Tag: drug-developer
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Dynavax says FDA rejects its hepatitis B vaccine
(Reuters) – The U.S. Food and Drug Administration rejected Dynavax Technologies Corp's marketing application for its hepatitis B vaccine, Heplisav-B, for the second time in three years, sending the company's shares tumbling 71 percent in premarket trade. The drug developer said on Monday it received a “complete response letter” from the FDA, seeking information about…
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French drug developer Pharnext to take rare approach to pricing
A privately held French drug developer is taking a rare approach to pricing its drug intended to treat a rare disease. Pharnext SAS, whose drug is the only treatment in a late-stage trial for treating a rare inherited disorder called Charcot-Marie-Tooth (CMT), sees potential to earn a healthy profit by selling the yet-to-be approved drug…