Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Abbott's Sevorane
Will be the subject of a two-day meeting of FDA's Anesthetic & Life Support Drugs Advisory Committee Jan. 17-18 beginning at 8:30 a.m. Abbott filed an NDA for Sevorane (sevoflurane, NDA 20-478), an inhalation anesthetic licensed from Japanese firm Maruishi, in the early fall ("The Pink Sheet" Oct. 17, p. 13). The anesthetic and life support committee is also scheduled to consider pending INDs and NDAs during a closed session on the afternoon of Jan. 18. The meeting will take place at FDA's Parklawn Building, Conference Rooms D&E
More from Archive
• By
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.
• By
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
• By
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.
• By
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
• By
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
• By
Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.
• By
Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.