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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