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October 23, 2012
07:48 EDTRHHBYRoche alleged non-compliance with pharmacovigilance obligations probed by EMA
The European Medicines Agency has started an infringement procedure against Roche Registration Ltd, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines. The initiation of the infringement procedure follows a pharmacovigilance inspection carried out in 2012 by the UK Medicines and Healthcare products Regulatory Agency, which identified serious shortcomings of Roche’s pharmacovigilance processes. The start of this procedure means that the Agency will further investigate the allegations against Roche, though it does not prejudge the outcome of the investigation. The Agency will report the outcome of its investigation to the European Commission who may impose fines or periodic penalty payments under the Regulation mentioned above if it finds that Roche has committed an infringement of its obligations.
News For RHHBY From The Last 14 Days
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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 17, 2015
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.
April 14, 2015
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.
April 8, 2015
15:19 EDTRHHBYRoche says receives European approval for Avastin plus chemotherapy
Roche announced that the European Commission approved Avastin -- bevacizumab -- in combination with standard chemotherapy for the treatment of adult patients with persistent, recurrent or metastatic carcinoma of the cervix. The EU approval was based on the significant survival benefit in the pivotal GOG-0240 study, which showed that women who received Avastin plus chemotherapy had a statistically significant 26% reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone.
April 7, 2015
07:14 EDTRHHBYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.

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