Amicus Therapeutics on Tuesday announced that a pre-New Drug Application (NDA) meeting was held with the U.S. Food and Drug Administration (FDA) to discuss the oral, small-molecule pharmacological chaperone migalastat for the treatment of Fabry disease. Read More »

Trial design is in keeping with FDA's newly released draft guidances. Read More »

U.S. Attorney Booth Goodwin said on Tuesday that Trivillian’s Pharmacy, in Kanawha City, West Virginia, was sentenced in federal court in Charleston to three years of probation for federal health care and drug crimes. Read More »

Lion Biotechnologies Inc. on Monday announced it has opened enrollment in a Phase 2 clinical trial of its lead product candidate, LN-144, for the treatment of refractory metastatic melanoma. Read More »

Kite Pharma receives exclusive option to license multiple T cell receptor gene sequences. Read More »

The Centers for Disease Control and Prevention recently released new recommendations advising all nursing homes to improve antibiotic prescribing practices to protect residents from the effects of antibiotic-resistant infections. Read More »

BioBlast Pharma Ltd. on Monday announced it has been granted a U.S. patent for Cabaletta (IV trehalose) titled "Compositions and Methods for Treating Spinocerebellar Ataxia (SCA)." Read More »

Baxalta Incorporated has announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for approval of an investigational 20 percent concentration immunoglobulin subcutaneous treatment. Read More »

Fresenius Kabi USA announced Friday it has introduced the anti-infective Moxifloxacin injection 400 mg per 250 mL in Freeflex bags. Read More »

EMD Millipore, Merck's life-sciences unit, has expanded its EMPROVE portfolio of pharmaceutical raw materials. The expanded portfolio of pharmaceutical raw materials assists drug-product manufacturers' risk assessment workflows and supplier qualifications. Read More »

Janssen Biotech said on Monday that it has submitted a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration for front-line use in patients with chronic lymphocytic leukemia (CLL). Read More »

Generic-drug maker Mylan N.V. said on Monday that it has officially launched its formal offer to acquire all outstanding ordinary shares of Perrigo Co. Plc, based in Ireland. "With the overwhelming support of Mylan shareholders, today we officially are taking our offer directly to the Perrigo shareholders,” Mylan Executive Chairman Robert Coury said. Read More »

An article in the medical journal Health Affairs this month cited research on the positive impact of reducing the cost of prescription drugs and other medical costs from the NACDS/PhRMA. Read More »

Sen. Bernie Sanders (I-Vt.) and House Oversight and Government Reform Committee Ranking Member Elijah Cummings (D-Md.) recently introduced legislation to address skyrocketing increases in prescription drug prices. Read More »

Soligenix, Inc., a late-stage biopharmaceutical company, has started treatment on patients enrolled in its Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer patients. Read More »

TG Therapeutics, Inc. announced Wednesday the start of a Phase 1/2 clinical study investigating the use of TGR-1202, TG Therapeutic’s oral PI3K delta inhibitor and TG-1101 (ublituximab), in patients with relapsed or refractory CLL. Read More »

Zafgen, Inc. announced Wednesday the completed enrollment of ZAF-203, a Phase 2b clinical trial of beloranib in the treatment of patients with both severe obesity and type 2 diabetes. Read More »

MorphoSys AG recently provided an update on the clinical development outlook for its proprietary drug pipeline. Read More »

The CVS Health Research Institute recently conducted a study that showed that members of drug benefit plans with narrow pharmacy networks demonstrated improved medication adherence. Read More »

Pluristem Therapeutics Inc. on Wednesday announced it has completed a successful meeting with the U.S. Food and Drug Administration (FDA) about the start of a Phase I clinical trial for its PLX-R18 cells in the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation. Read More »