BioSpace News Archive

Biotage AB, is pleased to announce the launch of the Biotage® VacMaster™ Disk, a vacuum extraction unit for performing manual, disk-based extractions of semi-volatile organic compounds and hexane-extractable materials from aqueous matrices.

Retrophin, based in San Diego, announced that the U.S. Food and Drug Administration (FDA) had given its 100 mg and 300 mg tablets of Thiola EC (tiopronin) the thumbs-up to treat cystinuria.

Under the agreement, Thermo Fisher will provide Amicus with immediate clinical and commercial manufacturing capabilities and capacity for Amicus’ intrathecal AAV Batten disease gene therapy programs.

The month of July is a slow one for the U.S. Food and Drug Administration (FDA), at least in terms of scheduled approval dates. Here’s a look at the three PDUFA dates the agency has on its calendar for the month.

Financial details of the deal were not disclosed, but Lonza said it plans to retain the Novartis employees currently working at the facility.

FDA Quality and Regulatory Consultants and its sister company, Solar Compliance have announced a unique tool to help in the due diligence and qualification of outsourced partners, The Orange Report.

An article published in Experimental Biology and Medicine identifies a new target for the treatment of idiopathic pulmonary fibrosis.

Retrophin, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA® EC (tiopronin), a new enteric-coated formulation of THIOLA® (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones.

Ascension Healthcare plc announces positive findings from its Flexiseq User Experience Study.

CENTOGENE revealed the growth in its knowledge-base of rare hereditary diseases.