FDA Says It Is No Slowpoke Approving New Drugs

Manufacturers and congressional Republicans have criticized the agency for making it too hard for new drugs to reach the market. Medscape Medical News

Novel Way to Screen Baby Boomers for Hepatitis

Screening for hepatitis during colonoscopy visits could boost the diagnosis of hepatitis infection among baby boomers. Medscape Medical News

Ventilator Recall Elevated to Class I

WASHINGTON (MedPage Today) — The FDA has raised the recall on a ventilator to class I — the agency’s most serious — because a defect can interrupt treatment and may cause neurological injury or death.

Kids Still Getting Too Many Antibiotics (CME/CE)

(MedPage Today) — Half of antibiotics given to children are broad-spectrum drugs, often with inappropriate indications, a national ambulatory care study found.

Ventilator Recall Elevated to Class I

WASHINGTON (MedPage Today) — The FDA has raised the recall on a ventilator to class I — the agency’s most serious — because a defect can interrupt treatment and may cause neurological injury or death.

Gilead, CRF commence ranolazine Phase 3 clinical trial for chronic stable angina in post-PCI setting

Gilead Sciences, Inc. and the Cardiovascular Research Foundation (CRF) today announced the initiation of RIVER-PCI (Ranolazine for Incomplete VEssel Revascularization post-PCI), a Phase 3 clinical trial evaluating the utility of ranolazine to prevent major adverse cardiovascular events (MACE) in patients with a history of chronic angina who have incomplete revascularization following percutaneous coronary intervention (PCI).

HyQ phase III study data in patients with primary immunodeficiencies presented at ACAAI meeting

Baxter International Inc. today announced the presentation of its phase III study data for HyQ, an investigational combination immunoglobulin (IG) product for use in patients with primary immunodeficiencies (PI).

NewCardio’s automated cardiac safety solution selected by top pharma company for Phase I drug study

NewCardio, Inc., a cardiovascular diagnostic solutions developer, announced today that a top 5 global pharmaceutical company has selected QTinno, their automated cardiac safety solution, for an upcoming Phase I drug safety study.

ACADIA and Meiji Seika collaborate to develop AM-831 for schizophrenia treatment

ACADIA Pharmaceuticals Inc., a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that the U.S. Food and Drug Administration has completed its review of ACADIA’s Investigational New Drug application to begin Phase I clinical studies with AM-831, an innovative small molecule [...]

KYTHERA presents long-term results from ATX-101 Phase 2 study at ASDS 2011

KYTHERA Biopharmaceuticals, Inc., a privately-held biotechnology company focused on the development and commercialization of prescription products in aesthetic medicine, presented results from a long-term follow up study assessing persistence of efficacy and post-treatment safety of ATX-101, a first-in-class, injectable drug that is under investigation for the reduction of submental fat.