BioSpace News Archive

Stephens & Associates, Inc., a contract research organization (CRO) dedicated to providing the most advanced, comprehensive clinical research services with the highest quality standards to skin science clients in dermatology, cosmetics, medical devices and personal care, announces the opening of its full service Phoenix, Arizona facility.

At this interim analysis after a median of 17 weeks of treatment, emicizumab prophylaxis demonstrated a clinically meaningful control of bleeding over time.

The SPIRA family of interbody implants represents the next generation of open architecture; 3-D printed, titanium implants designed to enhance fusion.

Separately, the company also announced that in November it entered into an accelerated share repurchase agreement to acquire $150M of Edwards’ common stock.

Metacrine today announced it has closed a $22M Series B financing led by new investor NEA, along with participation from existing investors ARCH, Polaris, venBio, and Alexandria Venture Investments.

The Company anticipates dosing its last subject during the first half of 2018, with study completion within twelve months, and an expected NDA filing in the fourth quarter of 2018.

Neon Therapeutics and Merck will collaborate on a Phase 1b clinical trial that will examine the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with KEYTRUDA, pemetrexed and carboplatin in patients with untreated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).

CEL-SCI Corporation announced today that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its review of the Phase 3 study data.

The U.S. Food and Drug Administration has granted Aptinyx Fast Track designation for the development of NYX-783 for the treatment of PTSD.

Updated preliminary results in a subgroup analysis of 57 efficacy evaluable patients with HER2-positive metastatic breast cancer pre-treated with ado-trastuzumab emtansine showed that DS-8201 demonstrated a confirmed overall response rate of 61.4 percent and a disease control rate of 94.7 percent.