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Industry groups are rushing to the aid of Pacira Pharmaceuticals in its ongoing legal battle with the FDA over promotional claims, asking the courts to side with the drugmaker. Read More
The National Health Service of England and the National Institute for Health and Care Excellence have unveiled a proposal that could provide a new pathway for innovative drugs to be assessed and made available to patients. Read More
The National Institute for Health and Care Excellence has given the green light to Bayer’s Xofigo in England and Wales as an option for treating adults with hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases, albeit with restrictions. Read More
Pfizer’s proposed merger with Irish drugmaker Allergan is catching flak from some members of Congress who are tying the trend of companies pursuing foreign mergers for tax purposes. Read More
The FDA has hit Life Support Development, a dietary supplement manufacturer and distributor, with a warning letter because its purported “hangover relief” product is considered an unapproved new drug. Read More
The FDA has rejected a single-dose version of AMAG Pharmaceuticals’ hormone injection Makena, requesting additional information from the company before making a decision on the product. Read More
Despite agreeing that Telesta’s bladder cancer biologic candidate would offer limited side effects and low toxicity — maybe even less than standard of care — FDA reviewers voted against recommending it Wednesday because of a lack of proven benefit. Read More
Biosimilars experts concluded that fostering the nascent industry would require many of the same elements that originally nurtured the generics industry: educational efforts, regulatory and patent changes, and most importantly, patience. Read More