Just like 180 days exclusivity and its forfeiter in US, SPC is the matter in EU that always lead to a critical analysis and interpretation of such legislation. Recently Antwerp Court of Appeal has decided in a case of Novartis v Teva, case 2010/RK/456 on 9 february 2011. Court ordered to stop launching of generic version of Co-diovan due to existance of SPC of this combination. I got this details from SPC blog and they have provided translated case details that you can read from here.
Showing posts with label Novartis. Show all posts
Showing posts with label Novartis. Show all posts
Tuesday, February 15, 2011
Wednesday, January 19, 2011
Pfizer sues Novartis over Vfend (Voriconazole) antifungal patents
Pfizer Inc. has sued Novartis' Sandoz unit, claiming infringement of its U.S. patents related to the antifungal treatment Vfend which contains Voriconazole as active agent.
Pfizer alleges that Sandoz is seeking permission from the U.S. Food and Drug Administration to sell a generic version of Vfend before the expiration of two patents issued in 1994 and 2003, respectively.
Pfizer in its complaint filed with the U.S. district court in Wilmington, Delaware has sought the court’s order to block Sandoz from selling any version of Vfend before the patents expire.
(Source: http://www.itagbs.com/weekly_news.html)
Pfizer alleges that Sandoz is seeking permission from the U.S. Food and Drug Administration to sell a generic version of Vfend before the expiration of two patents issued in 1994 and 2003, respectively.
Pfizer in its complaint filed with the U.S. district court in Wilmington, Delaware has sought the court’s order to block Sandoz from selling any version of Vfend before the patents expire.
(Source: http://www.itagbs.com/weekly_news.html)
Monday, September 6, 2010
FDA warns Novartis about facebook widget
Drug company Novartis recently received a warning letter from the Food and Drug Administration’s Division of Drug Marketing, Advertising, and Communications about a widget enabling visitors to the Web site for the company’s drug Tasigna to share information with their Facebook friends
The FDA claimed that the widget for Tasigna, a leukemia drug, violated federal regulations because it made representations about the drug’s efficacy and failed to communicate any risk information. Tasigna’s Web site offered Novartis-created information about the drug that Facebook users could “share” with their friends by posting it on their wall or sending it as a separate message. For example, one item read, “In addition to taking Tasigna (nilotinib) 200-mg capsules, talking to your doctor and receiving health tips can help you treat your CML [chronic myeloid leukemia].” For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug,” the FDA said.
Why it matters: Because drug advertising faces stricter regulation than other industries, companies have expressed concern about meeting their requirements in the world of social media. In April, pharmaceutical companies filed written statements with the FDA, urging it to adopt guidelines specific to Web marketing and the use of social media, arguing that it is impossible to convey the risk information required in other forms of advertising in a 140-character Tweet or an Internet banner ad. While the FDA has set no timetable for issuing such guidelines, its letter to Novartis – the first sent directly addressing marketing efforts on Facebook – highlights the fact that the agency is monitoring the use of social media.
For full story click here
The FDA claimed that the widget for Tasigna, a leukemia drug, violated federal regulations because it made representations about the drug’s efficacy and failed to communicate any risk information. Tasigna’s Web site offered Novartis-created information about the drug that Facebook users could “share” with their friends by posting it on their wall or sending it as a separate message. For example, one item read, “In addition to taking Tasigna (nilotinib) 200-mg capsules, talking to your doctor and receiving health tips can help you treat your CML [chronic myeloid leukemia].” For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug,” the FDA said.
Why it matters: Because drug advertising faces stricter regulation than other industries, companies have expressed concern about meeting their requirements in the world of social media. In April, pharmaceutical companies filed written statements with the FDA, urging it to adopt guidelines specific to Web marketing and the use of social media, arguing that it is impossible to convey the risk information required in other forms of advertising in a 140-character Tweet or an Internet banner ad. While the FDA has set no timetable for issuing such guidelines, its letter to Novartis – the first sent directly addressing marketing efforts on Facebook – highlights the fact that the agency is monitoring the use of social media.
For full story click here
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