Glenmark selects Cyndea to make gel capsule drugs
Cyndea Pharma and Glenmark Pharmaceuticals have partnered to make generic soft-gelatin capsule products for multiple markets.
Archives for July 18, 2017
US FDA warns opthalmic supplier Tubilux about Italian plant
The US FDA has called on Tubilux Pharma SPA to identify potential contamination sources at its eye medicine production plant in Italy in a warning letter this week.
ABL advancing HIV vaccine as part of 7 year, $318m contract
ABL, Inc. has been awarded a preclinical development support contract to help advance an HIV vaccine and other biologics candidates.
US FDA reaffirms hold on oral Proellex trials prompting Repros rethink
The US FDA has told Repros Therapeutics Inc. a new trial is needed to prove oral Proellex is safe, prompting the firm to consider refocusing on a vaginally-delivered formulation of the endometriosis candidate.
SQI Diagnostics signs commercial contract with global biotech
SQI Diagnostics Inc. has signed an agreement to commercialize a custom multiplexed assay for a Waltham, MA-based global biotechnology company's blood disorder drug program.
Eli Lilly licenses Adimab antibody discovery and optimization tech
Adimab, LLC is transferring its proprietary antibody discovery and optimization platform to Lilly research sites in San Diego and New York.
Update - comments from EMA and EFPIA
EU to probe if drug firms' pre-submission meetings sway EMA approval decisions
Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation