Regulatory
On Tuesday, a U.S. Food and Drug Administration advisory panel overwhelmingly supported approval of the nasal spray treatment.
Darzalex (daratumumab) for intravenous infusion is approved in the U.S. in combination with bortezomib, melphalan and prednisone for patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant.
At the same time, recognizing that use of supplements is widespread in the U.S., the agency also announced a plan for modernizing its regulation and oversight of dietary supplements.
Soligenix, Inc. announced the allowance of a new United States patent protecting its ricin toxin vaccine, RiVax®.
When the U.S. Food and Drug Administration approved Genentech’s Xofluza, a single-dose treatment for the flu, it was met with great fanfare, particularly in Japan, where the treatment was first discovered.
On Feb. 12, a U.S. Food and Drug Administration (FDA) advisory committee will debate whether to recommend Johnson & Johnson’s esketamine spray for major depression. It may be an uphill battle, although any positive results in this extremely difficult-to-treat patient population will no doubt be taken into account.
The U.S. Food and Drug Administration approved the first treatment for acquired thrombotic thrombocytopenic purpura (aTTP). Sanofi’s Cablivi was given the greenlight and will become a cornerstone of the company’s new rare blood disorders franchise.
After Health and Human Services Secretary Alex Azar, a former executive with Eli Lilly, unveiled a pricing reform that would allow pharma companies to end the rebate system and pass those savings directly to consumers, leaders from across the pharma industry are offering early support for the proposal.
Across the globe, pharma companies are making an impact. Last week BioSpace launched the first of a weekly roundup of international biotech and pharma news. Here’s the latest edition.
During the president’s annual address to Congress and the nation, Trump said that as a result of his administration’s efforts to lower the costs of prescription drugs, “in 2018 drug prices experienced their single largest decline in 46 years.”
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