On 5/19/09, NicOx (EPA: COX.PA) announced that quality of life and utility results from its first Phase 3 clinical trial for naproxcinod were presented at the International Society For Pharmacoeconomics and Outcomes Research Annual International Meeting in Orlando, FL. Naproxcinod is a novel type of anti-inflammatory agent, which completed a Phase 3 clinical program last year in patients with osteoarthritis.

The drug is designed to have an improved side effect profile (including a neutral effect on blood pressure) as compared to a standard dose of the widely used NSAID drug naproxen. Naproxcinod has completed three pivotal Phase 3 studies with positive results. On 9/25/09, NicOx submitted a NDA for naproxcinod to the FDA for an estimated decision date of 7/25/10 for a standard, 10-month review.

On 3/25/09, Allos Therapeutics (NASDAQ: ALTH) filed a NDA with the FDA for Folotyn (pralatrexate injection) in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). ALTH received a priority (six-month) review designation on 5/26/09 with a PDUFA decision date of 9/24/09 for a final decision by the FDA. PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens.

On 9/2/09, ALTH the Oncologic Drugs Advisory Committee (ODAC) of cancer experts voted 10-4 that the Company's drug would likely benefit patients with PTCL. On 9/25/09, ALTH announced that the FDA granted accelerated approval for Folotyn for use as a single agent for the treatment of patients with relapsed or refractory PTCL as the first and only drug approved by the FDA for this indication. In connection with the accelerated approval, ALTH has agreed to undertake additional clinical studies to further verify and describe the clinical benefit of FOLOTYN in patients with T-cell lymphoma.

On 9/25/09, YM BioSciences (AMEX: YMI) : Stock Quote, News and Research" target="_blank" href="/symbol/YMI">YMI) announced operating results and issued an update on its clinical development programs.