Pharma News

Aurinia Pharmaceuticals Inc, a clinical stage pharmaceutical company announced that after constructive interactions with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the company will initiate a study of voclosporin in healthy Japanese volunteers. With positive results from the pending phase 2b AURA-LV study in lupus nephritis (LN) and supportive safety, tolerability, pharmacokinetic and pharmacodynamic data from this clinical study, the company hopes to be able to incorporate Japanese patients into future global voclosporin studies, eliminating the need to conduct a stand-alone Japanese trial.

The U.S. Food and Drug Administration finalize rule that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human consumption or food-producing animals. The new sales data will improve the agency’s understanding of how antimicrobials are sold and distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.

X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking and increase the ability for T-cells to track and destroy cancer, announced dosing of the first patient in a phase 1/2 study of X4P-001, the company’s lead CXCR4 inhibitor, in patients with advanced clear cell renal cell carcinoma (ccRCC).

Two patients with melanoma that had spread to the liver survived for at least 8.5 and 12 years after resection of the hepatic tumor and treatment with patient-specific immunotherapeutic vaccines. The vaccines, designed to activate the immune system against the tumor, were derived from the patients' own dendritic cells loaded with proteins isolated from their tumors, as described in an article published in Cancer Biotherapy and Radiopharmaceuticals, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free for download on the Cancer Biotherapy and Radiopharmaceuticals website until June 10, 2016.

Signaling a potential new approach to treating diabetes, researchers at Washington University School of Medicine in St. Louis and Harvard University have produced insulin-secreting cells from stem cells derived from patients with type 1 diabetes.

For years, physicians have told patients that HDL (high-density lipoprotein cholesterol) helps protect them from cardiovascular disease (CVD). And the higher the number, the more the protection. HDL, often considered an independent predictor of heart disease, has been dubbed the "good" cholesterol, thanks to its protective effects. But a new study shows for the first time that HDL's protection depends on the levels of two other blood fats or lipids associated with heart disease. If these fats are not within normal ranges, even a high HDL may not be protective.

JHL Biotech (JHL), a biopharmaceutical company,opened the world’s first KUBio™ biopharmaceutical manufacturing facility with single-use bioprocessing technology at a ribbon-cutting ceremony in Wuhan, China today.

Morepen Laboratories Ltd. has established a leadership position for its anti-asthmatic bulk drug Montelukast in the global market. As per the latest report published by a global research firm - QYR Research, Morepen is the No.1 supplier globally in terms of total quantity sold, followed by Mylan and TAPI (Teva) who appear on the second and third position respectively.

Abbott announced that its pivotal clinical trial of the company's Tecnis® Symfony 1-Piece Acrylic Intraocular Lens (IOL) met its primary endpoint of improved intermediate vision.  Data from this study showed that people who received the Tecnis Symfony lens achieved significantly improved intermediate, as well as near, vision compared to those who received a monofocal IOL.  The data were presented  at the American Society of Cataract and Refractive Surgery (ASCRS) in New Orleans by Jason Jones, M.D., Jones Eye Clinic, Sioux City, Iowa. 

Epizyme, Inc. announced that it has entered into a collaboration agreement with the Lymphoma Study Association (LYSA) to investigate the combination of tazemetostat with R-CHOP as a front-line treatment in patients with diffuse large B-cell lymphoma (DLBCL). LYSA is a premier cooperative group in France dedicated to clinical and translational research for lymphoma, and is certified by the French National Cancer Institute. Under the agreement, the phase 1b/2 trial will be jointly conducted with the Lymphoma Academic Research Organisation (LYSARC), the operational arm of LYSA.