Proteon extends vonapanitase manufacturing deal with Lonza
Proteon Therapeutics has extended a deal with Lonza for the development and manufacture of its lead product, the pancreatic elastase candidate vonapanitase.
Archives for July 15, 2015
Peregrine flying high as CMO biz preps to open new mAb facility
Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine, which is hoping to commercialise its breast cancer candidate.
Pfizer to close Mumbai manufacturing facility
With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing.
Data management, SOP deficiencies cited often after 2014 GCP inspections, EMA report finds
The latest EMA (European Medicines Agency) report on GCP (good clinical practice) inspections reveals that deficiencies around SOPs (standard operating procedures), sponsor monitoring, data management, and essential documents linked to trials were most...
Nordea mulling holdings in drugmakers that source APIs from water polluters
Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.
Celgene boosting immune-inflammatory presence with $7.2bn Receptos deal
Celgene has shelled out $7.2bn (€6.6bn) to acquire Receptos which is developing an oral lymphocyte trafficking agent for multiple sclerosis and inflammatory bowel disorder.
AB Science hit with FDA warning letter over clinical trials
France’s AB Science has received a warning letter from the US FDA for its failure to adhere to agency regulations and to protect trial subjects’ safety in a pancreatic cancer study and GIST (gastrointestinal stromal tumor) studies from 2009 to 2013.