Marketing authorization

Aradigm Announces Submission of Responses to EMA Day 120 Questions and Meeting with FDA

Retrieved on: 
Wednesday, January 30, 2019
Health, Pharmaceutical, Health, Pharmaceuticals policy, Agencies of the European Union, Pharmaceutical industry, European Medicines Agency, European Union, Marketing authorization, EMA, Government agencies, Articles

Aradigm Corporation (OTCQB: ARDM) (Aradigm or the Company) submitted responses to the European Medicines Agency (EMA) Day 120 questions on 23 January 2019.

Key Points: 
  • Aradigm Corporation (OTCQB: ARDM) (Aradigm or the Company) submitted responses to the European Medicines Agency (EMA) Day 120 questions on 23 January 2019.
  • The submission of the responses to the questions triggers the restart of the regulatory clock.
  • As part of the EMA regulatory review calendar for marketing authorization application submissions to the EMA for approval, Aradigm will expect a Day 180 List of Outstanding Issues in late March.
  • The clock will stop again until Aradigm responds to those issues, usually within thirty to sixty days.

2-Day Seminar: The New EU Animal Health Legislation for Veterinary Medicinal Products (London, United Kingdom - March 6-7, 2019) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 22, 2019
Education, Health, Training, Veterinary, Pharmaceuticals policy, Organizations, Health, International organizations, European Union, Marketing authorization, European Medicines Agency

The "The New EU Animal Health Legislation for Veterinary Medicinal Products" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The New EU Animal Health Legislation for Veterinary Medicinal Products" conference has been added to ResearchAndMarkets.com's offering.
  • The new EU animal health legislation (EU Regulation 2019/6) for veterinary medicinal products will have massive implications for all animal health companies operating in, or wanting to operate in the EU.
  • This seminar will provide essential insight into these revolutionary changes and enable participants to plan their regulatory strategies going forward.
  • The programme will offer a comprehensive introduction to the legislative changes and will address the new issues, marketing authorisation (MA) submissions and dossiers.

BioMarin Receives Milestone Payments from Pfizer for Talazoparib

Retrieved on: 
Thursday, June 7, 2018
Health, Pharmaceutical industry, BioMarin Pharmaceutical, Novato, California, PARP inhibitors, Pfizer, Medivation, New Drug Application, Talazoparib, Marketing authorization, Food and Drug Administration

SAN RAFAEL, Calif., June 7, 2018 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the Company received $20 million in milestone payments from Pfizer Inc.

Key Points: 
  • SAN RAFAEL, Calif., June 7, 2018 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the Company received $20 million in milestone payments from Pfizer Inc.
  • These milestone payments were triggered by the U.S. Food and Drug Administration (FDA) acceptance of Pfizer'sNew Drug Application (NDA) submission for talazoparib and by the European Medicines Agency (EMA) acceptance of Pfizer's submission of a Marketing Authorization Application (MAA) for talazoparib.
  • These milestone payments are part of an agreement made with Medivation, Inc.when the company purchased talazoparib.
  • BioMarin is a registered trademark of BioMarin Pharmaceutical Inc.