We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Earlier this summer the FDA recommended a five-point scale to measure topical patch adhesion for drugmakers submitting abbreviated new drug applications (ANDA). However, the recommendations have only raised more questions. Read More
The UK’s drug pricing watchdog has recommended that the National Health Service reimburse Pfizer lung cancer drug Xalkori, while rejecting to refund Novartis’ breast cancer therapy Everolimus and Janssen’s non-Hodgkin’s lymphoma drug Imbruvica. Read More
The FDA has released its annual report to Congress on statistics on delays in approval of applications related to citizen petitions and petitions for stays of agency actions for the 2015 fiscal year. Read More
Investment firms T. Rowe and Alleghany have filed a suit against Valeant and six executives over the company’s sales strategy that involved price gouging and acquisitions, claiming those tactics cost investors billions. Read More
The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or restrict production to penicillin. Read More
The FDA has released its annual report to Congress on statistics on delays in approval of applications related to citizen petitions and petitions for stays of agency actions for the 2015 fiscal year. Read More