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Stock Market & Financial Investment News

News Breaks
July 28, 2014
12:24 EDTPCYC, JNJFDA expands approved use of Imbruvica for chronic lymphocytic leukemia
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17, which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. The FDA is also approving new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. Imbruvica’s new use is being approved more than two months ahead of the product’s prescription drug user fee goal date of Oct. 7, the date the FDA was scheduled to complete review of the drug application. Imbruvica also received accelerated approval in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Clinical studies to verify and describe Imbruvica’s clinical benefit in mantle cell lymphoma are ongoing. Imbruvica is being jointly developed and commercialized in the United States by Pharmacyclics (PCYC) and Janssen Biotech (JNJ).
News For PCYC;JNJ From The Last 14 Days
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June 17, 2015
07:21 EDTJNJGeneric ADHD drugs still sold despite FDA non-equivalance finding, NYT reports
The FDA announced last November that two generic versions of Johnson & Johnson's (JNJ) Concerta ADHD drug, one made by Mallinckrodt (MNK) and the other by UCB, could no longer be considered the equivalent of the branded drug after tests and analyses suggested that their effectiveness began to wear off much more quickly, but the drugs are still being sold despite an FDA mandated deadline having passed for the companies to either prove the drugs were equivalent or remove them from the market, said The New York Times. The report noted a third generic product, sold by Actavis (AGN), was found to be equivalent to the branded Concerta. Reference Link

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