Despite recent progress, the EC underestimated the challenge of getting non-EU regulators to ensure APIs shipped to the European Union (EU) meet new import requirements according to Eucope.
CRO Novotech has added two new clinical research sites in Hong Kong and the Philippines earlier than expected as demand from sponsors, particularly US biotech companies, has spiked.
Boehringer Ingelheim will build a biomanufacturing facility in Shanghai in a strategic alliance designed to cater for Pharmas nervous about setting up plants in China.
Yusen Logistics has launched a new air freight service to help UK drug major AstraZeneca ship its products to Australia in a new agreement announced today.
PRA International says technology and IT innovation will help it compete with rivals that have moved their service centres to cheaper locations in the East to cut costs.
Brand-to-generic conversions have been blamed for “somewhat softer than expected” financial results at McKesson, though significant FY2014 direct revenue growth has been predicted.
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020 policy, according to statements at this year’s BIO International Convention.
With backing from the Australian Government, DSM has opened a mammalian cell culture operation to fuel the growing demand in the Asia-Pacific biologics market.
DKSH has upgraded its cold chain infrastructure in Southeast Asia as both small and large manufacturers increase their access needs to emerging markets.
Globalisation, outsourcing and a move towards biopharmaceuticals are leading innovation for pharma distribution companies, according to DHL Global Forwarding.
Merck & Co. has opened a new packaging facility in China to support its emerging market strategy but says it is still committed to traditional regions.
An EMA report says increased Russian participation in European submitted clinical trials is part of a trend away from traditional regions, yet fluctuating legislation may affect numbers.
GE Healthcare and iBio are in talks about future projects after confirming they are working on a plant-based vaccine manufacturing site for Brazilian drugmaker Fiocruz/Bio-Manguinhosin.
Evonik gets the thumbs up from the MHRA, Recipharm's approved by Japan and Simcere passes the Chinese regulatory test – welcome to Outsourcing-Pharma’s round-up of GMP accreditation.
The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.
Merck Serono says “fast progress” in its restructure programme helped double its net savings guidance for 2012 though headcount dropped by almost 2,000 with more cuts to come.
Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
Formulations of two ophthalmic drugs have become the first exports to Europe from Bangladeshi company Beximco as they seek to expand into the EU market.
Clinical trials made public by Pfizer did not match internal reports or reflect what was done in studies of the seizure drug gabapentin say researchers calling for revision of journal publishing codes.
Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
Cambridge Major Labs’ (CML) new private-equity investor plans to expand the CMO’s chemistry and API business and assess cross selling synergies with other firms in its portfolio.
