Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.
Veeva Systems says its new global alignment solution for pharmaceutical companies will bring together data interactions and content into its Commercial Cloud.
CRO inVentiv Health Clinical and biotech sponsor Advaxis have entered into a global master services agreement for the clinical development of potential immunotherapies.
As part of a wave of good news for the beleaguered Hospira, the company said it will inject $120m into its McPherson, Kansas, facility, which will result in 150 new jobs over the next five years.
SOCMA’s (Society of Chemical Manufacturers and Affiliates) Bulk Pharmaceutical Task Force has written a letter to the US FDA taking issue with what may amount to a 40% drop in domestic API inspections for FY 2015.
Researchers in Texas have unveiled the fastest, smallest motor to date, which could pave the way for similar motors moving through the body to administer drugs or to target cancer cells.
CRO INC Research has inked a two-year partnership with the Society for Clinical Research Sites (SCRS) to become a more active voice in the site investigator community.
Evotec has acquired all shares in UK-based specialist CRO Euprotec for as much as $5.26m to add anti-infective drug discovery services to its offerings.
Clinverse, a company which automates the financial lifecycle of global clinical trial providers, and eClinical Insights, a provider of cloud-based clinical trials software, have formed a strategic partnership to offer an integrated tool for clients.
US scientists have tinkered with a virus so that it opens its cargo doors only in the presence of certain enzymes that could be used to drop therapeutics precisely onto a target.
A new tool will enable clinical trial heads to control drug supply and monitor patients and sites with their smartphones, according to tech firm Endpoint.
As the number of drug approvals declined between 2012 and 2013 by more than 30%, the value of new therapeutic agent approvals seems to indicate a stronger year than initially thought.
Clinical biomarker service company Targos is partnering with Wuxi PharmaTech to provide know-how, services, and quality standards to support Wuxi's bioanalytical work for biopharma customers.
Eli Lilly is maintaining greater in-house control as manufacturing processes become more complex, whilst MSD is leveraging external over-capacity to fulfil its needs, the firms told Outsourcing-Pharma.com during a recent visit to Ireland.
For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.
The US FDA has issued final guidance on the transferring of clinical studies between IRBs (institutional review boards) in order to help ensure that serious disruptions in clinical trials are rare.
Medidata will provide metrics and analytics help to industry group TransCelerate to answer questions on the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites.
California-based Relypsa has entered into a seven-year commercial manufacturing and supply agreement with DSM Fine Chemicals for the API for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. Financial details...
Amid ongoing efforts by the US FDA to crack down on foreign suppliers not meeting cGMP (current good manufacturing) requirements, India-based Sun Pharma is the latest company to be hit with a warning letter.
Outsourcing-Pharma.com reached out to contract testing supplier BioOutsource to see what its take is on biosimilars now that the FDA’s draft guidance on biosimilarity has been released. The following is a lightly edited interview with BioOutsource’s chief...
The US Food and Drug Administration (FDA) is founding a $3.3m (€2.4m) regulatory science centre jointly with the University of California San Francisco (UCSF) and Stanford University.
Manufacturing powerhouse Roche is doubling down on its small molecule manufacturing with investments of $134.6m in two facilities in Basel, Switzerland.
Both Fresenius Kabi and Abbott have extended their operations further in the Latin American market with new acquisitions that signal growth in the region.
Horizon, which supplies genomics research services, has bought cell-screening business CombinatoRx from Zalicus for £4.74m ($8m) and plans more acquisitions.
In a letter to the EMA (European Medicines Agency), the European Ombudsman Emily O'Reilly has expressed concern that a significant change of policy on trial data transparency could limit the amount of data that becomes available.
Crown Biosciences has partnered with China’s biggest producer of mutant mice to build better experimental models for its cancer research sponsors, as part of its $26.5m (£16m) venture funding.
In an industry first, bioanalytical CRO Tandem Labs has announced the availability of biomarker assays for human clinical studies using the Meso Scale Discovery V-PLEX biomarker platform, which have been already validated by Tandem in human serum.
China-based Wuxi announced 11% growth in its net revenues when compared to last year, which was boosted by manufacturing services the most of all service offerings.
As the worldwide pharma supply chain gets even more complex, the US FDA is looking to leverage its existing relationship with its EMA (European Medicines Agency) counterparts to boost drug quality with a new initiative.
Experiments on semiconductors reveal a new way to study and control crystallisation. The discovery has relevance to pharmaceutical manufacturing as many drugs are made from small molecules that must crystallise in just the right way to have the proper...
Chemists at MIT have created a triple warhead against cancer. They believe theirs is the first example a polymer nanoparticle which carries a precise ratio of three drugs that can be released in response to three distinct triggers.
Wuxi PharmaTech has completed an expansion of its materials characterization testing facility in St. Paul, Minnesota, as well as its work on a new biologics biosafety testing facility in Suzhou, China.
For the first time ever, Charles River Laboratories is seeing its biotech revenues eclipse its pharma revenues, Jim Foster, chairman, president and CEO of CRL, told participants at the Baird Growth Stock Conference last week.
Contract research organisations Covance, Harlan, Sequani, Charles River Laboratories and Huntingdon Life Sciences have signed an agreement to be open about their animal research.
Unilife says it is confident future revenue from current contracts could total $1bn and is scaling up manufacturing capacities despite no product sales in the third quarter.
A few clinical trial cancellations seem to be the cause behind Covance’s weaker-than-expected growth in the last quarter, Joe Herring, chairman and CEO of Covance, said.
