Header graphic for print
FDA Life News and Trends Impacting the FDA and Life Science Industry

Category Archives: Rare Diseases

Subscribe to Rare Diseases RSS Feed

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

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

Posted in Drugs, Labeling, Litigation, Rare Diseases

antibioticsAs discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015 to file an amended complaint and a temporary restraining … 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