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The U.S. Judicial Panel on Multidistrict Litigation is consolidating price-fixing suits against generics makers Covis Pharmaceuticals’ heart drug Lanoxin in Pennsylvania federal court. Read More
Healthcare providers spent $121 billion on prescription drugs covered under the Medicare Part D program in 2014, representing a 12.6 rise in spending from 2013. Read More
A federal judge rendered Janssen’s composition patent for Remicade invalid, marking a loss for the company engaged in ongoing efforts to block biosimilar competition. Read More
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies. Read More
The FDA awarded Janssen’s esketamine a second breakthrough designation for major depressive disorder with imminent risk of suicide, adding a second potential indication for the investigational compound. Read More
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