United States

Veteran Affairs, Seven Bridges partner on Million Veteran Program

Monday, April 11, 2016

Seven Bridges, a biomedical data analysis company, has signed a Collaborative Research and Development Agreement (CRADA) with the U.S. Department of Veteran Affairs (VA) to support two key research initiatives for the VA’s Million Veteran Program (MVP). The MVP is a national, voluntary research program funded by the VA’s Office of R&D, with the goal of partnering with Veterans receiving their care from the VA Healthcare System to study how genes affect health. Seven Bridges will serve as an industrial collaborator on the MVP, supporting the development of a hybrid cloud for large-scale data analysis, and a genotype-phenotype graph analysis engine.

[Read More]

INC Research, CISCRP collaborate on patient awareness

Wednesday, April 6, 2016

INC Research Holdings, a global phase I to IV CRO, has announced a strategic collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process. Through this collaboration, INC and CISCRP will jointly develop and implement educational initiatives designed to bring greater awareness to the importance of clinical trial participation in advancing public health.

[Read More]

Snapdragon Chemistry expands to new labs in Cambridge, MA

Tuesday, April 5, 2016

Snapdragon Chemistry has moved to new lab facilities in Cambridge, Massachusetts. Snapdragon’s corporate partner, Zaiput Flow Technologies, has also moved to the 85 Bolton Street site. This co-location will enhance the collaboration of these strategic partners and accelerate the development of advanced continuous chemical manufacturing technologies and solutions.

[Read More]

Watchdog group files amendment to FDA Citizen Petition

Wednesday, March 30, 2016

With deaths in clinical drug trials every month since December 2015, Center for Responsible Science (CRS) has updated its July 2015 citizen petition. The petition urges the FDA to update 29 regulations to allow the preclinical test method most predictive of human response is used during drug testing. Current regulations mandate the use of animal models, despite great progress in more human relevant tests.

[Read More]

Lilly’s Taltz (ixekizumab) receives FDA approval for plaque psoriasis

Friday, March 25, 2016

The FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.

[Read More]

PTC Therapeutics cuts workforce 18%

Thursday, March 24, 2016

PTC Therapeutics is reducing its workforce by approximately 18%, which will primarily affect employees and contractors in the U.S. This reduction is part of PTC’s program intended to optimally manage operating expenses following its recent setback related to the Refuse to File letter received from the FDA for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). 

[Read More]

FDA releases enhanced warnings for immediate-release opioid pain medications

Wednesday, March 23, 2016

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the FDA has announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. These actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

[Read More]

FDA approves new treatment for inhalation anthrax

Wednesday, March 23, 2016

The FDA has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

[Read More]