Two H1N1 Vaccine Doses Likely Needed for Young Kids

Children younger than 10 will probably need two doses of the pandemic H1N1 vaccine for optimal protection, according to an interim analysis of a randomized, controlled trial.

Finance Committee Sends Healthcare Bill to Senate Floor

WASHINGTON (MedPage Today) — The Senate Finance Committee voted 14 to 9 to send its healthcare reform bill to the full Senate, with one Republican on the panel voting to support the $829 billion package.

Outcomes and Cost Both Vital in Comparing Heart Failure Care (CME/CE, with audio)

When comparing hospitals on their quality of care for heart failure, it is important to include data on all patients, not just those who died, researchers found.

FDA Warns Illegal Codeine Makers

WASHINGTON (MedPage Today) — The FDA issued a strict warning to four drug manufacturers today: stop making unapproved and illegal codeine sulfate tablets.

FDA approves ZyStor Therapeutics’ ZC-701 for Phase I human safety trial

ZyStor Therapeutics, Inc., a biotechnology company developing a new class of targeted protein therapeutics for the treatment of Lysosomal Storage Diseases using the Company’s proprietary Glycosylation Independent Lysosomal Targeting technology, today announced that it has received clearance from the U. S. Food and Drug Administration to proceed into a clinical trial for its first drug [...]

Positive data from ZIOPHARM’s palifosfamide sarcoma Phase II trial

ZIOPHARM Oncology, Inc. announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed.

EMEA grants ArQule’s ARQ 197 orphan drug designation

ArQule, Inc. today announced that the European Medicines Evaluation Agency (EMEA) has designated ARQ 197 as an orphan medical product for the treatment of soft tissue sarcoma.

Provectus Pharmaceuticals commences compassionate use program of PV-10 for cancer

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has expanded its compassionate use program for PV-10, making the agent, which is being developed as a therapeutic agent for a broad spectrum of cancers, available for select cancer patients in the United States. The program is already in progress in Australia, where it was [...]

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of a Phase I/IIa dose escalation study of patients suffering from idiopathic CD4 lymphocytopenia (ICL).

Nobilon initiates a clinical Proof of Concept trial with SCH 900795 vaccine

Nobilon, the human vaccine business unit of Schering-Plough Corporation (NYSE: SGP), today announced that it has initiated a clinical Proof of Concept trial with SCH 900795, a new intranasal Live Attenuated Influenza Vaccine (LAIV) for annual seasonal use.