Bristol-Myers Squibb has acquired the rights to buy immunotherapy firm Promedior and could pay up to $1.25bn (€1.1bn) depending on the clinical development of its lead fibrosis product PRM-151.
Army training is ideal preparation for a biopharma career according to the US National Center for Therapeutics Manufacturing, which is seeking former military personnel interested in learning about bioprocessing.
Clinical trial operators are slowly converting to electronic Trial Master Files (eTMFs) but almost a third still rely on paper to manage data, according to cloud-based software provider Veeva.
New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US FDA told in-Pharmatechnologist.
The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.
Shire will use contractors to increase production of Cinryze, the half billion dollar-a-year Hereditary Angioedema (HAE) drug it bought with ViroPharma in 2014.
A drugmaker trialling an autoimmune disease treatment in the UK has been cleared to use electronic informed consent by the National Health Service (NHS).
WuXi PharmaTech has signed a strategic partnership deal to provide exclusive laboratory testing services to Hong Kong-headquartered Lee’s Pharmaceutical.
Novo Nordisk has confirmed it will build an API plant in the US, telling this publication a desire to have manufacturing capacity in the key market for its oral diabetes candidate, semaglutide, drove the decision.
Novo Nordisk could spend up to $2bn (€1.8bn) on two facilities to support its diabetes portfolio, including an oral long-acting GLP-1 analogue set to enter Phase III trials.
Pharma firms developing inhalable drugs often fail to test that their formulations are compatible with their intended delivery devices early enough according to the Intertek team behind research stressing the benefits of early assessment.
The US Department of Agriculture (USDA) has filed a complaint against antibody supplier Santa Cruz Biotechnology for its allegedly poor treatment of animals.
Covance has announced a contract expansion with one of its existing customers signing a multi-year deal to use the CROs trial optimization tech for lab monitoring.
The US Patent and Trademark Office (USPTO) has refused to review a challenge to Acorda Therapeutics’ patents from a group trying to block “abusive” IP claims.
Royal DSM will make up to 1100 staff redundant by the end of 2017 to cut costs following the formation of its Sinochem JV and pharma products deal with Patheon.
Testing laws introduced after Nazi attrocities in the 40s combined with the paucity of validated in vitro toxicity assays mean animal models are still essential for preclinical research say experts.
Drugmakers trying to make blue or green pills for the US market have a new option after the FDA approved a bacteria-derived extract developed by Colorcon for pharma applications.
The UK’s BioCity in Nottingham is adding a £30m ($47m) facility to house life science start-ups including CROs. The site will also become a hunting ground for a soon-to-launch venture capital fund which will invest in the SME tenants.
Anti-infectives firm Xellia has moved its North American HQ to the lyophilisation plant in Raleigh, North Carolina that it bought from Fresenius Kabi last July.
The Italian Ministry of Health has banned compounding pharmacies from preparing drugs containing any of seven APIs after chemists were discovered making dangerous off-label weight loss treatments.
There’s little chance US companies will consider Iran as a venue for pharmaceutical contract manufacturing, even in the current era of limited détente between the two countries, experts say.
Hemispherx Biopharma has signed extended US distribution agreements as part of efforts to relaunch Alferon N Injection, a genital wart treatment it pulled in 2008 after production costs soared.
