United States

Greater Gift brings clinical trial awareness through Hero’s Journey art project

Monday, November 6, 2017

Winston-Salem, North Carolina, will be one of only three cities across the nation to host a Hero’s Journey Art sculpture when it is unveiled next month at the Benton Convention Center. Greater Gift, a Winston-Salem non-profit with a mission to highlight the impact of clinical trial research, has partnered with Eli Lilly to honor clinical trial participants through the commissioning of three art pieces, by artist John Magnan, which will be displayed in Winston-Salem, Austin, Texas and Indianapolis, Indiana.

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FDA approves Bydureon BCise for type 2 diabetes

Thursday, October 26, 2017

AstraZeneca announced that the FDA has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control.

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Shire’s SHP654 receives Orphan Designation for hemophilia A

Thursday, October 26, 2017

Shire, a global biotechnology leader in rare diseases, announced the FDA awarded Orphan Drug Designation to Shire’s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.

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OCT expands presence in U.S.

Wednesday, October 25, 2017

OCT, an Eastern European CRO, expands its presence in North America. In October 2017, OCT’s representative office in the U.S. has been strengthened by additional employees. In particular, the U.S. team was complemented by Anna Yanaeva, Business Development Director.

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ACRO testifies about clinical trials in New Jersey

Tuesday, October 24, 2017

ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of the New Jersey Division of Consumer Affairs about a regulation that, if adopted, would have a devastating impact on the availability of clinical trials for patients in New Jersey and cripple the ability of New Jersey physicians to conduct industry-sponsored clinical trial research on investigational therapies.

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FDA approves CAR-T cell therapy for large B-cell lymphoma

Friday, October 20, 2017

The FDA approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

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