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January 24, 2014
11:35 EDTRHHBY, HALOHalozyme announces positive CHMP opinion on Roche's MabThera SC
Halozyme Therapeutics (HALO) announced that the EU Committee for Medicinal Products for Human Use, or CHMP, has recommended that the European Commission approve Roche's (RHHBY) subcutaneous formulation of MabThera using Halozyme's recombinant human hyaluronidase for the treatment of patients with common forms of non-Hodgkin lymphoma. The CHMP opinion is based primarily on data from Roche's Phase 3 SABRINA study. Roche expects a final decision from the European Commission in the coming months, Halozyme said. In 2006, Halozyme entered into an agreement with Roche and to date, Roche has elected to explore the use of rHuPH20 for up to a total of five exclusive targets, and Roche retains the option to apply rHuPH20 to three additional targets through the payment of annual license maintenance fees. Subject to the successful achievement of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on product sales for Herceptin SC, MabThera SC and any other product candidates which would be successfully developed and commercialized under the agreement.
News For HALO;RHHBY From The Last 14 Days
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July 31, 2015
07:58 EDTHALOHalozyme and Eisai partner to investigate eribulin and PEGPH20 in breast cancer
Halozyme and Eisai Co. have signed a clinical collaboration agreement to evaluate Eisai's agent eribulin mesylate - brand name: Halaven - in combination with Halozyme's investigational drug PEGPH20 in first line HER2-negative metastatic breast cancer. The companies will jointly share the costs of a phase 1b/2 clinical trial to assess whether or not eribulin, in combination with PEGPH20, can improve overall response rate as compared with eribulin alone as a therapy in women with advanced breast cancer. In hyaluronan-rich triple-negative breast preclinical animal models, the addition of PEGPH20 to eribulin showed a significantly higher tumor growth inhibition and overall tumor regression when compared to eribulin alone. Eribulin is not indicated for first-line therapy for patients with HER2-negative metastatic breast cancer.
06:36 EDTRHHBYImmunoGen: enrollment in expansion cohort for IMGN853 to complete by year end
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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.
05:57 EDTRHHBYRoche 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
07:08 EDTRHHBYRoche introduced several diagnostic testing platforms at the AACC 2015
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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 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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