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News Breaks
July 10, 2014
12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
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December 22, 2014
17:23 EDTBMYBristol-Myers confirms FDA approval of Opdivo
Bristol-Myers Squibb Company announced that the FDA approved Opdivo injection, for intravenous use. Opdivo is a human programmed death receptor-1 blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The company expects to begin shipping Opdivo within one to two weeks of today’s approval.
15:12 EDTBMYBristol-Myers confirms FDA approval of Opdivo
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14:34 EDTBMYBristol-Myers prices Opdivo at $12.5K per month, CNBC report
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14:28 EDTBMYFDA grants accelerated approval to Bristol-Myers melanoma drug
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December 16, 2014
08:47 EDTBMYHemispherx Ampligen provides anti-tumor activity
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