology
  • FDA exceeds FY2013 GDUFA hiring goals (DSN) (IHP)
  • In Rare Move, Sanofi to Withdraw NDA for Diabetes Treatment to Wait for Additional Study Data (Reuters) (SCRIP) (Pharma Letter) (Pharma Times) (Bloomberg)
  • Johnson & Johnson recalls schizophrenia drug after discovering mold (Reuters) (WSJ)
  • FDA approves Botox Cosmetic to improve the appearance of crow's feet lines (FDA) (Allergan) (SCRIP) (Fierce) (CBS)
  • House Floats Requirements For 'Outsourcing Facilities' In New Drug Compounding Draft (IHP)
  • Syndax scores a coveted 'breakthrough' designation for PhIII cancer drug (Fierce) (Syndax) (SCRIP) (BioCentury)
  • Gilead Seeks FDA OK for Lymphoma Drug, First Big Move into Cancer (Xconomy) (SCRIP) (Gilead) (BioCentury)
  • FDA to again review United Therapeutics Corp's oral treprostinil for PAH (BioCentury)
  • Another Compounding Pharmacy Recall Related to Sterility Concerns (FDA)
  • Further FDA crackdown on opioids could close market to generics (EP Vantage)
  • Chimerix reports PhII failure for lead antiviral (Fierce)
  • Fluctuation, speculation and a demanding patient population: Sarepta's DMD story so far (SCRIP)
  • Hospira: Rocky Mount Remediation Will Be Completed in 2013 (In-Pharma)
  • Chimerix's viral drug fails to show improvement in mid-stage study (Reuters)
  • Allergan Asks Fed. Circ. For Block On Generic Zymaxid (Law 360)
  • Zephrex-D, Nexafed Make Marketing Pitch As Meth-Fighting Decongestants (Pink Sheet)
  • Biosimilars Are Just 'A Matter Of Time, Says Pfizer Exec (Pharmalot)
  • Bristol's Yervoy falls short in prostate cancer study (Reuters) (BMS)
Medical Devices
  • Friends of Cancer Research proposing breakthrough companion diagnostics (BioCentury)
  • Unique Device Identification System Overview and What it Means for Medical Device Manufacturers (MedDevice Summit)
  • Dako gets FDA warning letter tied to Roche companion Dx (Fierce)
  • Class 1 Recall for Siemens' MicroScan Synergies Plus Panels (FDA)
  • Consumers Union launches campaign to get hip and knee implant warranties (CU)
  • Syneron Medical Receives FDA Clearance for Abdominal Circumferential Reduction and CE mark for the New VelaShape III Platform (Syneron)
  • Rehrig Pacific Company Receives FDA Clearance for New Reusable Sharps Container (Rehrig)
Assorted And Government
  • Rep. Lance to reintroduce MODDERN Cures Act (BioCentury)
  • Massachusetts Legislature Schedules Meeting to Define What a "Modest" Meal or Refreshment is in Prescriber Educational Settings and to Limit "Undue Influence" (Scout) (Scout) (Scout)
  • Drugmakers And Pharmacists Sue Maine Over Importation Law (Pharmalot)
  • FDA Issues Final Guidance on Risk-Based Approach to Monitoring Clinical Investigations (King & Spalding)
  • Collaborations of hope: PhRMA honors the vaccine enterprise (SCRIP)
  • Boiron Faces New False Ad Suit Over Homeopathic Flu Drug (Law 360)
  • Meeting of the Secretary's Advisory Committee on Human Research Protections (DHHS)
  • FDA Enforcement Report - Week of September 11, 2013 (FDA)
Upcoming Meetings And Events
  • 12 September 2013: Oncologic Drugs Advisory Committee Meeting  (FDA)
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 September 2013: ENVI Meeting, no Known Agenda as of Yet (ENVI)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 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

  • EMA hears views from stakeholders on its conflicts of interests policy for scientific  experts (EMA)
  • UK MHRA licenses Allergan's Botox for use in patients with overactive bladder (Pharma Letter)
  • EMA gives Patrys cancer drug orphan status (BioSpectrum)
  • MPs urged to back bill to support medical innovation (Pharma Times)
  • UK to improve commercial viability of antibiotic research (PMLive)

Asia

  • Celltrion seeking Japanese approval of Remicade biosimilar (BioCentury)
  • After FDA Warning Letter, Wockhardt Restructures Quality Control Team (BioSpectrum)
  • India's Compulsory License Threat Haunts BMS' Sprycel (PharmAsia) (SCRIP) (PMLive)
  • Pharma companies, research bodies face confidentiality test in India (Economic Times)
  • Indian Newspaper Slams DCGI for Alleged HPV Trial Irregularities (The Hindu)
  • Glaxo's Drug Approvals Boost Morale as China Probe Drags (Blooomberg)
  • China drugmaker Sino Biopharmaceutical investigating TV corruption report (Reuters)
  • Gan & Lee First China Drug Maker Named In Pharma Bribery Scandal (PharmAsia)
  • Roche lung cancer Dx achieves Chinese approval (Fierce)
  • Ventana receives approval from China's FDA for first fully automated IHC companion diagnostic identifying ALK protein expression in lung cancer patients (Ventana)

Other International

General Regulatory And Interesting Articles

  • Interlace realigns business to focus on communications (PMLive) 
  • Fast Tests For Drug Resistance Bolster Malaria Fight (NPR)
  • From Club to Clinic: Physicians Push Off-Label Ketamine as Rapid Depression Treatment, Part 1 (Scientific American)
  • How to Trace a Sarin Attack (MIT)
  • BioPharma Tech Firms Can Help Prevent Bioweapon Production, Says UN (Biopharma Reporter)

Regulatory Reconnaissance #152 - 12 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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