China now accepting clinical trial data from other countries
China has announced that it will now accept clinical trial data from other countries in a new guideline that aims to reform the management of clinical trials.
Archives for October 11, 2017
BTS receives AAALAC accreditation following animal-welfare controversy
BTS research has been recommended for AAALAC full accreditation at their new facility, which recently came under fire for reported violations of the federal Animal Welfare Act.
GMO regulations a ‘significant burden’ on gene therapy clinical trials
Gene therapy developers should start planning earlier, as EU GMO regulations are delaying clinical trial start-up across the bloc, according to a new expert position paper.
news in brief
Xellia starts work on Copenhagen sterile drug plant
Xellia Pharmaceutical ApS has started constructing a sterile manufacturing building at its plant in Copenhagen, Denmark.
Depomed warns of Nucynta ER delays citing damage to Puerto Rico CMO
Depomed Inc. says supplies of the extended release version of Nucynta will be delayed as a result of damage to a Puerto Rico manufacturing plant caused by hurricane Maria.
Pfizer sells ex-Hospira API plant in Colorado to CDMO CordenPharma
CordenPharma will supply Pfizer with highly potent active pharmaceutical ingredients (HPAPIs) from the facility in Boulder once earmarked for closure by the Big Pharma firm.
Update
Piramal boosts HPAPI site in Michigan, US
Piramal Pharma Solutions will expand its high potency active pharmaceutical ingredient (HPAPI) capabilities at its Riverview site in Michigan, US.