Regulatory Focus™ > News Articles > Regulatory Recon: Long-Sought OK in UK for Biogen's Tecfidera (11 July 2014)

Regulatory Recon: Long-Sought OK in UK for Biogen's Tecfidera (11 July 2014)

Posted 11 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Long-Sought OK in UK for Biogen's Tecfidera (11 July 2014)

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In Focus: US

  • FDA Briefing on Social Media Guidances Implodes Over Technical Problems (RegulatoryRX) (FDA Slides) (BioWorld)
  • US FDA offers draft guidance on conducting shedding studies for gene therapies (BioPharma Reporter)
  • Questcor Reveals Adverse Events Data for Acthar for First Time (NYTimes)
  • FDA on course for repeat oncology approvals performance (SCRIP-$)
  • Frances Kelsey still going strong at 100 (Cowichan Citizen)
  • Indian Pharma Groups Accuse US Companies of Campaign to Ruin Reputation (In-Pharma)
  • What Does the Future Hold for Medtech? Regulators Will Strive for Efficiency (MDDI)
  • Federal health IT policy committee work groups consolidate (Modern Healthcare-$)

In Focus: International

  • NICE OK for Biogen MS pill Tecfidera (Pharma Times)
  • Europe Gears Up to Attack Counterfeit Medicines—But Only Some of Them (PharmExec)
  • Drug apps should be reviewed by pharmacists (PMLive)
  • Wockhardt faces drug alert in UK (Business Standard)
  • EMA Approvals Down in 2014 from 2013 (Pharma Letter-$)
  • China commits to developing stricter controls on bulk chemical manufacturers (BioCentury)
  • Biotech associations form international council (BioCentury) (PharmExec)

US: Pharmaceuticals and Biotechnology

  • FDA Briefing on Social Media Guidances Implodes Over Technical Problems (RegulatoryRX) (FDA Slides) (BioWorld)
  • US FDA offers draft guidance on conducting shedding studies for gene therapies (BioPharma Reporter)
  • Questcor Reveals Adverse Events Data for Acthar for First Time (NYTimes)
  • Protecting the Global Drug Supply: FDASIA Title VII (FDA)
  • FDA on course for repeat oncology approvals performance (SCRIP-$)
  • Frances Kelsey still going strong at 100 (Cowichan Citizen)
  • Indian Pharma Groups Accuse US Companies of Campaign to Ruin Reputation (In-Pharma)
  • Massachusetts gives state boards more power over compounding pharmacies (Reuters) (Law 360-$)
  • Pre-emption and States' Rights (PharmExec)
  • Tufts study: Orphan drug approvals up, but high costs pose challenges (Boston Globe)
  • Two Chinese Pharma Companies Put on Import Alert (FDA)
  • Janet Woodcock Talks Mini-Sentinel (Federal News Radio)
  • ‘Gay Blood Drives’ Put Pressure on FDA to Lift Donor Ban (Boston Globe)
  • FDA Spread Thinly Abroad (PharmExec)
  • Sunscreen Innovation Act to get Full Committee Markup in House (E&C)
  • India's Sun Pharma recalls 41,000 bottles of antidepressant over failed dissolution testing (Reuters) (India Times)
  • Forest's Bystolic Fails Dissolution Testing, Recalls 92,000 Bottles (FDA)
  • Baxter Recalls 20,000 Bottles of Brevibloc Due to Iron Oxide Agglomeration (FDA)
  • West-Ward Pharma Recalls 27,000 Bottles of Isoniazid Tabs for Failed Dissolution Testing (FDA)
  • FDA Seeks Access to OTC Drug Utilization Data (FDA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

US: Pharmaceuticals and Biotechnology: General

  • WLF Slams Alemeda County Drug Disposal Ordinance (Forbes)
  • U.S. bioterror readiness highlighted after NIH smallpox discovery (Fierce)
  • Who Should Pay the Bill for Wonder Drugs? (Bloomberg)

US: Medical Devices

  • What Does the Future Hold for Medtech? Regulators Will Strive for Efficiency (MDDI)
  • Federal health IT policy committee work groups consolidate (Modern Healthcare-$)
  • Congress to Hear how Technology Can Inform 21st Century Cures (E&C)
  • Will Doctors Soon Prescribe Videogames? (FastCompany)
  • Ventlab, LLC., Ventlab Manual Resuscitator, Duckbill Valve May Stick and Prevent Air from Getting to the Patient (FDA)

US: Dietary Supplements

  • In light of FDA's reticence, professional help critical in NDI submissions (NI-USA)

US: Assorted And Government

  • Senate confirms Donovan to head OMB (The Hill)

Europe

  • NICE OK for Biogen MS pill Tecfidera (Pharma Times)
  • Europe Gears Up to Attack Counterfeit Medicines—But Only Some of Them (PharmExec)
  • 'Shocking and unacceptable' rise in UK animal testing (PharmaTimes)
  • Drug apps should be reviewed by pharmacists (PMLive)
  • Wockhardt faces drug alert in UK (Business Standard)
  • European Medicines Agency approves fewer drugs in first half of 2014 than same period in 2013 (Pharma Letter-$)
  • PRAC Concludes Safety Review of Several Medicines, Including Oral Methadone (EMA)
  • A million more offered bariatric surgery under NICE obesity guidelines (Pharma Times)
  • EU Nations Come Together Against 'Exorbitant' Hepatitis C Drug (MedIndia)
  • Natera Achieves CE Mark for Its Cloud-based Analytical Software to Support the Panorama Non-invasive Prenatal Test (Press)
  • Sigma-Tau Rare Disease Submits Application to the European Medicines Agency (EMA) for Use of PegylatedL-Asparaginase (Oncaspar®) in the Treatment of Acute Lymphoblastic Leukaemia (Press)
  • Servier to appeal EC fine over perindopril (Pharma letter-$)
  • France's ANSM to Test Breast Implants (ANSM)

India

  • Special cell in CDSCO to coordinate with agencies like ICMR for monitoring studies (PharmaBiz)

China

  • China commits to developing stricter controls on bulk chemical manufacturers (BioCentury)
  • Neptune Waterproof Cochlear Implant Sound Processor from Advanced Bionics Receives Approval in China (Press)
  • Beike receives approval from Chinese FDA for umbilical stem cells in lupus (Pharma Letter-$)

Japan

  • Japan Approves 22 Drugs Including First IFN-Free Hep C Therapy (PharmAsia-$)

Canada

  • Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily Adjunctive Treatment for Partial-Onset Seizures in Patients with Epilepsy (Press)

Other International

Clinical Trials

  • The Era Of Big Data And Its Implications For Big Pharma (Health Affairs)
  • Ebola Treatments Face Testing Hurdles as Hundreds Die (Bloomberg)

General Regulatory And Interesting Articles

  • Risk-Based Approach to Regulatory Compliance in Life Sciences – Beyond GxP Assessment (PCM)
  • New DARPA Project To Develop Implantable "Neuroprosthetics" (MedDevice Online)
  • It’s 10 o'Clock -- Do You Know Where Your Bubonic Plague Is? (Foreign Policy)
  • Combining vaccines may help eradicate polio (Reuters)

Regulatory Reconnaissance #355 – 11 July 2014

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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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