Regulatory Focus™ > News Articles > Regulatory Recon: First US Vaccine for Meningitis B Approved (30 October 2014)

Regulatory Recon: First US Vaccine for Meningitis B Approved (30 October 2014)

Posted 30 October 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: First US Vaccine for Meningitis B Approved (30 October 2014)

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

In Focus: US

  • First vaccine approved by FDA to prevent serogroup B Meningococcal disease (FDA) (Press) (Fierce) (Reuters) (NYTimes) (SCRIP-$) (Pink Sheet-$) (Medscape) (PharmaTimes) (BioCentury)
  • Moms, Regulators, Biotech Startups, and the Battle Over a Potentially Life-Saving Drug (Bloomberg)
  • FDA GMP Quality Metrics Will Be Industry’s ‘SAT Score’ (Pink Sheet-$)
  • North Dakota Court Bans Use of Drug in Abortions (PharmPro) (Jurist)
  • Feeling Dissed, Amgen Sues After Sandoz Abandons the BPCIA Patent Dance Procedures for NEUPOGEN Biosimilar; Alleges Unfair Competition, Patent Infringement, and Theft (FDA Law Blog)
  • Rep. McCaul outlines compassionate access bill (BioCentury)
  • FDA's Drug Risk Promo Proposal Slammed By All Sides (Law 360-$)
  • FDA Zeros In on Abuse-Deterrent Opioids (MedPage Today)
  • Will different medical devices call for different cyber standards? (Fedscoop)
  • Judge Takes Broad View On FTC's Bayer Complaint Despite DoJ's Narrow Focus (Tan Sheet-$)

In Focus: International

  • EMA advises on development plan for GSK Ebola vaccine (EMA) (SCRIP-$)
  • Revised framework for development of influenza vaccines (EMA) (EMA)
  • EMA Releases New Discussion Paper on Alzheimer's Disease (EMA)
  • Cipla asks government to revoke five patents held by Novartis (India Times) (Reuters)
  • Database Exploitation Could Slash Clinical Trial Durations, Cut Costs (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology

  • First vaccine approved by FDA to prevent serogroup B Meningococcal disease (FDA) (Press) (Fierce) (Reuters) (NYTimes) (SCRIP-$) (Pink Sheet-$) (Medscape) (PharmaTimes) (BioCentury)
  • Moms, Regulators, Biotech Startups, and the Battle Over a Potentially Life-Saving Drug (Bloomberg)
  • FDA GMP Quality Metrics Will Be Industry’s ‘SAT Score’ (Pink Sheet-$)
  • North Dakota Court Bans Use of Drug in Abortions (PharmPro) (Jurist)
  • Feeling Dissed, Amgen Sues After Sandoz Abandons the BPCIA Patent Dance Procedures for NEUPOGEN Biosimilar; Alleges Unfair Competition, Patent Infringement, and Theft (FDA Law Blog)
  • Rep. McCaul outlines compassionate access bill (BioCentury)
  • FDA's Drug Risk Promo Proposal Slammed By All Sides (Law 360-$)
  • FDA Zeros In on Abuse-Deterrent Opioids (MedPage Today)
  • CDER Office of Product Quality Raises Manufacturing Profile Within FDA, Poses Similar Challenge To Industry (RPM Report-$)
  • Office of Pharmaceutical Quality Means No More ‘Shaking the Tree’ at FDA (Gold Sheet-$)
  • Generics Industry Asks FDA to Focus Definition of Controlled Correspondence (FDAnews-$)
  • FDA Puts an Accent on the Positive (Gold Sheet-$)
  • Flublok Now Approved for Use in All Adults (MPR) (Press)
  • AstraZeneca wins U.S. approval for two-in-one diabetes pill (Reuters) (Press)
  • The FDA Warning on Antidepressants and Suicidality — Why the Controversy? (NEJM) (NEJM)
  • Make all Rx contraceptives OTC, lawyer urges FDA (MM&M)
  • Female Libido: Should There Be a Drug for That? (MedPage Today)
  • Selling Imported Medicines in Maine (Pharmalot)
  • Petition: Restrict Use of Cipro (FDA)
  • Petition: Extend Recommended Duration of Treatment Labeling for Tamoxifen Citrate (FDA)
  • Princeton University unsure whether it will offer first FDA-approved meningitis B vaccines (NJ Star Ledger)

