The second draft of Excipact, a set of certification standards for drug excipient producers being developed by the EFCG, FECC, IPEC and PQD, has been sent to industry stakeholders for consultation.
Royal DSM NV says its pharmaceutical contract manufacturing business model is ‘out of step with market needs’ after the unit’s Q1 performance blots an otherwise positive set of financials.
Drug developers are pursuing new strategies to help improve the operational efficiency of their clinical trials, according to a panel of industry leaders recently convened by the Tufts Centre for the Study of Drug Development (CSDD) in Boston, US.
The United States Pharmacopeial Convention (USP) and the Chinese Pharmacopoeia Commission (ChP) have made mutual executive appointments in an effort to further align drug quality standards.
The top seven CROs will have captured half the market by 2015 as big pharma, including Pfizer, enters into strategic relationships with major players, Jeffries & Company said.
Clinical trial sites must take a proactive approach to non-compliance by identifying risks and having corrective action plans, says a former FDA investigator.
Algorithmic Research (ARX), the digital signature specialist, has released a short video to highlight the benefits of using digital signature technology in clinical environments.
French preclinical contract research organisation (CRO) CIT has said it will buy Canadian counterpart LAB Research in a deal that would rescue the Quebec-based firm from the receivers.
Microbiology media maker Cherwell Laboratories has announced plans to expand its manufacturing capacity in response to growing industry demand for environmental monitoring products.
US drugmaker Amgen has acquired Brazilian manufacturer Bergamo in a bid to improve its access to ‘one of the fastest growing pharmaceutical markets in the world.”
Contract research organisation (CRO) Clearstone Central Laboratories has unveiled a ‘preferred provider’ partnership with Mitsubishi Chemical Medience (MCM), continuing its efforts to expand in Asia.
LB Bohle says healthy level of demand for processing technology demos at its recently opened service centre is an indication of processing tech market recovery.
Unilife has begun a ‘scheduled realignment’ of its operating infrastructure to support the production and sale of its Unifill prefilled syringe, according to a statement released by the company.
Contract manufacturing organisation (CMO) Patheon has launched a new ‘back up’ sterile manufacturing service to help drug firms cope with supply interruptions and, it hopes, attract new business.
Adaptive clinical design can lead to significant time savings when implemented successfully, claims a new study by Cutting Edge Information, the North Carolina, US-based business consultancy firm.
The pharmaceutical manufacturing sector in Puerto Rico will thrive because of and not in spite of changes to the country’s tax and incentive laws according to the Puerto Rico Industrial Development Company (PRIDCO).
Chiltern International, a global contract research organisation (CRO) has expanded its European operations with the opening of a new office in the Netherlands.
Michigan, US-based clinical research organisation (CRO), Imperial, has completed the acquisition of clinical trial specialists, D. Anderson & Company for an undisclosed fee.
Perceptive Informatics, an eClinical solutions provider, has announced the results of a survey to find out what the biopharma industry considers the most important eClinical attributes.
Novartis has acquired a majority stake in vaccine maker Zhejiang Tianyuan Bio-Pharmaceutical, continuing its efforts to accelerate revenue growth in China.
Almac Pharma Services has expanded its cold storage capacity for biopharmaceuticals, continuing the contract manufacturing organisation’s (CMO) busy expansion programme.