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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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April 22, 2015
05:27 EDTRHHBYRoche sees FY15 core EPS to grow ahead of sales at constant exchange rates
Expects FY15 sales to grow low- to mid-single digit, at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
05:27 EDTRHHBYRoche reports Q1 group sales CHF 11.83B vs. CHF 11.50B
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April 21, 2015
07:06 EDTRHHBYBina Tech, AstraZeneca announce collaborative agreement for GMS
Bina Technologies, a member of the Roche Group (RHHBY), and AstraZeneca (AZN) announced that they have entered into an agreement for AstraZeneca to become the first member to join the Bina Alliance Program and to further develop the Bina Genomic Management Solution. AstraZeneca will utilize the Bina GMS as an enterprise platform to support its development work across three main therapeutic areas: oncology, cardiovascular and metabolic disease, and respiratory, inflammation and autoimmunity. Bina’s proprietary technology enables translational and academic researchers to perform fast and scalable analyses to maximize the value of genomic data. Under the terms of the agreement, AstraZeneca will adopt Bina GMS globally to support enterprise genomic data analysis and management. Bina in turn will provide AstraZeneca with direct access to its scientific and engineering teams to further develop the Bina GMS for pharmaceutical applications.
05:33 EDTRHHBYInovio, Roche initiate clinical trial for DNA immunotherapy to treat HCB
Inovio Pharmaceuticals (INO) announced that it has initiated a Phase I trial to evaluate Inovio's DNA immunotherapy in patients who are chronically infected with hepatitis B. In 2013, Roche (RHHBY) and Inovio entered into a partnership to co-develop and commercialize Inovio's hepatitis B immunotherapy. This trial initiation triggers a $3M milestone payment from Roche to Inovio. This phase I, randomized, open-label, active-controlled, dose escalation study will evaluate the safety, tolerability, and immunogenicity of Inovio's hepatitis B immunotherapy, INO-1800, alone or in combination with INO-9112, Inovio's IL-12-based immune activator. This international study will enroll patients in the United States and Asia Pacific region with a primary endpoint of safety and tolerability of the therapy. The secondary endpoints will evaluate the cellular and humoral immune response to INO-1800 and investigate the therapy's effect on several viral and antiviral parameters. All trial subjects are also medicated with standard-of-care antiviral therapies.
April 20, 2015
08:24 EDTHALOHalozyme PEGPH20 data supports ongoing work
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07:57 EDTHALOHalozyme an underappreciated story with catalysts, says UBS
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April 17, 2015
07:14 EDTHALOHalozyme management to meet with UBS
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05:32 EDTRHHBYAccelerate Diagnostics appoints Pete Bantock to Chief Culture Officer
Accelerate Diagnostics (AXDX) appointed Pete Bantock to the newly created position of Chief Culture Officer and Head of Human Resources. Bantock was most recently the SVP and Head of commercial Operations for the Americas. He will be replaced by Ron Price, who joins the company from Roche (RHHBY) where he held the position of VP of Point of Care and Commercial Operations.
April 16, 2015
08:04 EDTRHHBYRoche granted orphan status for lymphoma treatment
The FDA granted Roche's Genentech unit orphan status for Gazyva, its treatment of follicular lymphoma.
07:10 EDTHALOHalozyme management to meet with UBS
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April 14, 2015
07:10 EDTHALOHalozyme management to meet with UBS
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06:30 EDTRHHBYRoche to seek to have cancer drug tested in 11 trials in 2015, Reuters says
Roche said it would seek to have its immunotherapy cancer drug, MPDL3280A, in 11 late stage trials by the end of 2015, aaccording to Reuters. The drug is being tested in melanoma, as well as lung, bladder, kidney, bowel and blood cancers, the news service noted. Reference Link
April 13, 2015
10:01 EDTRHHBYRoche acquires CAPP Medical
Roche announced it has acquired CAPP Medical, a genomics research company founded by Stanford University oncologists and industry veterans, to advance the development of technology for cancer screening and monitoring through the detection of circulating tumor DNA in blood.
09:05 EDTHALOHalozyme appoints Harry Leonhardt as Chief Compliance Officer
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