Company Overview and News
Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced that it will discontinue the phase III study evaluating its key pipeline candidate, fremanezumab for the treatment of chronic cluster headache. This decision was based on data from a pre-specified futility analysis of the study, which showed that the study is unlikely to meet its primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks over a 12-week period.
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SOUTH SAN FRANCISCO, Calif., June 16, 2018 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced data from the Phase 2 clinical study of reldesemtiv in patients with spinal muscular atrophy (SMA) were presented in an oral presentation by John W. Day, M.D., Ph.D., Professor of Neurology and Pediatrics (Genetics), Stanford University, at the 2018 Annual Cure SMA Conference in Dallas.
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Resverlogix (OTCPK:RVXCF) recently announced that the FDA has accepted the statistical analysis plan and endpoints for the large-scale Phase 3 trial of assessment of cardiovascular benefits of its lead candidate apabetalone. The projected endpoint of the study is the reduction of major adverse cardiovascular events (MACE) in a high cardiovascular risk in type 2 diabetes population. The same population often also displayed low levels of high density lipoproteins (HDL).
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GlaxoSmithKline (NYSE:GSK) is one of the world's largest pharmaceutical companies. Its headquarters are in London, England. It pays a hefty dividend. Its array of products is quite diverse, including consumer healthcare products as well as new, cutting-edge medicines. In this article I will analyze whether the dividend is safe given Glaxo's potential for revenue growth (or decline).
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Roche (RHHBY - Free Report) announced that the FDA has approved the label expansion for its oncology drug Avastin (bevacizumab). The FDA approved Avastin in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection.
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Allergan PLC (AGN - Free Report) announced positive top-line results from a phase III study, evaluating its pipeline candidate Bimatoprost SR. Bimatoprost SR is Allergan’s investigational implant, developed as the first sustained-release drop-free treatment option for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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Tetraphase Pharma (TTPH) has a PDUFA on August 28 for its lead drug candidate ERAVACYCLINE in one indication - cIAI - complicated intra-abdominal infections. This PDUFA is based on an NDA filed on Feb 27 - the 6-month duration comes from a Fast Track designation; they also have a Qualified Infectious Disease Product (‘QIDP) for the drug candidate.
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SOUTH SAN FRANCISCO, Calif., June 13, 2018 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the JMP Securities Life Sciences Conference on Wednesday, June 20, 2018 at 11:00 AM EDT at the St. Regis Hotel in New York.
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The biotech sector was in focus last week with regular pipeline updates and collaboration/licensing deals. While biotech bigwig Amgen’s (AMGN - Free Report) drugs won both FDA and EC approvals, Axovant (AXON - Free Report) soared on a licensing deal Oxford BioMedica. Meanwhile, Regeneron (REGN - Free Report) collaborated with Zoetis to discover new veterinary treatments.
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2018-06-18 - Asif
Business Arrowhead develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Deemed to be one of the most important recent discoveries in life science with the potential to transform medicine, the discoverers of RNAi were awarded a Nobel Prize in 2006 for their work. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. In fiscal 2017, Arrowhead refocused its resources on therapeutics that exclusively utilize the company’s Targeted RNAi Molecule (TRiMTM) platform technology. Therapeutics built on the TRiMTM platform have demonstrated high levels of pha...
2018-06-11 - Asif
Overview Proteon Therapeutics is a late-stage biopharmaceutical company focused on the development of novel, first-in-class pharmaceuticals to address the needs of patients with renal and vascular disease. The company's product candidate, vonapanitase, is a recombinant human elastase that Proteon Therapeutics is developing to improve vascular access outcomes in patients with chronic kidney disease, or CKD, undergoing or planning for hemodialysis, a lifesaving treatment that cannot be conducted without a functioning vascular access. The company believe data from its completed Phase 2 and Phase 3 clinical trials of vonapanitase support that a one-time, local application of investigational vonapanitase during surgical creation of a radiocephalic fistula for hemodialysis may improve fistula use for hemodialysis and secondary patency (time to fistula abandonment), thereby improving patient outcomes and reducing the burden on patients and the healthcare system. Arteriovenous fistu...
2018-06-11 - Asif
Overview Galena Biopharma is a clinical-stage biopharmaceutical company focused on novel cancer immunotherapeutics for a broad range of cancer indications. The company's lead product candidate, galinpepimut-S, or GPS, is a cancer i unotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center, or MSK, that targets the Wilms tumor 1, or WT1, protein, which is present in 20 or more cancer types. Based on its mechanism of action as a directly immunizing agent, GPS has the potential as a monotherapy or in combination with other immunotherapeutic agents to address a broad spectrum of hematologic, or blood, cancers and solid tumor indications. Phase 2 clinical trials for GPS have been completed and Galena Biopharma has planned Phase 3 clinical trials (pending funding availability) for two indications, acute myeloid leukemia, or AML, and malignant pleural mesothelioma, or MPM. GPS is also in development as a potential treatment for multiple myeloma, or MM, and ovarian can...
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