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News Breaks
June 4, 2014
10:14 EDTAZN, RHHBYRoche, AstraZeneca units collaborate on PD-L1 assay for immunotherapy trials
Ventana Medical Systems, a member of the Roche Group (RHHBY), and MedImmune, the biologics research and development arm of AstraZeneca (AZN), announced they are jointly developing a PD-L1 immunohistochemistry assay to enroll patients in clinical trials for MedImmune's MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma. This includes the recently commenced MEDI4736 ATLANTIC trial that will enroll only patients who express PD-L1 as determined by the VENTANA assay.
News For RHHBY;AZN From The Last 14 Days
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July 30, 2015
09:25 EDTRHHBYLeerink life science tools analyst holds an analyst/industry conference call
Life Science Tools & Diagnostics Analyst Leonard, along with Dr. Anami Patel and Dr. Nathan Ledeboer, discuss their perspectives on Point-of-Care molecular tests including the opportunity in virology / microbiology, the threat to traditional lab-based testing and point-of-care instruments on an Analyst/Industry conference call to be held on July 30 at 11 am.
09:10 EDTAZNAstraZeneca CEO: Acquisition purchasing prices 'pretty hefty,' Reuters reports
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07:25 EDTAZNCharles River, AstraZeneca renew strategic partnership agreement
Charles River Laboratories International (CRL) announced that it has extended its initial three-year partnership with AstraZeneca (AZN) for an additional five-year period. Under the agreement, which extends into 2020, Charles River retains its position as AstraZeneca’s preferred strategic partner for outsourced regulated safety assessment and development DMPK.
05:57 EDTRHHBY, AZNRoche submits filing to FDA for companion diagnostic for NSCLC drug therapy
Roche announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval, or PMA, to the FDA, as a companion diagnostic test for AZD9291, an AstraZeneca (AZN) investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation. Patients with non-small cell lung cancer who have adenocarcinoma with tumor containing an EGFR sensitizing mutation show significant benefit from currently available EGFR TKI therapies. However, approximately two-thirds of these patients will relapse and develop drug resistance. In many cases, this resistance is caused by an acquired mutation called T790M. The cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca's novel therapy.
July 28, 2015
07:20 EDTAZNBrookings Institute to hold a public meeting
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07:08 EDTRHHBYRoche introduced several diagnostic testing platforms at the AACC 2015
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July 27, 2015
05:25 EDTAZNGenzyme acquires Caprelsa from AstraZeneca for $300M
Genzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.
July 23, 2015
06:27 EDTRHHBYRoche CEO expects biosimilars in Europe by late 2017, Reuters reports
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05:46 EDTRHHBYRoche expects FY15 sales to grow low- mid-single digits
Expects FY15 core EPS to grow ahead of sales at constant exchange rates. Roche expects to further increase dividend in Swiss francs.
05:45 EDTRHHBYRoche reports 1H15 core EPS CHF 7.22 vs. 7.57 last year
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July 22, 2015
13:58 EDTAZNPiper cuts Array target by only 50c after failed trial
Piper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.
09:07 EDTAZNOn The Fly: Pre-market Movers
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05:12 EDTAZNAstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
July 21, 2015
07:05 EDTRHHBYOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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July 20, 2015
07:33 EDTRHHBYInternational AIDS Society to hold a conference
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05:13 EDTRHHBYRoche expands HIV Global Access Program
Roche announced an expansion to the HIV Global Access Program to include early infant HIV diagnostic testing for low and middle income countries. Roche, in partnership with the Joint United Nations Programme on HIV/AIDS, or UNAIDS, the Clinton Health Access Initiative, or CHAI, UNITAID, the U.S. President's Emergency Plan For AIDS Relief, or PEPFAR, and the Global Fund to fight AIDS, TB and Malaria, is committed to working with the Diagnostics Access Initiative by providing state-of-the-art solutions to achieve the 90-90-90 goal set forth by UNAIDS. Announced in 2014, the HIV Global Access Program is Roche's most recent addition to the AmpliCare Initiative, which launched in 2002 in South Africa.

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