Regulatory Focus™ > News Articles > Regulatory Recon: Landmark Advisory Committee Meeting Recommends Biosimilar (8 January 2015)

Regulatory Recon: Landmark Advisory Committee Meeting Recommends Biosimilar (8 January 2015)

Posted 08 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Landmark Advisory Committee Meeting Recommends Biosimilar (8 January 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • Pharma 'shocked' as drugs cut from Cancer Drugs Fund (PharmaPhorum) (Pharma Times) (Pharmafile) (Fierce)
  • Is pharma ready to disclose its payments to doctors in Europe? (PharmaPhorum)
  • CHMP Recommends Approval of Xadago (Safinamide) to Treat Parkinson´s Disease in the EU (Press)
  • India: Select cancer drugs may skip clinical trials if safely marketed abroad (India Times)
  • Australia: Outsourcing approvals would put patients at risk, advocates say (SMH)

US: Pharmaceuticals and Biotechnology

  • Sandoz’s Biosimilar Filgrastim Sails Through FDA Panel (Pink Sheet-$) (Pharma Times) (NYTimes) (Fierce) (Reuters) (BioCentury) (Tarius) (SCRIP-$) (SCRIP-$)
  • ODAC Asks Sandoz If Biosimilar Price Is Right (Pink Sheet-$)
  • House legislators pushing for centralized IRBs (BioCentury)
  • FDA Approvals 1996 vs. 2014: The Two Most Prolific Years, But Stark Differences (Forbes)
  • Amgen Tries To Force Sandoz Biosimilar Disclosures (Law 360-$)
  • Sunrise For Sunscreen Innovation Act – FDA Seeks Comment On TEA Decisions (Tan Sheet-$) (FDA) (FR)
  • Adverse Event Reviews: FDA Needs To Boost ‘Accuracy And Efficiency’ (Pink Sheet-$)
  • A Conversation with FDA Commissioner Dr. Margaret Hamburg (FOCR)
  • BIO urges FDA to release guidance on biosimilars (Biosimilar News)
  • Why The U.S. Still Bans Blood Donations From Some U.K. Travelers (NPR)
  • Judge Orders Actavis to Continue Distribution of Alzheimer's Drug (AP)
  • Georgia ‘Right to Try’ Bill Would Nullify Some FDA Rules, Help Terminally Ill (10th Amendment Center)
  • US Seizes $18M From NECC Owners Charged In Outbreak (Law 360-$) (AP)
  • 10 drug approvals to watch for in 2015 (SCRIP-$)
  • Draft 2015 IMEDS Methods Research Agenda (Reagan-Udall)
  • Cadila recalls 19,536 bottles of cough treatment drug in US (Business Standard)
  • Pfizer complains, advertising watchdog acts against Novartis Theraflu promo (Fierce)
  • AngioDynamics still working to resolve 483s, Warning Letter (SEC)

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

  • Novartis Seeks U.S. Approval for Two Smoker’s Cough Drugs (Bloomberg) (Reuters) (Pharmafile)
  • Sosei Confirms the Submission of Regulatory Applications to US FDA and Robust Phase III Results for QVA149 and NVA237 (Press)
  • Impax's Parkinson's drug gets FDA approval (Reuters) (Press)
  • Pfizer: ODAC Won't Hold Meeting on Ibrance (Palbociclib) (Press)
  • AbbVie, Neurocrine drug successful in endometriosis trial (Reuters)
  • Biogen says mid-stage optic nerve treatment study succeeds (Reuters) (Press) (The Street) (Fierce)
  • Achaogen Announces Plazomicin Granted QIDP Designation by FDA (Press)
  • Melinta Therapeutics Reports Positive Phase 3 Results for Captisol-enabled Delafloxacin IV (Press)
  • FDA Grants Fast Track Designation to Debiopharm Group's Antibiotic Debio 1450 (Press)
  • Aeolus Announces Response to FDA Clinical Hold and Plan for Clinical Development of AEOL 10150 (Press)
  • Karyopharm Announces Orphan Designation Granted by FDA for Selinexor (KPT-330) in Multiple Myeloma (Press)
  • Infinity Pharma to stop developing drug for rheumatoid arthritis (Reuters)
  • CytRx cancer drug shows promise in mid-stage study (Reuters)
  • GW Pharma's cannabis drug fails in cancer pain study (Reuters)
  • Genervon Announces ALS Compassionate Use Results (Press)

