B-MS recalls CMO made injectable blood thinner after finding "visible particles"
Bristol Myers Squibb (B-MS) has recalled several batches of the injectable version of the blood thinner Coumadin made by its CMO, Pharmalucence.
Archives for July 1, 2014
US FDA issues draft strategic priorities document
The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.
EMA revises what it classifies as advanced-therapy treatments
The European Medicines Agency’s Committee for Advanced Therapies (CAT) has revised a reflection paper on the classification of advanced-therapy medicinal products (ATMPs) to reflect cases in which medicines can be classified as ATMPs.
US FDA to set more specific GMP regulations for outsourcing facilities
Until final regulations are finished, the US FDA has released draft guidance describing the agency’s expectations for outsourcing facilities and the cGMP requirements for them.
Parexel taps Middle East, North Africa with Atlas acquisition
CRO Parexel has shifted its attention overseas with the acquisition of Atlas Medical Services, a provider of clinical research services in Turkey, the Middle East, and North Africa.
Quintiles completes Encore analytics acquisition
Quintiles announced yesterday it has completed the acquisition of Encore Health Resources, a health information analytics and technology consultancy.
Catalent to open Japanese development lab
Catalent Pharma Solutions will open a development lab for oral formulation in Japan, citing the popularity of fast dissolve formulations in the country as a key driver.
US venture capital investors continue to back biotech
Biopharma firms continued to attract US venture capital investment in Q1 according to new analysis by PricewaterhouseCoopers (PwC), which says the number of firms that received backing is encouraging.