FDAnews Drug Daily Bulletin

Gilead Sciences’ pulmonary arterial hypertension (PAH) drug cicletanine did not meet its primary endpoint in a Phase II trial, leading Gilead to terminate the study and drop plans to further develop the drug for PAH.

Pfizer, Johnson & Johnson and Elan’s termination of their late-stage program for investigational Alzheimer’s drug bapineuzumab following the second failed study may not negatively impact the companies but could foreshadow a bleak outlook for the future of Alzheimer’s drug development, analysts say.

Companies blazing a path in the biosimilars arena likely have a long wait before their products can achieve an interchangeability designation, as the FDA admits to slow progress on that standard.

Pfizer and Mylan have entered into a collaboration agreement to develop, manufacture, distribute and market generic drugs in Japan.

GlaxoSmithKline and Johnson & Johnson’s Janssen Biologics said Thursday they have begun late-stage trial testing of a new treatment for moderately active to severely active rheumatoid arthritis.

Xoma lead drug, gevokizumab, was granted orphan drug status for an inflammatory eye disease.

Pfizer, whose Wyeth unit set aside more than $21 billion to settle lawsuits over the fen-phen diet drug, is asking a judge to throw out claims that the pills caused a fatal disease years after users stopped taking them.

Novartis, Europe’s largest drugmaker by revenue, is understood to be considering expanding its Irish operations.

West Pharmaceutical India Packaging has launched construction of a compression molding plant in Sri City, India.