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Category Archives: Generic Drugs

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International Council on Harmonisation (ICH) Includes Generic and Biosimilars Trade Organization (IGBA) for the First Time

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs

ThinkstockPhotos-179040440On June 15, 2016, the International Council for Harmonisation (ICH) (formerly the International Conference on Harmonisation) announced that the International Generic and Biosimilars Medicines Association (IGBA) could join ICH as an Assembly Member.  For the first time, an association representing … Continue Reading

IGBA and Medicines for Europe Hold Joint Annual Meeting in Dubrovnik, Croatia, in June 2016 – Part 2 of 2

Posted in Biosimilars, European Union, Generic Drugs, Meetings

croatiaThis is a continuation of coverage of the International Generic and Biosimilars Association (IGBA) (formerly known as the International Generic Pharmaceutical Alliance (IGPA)) and Medicines for Europe (formerly known as the European Generic and Biosimilars Association (EGA)) joint 19th IGBA Continue Reading

IGBA and Medicines for Europe Hold Joint Annual Meeting in Dubrovnik, Croatia, in June 2016 – Part 1 of 2

Posted in Biosimilars, European Union, Generic Drugs, Meetings

croatiaOn June 8-10, 2016, the International Generic and Biosimilars Association (IGBA) (formerly known as the International Generic Pharmaceutical Alliance (IGPA)) and Medicines for Europe (formerly known as the European Generic and Biosimilars Association (EGA)) held a joint 19th IGBA Continue Reading

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

Posted in Antitrust, Drugs, Generic Drugs, Litigation, Rare Diseases

antibioticsOn May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”), holding that … Continue Reading

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

Posted in Biosimilars, Clinical Studies, Drugs, European Union, Generic Drugs, Litigation, Meetings, Rare Diseases

EGA Legal Affairs ForumOn the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates and strategies (see here for a … Continue Reading

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part One of Two

Posted in Biosimilars, Drugs, European Union, Generic Drugs, Meetings, Patents

EGA Legal Affairs ForumOn March 26-27, 2015, the European Generic and Biosimilar Medicines Association (“EGA”) held its 11th Annual Legal Affairs Forum. The Forum kicked off with an introduction by Sergio Napolitano, Legal Affairs and Trade Director, EGA, who organized this … Continue Reading

EGA’s 11th Legal Affairs Forum in Brussels Later This Week: Still Time to Register!

Posted in Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Legislation, Litigation

EGA Legal Affairs ForumLater this week in Brussels, Belgium, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum. The Forum will be held on March 26-27, 2015 utilizing an interactive format that provides ample opportunities … Continue Reading

11th Legal Affairs Forum in Brussels, Belgium on March 26-27, 2015

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Litigation, Meetings, Patents

EGA Legal Affairs ForumOn March 26-27, 2015, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum in Brussels, Belgium. The Forum will focus particularly on:

–       EGA 2020: Where Are the Latest Trends Leading this Sector?

A … Continue Reading

McGuireWoods’ Brian Malkin Speaks on Biosimilars Patent Litigation at EGA’s Legal Affairs Forum in Brussels on March 27, 2015

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs, Meetings

EU buildingOn March 27, 2015, McGuireWoods’ Brian J. Malkin will be speaking on “Biosimilars Patent Litigation” at the European Generic Medicines Association’s (EGA’s) Legal Affairs Forum in Brussels, Belgium. The Legal Affairs Forum highlights trends in the generic sector leading to … Continue Reading

NYSBA Food, Drug and Cosmetic Section Annual Meeting Features Medical Device Advertising (FDA and FTC), Laboratory Developed Tests, Attorney Ethics Representing Medical Marijuana Clients, and Important Case Updates Featuring New York’s Chief of the Antitrust Bureau

Posted in Advertising and Promotion, Drugs, Enforcement, Generic Drugs, Healthcare, Legislation, Litigation, Medical Devices, Meetings

On January 29, 2015, the Food, Drug and Cosmetic Law Section (FDC Section) of the New York State Bar Association (NYSBA) will hold its Annual Meeting at the New York Hilton Midtown, New York City.  This year’s meeting includes a Continue Reading

GPhA Fall Technical Conference 2014 Gets Technical Again with FDA Demanding More Quality – Part 1 of 2

Posted in Drugs, Generic Drugs, Meetings

On October 27-29, 2014, the Generic Pharmaceutical Association (GPhA) held its annual Fall Technical Conference.  The Conference featured a pre-conference on the United States Pharmacopeia’s initiatives and various hot button-issues, such as biosimilar naming and interchangeability and risk evaluation Continue Reading