United States

NIH’s All of Us Research Program expands medical centers network

Wednesday, August 30, 2017

Three sets of healthcare provider organizations will add to a growing network of trusted leaders charged with implementing the NIH’s All of Us Research Program, an ambitious effort to advance research into precision medicine. Combined, the new awardees will receive $13.8 million to enroll interested individuals, gather participant health information and help retain participants in the program through ongoing engagement efforts. These awardees will extend the geographic coverage of the program and strengthen its reach within underserved communities, including lower-income, Hispanic and Latino, African American, American Indian and rural communities.

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Abeona receives FDA breakthrough designation for epidermolysis bullosa

Wednesday, August 30, 2017

Abeona Therapeutics, a clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced that the FDA has granted Breakthrough Therapy designation status to the company’s EB-101 gene therapy program for patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB). The designation from the FDA enables collaborative discussions with senior FDA personnel, priority review and an expedited approval process to drug candidates where preliminary clinical trials indicate that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.

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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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Boehringer Ingelheim initiates phase IIa study of liver disease NASH compound

Tuesday, August 29, 2017

Boehringer Ingelheim and pharmaceutical company Pharmaxis announce that Boehringer Ingelheim has initiated a European and North American phase IIa trial in NASH with BI 1467335 (formerly known as PXS-4728A), acquired from Pharmaxis in May 2015. The compound is an oral inhibitor of amine oxidase, copper containing 3 (AOC3), and works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.

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Omeros responds to Statnews.com story

Tuesday, August 29, 2017

Omeros stated that it continues to pursue legal action to hold responsible those behind a series of defamatory reports about the company posted online under the pseudonym “Art Doyle,” an entity or group that self-identifies as having a short position in Omeros’ stock. Because of its ongoing legal action, including a number of steps aimed at unmasking the identity of the individual(s) responsible, Omeros elected not to respond to queries from a writer for statnews.com who evidently had early access to and commented through Twitter on the initial “Art Doyle” false report before it was broadly made public.

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Clinerion improves functionality for Patient Recruitment System

Monday, August 28, 2017

Clinerion has redesigned the web application for Patient Recruitment System, creating a sleek, professional and intuitive new user interface with analytical capabilities. The system’s functionality and speed have been improved, further supporting decision-making for clinical trial site selection and recruitment strategies.

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FDA to enforcement oversight of stem cell therapies and regenerative medicine

Monday, August 28, 2017

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes among many others.

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