Regulatory Focus™ > News Articles > Regulatory Reconnaissance (27 August 2013)

Regulatory Reconnaissance (27 August 2013)

Posted 27 August 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your Focus editor will be at the 2013 RAPS: The Regulatory Convergence next month in Boston--will you? Early-bird registration ends this Friday. Find out more here.

In Focus: US

  • FDA OKs Topical Gel to Take Red Out of Rosacea (MedPage Today) (Galderma) (Pharma Letter) (SCRIP) (Pink Sheet)
  • An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions (FDA Law Blog)
  • White Paper Asserts That Existing Trade Agreements Provide No Data Exclusivity for Biologics (Patent Docs)
  • FDA Pushes Back ANDA Stability Guidance Enforcement By Six Months (Pink Sheet)
  • Dropout Rates for Oncology Phase I Trials Remain Under 10% (PR)
  • FDA's Secure Supply Chain Pilot Program Presents Opportunity for Expedited Imports of API and Finished Drug Products (Venable)
  • Hacking healthcare: Would we know if a medical device was hacked? (Mass Device)
  • FDA Takes On Enhanced, More Proactive Role In Trade Negotiations (IHP)

In Focus: International

  • China Orders Internet-Access Firms To Ban Illicit-Drug Ads (PharmAsia)
  • India firming up guidelines to regulate drug marketing practices (SCRIP)
  • EFPIA Backs MHRA Plan to Inspect APIs at Plants Not Ports (In-Pharma)
  • India mulls free diagnostic services for poor as free drugs plan stalls (SCRIP) (India Times)
  • Australia to track Yervoy patients to see if it's worth the $110K price (Fierce)

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

US

Pharmaceuticals/Biotechnology
  • FDA OKs Topical Gel to Take Red Out of Rosacea (MedPage Today) (Galderma) (Pharma Letter) (SCRIP) (Pink Sheet)
  • An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions (FDA Law Blog)
  • White Paper Asserts That Existing Trade Agreements Provide No Data Exclusivity for Biologics (Patent Docs)
  • FDA Pushes Back ANDA Stability Guidance Enforcement By Six Months (Pink Sheet)
  • Another Compounding Pharmacy Recalls Products due to Lack of Sterility Assurance (FDA)
  • Dropout Rates for Oncology Phase I Trials Remain Under 10% (PR)
  • Quickly Take Your Medicine: FDA's Secure Supply Chain Pilot Program Presents Opportunity for Expedited Imports of API and Finished Drug Products (Venable)
  • Bayer's Nexavar (sorafenib) Granted Priority Review for Differentiated Thyroid Cancer in the U.S. (Bayer) (Pharma Letter) (Reuters)
  • Catalyst Pharmaceutical Partners Receives Breakthrough Therapy Designation From FDA for Firdapse for the Treatment of LEMS (Catalyst)
  • California Assembly Passes Bill on Biosimilar Drug Use (Bloomberg)
  • Acura's abuse-deterrent pain drug fails mid-stage study goal (Reuters)
  • New Animal Drugs: Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol (FDA)
  • Auxilium Prediction: FDA Rejects Crooked Penis Drug (The Street)
  • Takeda and Zinfandel Pharmaceuticals Initiate Phase 3 TOMMORROW Trial of AD-4833 for the Delay of Onset of Mild Cognitive Impairment Due to Alzheimer's Disease in Subjects Selected Using a Genetic-Based Biomarker Risk Assignment Algorithm (Takeda)
Pharmaceuticals: General
  • HHS may contract with pharma subsidiary to reduce readmissions (BioCentury)
  • NIH: Prospective Grant of Exclusive Patent License: Use of Scopolamine to Treat Depression (NIH)
Medical Devices
  • Hacking healthcare: Would we know if a medical device was hacked? (Mass Device)
  • Clash between company and doc shakes HeartWare shares (Mass Device)
  • New Subcutaneous ICD Said To Pose 'Existential Crisis' For Older ICDs (Forbes)
  • BD Supports the FDA's Proposal to Reclassify Rapid Influenza Tests (BD)
  • Class 1 Recall: Trial Stem For Mp(R) Reconstruction Prothesis (FDA)
  • FDA clears Theradome's hair-loss helmet (Mass Device)
  • Magellan Diagnostics Receives FDA Clearance for LeadCare Ultra Bench-top Clinical Lead Analyzer (Magellan)
Assorted And Government
  • FDA Takes On Enhanced, More Proactive Role In Trade Negotiations (IHP)
  • PhRMA: The Best - Not Fastest - Deal Should be U.S. Goal in TPP (PhRMA)
  • Taylor: Defining Boundaries for Caffeine in Today's Marketplace (FDA)
Upcoming Meetings And Events
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • 4-5 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (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

  • EU-wide Holiday on Monday Means No News…

Asia

  • China Orders Internet-Access Firms To Ban Illicit-Drug Ads (PharmAsia)
  • India firming up guidelines to regulate drug marketing practices (SCRIP)
  • EFPIA Backs MHRA Plan to Inspect APIs at Plants Not Ports (In-Pharma)
  • India mulls free diagnostic services for poor as free drugs plan stalls (SCRIP) (India Times)
  • Russian government to change rules on public procurement of essential drugs (Pharma Letter)
  • Japan's First Committee On Drugs Approves 8 New Agents Including Takeda Obesity Drug (PharmAsia)
  • Japan's PM supports reform of drug pricing rules (Pharma Letter)
  • Novartis' Lucentis Approved In Japan For Choroidal Neovascularization And Macular Edema (PharmAsia)
  • China accuses Briton, American of illegally buying private data (Reuters) (FT)

Other International

  • Australia to track Yervoy patients to see if it's worth the $110K price (Fierce)
  • Addressing Pharma IP Law Imbalances in Australia (JD Supra)
  • Eisai Receives Prequalification From World Health Organization For Lymphatic Filariasis Medicine Diethylcarbamazine (Eisai)

General Regulatory And Interesting Articles

  • Antidepressants Linked to Postpartum Hemorrhage (Medscape)
  • 'Shapeshifting' computer program will open up drug discovery for tricky disease targets (EurekAlert)
  • Procarbazine, dacarbazine may up stomach cancer risk in Hodgkin's (SCRIP)
  • Why Aren't There More Cancer Vaccines? Blame America's lousy patent system. (Slate)

Regulatory Reconnaissance #140  - 27 August 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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