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News Breaks
January 9, 2014
08:38 EDTBMY, VRTXVertex announces first data from initial cohorts of VX-135 Phase 2a study
Vertex Pharmaceuticals (VRTX) announced the first data from the initial cohorts of an open-label Phase 2a study of VX-135 in combination with daclatasvir, Bristol-Myers Squibb's (BMY) NS5A replication complex inhibitor. In an intent-to-treat analysis, the sustained viral response rate four weeks after the completion of treatment was 83% in treatment-naÔve genotype 1 patients who received 200 mg of VX-135 in combination with daclatasvir. In this arm, one patient discontinued treatment after the first dose due to a serious adverse event of vomiting/nausea. The 11 other patients in this arm completed 12 weeks of treatment, and 91 percent (10 of 11) achieved SVR4. In the study, the majority of adverse events were mild. Vertex expects to submit data to present at a medical meeting in 2014.
News For VRTX;BMY From The Last 14 Days
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July 2, 2015
16:28 EDTVRTXOn The Fly: Top stock stories for Thursday
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14:51 EDTVRTXVertex expects payers to provide 'broad access' for Orkambi
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14:50 EDTVRTXVertex to resume trading at 3:00 PM ET
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14:42 EDTVRTXVertex says 'too early to comment' on international Orkambi pricing
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14:33 EDTVRTXVertex sets Orkambi price at $259,000, sees delivery to pharmacies 'within days'
Following today's confirmation from Vertex that Orkambi has received FDA approval, the company held a conference call providing an update on the drug. Vertex remarked that it is "ready to launch this medicine." Vertex will offer a co-pay assistance program for the drug, with certain eligibility criteria. Company believes it can achieve a similar patient cost situation as Kalydeco. Sets price of Orkambi at $259,000 per year. Expects delivery to pharmacy network "within days."
13:52 EDTVRTXVertex to hold a conference call
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13:47 EDTVRTXVertex confirms FDA approval of ORKAMBI
Vertex Pharmaceuticals announced that the U.S. FDA approved ORKAMBI, the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. It is only indicated for these patients, who can be identified with a genetic test. People with two copies of the F508del mutation represent the largest group of people with CF. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two copies of the F508del mutation. ORKAMBI will be available for shipment to specialty pharmacies in the United States within days.
12:47 EDTVRTXVertex to return to profitability with approval, says Piper Jaffray
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12:00 EDTVRTXVertex receives FDA approval for Orkambi
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11:50 EDTVRTXVertex trading halted, pending news
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June 30, 2015
07:32 EDTVRTXVertex should get Orkambi approval by Monday or sooner, says Piper Jaffray
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June 29, 2015
15:28 EDTVRTXVertex management to meet with UBS
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07:47 EDTVRTXCerulean appoints Stuart A. Arbuckle to board of directors, effective June 26
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June 26, 2015
08:31 EDTBMYAlexandria Real Estate announces lease with Bristol-Myers in Cambridge
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June 25, 2015
09:34 EDTBMYBristol-Myers expects Waltham site to close in early 2018
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09:32 EDTBMYBristol-Myers opens research site in Cambridge, discontinues virology research
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June 24, 2015
07:29 EDTBMYFDAnews to hold a summit
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June 22, 2015
08:52 EDTBMYPortola, Bristol-Myers, and Pfizer announce results from Phase 3 ANNEXA study
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05:35 EDTBMYAllied-Bristol Life Sciences licenses IP from Harvard University
Allied-Bristol Life Sciences, a biopharmaceutical enterprise jointly owned by Allied Minds and Bristol-Myers Squibb, announced that it has entered into a licensing agreement with Harvard University based on research and intellectual property developed in Professor Malcolm Whitmanís lab at the Harvard School of Dental Medicine. Building on previous studies conducted with Mark Sundrud, PhD, and Anjana Rao, PhD, at Boston Childrenís Hospital, Professor Whitmanís lab, in collaboration with Professor Ralph Mazitschek, PhD, at the Center for Systems Biology at Massachusetts General Hospital, has shown that HF works through inhibition of Prolyl-tRNA synthetase, which leads to activation of an amino acid restriction response pathway. Based on this novel and differentiated mechanism, several lead molecules have been identified by the groups at HMS and MGH that have the potential to lead to effective therapy for several conditions including fibrotic and autoimmune diseases. The licensing agreement with Harvardís Office of Technology Development is among the first in a series of discovery and development projects that Allied-Bristol Life Sciences intends to pursue. The license to the technology from Professor Whitmanís lab will be held by a new ABLS subsidiary specifically formed to pursue further research and pre-clinical development of the technology and associated molecules.
June 19, 2015
11:39 EDTBMYBristol-Myers announces European Commission approval of Opdivo
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