CombinatoRx scores $40M payout on FDA approval

CombinatoRx's complex merger deal with Neuromed will pay off with a $40 million milestone earned with today's announcement that the FDA has approved Exalgo, a once-daily pain therapy. Covidien, which partnered on the program, will handle the commercial rollout and fork over the...

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in...

FDA warns of heart risk with HIV drug combination

(AP) -- The Food and Drug Administration issued a warning Tuesday about potential heart risks when combining two HIV...

FDA Grants Orphan Drug Status for Quark’s QPI-1002 for the Prophylaxis of Delayed Graft Function in Kidney Transplant Patients

FREMONT, Calif., Feb. 16 /PRNewswire/ -- Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, announced today that the US FDA has granted orphan drug designation for QPI-1002 (also referred to as "I5NP"), a synthetic siRNA targeting p53 mRNA for the prophylaxis of delayed graft function (DGF) in kidney transplant patients. Quark has completed enrollment and dosing in the dose-escalation safety portion (Part A) of a Phase 1/2 study and has...

Oncolytics Biotech receives U.K. MHRA approval for REOLYSIN combination Phase 3 trial

Oncolytics Biotech Inc. today announced that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. This is the same trial that the Company previously reached an agreement on with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA)...