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