Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Alpharma ANDA (75-518) for private label version of Pharmacia & Upjohn's Rogaine Extra Strength for Men tentatively approved July 22. Three-year marketing exclusivity for P&U's 5% minoxidil topical solution expires Nov. 14, 2000. At a July 29 American Academy of Dermatology meeting, Marty Sawaya, MD, University of Miami, noted hair loss treatments undergoing clinical trials include 5% minoxidil for women, for which P&U previously has said clinical trials have not shown significant effects. "We hope that by early next year 5% minoxidil [for women] will gain approval so that we can offer more treatment options," Sawaya said
Create an account to read this article
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.’
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.