US: Pharmaceuticals and Biotechnology: General

  • US hedge fund plans to take on big pharma over patents (Reuters) (Business Insider)
  • The Drugs That Companies Promote to Doctors Are Rarely Breakthroughs (The Upshot) (ProPublica)
  • Express Scripts' Miller lays out manifesto to fight sky-high drug prices (Fierce)
  • New York Vaccine Requirement Is Lawful, a 2nd Court Says (NYTimes)
  • Senator Markey Queries Pharmacies on Prescription Drug Labeling to Aid the Blind and Visually-Impaired (Press)

US: Medical Devices

  • PMA Decision Times Edged Upward, Likely Due To More Advisory Panels (Gray Sheet-$)
  • Should the government regulate laboratory-developed tests? (Modern Healthcare)
  • AdvaMedDx Statement on FDA LDT Public Workshop (AdvaMed)
  • Enhance Medical Device Cybersecurity to Help Prevent Product Recalls (Expert Recall)
  • Application of Quality by Design (QbD) Approach to Ultrasonic Atomization Spray Coating of Drug-Eluting Stents (PubMed)
  • OSHA NRTL’s approved for AAMI ES 60601-1 3rd edition + Amendment 1 (or edition 3.1) (Eisner Safety)
  • FTC's Edith Ramirez: Connected health devices create bevy of privacy risks (Fierce)
  • SynCardia wins FDA nod for destination therapy trial (Mass Device) (Fierce)
  • Webinar: FDA's Medical Device Clinical Trials Program - January 22, 2015 (FDA)

US: Dietary Supplements

  • FDA’s Letter to Herbalife: Who’s Misleading Whom? (FDA Law Blog)

US: Assorted And Government

  • FDA's Immergut to Bayer in Top US Comms Post (Press)
  • Enforcement Report - Week of December 31, 2014 (FDA)
  • Alexander Elected by Republican Colleagues to Chair the Senate Health, Education, Labor and Pensions Committee (Press)

Upcoming Meetings

Europe

  • Pharma 'shocked' as drugs cut from Cancer Drugs Fund (PharmaPhorum) (Pharma Times) (Pharmafile) (Fierce)
  • Is pharma ready to disclose its payments to doctors in Europe? (PharmaPhorum)
  • CHMP Recommends Approval of Xadago (Safinamide) to Treat Parkinson´s Disease in the EU (Press)
  • MHRA helps track and charge counterfeit drugs seller (Securing Industry) (MHRA)
  • EMA/EFPIA workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products (EMA)
  • EU Commission concessions ensure consistency at critical time (Clinica-$)
  • AVEO Receives Confirmation of Eligibility for Submission of a Tivozanib Marketing Authorization Application to the European Medicines Agency (Press)
  • Shield Therapeutics' 'Novel' oral iron drug accepted for review in Europe (SCRIP-$)
  • NephroGenex Announces that the European Medicines Agency Supports the Company’s Study Design for Ongoing Trial in Diabetic Nephropathy (Press)
  • Magnus Life Science Announces Recommendation for Orphan Designation (Press)

India

  • Select cancer drugs may skip clinical trials if safely marketed abroad (India Times)
  • Four large northern states lagging behind in ADR reporting, drug utilisation research (PharmaBiz)

China

  • China Introduces New Medical Device GMP and GSP Rules (Ropes & Gray)

Canada

  • Health Canada approves ACTEMRA (tocilizumab) for use in patients with early rheumatoid arthritis (RA) (Press)

Australia

  • Outsourcing approvals would put patients at risk, advocates say (SMH)

General Regulatory And Interesting Articles

  • From a Pile of Dirt, Hope for a Powerful New Antibiotic (NYTimes)

Regulatory Reconnaissance #467 – 8 January 2015

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.

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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