Regulatory Focus™ > News Articles > Regulatory Reconnaissance (25 November 2013)

Regulatory Reconnaissance (25 November 2013)

Posted 25 November 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

  • EMA recommends approval of sofosbuvir for the treatment of chronic hepatitis C (EMA) (BioCentury) (SCRIP-$) (PMLIve)
  • Otsuka's Tuberculosis Drug Delamanid Wins Backing of European Panel (WSJ-$) (EMA) (BioCentury) (Press) (SCRIP-$)
  • EMA recommends approval of new HIV medicine Tivacay (Dolutaegravir) (EMA) (Press)
  • Biogen wins protection for MS drug Tecfidera in Europe (Press) (Fierce) (Reuters) (SCRIP-$) (PMLive)
  • Indian health activists move to prevent Gilead's drug patent (Financial Times-$)
  • India: Need for a change in mindset to meet regulatory challenges in India: Experts (PharmaBiz)

US: Pharmaceuticals/Biotechnology

  • NRDC Lawsuit forces FDA to Take Action on Dangerous Chemical in Soaps (Press)
  • Margaret Hamburg on Personalized Medicine, Globalization, Budget Issues and More (BioCentury)
  • FDA approves J&J's new treatment for hepatitis C virus (FDA) (Pharma Times) (Pink Sheet-$) (Reuters) (AP) (BioCentury) (Press) (SCRIP-$)
  • FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza (FDA) (Fierce) (Reuters) (BioCentury) (SCRIP-$)
  • U.S. FDA approves Bayer/Onyx drug for a type of thyroid cancer (Reuters) (FDA) (MedPage Today) (Press) (SCRIP-$) (Pharma Times)
  • FDA GMP "Surveillance" Will Link Quality, Compliance Information To Inspections (Pink Sheet-$)
  • FDA: Anti-smoking drug Chantix linked to more than 500 suicides (Al Jazeera)
  • J&J Hit With Subpoena For Marketing of Percocet (Crain's)
  • Selling That New-Man Feeling: The Marketing of Low-T Drugs (NYTimes)
  • Genzyme's Lemtrada Experience Offers Lessons for "Breakthrough" Sponsors (RPM Report-$)
  • FDA Trial Design Challenge: Does Same Indication Demand Same Kind Of Study? (Pink Sheet-$)
  • OGD Serious About Its Revised Communication Practices (Lachman)
  • CV Adjudication Not Always Best Option To Ensure Trial Quality (Pink Sheet-$)
  • U.S. ANDA Review Shows India Drug Makers Leading Filer Past Two Years (PharmAsia-$)
  • Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates (FDA)
  • Vimizim Panel's Desire For Quality-Of-Life Data Runs Into Regulatory Reality (Pink Sheet-$)
  • House Pushes FDA To Expedite Sunscreen Ingredient Reviews (Tan Sheet-$)
  • Regeneron gains on Phase III data for RA compound (BioCentury) (Press) (SCRIP-$)
  • Avedro Announces FDA Priority Review Status for Corneal Cross-linking New Drug Application (Press)

US: Pharmaceuticals and Biotechnology: General

  • The Media Needs to Stop Stigmatizing Our Best Weapon Against Heroin Addiction (TNR)
  • This drug could make a huge dent in heroin addiction. So why isn't it used more? (Washington Post)
  • Meningitis victims hope for Mass. criminal charges (AP)

US: Medical Devices

  • Hiring Up for Regulatory Affairs in MedTech (MDDI)
  • How FDA Quietly Dropped Patient Warning Rule from LASIK Approvals (MDDI)
  • New FDA Pilot Program To Identify 'Critical-To-Quality' Points (Gray Sheet-$)
  • Industry Encouraged By FDA Fulfillment Of MDUFA 2013 Goals (Gray Sheet-$)
  • FDA, Lawmakers Blast CMS For Eying Hospital-Driven Imaging Maintenance (IHP-$)
  • Fenwal lands 510(k) clearance for Alyx blood collection software (Mass Device)
  • Kinetic Concepts wins FDA OK for new wound therapy device (Mass Device)
  • The Artificial Pancreas: A Race To The Finish (In Vivo-$)

