Latest Headlines

Latest Headlines

Pfizer faces delay on tofacitinib as new data adds blockbuster luster

Pfizer's quest to gain an approval for a potential new blockbuster for rheumatoid arthritis has run into a speed bump at the FDA. Following a lopsided expert panel vote in its favor back in May, Pfizer CEO Ian Read told analysts on Tuesday that the agency is looking for some additional data analysis before it can come up with a formal decision on marketing the JAK inhibitor.

FDA harps on risks of Pfizer's tofacitinib as panel looms

FDA staffers raised concerns about increased risks of malignant cancers--particularly lymphomas--and infections tied to the drug.

FDA calls on contractors, India to counter Ben Venue drug shortages

A non-FDA approved drug from India and U.S. contract manufacturers will address cancer drug shortages resulting from production and quality problems at Ben Venue Laboratories ' now notorious Ohio...

FDA brings Sun's Doxil copy online to fix shortage

Fresh off its cobbled-together solution to a methotrexate shortage, the FDA says it's sewn up an alternate supply of the scarce cancer drug Doxil. The agency has approved a substitute for the...

Leukemia drug shortage averted for now, FDA says

Disaster averted, say federal health officials. HHS Secretary Kathleen Sebelius told Congress yesterday that new supplies of the critically scarce drug methotrexate would be released in the coming

Ben Venue's idled plant triggers 'dire' leukemia-drug shortage

Ben Venue Laboratories has another black eye. We've heard a lot about the ongoing shortages of Johnson & Johnson's ($JNJ) cancer treatment Doxil, the supply of which is suffering from...

Ben Venue can't say when crucial cancer drug will be available

Fallout from the closing of a Ben Venue Laboratories ' manufacturing facility over quality issues could prove deadly. The Bedford, OH, facility was the primary source of methotrexate, which is...

Tainted injectables recalled by Sandoz, B. Braun

Two injectable drugs are subject to new recalls because of old problems. First, the Novartis generics unit Sandoz has initiated a recall of 24 lots of methotrexate, which is used to treat rheumatoid

U.K. trust sues UCB for royalties on Cimzia

UCB could end up paying Cimzia royalties to a U.K. charitable trust. The Mathilda and Terence Kennedy Institute of Rheumatology Trust has sued the Belgian drugmaker for patent infringement in a case

Study: Enbrel plus methotrexate helps RA

A new study published online by The Lancet on July 15, 2008, said that most patients taking a combination of Enbrel and methotrexate had no progression of joint damage halfway into a two-year study.