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

  • U.S. FDA Grants Fast Track Designation to Novavax' H7N9 Influenza Virus-Like Particle Vaccine Candidate Adjuvanted With Matrix-M (Press)
  • RetroSense Therapeutics Granted Orphan Drug Designation for Lead Product RST-001 for Retinitis Pigmentosa (Press)
  • Neurocrine Biosciences Receives Breakthrough Therapy Designation for NBI-98854 in Tardive Dyskinesia (Press)
  • Novo Nordisk more cautious on timing of U.S. Tresiba launch (Reuters)
  • Baxter’s Investigational 20% Subcutaneous Immunoglobulin Treatment Meets Efficacy and Tolerability Endpoints in Phase 2/3 Study (Press)
  • GW Pharmaceuticals Commences Phase 2/3 Clinical Trial of Epidiolex(R) as a Potential Treatment for Epilepsy in Dravet Syndrome (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Will different medical devices call for different cyber standards? (Fedscoop)
  • FDA Encourages Development of Devices for Patients with Disabilities (FDA)
  • Chembio's DPP(R) HIV 1/2 Assay Receives CLIA Waiver From FDA (Press)

US: Dietary Supplements

  • Judge Takes Broad View On FTC's Bayer Complaint Despite DoJ's Narrow Focus (Tan Sheet-$)
  • US: Assorted And Government

Upcoming Meetings

Ebola Outbreak

  • EMA advises on development plan for GSK Ebola vaccine (EMA) (SCRIP-$)
  • FDA as part of a coordinated global response on Ebola (FDA) (WebMD)
  • Canadian Ebola vaccine to be tested in Europe, Gabon, Kenya (Reuters)
  • Chimerix Plans $105M Stock Offering to Finance Ebola Drug Trials (Xconomy)

Europe

  • Revised framework for development of influenza vaccines (EMA) (EMA)
  • EMA Releases New Discussion Paper on Alzheimer's Disease (EMA)
  • Greek industry seeks justice after government pricing blunders (SCRIP-$)
  • European Medicines Agency closed 31 October 2014 (EMA)
  • The HTA Network Strategy and EUnetHTA JA2 Recommendations endorsed and go live at HTA 2.0 Europe in Rome (EUnetHTA)

India

  • Cipla asks government to revoke five patents held by Novartis (India Times) (Reuters)
  • Patent office eases rule for pharma companies  (LiveMint)
  • DCGI to approve clinical trial proposals for new drugs approved abroad, FDCs, subsequent new drugs & vaccines (PharmaBiz)
  • Indian drugmakers asks US Trade Representative body to restore faith in new trade policy (India Times)

Canada

  • Health Canada approves sales of Spartan DNA testing device (Globe and Mail)

Other International

  • South Africa MCC updates eCTD implementation roadmap (Exalon)

Clinical Trials

  • Are Internet-Based Studies the Future of Clinical Research? (Lilly)
  • Database Exploitation Could Slash Clinical Trial Durations, Cut Costs (Pink Sheet-$)
  • Millionaire crowdfunding: the future of clinical trials? (Outsourcing Pharma)

General Regulatory And Interesting Articles

  • Tips on Getting a Regulatory Affairs Job with No Work Experience (Regdy)
  • How to Tell Which Contract Manufacturer to Use (Gold Sheet-$)
  • Some Antibiotics Humor in Honor of Halloween (Imgur)
  • The New Heroin Epidemic (The Atlantic)
  • Security Risks Inherent in the Medical Device Lifecycle (MedicalDesign)

Regulatory Reconnaissance #430 – 30 October 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.

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.


Categories: Recon, Regulatory News

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