505(b)(2): It’s A Different Animal
Camargo
Hot Topics > Globalisation
Globalisation
When national businesses become global operations… With the industry sourcing more raw materials and services from around the world and distributing its products in new markets, companies are adapting their business processes to suit a more complex global operating environment.
Yusen to Fly AstraZeneca's Drugs to Australia
15-May-2013 - 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.
Clinical Cymru Can Compete on Costs says PRA
15-May-2013 - 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.
McKesson Confident FY2014 Will See Revenue Growth
13-May-2013 - 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.
DKSH Ups Asian Distribution Services; Sanofi Invests In-House in Africa
22-Apr-2013 - DKSH has upgraded its cold chain infrastructure in Southeast Asia as both small and large manufacturers increase their access needs to emerging markets.
DHL: Globalisation, Generics & Biologics Drive Cold Chain Expansion
17-Apr-2013 - Globalisation, outsourcing and a move towards biopharmaceuticals are leading innovation for pharma distribution companies, according to DHL Global Forwarding.
DKSH Bags Pfizer Deal in Cambodia
17-Apr-2013 - DKSH has won a second deal with a Big Pharma firmin Asia in as many months, with US giant Pfizer signing up the firm as its agent in Cambodia.
Rise of Russia as EMA Reports Global Stretch of Clinical Trials
15-Apr-2013 - 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.
Telerx's Sentrx Takeover Driven by Drug Industry Demand for Safety Services
10-Apr-2013 - High drug industry demand for safety monitoring expertise drove Telerx’s acquisition of Sentrx Safety Solutions says deal broker.
Contract Manufacturing Regulatory Approval Round-Up
26-Mar-2013 - 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.
Catalent Focuses on Clinical Services in One of Two Chinese Ventures
13-Mar-2013 - Catalent has penned a deal with CRO ShangPharma as part of a two-pronged plan into China and expects more investments to come.
Marken Opens Depot to Support Growth in Chinese Clinical Trials
13-Mar-2013 - Marken says the opening of its new pharma depot is part of a whole strategy within China and was driven by demand from an increase in clinical trials.
CDSCO Moves to Speed UP Ethics and SAE Review Processes After Criticism
07-Mar-2013 - The CDSCO has started prescreening applications to register clinical trial ethics committees in a move designed to streamline the approval process.
PRA says Clinstar Takeover Offers Quicker and Cheaper Patient Enrollment
05-Mar-2013 - US CRO PRA international has expanded its presence in Eastern Europe with the acquisition of privately-owned trial services firm ClinStar.
News in brief
Synteract and HCR Complete Merger to Become Global CRO
04-Mar-2013 - Following its acquisition of HCR, Synteract has become a multinational CRO with a presence in 16 countries.
CiToxLAB Beats Preclinical Market Trends
21-Feb-2013 - CiToxLAB says strong revenue growth in 2012 was due to a new global status following its acquisition of Lab Research.
TFS to buy Semcon Caran's EDC business
12-Feb-2013 - Swedish CRO Trial Form Support has announced plans to make its second late-stage, IT focused acquisition in the space of three months.
QPS adds Phase I capacity in the US with MRA buy
07-Feb-2013 - QPS has acquired Florida-based trial site Miami Research Associates (MRA), adding first-in-man capacity to its US services offering.
update
Trials published by Pfizer didn't match internal docs say researchers calling for CONSORT revision
05-Feb-2013 - 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...
Variations in site recruitment performance a risk, says Tufts
16-Jan-2013 - Variation in site recruitment performance is a major risk factor for CROs and their sponsors according to new research.
Wuxi JV is about building in China's late-stage sector says PRA
15-Jan-2013 - PRA wants to build its late-phase offering in China and has committed to provide staff and knowhow to Wuxi Pharmatech joint venture.
American Capital to expand Cambridge Major Labs' API biz
15-Jan-2013 - 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.
UPS’ TNT takeover bid fizzles out
14-Jan-2013 - United Parcel Service (UPS) has abandoned its bid to buy Holland-based logistics firm TNT Express after the European Commission said it would block the deal.
News in brief
Exela expands North Carolina facility
09-Jan-2013 - Exela Pharma Sciences will invest $8.5million in its research and manufacturing plant in North Carolina. The venture, to be spread over the next three years, will provide 38 new jobs...
Lonza to boost complex manufacturing at underperforming Visp plant
09-Jan-2013 - Swiss supplier Lonza has underlined its belief that ramping up complex manufacturing is key to improving the profitability of its Visp plant.
Australian CRO buys in New Zealand to establish ‘regional solution’
07-Jan-2013 - Australian CRO Clinical Network Services (CNS) has positioned itself as a “truly regional solution” with the acquisition of New Zealand-based Beltas.
