Compound sentence? Two 'outsourcing facilities' hit with US FDA warning letters
Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.
Archives for July 21, 2015
Independent lab network enters CRO market with acquisition of ABC Laboratories
EAG (Evans Analytical Group), an independent laboratory network, has acquired Missouri-based Analytical Bio-Chemistry Laboratories (ABC Labs). Financial terms of the transaction were not disclosed.
Novartis defends Afinitor after thrashing from BMS and Exelixis trials
Novartis expects sales of Afinitor to slow after BMS and Exelixis announced this week their pipeline drugs beat it on renal cell carcinoma.
Ethiopia: GMP compliant local drug and API sector would yield health and economic benefits
Ethiopia will start making its own APIs in 2020 according to the Government which says local manufacture will improve access to medicines, curb sale of counterfeits and promote innovation.
Lonza: global hedge helped offset currency exposure but Visp still a risk
Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.
Twice single-use? MHRA issues draft guidance for device makers
Companies that recommission old single-use devices would have the same liability as the original device maker under draft guidelines proposed by the MHRA.
IPEC calls on FDA to establish new review process for novel excipients
As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.