EMA and FDA team on QbD parallel evaluation pilot scheme
The EMA and the US FDA will conduct parallel assessment of QbD development and manufacturing data for new drug submissions under a new pilot scheme announced this week.
Almac installs time saving wallet presses
Almac Clinical Services has added to installed two new automated wallet presses at its facilities in Craigavon, Northern Ireland and Pennsylvania in the US.
SAFC announce new POC manufacturing services
SAFC, the custom manufacturing wing of global healthcare giant Sigma Aldritch, has announced the launch of raw materials and custom services specifically developed for point-of-care (POC) diagnostics manufacture.
Cytovance secures $22.5m equity investment from Great Point Partners
Cytovance Biologics, the US-based biopharmaceutical contract manufacturer (CMO), has secured a growth equity investment from Connecticut, US-based private investors, Great Point Partners.
Johnson & Johnson finalises terms of FDA consent decree
Johnson & Johnson, the multinational healthcare giant, has announced it has finalised the terms of a consent decree with the FDA over its stricken McNeil PPC manufacturing plants.
Biopharma key to Pall’s Q2 gains
Life sciences drove Pall’s growth in the second quarter of fiscal 2011, with sales to the biopharmaceuticals sector making the biggest gains.
GEA gets FDA OK for H202 steralisation tech for freeze dryers
GEA Lyophil has won US FDA approval for a new gas-based steralistion technology for pharmaceutical freeze drying.
Fette sets up Goa tablet testing unit
German machine tool maker Fette Compacting has set up a tablet compression and flowability testing centre in Goa, India.
Early end to cephalosporin contract helps Patheon in Q1 fiscal 2011
A customer decision to halt development of an antibiotic and end a manufacturing contract early helped Patheon to an improved set results for the first quarter of fiscal 2011.
Tracelink updates on Catalent
Supply chain services firm Tracelink says that half of Catalent Pharma Solutions’ US manufacturing sites have been added to its network under the strategic partnership signed last summer.
Carbon dioxide may be drug processing 'shortcut,' study
A new study suggests pressurised carbon dioxide can accelerate crystalisation during drug production, and potentially save manufacturers time and money.
New J&J recall insulin pump cartridges
US healthcare giant Johnson & Johnson (J&J) has recalled 384,000 of its insulin cartridges on concerns the products could cause serious health problems for diabetics.
GEA strikes Scandinavian representation deal with Christian Berner
GEA Pharma Systems, the German drug processing equipment manufacturer, has signed a representation agreement with Swedish hi-tech firm Christian Berner Tech Trade.
The WHO expects global vaccine supplies will benefit significantly after it approved the Chinese SFDA regulatory system.
New CDMO Amatsi-Avogadro formed
Amatsi and Avogadro have announced plans to team up and create what they claim will be the leading CDMO in France.