Regulatory Focus™ > News Articles > Regulatory Recon: Novartis, Pfizer File MenB Vaccine Applications (17 June 2014)

Regulatory Recon: Novartis, Pfizer File MenB Vaccine Applications (17 June 2014)

Posted 17 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Novartis, Pfizer File MenB Vaccine Applications (17 June 2014)

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

In Focus: US

  • Novartis submits meningitis B drug for U.S. approval (Reuters)
  • Pfizer Announces Submission of Biologics License Application to the FDA for Investigational Meningococcal B Vaccine (Press)
  • TAVI: Edwards lands FDA approval for next-gen Sapien XT (Mass Device) (Forbes) (Reuters)
  • Testosterone, Adcetris and Antidepressants all on FDA's Radar Following Adverse Events (FDA)
  • Boehringer Says it Expects FDA Action on Diabetes Drug Empagliflozin by End of Year (PMLive)
  • PhRMA Comes Out Against "Well-Intentioned" State Right-to-Try Legislation (PhRMA) (BioCentury)
  • FDA Rule Could End Consumer Access to Antibacterial Soaps (ACI)

In Focus: International

  • Decline of Clinical Trials in Central and Eastern Europe: Fluctuation or Trend? (Applied Clinical Trials)
  • ABPI president: NICE needs political reform (Pharmafile)
  • EU agency chiefs say Europe risks falling 'further behind' on innovation and access to medicines (SCRIP-$)
  • Four High MNC Executives Leaving India In Wake Of Regulatory Changes (PharmAsia-$)
  • Drug Lag Debate In China Expands Beyond Industry, Regulator Corridors (PharmAsia-$)
  • China: An Analysis Of Drug Trademark Genericide And Protection Of Brands From Dilution (Mondaq)

US: Pharmaceuticals and Biotechnology

  • Testosterone, Adcetris and Antidepressants all on FDA's Radar Following Adverse Events (FDA)
  • Boehringer Says it Expects FDA Action on Diabetes Drug Empagliflozin by End of Year (PMLive)
  • PhRMA Comes Out Against "Well-Intentioned" State Right-to-Try Legislation (PhRMA) (BioCentury)
  • FDA Rule Could End Consumer Access to Antibacterial Soaps (ACI)
  • The End Of The Blockbuster? Implications For Pricing Of New Drugs (Health Affairs)
  • Caregivers want more real-world, caregiver-reported outcomes in inborn errors (BioCentury)
  • Sources: Bayer, J&J's Xarelto faces first U.S. lawsuits (Fierce) (Reuters)
  • National Pain Strategy Expected in September 2014 (Boston Globe)
  • Ban on Prescription Drug Reimportation Introduced in the NY Senate (Bill)
  • Lannett Receives FDA Approval for Codeine Sulfate Tablets USP, 15 mg, 30 mg and 60 mg (Press)
  • Scientific Information Request on Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (AHRQ)
  • National Preparedness and Response Science Board (previously known as the “National Biodefense Science Board”) Call for Nominees (HHS)
  • FDA Licenses First US Facility for Cell-Culture Influenza Vaccines (PharmTech)

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

  • Novartis submits meningitis B drug for U.S. approval (Reuters)
  • Pfizer Announces Submission of Biologics License Application to the FDA for Investigational Meningococcal B Vaccine (Press)
  • FDA Accepts New Drug Application for Symplmed’s Prestalia for the Treatment of Hypertension (Press)
  • FDA Grants Orphan Drug Designation to Soliris (eculizumab) for the Treatment of Patients with Myasthenia Gravis (MG) (Press)
  • Mirati Therapeutics Receives Orphan Drug Designation from FDA for Mocetinostat in Myelodysplastic Syndrome (Press)
  • DARA BioSciences' KRN5500 Granted Orphan Drug Designation by FDA for Treatment of Multiple Myeloma (Press)
  • Biogen and AbbVie release Phase III data for MS treatment (Pharma Letter-$) (BioCentury) (Reuters)
  • Late-stage trial success gives Actelion a 2nd potential big seller PAH drug (Reuters)
  • Phase III Trial Of Antiepileptic Drug Fycompa (Perampanel) Meets Primary Endpoints As Adjunctive Therapy In Patients With Uncontrolled Primary Generalized Tonic-Clonic Seizures (Eisai)
  • Vidaza misses in Phase III AML trial (BioCentury)
  • Karyopharm's drug for dog lymphoma nears approval (BioFlash)
  • Avion Gets Positive FDA Feedback Women's Health NDAs (Press)
  • Pfizer retracts another experimental cancer drug study (Retraction Watch)

US: Pharmaceuticals and Biotechnology: General

  • TrustInAds.org Releases New Trend Alert on Fraudulent Weight Loss Advertisements (Press)
  • Pfizer Says Nev. AG Hid Doc Destruction In Hormone Drug Suit (Law 360-$)
  • Physician Payments Sunshine Act: Issues To Watch For As You Submit Phase 2 Data (Policy and Medicine)

US: Medical Devices

  • TAVI: Edwards lands FDA approval for next-gen Sapien XT (Mass Device) (Forbes) (Reuters)
  • Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis (FDA)
  • FDA makes clear it won’t regulate apps like Apple’s HealthKit (MobiHealthNews)
  • Obesity device before FDA panel despite not meeting primary endpoints (Fierce) (CBS)
  • Can You Trust Lyme Disease Tests? (NECIR)

US: Assorted And Government

  • Counting value under the US Sunshine Act (PMLive)

Europe

  • Decline of Clinical Trials in Central and Eastern Europe: Fluctuation or Trend? (Applied Clinical Trials)
  • ABPI president: NICE needs political reform (Pharmafile)
  • EU agency chiefs say Europe risks falling 'further behind' on innovation and access to medicines (SCRIP-$)
  • Guideline on Influenza Vaccines – Quality Module (EMA)
  • EMA accepts Sanofi's Toujeo for review (BioCentury)
  • EMA Validates Marketing Authorization Applications for AbbVie’s Investigational, All-Oral, Interferon-Free Regimen for Genotype 1 Chronic Hepatitis C (Press)
  • EU Publishes Safety Assessment of Nanosilver (SCENIHR)
  • UK men first to get erection cream Vitaros (Pharma Times)

India

  • Four High MNC Executives Leaving India In Wake Of Regulatory Changes (PharmAsia-$)

Japan & China

  • Drug Lag Debate In China Expands Beyond Industry, Regulator Corridors (PharmAsia-$)
  • China: An Analysis Of Drug Trademark Genericide And Protection Of Brands From Dilution (Mondaq)
  • A Chinese Chemical Company And A 'Bath Salts' Epidemic (NPR)

Canada

  • Canada Opens Consultation on Prescription Drug Abuse (Health Canada)
  • Vertex Announces a Signed Letter of Intent to Enable Public Reimbursement of KALYDECO (ivacaftor) in Canada for Eligible People with Cystic Fibrosis (Press)

Other International

  • ANVISA proposing eased registration for lower-risk medical devices (Mass Device)
  • TGA joins EDQM's CEP assessment process (TGA)

General Regulatory And Interesting Articles

  • Cultivating Biosimilars: Pharma's challenge is to mirror both process and product to create "similar" biologic therapies (Pharma Manufacturing)

Regulatory Reconnaissance #338 – 17 June 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.

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


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