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April 1, 2013
06:01 EDTBMY, LHLabCorp Clinical Trials selected as preferred provider by Bristol-Myers
LabCorp (LH) announced that LabCorp Clinical Trials has been selected as a preferred provider for full-service global central laboratory services and biomarker testing by Bristol-Myers (BMY). The five-year agreement builds on a long-standing partnership between the two companies during which LabCorp's global central lab, biomarker and specialty testing capabilities have supported various Bristol-Myers Squibb early and late-stage clinical development programs.
News For LH;BMY From The Last 14 Days
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October 13, 2015
16:06 EDTLHViking Global Investors reports 5.3% passive stake in LabCorp
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October 12, 2015
08:06 EDTLH, BMYLabCorp to offer new PD-L1 test for Bristol-Myers' Opdivo
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05:17 EDTBMYDasko announces FDA approval of Opdivo for patients with non-squamous NSCLC
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October 9, 2015
18:31 EDTBMYQuest Diagnostics introduces Dako's PD-L1 companion diagnostic for OPDIVO
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15:23 EDTBMYDako announces FDA approval of new lung test for cancer patients
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15:05 EDTBMYBristol-Myers confirms expanded FDA approval of Opdivo
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14:19 EDTBMYFDA expands approved use of Opdivo in advanced lung cancer
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October 8, 2015
06:32 EDTBMYPiper Jaffray explains why drug prices are justifiable
Piper Jaffray's team of Biopharma analysts, led by Joshua Schimmer, explain this morning in research note to investors why they believe drug prices are justifiable. The "fairly lopsided" drug-pricing discussion "noise" has created attractive entry points for stocks in the sector, the analysts argue. They say that after adjusting for actual inflation, the growth of drug prices "does not seem particularly concerning." The current dialogue on the topic under-emphasizes the need to provide "extremely attractive incentives" for companies to embark on the "highly risky, capital-intensive, long-development cycle drug development path which is needed to bring new cures for important diseases," the analysts contend. Schimmer's top picks are Alexion (ALXN), Celgene (CELG) and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC) and Ignyta (RXDX) in the small-cap sector.
October 7, 2015
08:04 EDTBMYSeattle Genetics initiates Phase 1/2 trial of ADCETRIS
Seattle Genetics (SGEN) announced that it has initiated a phase 1/2 clinical trial of ADCETRIS in combination with Opdivo for patients with relapsed or refractory Hodgkin lymphoma, or HL, after failure of frontline treatment. The trial is being conducted under a previously announced clinical trial collaboration agreement with Bristol-Myers Squibb (BMY). ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Opdivo is a human antibody that targets and inhibits the programmed death receptor-1, resulting in T-cell activation. Opdivo is part of a new class of cancer immunotherapy treatments known as checkpoint inhibitors, which are designed to harness the body's own immune system in fighting cancer by targeting distinct regulatory components of the immune system. A second trial under the collaboration is planned to begin later in 2015 for relapsed or refractory B-cell and T-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma.
07:36 EDTBMYInfectious Diseases Society of America to hold a conference
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October 6, 2015
13:32 EDTBMYBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
07:01 EDTBMYBristol-Myers says granted FDA priority review for Daklinza sNDAs
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October 5, 2015
11:09 EDTBMYBristol-Myers to pay $14M to settle SEC charge of FCPA violations
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October 2, 2015
15:57 EDTLHLabCorp to offer PD-L1 companion diagnostic
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October 1, 2015
11:04 EDTBMYBristol-Myers says Opdivo-Yervoy combo to cost about $265,000/year on average
Bloomberg reported on pricing for Bristol-Myers' Opdivo in combination with Yervoy, citing a company spokesperson.
07:39 EDTBMYJPMorgan sees opportunities in pharma after pullback
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07:31 EDTBMYLeerink to hold a roundtable
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07:04 EDTBMYBristol-Myers' Opdivo + Yervoy regimen for melanoma approved by FDA
Bristol-Myers announced that the FDA approved Opdivo - nivolumab - in combination with Yervoy - ipilimumab -, for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. This is the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. 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 confirmatory trials. The approval is based on data from the pivotal study, CheckMate -069. Results from the trial demonstrated a statistically significant increase in confirmed objective response rate - the study's primary endpoint - in patients with BRAF wild-type melanoma treated with the Opdivo + Yervoy Regimen vs. those treated with Yervoy monotherapy. Complete responses were seen in 17% of patients. Partial responses were seen in 43% of the Regimen group and 11% of the Yervoy monotherapy group. Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, other adverse reactions; infusion reactions; and embryofetal toxicity.
September 30, 2015
08:46 EDTLHLabCorp's Bode Cellmark enters service pact with DANY
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