Pharma News

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.

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.

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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.