Bristol-Myers Squibb’s new dosing for cancer drug Opdivo gets FDA green light
The approval is for a supplemental Biologics Licence Application which updates the Opdivo (nivolumab) dosing schedule to include 480 mg infused every four weeks
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NYSE:BMY
Bristol-Myers Squibb Co is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
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The approval is for a supplemental Biologics Licence Application which updates the Opdivo (nivolumab) dosing schedule to include 480 mg infused every four weeks
Its Opdivo and Yervoy cancer drug combination showed improved progression-free survival in patients with advanced lung cancer compared to chemotherapy in a Phase III trial
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Results from a large-scale trial showed a combination of Merck’s Keytruda drug and an older type of chemotherapy helped newly-diagnosed cancer patients live longer and stop the disease from advancing
Third quarter profits slumped to US$845mln or 51 cents per share from US$1.20bn or 72 cents a share in the year-earlier period
Halozyme gets US$105mln upfront plus milestone payments and a share of future revenues
The pharmaceutical company's combination treatment for renal cell carcinoma showed superior overall survival rates in previously untreated patients compared to chemotherapy
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Array, MEK inhibitor, binimetinib, Bristol-Myers, immuno-oncology, Opdivo.
Opdivo sales jumped by 60% in the three months to March
Bristol is licensing an experimental neurodegenerative disorder drug to Biogen and a Duchenne muscular dystrophy treatment to Roche
CytomX will also be eligible to receive up to US$448mln in milestone payments, as well as royalty payments, if development, regulatory and sales targets are met.
Exelisis will combine Cabometyx with blockbuster PD-1 immunotherapy drug Opdivo (nivolumab)
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The commencement of the trial will trigger a milestone payment.
US stocks closed higher on Friday, but little changed following Donald Trump’s first speech as President
It made the decision about the Opdivo and Yervoy combination after assessing the data available
US shares ended higher on Wednesday, as energy investors shrugged off a jump in US oil stocks, and markets took a sanguine view of President-elect Donald Trump’s first speech since he won the November election
Bristol-Myers Squibb Company on Tuesday announced updated results for Opdivo monotherapy
US stocks ended lower, swinging from initial gains amid mixed earnings results, as a global bonds sell-off ensued on growing expectations for a Dec rate hike