Pharma News

Caladrius Biosciences, Inc., announces that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) for the treatment of recent-onset type 1 diabetes (“T1D”) was granted orphan-drug designation by the US Food and Drug Administration (“FDA”) for the treatment of type 1 diabetes mellitus with residual beta cell function.

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.

Two linked papers in The BMJ this week shed new light on the relation of alcohol and diet with breast cancer and heart disease.The first study reports that high fruit consumption during adolescence may be associated with lower breast cancer risk, while the second study finds that increasing alcohol intake in later life is associated with an increased risk of breast cancer.

A new study in which researchers rapidly screened more than 11,000 bioactive molecules for activity against an antibiotic-resistant strain of Klebsiella pneumoniae bacteria identified multiple compounds with potent antimicrobial activity. These active compounds included two existing drugs, azidothymidine, an antiviral used to treat HIV infection, and spectinomycin, an antibacterial agent used to treat gonorrhea, as reported in ASSAY and Drug Development Technologies, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the ASSAY and Drug Development Technologies website until June 11, 2016.

Zika virus infects and crosses the placentas of pregnant mice and causes severe damage or death in fetal mice, report scientists funded by the National Institutes of Health. Investigators from the Washington University School of Medicine in St. Louis have developed two mouse models of Zika infection in pregnancy that will enable rapid testing of experimental Zika drugs to prevent congenital abnormalities, and may aid in better understanding how the virus affects pregnant women.

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.