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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
The UK’s National Institute for Health and Care Excellence says it will not recommend Amgen’s Repatha as an option for people with high cholesterol and mixed dyslipidemia. Read More
A new report is predicting that spending on prescription and OTC medications will climb 30 percent in the next five years, fueled largely by improved sales and access in emerging markets. Read More
German drugmaker Merck KGaA and Pfizer have received breakthrough therapy designation for immunotherapy avelumab for second-line treatment of metastatic Merkel cell carcinoma. Read More