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Generex Biotechnology has announced that its wholly owned subsidiary, Antigen
Express, has established collaborations with Emory University and the Imperial
College of London to develop a novel smallpox vaccine.
Medtronic and Alnylam Pharmaceuticals will collaborate to pursue potential
therapies designed to treat neurodegenerative disorders such as Huntington's,
Alzheimer's and Parkinson's disease.
Hana Biosciences has announced an initial clinical study that will compare
the pharmacokinetic profile of the lingual spray formulation of ondansetron
to the approved oral dosage of Zofran, the world's best-selling anti-emetic
agent, currently marketed in the U.S. by GlaxoSmithKline.
The New England Journal of Medicine has published results of a Celgene-sponsored
Phase I/II trial evaluating Revlimid therapy for myelodysplastic syndromes (MDS).
Vical has successfully completed a special protocol assessment (SPA) with the
FDA for a Phase III trial of high-dose (2 mg) Allovectin-7 for certain patients
with metastatic melanoma.
Vion Pharmaceuticals has reached agreement on a special protocol assessment
(SPA) with the FDA for a Phase III clinical trial of Cloretazine in combination
with Ara-C in relapsed acute myelogenous leukemia (AML).
Join FDAnews Feb. 24 to learn about "Drug Marketing Practices in
Europe: Navigating Tough Rules and New Enforcement," a 90-minute audioconference.
Hear former FDA official Linda Horton, now an attorney with Hogan &
Hartson, explain how the new EU Community Code on Medicinal Products affects
your marketing activities, including your relationship with health professionals.
On Feb. 25, receive a concise and expert analysis of the "Medicare Part
D for Drugmakers: New Requirements, New Risks, New Markets," presented
in a 90-minute audioconference by Keith Korenchuk of McGuireWoods and
Sheryl Vacca of Deloitte & Touche.
The FDA has accepted BioMarin Pharmaceutical's biologics license application
for its enzyme replacement therapy rhASB and has assigned the drug a six-month
review.