Roche

Tekmira changes name to Arbutus Biopharma, a hepatitis B solutions company

Wednesday, July 22, 2015 01:57 PM

Tekmira Pharmaceuticals, headquartered in Vancouver, Canada, plans to change its corporate name to Arbutus Biopharma, a therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), to be effective on or before Aug. 3. The name change affirms the successful integration of OnCore BioPharma and Tekmira Pharmaceuticals into a combined company with the singular goal of delivering a cure for chronic HBV. The combined entity currently fields a large portfolio of HBV product candidates in the industry.

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Evotec, Roche provide initial update from phase IIb trial in Alzheimer's disease

Wednesday, July 8, 2015 11:12 AM

Evotec was updated by its partner Roche on the initial results of the phase IIb trial with Sembragiline (RG1577, EVT302), a MAO-B inhibitor for the treatment of Alzheimer's disease (AD). In this study, Sembragiline failed to demonstrate benefit on the primary endpoint (Alzheimer's Disease Assessment Scale—Cognitive Behaviour Subscale, ADAS-cog-11) after 52 weeks of treatment.

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FDA extends PDUFA date for Genentech’s cobimetinib NDA

Thursday, July 2, 2015 09:17 AM

Exelixis has been informed by partner Genentech, a member of the Roche Group, that, in order to accommodate its review of a supplemental data submission, the FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech's NDA for cobimetinib by the standard extension period of three months, from Aug. 11 to Nov. 11.

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Roche launches a new strategy in Africa

Wednesday, June 24, 2015 09:52 AM

Roche has launched a new Africa Strategy in an effort to expand its footprint in parts of the continent.  

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Report: Innovation trends in treatments for rare diseases and widespread conditions

Wednesday, June 17, 2015 08:45 AM

The antibiotics market is at risk of losing another decade to inadequate levels of research and innovation, according to international intellectual property firm Marks & Clerk’s new report From rare to routine—medicines for rare diseases, vaccines and antibiotics. Research highlights the striking difference between research levels into rare diseases, vaccines and antibiotics across the globe.

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FDA grants Breakthrough designation for Actemra in Systemic Sclerosis

Thursday, June 11, 2015 12:59 PM

Genentech, a member of the Roche Group, has announced that the FDA has granted Breakthrough Therapy designation status to Actemra (tocilizumab) for systemic sclerosis, also known as scleroderma. This designation is intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases and to help ensure patients have access to them as soon as possible. Genentech also has initiated a phase III study in systemic sclerosis (NCT02453256), a disease for which there are inadequate treatment options.

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New Synexus board gears up for expansion through organic growth and acquisition

Wednesday, June 10, 2015 11:07 AM

Following the completion of the management buyout of Synexus, the new board confirms its intention to expand the footprint of the company through organic growth and acquisition. Synexus, a multi-national company dedicated to the recruitment and running of clinical trials at its own research centers across the globe, intends to become a major player in the U.S., continue to expand its existing network of sites in Europe and Africa and develop a presence in Asia and South America.

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CISCRP Medical Heroes Appreciation event returns to DIA to celebrate clinical trial volunteers

Wednesday, May 27, 2015 01:38 PM

The Center for Information and Study on Clinical Research Participation (CISCRP), an independent nonprofit organization, has announced the upcoming Medical Heroes Appreciation Walk in Washington D.C. to honor the volunteers who give the gift of participation in clinical research and to raise awareness about the importance of clinical research in advancing public health.

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AbbVie’s Venetoclax receives FDA Breakthrough Therapy designation for CLL

Thursday, May 7, 2015 12:54 PM

AbbVie has announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

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Curadev, Roche ink research cancer immunotherapeutic collaboration

Wednesday, April 22, 2015 12:13 PM

Curadev Pharma, headquartered in New Delhi, India, has entered into a research collaboration and exclusive license agreement with Roche for the development and commercialization of IDO1 and TDO inhibitors. The agreement covers the development of the lead preclinical immune tolerance inhibitor and a research collaboration with Roche's research and early development organization to further explore the IDO and TDO pathways.

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CWWeekly

July 27

AB Science warned about putting study volunteers in danger

FDA, Google unite to detect search-data adverse events

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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