BIOGEN AVONEX APPROVAL ALLOWED BY LACK OF INJECTION-SITE NECROSIS seen with Berlex/Chiron's Betaseron (interferon beta-1b), FDA said in approving the Biogen multiple sclerosis product. In a May 18 "Talk Paper," FDA said that "this new product has been allowed to enter the market because it differs from interferon beta-1b based on an absence of reports of injection site necrosis." FDA does not indicate whether the molecular difference of one amino acid between the products played a role in its decision to allow Avonex on the market despite Chiron's orphan exclusivity for Betaseron.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
