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news.FDA requests additional trial data for SkyePharma asthma drug
SkyePharma says further discussions will be held over the coming weeks with the FDA to agree the scope of any additional clinical work. Undertaking this work could result
SkyePharma says further discussions will be held over the coming weeks with the FDA to agree the scope of any additional clinical work. Undertaking this work could result
The company said that the positive results demonstrated the ability of Phosphagenics’s TPM technology to deliver insulin into the bloodstream in a non-invasive manner without causing any adverse
Neuromed said that the drug, MK-6721, does not demonstrate the ideal pharmaceutical characteristics considered necessary to advance the compound further in development. However, a joint research collaboration will
The amended agreements restructure the agreements originally signed in 2001, and are based upon the letter of intent signed in January 2006. Under the terms of the restated
Meridian will manufacture up to 10 clinical experimental vaccines per year at its biopharmaceutical facility located in Memphis, Tennessee. Meridian will be working closely with the Laboratory of
Abraxis Pharmaceutical Products (APP) currently manufactures and distributes Oxytocin in 1ml and 10ml vials. The company will distribute the larger size in multi-dose vials with latex-free stoppers and
The agreement provides Archemix with access to approximately four hundred issued and pending Isis patents covering proprietary chemistries, analytical methods and manufacturing methods related to the research, development
GSK has agreed to waive royalties on the basis that Apotex’s triple combination generic ARV will be supplied on a no profit basis. The drug contains two molecules
In the preclinical toxicology studies, the compound was generally safe and well tolerated in animals at dose levels that are expected to exceed a therapeutically relevant dose. In
The supplemental biologics license application (sBLA) is based on data a double-blind, randomized trial that consisted of three periods; the first period involved a four-month open-label lead-in treatment