United States

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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Walgreens to promote ongoing outcomes studies beneficial in clinical research

Monday, August 28, 2017

In a move that mirrors longstanding practices in the pharma clinical trial research arena, Walgreens is making a case for partnerships between clinical researchers and a retail pharmacy provider. This month the company announced the creation of its Center for Health & Wellbeing Research (CHWB) website that will initially showcase 50 “outcomes studies” the company has completed over the past six years.

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FDA approves Ironwood’s duzallo for gout

Thursday, August 24, 2017

Ironwood Pharmaceuticals announced DUZALLO was approved by the FDA as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. DUZALLO is not recommended for the treatment of asymptomatic hyperuricemia. Ironwood expects DUZALLO to be commercially available early in the fourth quarter of 2017.

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CRISPR, Massachusetts General Hospital partner on CRISPR/Cas9 in T cell cancer therapies

Thursday, August 24, 2017

CRISPR Therapeutics, a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Massachusetts General Hospital Cancer Center (MGHCC), a scientific and clinical institution, have entered into a two-year research collaboration and license option agreement to develop novel T cell therapies for cancer. As part of the collaboration, CRISPR/Cas9 gene editing will be utilized to improve upon current T cell therapies in development, ultimately addressing unmet needs in both hematologic and solid tumors. Marcela V. Maus, M.D., Ph.D., director of the Cellular Immunotherapy Program at MGHCC and Assistant Professor of Medicine at Harvard Medical, will lead the scientific work at MGH.

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Alkermes initiates ALKS 5461 NDA for major depressive disorder

Tuesday, August 22, 2017

Alkermes announced the initiation of its rolling submission of a New Drug Application (NDA) to the FDA, seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action, for the adjunctive treatment of major depressive disorder (MDD). The company expects to complete the submission of the NDA for this Fast Track designated medicine by year-end 2017.

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LifeNet Health to create 321 new jobs in Virginia

Friday, August 18, 2017

LifeNet Health, a global regenerative medicine company, has announced that it will invest $12.25 million to expand its global headquarters operation in the City of Virginia Beach. The non-profit will add a 100,000-square-foot warehouse, 20,000 square feet of office space, and an 18,000-square-foot R&D and production facility across three campuses. Virginia successfully competed against Florida, North Carolina, and Washington for the project, which will create 321 new jobs.

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