US: Dietary Supplements

  • FDA to outline where a liquid supplement ends and a conventional food and beverage begins (Food Navigator)
  • We don't see the pre-workout sector going in the right direction post-DMAA: Chromadex CEO (Nutra-Ingredients)

US: Assorted And Government

  • Announcement of Requirements and Registration for the Predict the Influenza Season Challenge (CDC)
  • Enforcement Report - Week of November 20, 2013 (FDA)
  • SCRIP's Capitol Capsule (SCRIP-$)
  • Roth, Who Led FDA's Criminal Probes, Nominated As Homeland Security IG (IHP-$)

Upcoming Meetings And Events

  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA recommends approval of sofosbuvir for the treatment of chronic hepatitis C (EMA) (BioCentury) (SCRIP-$) (PMLIve)
  • Otsuka's Tuberculosis Drug Delamanid Wins Backing of European Panel (WSJ-$) (EMA) (BioCentury) (Press) (SCRIP-$)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 2013 (EMA)
  • EMA recommends approval of new HIV medicine Tivacay (Dolutaegravir) (EMA) (Press)
  • Biogen wins protection for MS drug Tecfidera in Europe (Press) (Fierce) (Reuters) (SCRIP-$) (PMLive)
  • ViiV's dolutegravir backed by CHMP (BioCentury) (SCRIP-$)
  • European Medicines Agency advises on compassionate use of daclatasvir (EMA)
  • European agency backs Ariad's leukemia drug Iclusig, shares jump (EMA) (Press) (Reuters) (SCRIP-$) (PMLive)
  • Report: EU regulator readying pay-for-delay move on J&J, Novartis (Fierce) (Reuters)
  • Decision Due in EMA vs. Abbvia/Intermune Case in Coming Weeks (AllTrials)
  • Sorin wins CE Mark for stentless heart valve (Mass Device) (Fierce) (Press)

Asia

  • Indian health activists move to prevent Gilead's drug patent (Financial Times-$)
  • India: Need for a change in mindset to meet regulatory challenges in India: Experts (PharmaBiz)
  • India: Supreme Court to resume hearing case against market-based drug pricing on Nov 25 (PharmaBiz)
  • India: Govt considering to have separate pricing policy for biosimilars soon (PharmaBiz)
  • Philippines Orders Recall Of Eight More Lilly Drugs For Lack Of Certificate (PharmAsia-$)

Other International

  • Canada's top court upholds Ontario ban on private-label drugs (Reuters) (Law 360-$)

General Regulatory And Interesting Articles

  • Only Half of Drugs Removed by Sewage Treatment (Scientific American)
  • ADHD Fakers Hankering for Pills Thwarted by Lie Detectors (Bloomberg)
  • NIH mouse study finds gut microorganisms may determine cancer treatment outcome (NIH) (EurekAlert)
  • Italian Study Supports Association between Diabetes Drugs and Pancreatitis (DSM)
  • Steroid injections for pre-term babies linked to mental health risk (Reuters)
  • Acne drug users need to know birth control options: study (Reuters)
  • Too much Tylenol in pregnancy could affect development (Reuters)
  • University patents limit access to medicine. These students want to change that. (Washington Post)
  • Is a new device the next frontier for weight loss? (Beaker's Blog)
  • Antidepressant medication does not increase the risk of autism (EurekAlert)
  • Antiviral Drugs, Found to Curb Flu Deaths in Children, Fall in Use (NYTimes)
  • When We Lose Antibiotics, Here's Everything Else We'll Lose Too (Wired)

Regulatory Reconnaissance #209 - 25 November 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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