Government
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.
When biotech companies post openings for new positions, hiring managers often face the immense task of sorting through numerous resumes of qualified candidates. However, in South Korea, hiring managers are facing a different problem – a dearth of qualified candidates.
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.
The government shutdown threw a wrench into several biotech company’s plans for initial public offerings (IPOs). Although the government is only guaranteed to stay open until February 15, several biotechs are working to get their IPOs launched in that window. Here’s a look.
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.
Takeda Pharmaceutical released data from its Phase IIIb/IV clinical trial for Adynovate. On the same day, jurors in a Delaware federal court ordered Takeda’s Baxalta unit to pay $155.19 million to Bayer AG for infringing a patent for Adynovate.
PRESS RELEASES