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July 15, 2014
07:35 EDTMRK, PRGO, LLY, BMYPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
News For PRGO;BMY;LLY;MRK From The Last 14 Days
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October 5, 2015
10:52 EDTPRGOFlamel confirms exclusive licensing agreement with Perrigo
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09:56 EDTPRGOPerrigo and Flamel enter into exclusive licensing agreement for LiquiTime
Perrigo (PRGO) and Flamel (FLML) announced that they have entered into an exclusive licensing agreement for LiquiTime(R) extended release suspension. The technology will be utilized in the development of a portfolio of extended release suspension products intended for the U.S. OTC marketplace.
05:29 EDTMRKDako announces FDA approval of new companion diagnostic assay
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October 4, 2015
14:28 EDTMRKMerck to license Dificid in Taiwan for $3M plus milestone payments
OBI Pharma announced an agreement with Merck to transfer exclusive rights to develop and commercialize Dificid, or fidaxomicin, in Taiwan to Merck. OBI Pharma will receive an initial up-front payment of $3M and is eligible to receive royalties and payments associated with the completion of certain undisclosed milestones. Merck will be responsible for all future costs associated with commercialization, development, and manufacturing of Dificid in Taiwan.
October 2, 2015
15:43 EDTMRKQuest Diagnostics introduces Dako's PD-L1 companion diagnostic for KEYTRUDA
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15:25 EDTMRKAgilent's Dako confirms FDA approval of NSCLC diagnostic
Dako, an Agilent Technologies (A) company and a worldwide provider of cancer diagnostics, announced the FDA approval of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer, or NSCLC, is likely to respond to a new form of treatment. The approval of PD-L1 IHC 22C3 pharmDx strengthens Dako's portfolio of companion diagnostics and the company's leadership position in developing and commercializing companion diagnostic products. Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck (MRK), maker of the anti-PD-1 therapy Keytruda. The FDA approved PD-L1 IHC 22C3 pharmDx for use in the United States. Dako hopes to gain regulatory approval for the new diagnostic in Canada, Europe and other jurisdictions next year.
14:50 EDTMRKMerck confirms FDA approval of Keytruda
Merck announced that the FDA has approved Keytruda monotherapy, the company's anti-PD-1 therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. Under FDA's accelerated approval regulations, this indication for Keytruda is approved based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
13:51 EDTMRKFDA approves Merck's Keytruda for advanced non-small cell lung cancer
The U.S. Food and Drug Administration granted accelerated approval for Keytruda to treat patients with advanced non-small cell lung cancer whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors. In 2014, Keytruda was approved to treat patients with advanced melanoma following treatment with ipilimumab, a type of immunotherapy. Keytruda is marketed by Merck and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America.
13:43 EDTMRKFDA approves Merck lung cancer treatment Keytruda
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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.
10:37 EDTLLYBofA/Merrill's Top 10 US Ideas for Q4 2015
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08:06 EDTMRKMerck, DNAtrix announce Phase 2 immuno-oncology collaboration
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07:39 EDTBMYJPMorgan sees opportunities in pharma after pullback
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07:31 EDTBMYLeerink to hold a roundtable
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07:23 EDTMRKNewLink Genetics awarded $18M contract option from BARDA
NewLink Genetics Corporation (NLNK) announced today that the Biomedical Advanced Research and Development Authority, or BARDA, of the United States Department of Health and Human Services, or HHS, has exercised an $18M option on NewLink Genetics' existing contract to support the scale-up of the manufacturing process relating to its investigational rVSV-ZEBOV GP vaccine candidate. BARDA made an initial $30M contract award to NewLink in late 2014 and is now providing additional funding to continue development of the Ebola vaccine candidate. Merck (MRK) has the license for research, development, manufacturing and commercialization of the rVSV-ZEBOV GP vaccine.
07:23 EDTMRKNewLink Genetics awarded $18M contract option from BARDA
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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.
05:18 EDTMRKBioMarin to host a conference call
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September 30, 2015
06:16 EDTLLYEli Lilly volatility at 52-week highs
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05:41 EDTLLYEli Lilly, Adocia initiate new Phase 1b study evaluating BioChaperone Lispro
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