FDA Class-Wide REMS Meeting Won’t Deter Embeda Approval, King Believes
This article was originally published in The Pink Sheet Daily
Executive Summary
Drug maker expects to meet with FDA in July on “complete response” for Remoxy.
You may also be interested in...
Now Who Needs a Painkiller? King and Pain Therapeutics Face a Remoxy Setback
A filing is now expected in mid-2010, although the delay looks to be a bigger hit to Pain Therapeutics than King, S&P analyst says.
Now Who Needs a Painkiller? King and Pain Therapeutics Face a Remoxy Setback
A filing is now expected in mid-2010, although the delay looks to be a bigger hit to Pain Therapeutics than King, S&P analyst says.
Business In Brief
Graceway licenses derm compounds from Pfizer: In Pfizer's first out-licensing transaction since announcing its merger with Wyeth in January, the pharma is selling worldwide commercial rights and related intellectual property to three investigational dermatology candidates to Graceway Pharmaceuticals. Financial terms were not disclosed. Pfizer said the deal is part of its "plan to out-license R&D programs that are no longer core to its strategy." Privately held Graceway gains two Phase II programs for treatment of oily skin and acne - an SCD1 inhibitor and an ACAT inhibitor - along with a preclinical ALK-5 inhibitor for reduction of surgical and traumatic scars. In addition to dermatology, Graceway also markets drugs in the respiratory and women's health areas