Industry News

H3 Biomedicine Inc., announced that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate H3B-8800. The compound is an oral and selective small molecule modulator of splicing factor 3b subunit 1 (SF3B1), which is being developed by H3 Biomedicine as an anticancer therapeutic agent for the potential treatment of select hematologic malignancies.

NinePoint Medical, Inc., has received US Food and Drug Administration (FDA) 510(k) clearance to market its Real-time Targeting feature for its flagship product, the NvisionVLE Imaging System. In addition, the first procedures with this new system were performed at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

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The European Commission has granted orphan drug status to Cytori Therapeutics' broad range of Cytori Cell Therapy formulations when used for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma.

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. in 2003.

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).

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.