The US FDA has issued a warning about Hospira’s Carpuject prefilled cartridges after batches were found containing more than twice the amount of recommended dosage.
Bend Research says the addition of a new 18mm extruder to its hot melt tech will cut costs and will allow it work with customers earlier in the drug development process.
Lonza is targeting the gene therapy sector through a new partnership with Avalanche Biotechnologies that will seek to outlicense viral vector tech and process development knowhow.
IPEC (International Pharmaceutical Excipients) Federation is calling on foreign gelatin makers to set up manufacturing plants in India in a bid to tackle an “acute” shortage of the excipient.
US CRO Pharmaceutical Product Development (PPD) predicts that new CEO Dave Simmons' ‘pharmaceutical industry experience’ gained at Pfizer will be an asset in guiding partnerships.
The US FDA will have more powers to inspect ‘risky’ overseas pharmaceutical plants according to supporters of a bill being considered by the US senate this week.
‘CROs: look at the entire portfolio, not just the individual project, when planning clinical studies,’ says DIA’s adaptive design scientific working group.
Ideal Cures has expanded its drug delivery tech portfolio with a new alginic acid-based, delayed-release coating that – it claims – has advantages over shellac and starch.
Quanticate says it will eliminate unnecessarily “complicated spreadsheets” in clinical trial data analysis after integrating a new simplified web-based program into its own.
The US FDA has updated its preclinical testing requirements for biotech drugs citing advances since the publication of ICH S6 and the need to harmonize with international standards.
Outsourcing-Pharma presents its weekly round-up of the latest new appointments in the pharmaceutical industry, including news from Aptiv, Truveris and CMI.
SNBL USA has invested in ‘social housing’ at its lab in Everett, Washington citing ‘recent reductions’ in US non-human primate lab capacity as the driver.
in-PharmaTechnologist.com presents the latest new facilities to spring up all over the world, including a plasma-based therapy expansion for Baxter, a North African foray for Julphar, and a supply chain step-up for Vetter.
Ensuring outsourced clinical research is of a high standard is critical to the viability of the pharma sector and requires cross industry collaboration according to leaders gathered at the Avoca Group’s Quality Summit.
Outsourcing-Pharma presents its weekly round-up of the latest changes within the pharmaceutical industry, including news from Aptiv, AmerisourceBergen, and AMRI.
Preclinical services firm SNBL has fixed most of the deficiencies observed during a US FDA inspection in 2010 and says it is working to ‘quickly’ resolve the remaining issues.
