United States

Novartis’s CTL019 receives FDA Breakthrough Therapy designation

Thursday, April 20, 2017

Novartis announced that the FDA has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. This is the second indication for which CTL019 has received this designation; the first being for the treatment of r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients.

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ArQule Receives FDA IND clearance for BTK inhibitor ARQ 531

Wednesday, April 12, 2017

ArQule has received clearance from the FDA for the Investigational New Drug (IND) application to conduct a phase I clinical trial with ARQ 531 in patients with B-cell malignancies who are refractory to other therapeutic options. ARQ 531 is an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK).

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FDA, Emulate partner on organs-on-chips technology

Wednesday, April 12, 2017

Emulate has entered into a Cooperative Research and Development Agreement (CRADA) with the FDA’s Office of Foods and Veterinary Medicine. Under this multi-year CRADA, Emulate and FDA will collaborate to evaluate and qualify the use of Emulate’s Organs-on-Chips technology as a platform for toxicology testing to meet regulatory evaluation criteria for products—including foods, dietary supplements and cosmetics. The CRADA studies will use Emulate’s Human Emulation System, comprised of Organ-Chips, instrumentation and software apps. The system recreates the natural physiology of specific human tissues and organs, and is designed to provide a predictive model of human response to diseases, medicines, chemicals, and foods with greater precision and detail than other preclinical testing methods, such as cell culture or animal-based experimental testing.

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Domestic Research Enhancement Act of 2017 endorsed by many

Tuesday, April 11, 2017

The Domestic Research Enhancement Act of 2017 (H.R. 1234), which modernizes the R&D tax credit to recognize the essential role contract research now plays in the development of new pharmaceuticals, biologics and medical devices, has been introduced by Rep. Pat Meehan (R-PA) and co-sponsors Rep. George Holding (R-NC) and G.K. Butterfield (D-NC).

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CSSi LifeSciences, the Prince William Science Accelerator partner

Friday, April 7, 2017

CSSi LifeSciences, a partner from discovery to commercialization for biologics and vaccines, is partnering with the Prince William Science Accelerator, a public-private, commercially available wet lab space in Northern Virginia. The partnership promotes the development of new businesses and the retention and expansion of existing businesses within the county’s growing and diverse life sciences community through CSSi LifeSciences’ technical assistance, regulatory, clinical and commercial assessment for all Prince William Science Accelerator tenants.

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Humacyte receives FDA RMAT designation for Humacyl in vascular access for hemodialysis

Monday, March 27, 2017

Humacyte, an innovator in biotechnology and regenerative medicine, announced that the FDA has granted Humacyl, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that the FDA will help facilitate the efficient development and expedited review of the HAV for vascular access to patients in need of life-sustaining hemodialysis. Carved from the model of other FDA expedited programs such as Breakthrough Therapy, the RMAT designation is a new expedited program for regenerative medicine products.

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Charles River Laboratories International to pay $1.8M to settle False Claims Act allegations

Friday, March 24, 2017

Charles River Laboratories International has agreed to pay the U.S. government $1.8 million to settle claims that it violated the False Claims Act by improperly charging for labor and other associated costs that were not actually provided on certain NIH contracts, the Justice Department announced. Charles River is a for-profit corporation headquartered in Wilmington, Massachusetts. 

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