Regulatory Focus™ > News Articles > Regulatory Reconnaissance (23 October 2013)

Regulatory Reconnaissance (23 October 2013)

Posted 23 October 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

  • J&J's hepatitis C drug simeprevir gets nod from FDA staff before panel (AP) (SCRIP-$) (Fierce) (Pink Sheet-$) (Bloomberg)
  • Report: Feds get big 'bang for the buck' in fighting pharma fraud (Fierce)
  • FDA's Stem Cell Oversight Faces Pivotal Test In DC Court Case (Law 360-$)
  • FDA Hopes Not To Repeat Exchange Portal Glitches With UDI Database (IHP-$)
  • AHPA requests 'common sense' change to way FDA issues GMP inspection reports (Nutra Ingredients)
  • NIH awards $79M for clinical and translational science (GovHealthIT) (NIH)

In Focus: International

  • NICE backs Novartis/ ThromboGenics' eye drug (PMLive) (Pharma Letter-$)
  • EC approves Gentium's defibrotide (BioCentury)
  • New rules for German biosimilars on the cards (SCRIP-$)
  • India Drug Innovators Threaten To Take Clinical Trials Elsewhere (PharmAsia-$)
  • 3D Printing Umbilical Cord Clamps in Haiti (Makezine)

US: Pharmaceuticals/Biotechnology

  • J&J's hepatitis C drug simeprevir gets nod from FDA staff before panel (AP) (SCRIP-$) (Fierce) (Pink Sheet-$) (Bloomberg)
  • FDA Broadens Use for Alvimopan (MedPage Today)
  • Report: Feds get big 'bang for the buck' in fighting pharma fraud (Fierce)
  • FDA's Stem Cell Oversight Faces Pivotal Test In DC Court Case (Law 360-$)
  • Astellas/Medivation stop prostate cancer trial early (Pharma Times)
  • FDA panel to discuss pediatric cancer products (BioCentury)
  • GSK announces US regulatory submission for fluticasone furoate monotherapy for asthma (Press)
  • ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV (Press) (SCRIP-$) (MM&M)
  • Cubist Announces Submission of New Drug Application for Investigational Antibiotic Tedizolid for Treatment of Serious Skin Infections (Press) (SCRIP-$) (BioCentury)
  • FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer (Press)
  • Merck & Co hep C combo designated as breakthrough (Press) (Pharma Times) (Fierce)
  • Merck Heart Drug Anacetrapib Runs Into New Worry (Forbes)
  • Breathe Deeply: Did Insmed Release Dodgy Data For Its Drug? (Pharmalot)
  • Pfizer's Remoxy Clears Manufacturing Hurdle, Still Needs BE, Abuse-Potential Studies (Pink Sheet-$)
  • FDA approves generic antidepressant, anti-smoking drugs (DSN)
  • FDA approves generic drug for bacterial vaginosis, protozoan infections (DSN)
  • Famy Care wins approval for generic contraceptive (DSN)
  • Poll suggests oncologists already using GSK melanoma drugs off-label (MM&M)
  • FDA announces voluntary recall of certain sterile products from Specialty Medicine Compounding Pharmacy  (FDA)

US: Pharmaceuticals and Biotechnology: General

  • Think Your Prescription Drug History is Private? Think Again. (LATimes)
  • NABP white paper stresses drug supply chain security (DSN)
  • As Drug Costs Rise, Bending the Law Is One Remedy (NYTimes)
  • Senators want prescription drug ads off Craigslist (MedCity News)

US: Medical Devices

  • FDA Hopes Not To Repeat Exchange Portal Glitches With UDI Database (IHP-$)
  • Improving Health Care through Mobile Medical Devices and Sensors (Brookings) (Paper)
  • St. Jude Medical wins FDA approval for Ilumien Optis device (Mass Device)

US: Dietary Supplements

  • AHPA requests 'common sense' change to way FDA issues GMP inspection reports (Nutra Ingredients)
  • Panel of experts proposes monograph system to regulate probiotics claims in US (Nutra Ingredients)

US: Assorted And Government

  • Recommendations to expand access to clinical trial data (MNT) (BioCentury)
  • NIH awards $79M for clinical and translational science (GovHealthIT) (NIH)
  • Administration releases preliminary cybersecurity standards (The Hill)
  • PEPFAR's Impending Leadership Transition (CGDev)

Upcoming Meetings And Events

  • 17-18 October 2013: Anti-Infective Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 21-22 October 2013: Public Workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II) (FDA)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA) (POSTPONED)
  • 23 October 2013: Investigational Device Exemption Process Meeting (FDA) (FDA)
  • 22-23 October 2013: FSMA Public Meeting Concerning Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies (FDA)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • NICE backs Novartis/ ThromboGenics' eye drug (PMLive) (Pharma Letter-$)
  • EC approves Gentium's defibrotide (BioCentury)
  • Ben Venue closure: Company evaluates facility, EMA evaluates shortages (Outsourcing Pharma)
  • New rules for German biosimilars on the cards (SCRIP-$)
  • Applications for new human medicines under evaluationby the Committee for Medicinal Products for Human Use (EMA)
  • Toumaz Receives CE Mark Approval for SensiumVitals Patient Monitoring System  (MedGadget)
  • Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle (EMA)

Asia

  • India Drug Innovators Threaten To Take Clinical Trials Elsewhere (PharmAsia-$)
  • Slump in GSK China sales caused by probe  (BioSpectrum)
  • Southeast Asian Regulators Ramp Up Anti-Corruption, Bribery Enforcement Ahead of ASEAN Pact (PharmAsia-$)

General Regulatory And Interesting Articles

  • 3D Printing Umbilical Cord Clamps in Haiti (Makezine)
  • Flu Vaccine May Help Prevent Cardiovascular Events (Forbes)
  • Study Illustrates Cognitive, Psychomotor Impairment of Epilepsy Drug Sodium Valproate (DSM)

Regulatory Reconnaissance #185 - 23 October 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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