Roche

Warp Drive Bio to combat multi-drug-resistant bacterial infections

Tuesday, October 17, 2017

Warp Drive Bio, a drug discovery company developing therapeutics that exploit the molecules and mechanisms of nature, has formed a strategic collaboration with Roche to discover and develop multiple novel classes of antibiotics. The serious global health threat of multi-drug-resistant bacterial infections has created an urgent need for new antibiotics with novel structures and mechanisms of action.

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NIH partners with 11 biopharmaceutical companies on cancer immunotherapy strategies

Friday, October 13, 2017

The NIH and 11 biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role. 

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FDA selects participants for new digital health software precertification pilot program

Wednesday, September 27, 2017

The FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. FDA Commissioner Scott Gottlieb, M.D. announced the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

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FDA grants Priority Review for Genentech’s Gazyva

Tuesday, August 29, 2017

Genentech, a member of the Roche Group, announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.

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WCG’s MedAvante-ProPhase expands executives

Tuesday, August 15, 2017

WIRB-Copernicus Group (WCG), a provider of solutions that measurably improve the quality and efficiency of clinical research, announced that industry experts Steven Herne and Michael Cioffi have joined the leadership of MedAvanteProPhase, the Group’s electronic clinical outcomes assessment (eCOA) arm. Herne and Cioffi are tasked with expanding MedAvante-ProPhase’s already formidable portfolio of services and technologies, which improve the quality of clinical trial data collection and analysis in the fields of CNS and mental health.

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Adimab announces platform transfer with Lilly

Friday, July 21, 2017

Adimab, a global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, has entered into an agreement with Eli Lilly to transfer the Adimab Platform to Lilly for the discovery and optimization of antibody-based drugs in all therapeutic areas. This technology transfer expands an ongoing collaboration between the two companies that was initiated in 2010, which has yielded several undisclosed therapeutic candidates for Lilly.

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Roche acquires mySugr to form digital diabetes management open platform

Friday, June 30, 2017

Roche and mySugr announced that the two partners have signed an agreement under which Roche acquired all shares of mySugr. Counting more than one million users globally, mySugr is one of the leading mobile diabetes platforms in the market and will become an integral part of Roche’s new patient-centered digital health services platform in diabetes care. The acquisition allows Roche to expand its leading position in the area of diabetes management.

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Improved perception of the industry

Monday, June 12, 2017

The 2017 Global Pharmaceutical Reptrak study, prepared each year by Boston’s Reputation Institute, showed that the public’s perception of the pharmaceutical industry has improved, earning an industry score of 71.8, up from 68.2 in 2016. Furthermore, about 44% of respondents viewed the industry as having an excellent reputation, a seven point increase since 2016. Similarly, the number of respondents who perceived the industry as weak or poor declined, moving to 26% from 35% in 2016.

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Genentech’s Actemra FDA approved for giant cell arteritis

Friday, May 26, 2017

Genentech, a member of the Roche Group, announced that the FDA has approved Actemra (tocilizumab) subcutaneous injection for the treatment of giant cell arteritis (GCA), a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010.

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FDA grants Breakthrough designation for Rituxan (Rituximab) in pemphigus vulgaris

Friday, March 24, 2017

Genentech, a member of the Roche Group, has announced that the FDA granted Breakthrough Therapy Designation status to Rituxan (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible. Genentech is currently enrolling a phase III study in pemphigus vulgaris (PEMPHIX, NCT02383589), a disease for which there are limited treatment options. 

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