$MRK (Merck & Co. Inc.)

$MRK {{ '2016-04-13T13:21:39+0000' | timeago}} • Announcement

Healthcare company $MRK said the U.S. FDA has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA., an antibody that is used in the treatment of recurrent or metastatic head and neck cancer. The application is seeking approval for KEYTRUDA as a single agent at a dose of 200 mg.

$MYL {{ '2017-10-02T17:33:18+0000' | timeago}} • Announcement

$MYL announced the U.S. launch of Caspofungin Acetate for Injection, one of the first generic version of $MRK's Cancidas. $MYL received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for this antifungal which has multiple indications.

$A {{ '2017-09-22T21:43:23+0000' | timeago}} • Announcement

$A said its Dako PD-L1 IHC 22C3 pharmDx assay has an expanded label approved by the US FDA to aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA, an anti-PD-1 therapy manufactured by $MRK. These approvals mean these patients have the possibility of receiving a targeted anti-PD-L1 immunotherapy.

$MRK {{ '2017-09-11T17:08:33+0000' | timeago}} • Announcement

$MRK announced that Keytruda is the only programmed death (PD-1) drug with data to show it can improve overall survival rate in the second-line bladder cancer. Phase 3 results show that patients whose disease had progressed following platinum chemo treatment, Keytruda demonstrated an OS advantage vs. chemo with median follow-up of 22.5 months.

$MRK {{ '2017-08-29T14:59:23+0000' | timeago}} • Announcement

$MRK and Oxford University's Clinical Trial Service Unit announced the REVEAL study results of anacetrapib, the company's investigational cholesteryl ester transfer protein (CETP) inhibitor. Anacetrapib reduced the risk of major coronary events by 9% relative to placebo. $MRK is reviewing the results with external experts for filing NDA with FDA.

$MRK {{ '2017-08-18T15:18:52+0000' | timeago}} • Announcement

Lynparza, which is developed and marketed by AstraZeneca and $MRK, announced that it got approval for a two-tablet regimen, regardless of whether patients test positive for BRCA genetic mutations associated with high risk for the cancer. This helps Lynparza to compete with Tesaro’s Zejula and Clovis Oncology's Rubraca.

$MRK {{ '2017-08-18T13:37:46+0000' | timeago}} • Announcement

Lynparza has received FDA approval to include the drug in ongoing treatment of patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. Lynparza (olaparib) claims to be the world's first poly (ADP-ribose) polymerase [PARP] inhibitor. The drug is jointly developed and sold by AstraZeneca and $MRK.

$MRK {{ '2017-07-28T15:52:14+0000' | timeago}} • Announcement

Pharma segment, $MRK's only reportable segment and money-spinner, rose modestly to $8.76Bil. Growth was mainly due to new product launches offset by generic drug launches from competition and lower diabetes drug sales. Merck also narrowed and raised its 2017 revenue outlook to $39.4-40.4Bil, but reduced its 2017 GAAP EPS forecast to $1.60-1.72.

$MRK {{ '2017-07-28T15:26:51+0000' | timeago}} • Announcement

Pharma giant $MRK reported better-than-expected sales due to strong demand from its cancer drug KEYTRUDA. Sales for KEYTRUDA tripled to $881MM vs. $314MM in 2Q16. Drugmarker also disclosed that cyber-attack (June 27) had a dent on its operations. Magnitude of the disruption is yet to be ascertained, as $MRK tries to restore from the attack.

$MRK {{ '2017-07-28T13:05:50+0000' | timeago}} • Infographic

$MRK Merck Earnings AlphaGraphic: Q2 2017 Highlights

$MRK {{ '2017-07-26T13:49:00+0000' | timeago}} • Announcement

$MRK's BoD declared a quarterly dividend of $0.47 per share of its common stock for 4Q17. The dividend will be paid on Oct. 6, 2017 to shareholders of record at the close of business on Sept. 15, 2017.

$MRK {{ '2017-07-25T17:08:10+0000' | timeago}} • Announcement

$MRK announced the presentation of results from the Drive-Ahead study, the second of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of doravirine, the company's investigational, non-nucleoside reverse transcriptase inhibitor (NNRTI), for the treatment of HIV-1 infection.

$MRK {{ '2017-07-25T11:50:57+0000' | timeago}} • Announcement

$MRK said that its anti-programmed cell death protein 1 (PD1) drug Keytruda (pembrolizumab) failed to meet the primary endpoint in the Phase III KEYNOTE-040 trial for previously treated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). When compared with standard treatment, Keytruda failed to improve the overall survival rate.

$MRK {{ '2017-07-24T18:28:47+0000' | timeago}} • Announcement

$MRK today announced the US launch of RENFLEXIS, a biosimilar for Remicade, which was approved by FDA for all eligible indications. RENFLEXIS will have a wholesale acquisition cost of $753.39, which is a 35% discount compared to Remicade. Remicade was the fifth bestselling drug in the US in 2016 raking in $5.3Bil on an invoice price basis.

$MRK {{ '2017-07-21T15:21:07+0000' | timeago}} • Announcement

President Donald Trump announced that pharma giants $MRK and $PFE are collaborating with Gorilla Glass manufacturer Corning ($GLW) for manufacturing a new glass (Valor Glass), which is superior and reliable for the delivery of injectable drugs. Corning is planning to initially invest $500MM creating 1,000 jobs at 3 facilities in US.

$MRK {{ '2017-07-20T14:29:27+0000' | timeago}} • Announcement

$MRK announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for its 100 units/mL insulin glargine injection, a follow-on biologic basal insulin in a pre-filled dosing device.

$MRK {{ '2017-07-06T12:50:08+0000' | timeago}} • Announcement

Pharma company $MRK will present its HIV portfolio and pipeline at the 9th IAS Conference on HIV Science. The presentations include late-breaker abstracts from two phase-3 pivotal clinical trials and a phase-1 study of MK-8591, Merck’s investigational nucleoside reverse transcriptase translocation inhibitor in adult patients with HIV-1 infection.

$MRK {{ '2017-07-05T22:11:39+0000' | timeago}} • Announcement

$MRK said the US FDA has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in the blood cancer multiple myeloma. The FDA has determined that the risks of KEYTRUDA outweigh any potential benefit for patients with multiple myeloma.

$MRK {{ '2017-06-27T14:06:02+0000' | timeago}} • Announcement

$MRK provided update on Reveal outcomes study of anacetrapid. $MRK plans to review the results of the trial with external experts, and will consider whether to file new drug applications with the FDA and other regulatory agencies. The results will be presented at the European Society of Cardiology meeting on Aug. 29, 2017.

$MRK {{ '2017-06-27T14:04:38+0000' | timeago}} • Announcement

$MRK announced that the Reveal (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib met its primary endpoint, significantly reducing major coronary events compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen.

$MRK {{ '2017-06-12T11:25:01+0000' | timeago}} • Announcement

$MRK, in partnership with $PFE, announced that two Phase 3 studies of ertugliflozin, an investigational oral drug to help improve glucose level control in adults with type 2 diabetes, met their primary endpoints.

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