University of Rochester Medical Center joined the global health research network aiming to ‘expand its access to advanced clinical trials’, TriNetX announced.
CRF Bracket is expanding its offering across the Asia-Pacific region with a new Tokyo office to help it better serve the area’s diverse and underserved patient population.
As WuXi STA expands its facility footprint in China, a VP of the company explains how global regulatory approvals fit with strategic plans for services to be concentrated geographically.
Senator Flake will discuss regulatory guidance impacting innovation and his perspective on the state of the industry during his keynote address at CPhI North America.
Jordan-based MS Pharma announces the acquisition of the Greek generic manufacturer Genepharm, aiming to add cardiovascular, CNS and oncology products to its portfolio.
Novotech signs on two major hospitals to its CRO partnership program in South Korea – a market seeing greater interest from North American and European companies.
An observation by the US FDA notes that Aurobindo had no established control procedures to monitor its manufacturing process, resulting in batches contaminated with unidentified material.
The Brazil-headquartered antibiotics company announces that it has invested in two new buildings, a few years after running into regulatory trouble due to non-compliance with cGMP.
Synteract is opening a new office in Swansea, Wales in response to increased demand across its core therapeutic areas for both full-service work and more consultative, standalone projects, says CEO.
There is a common and often unchallenged perception that manufacturing quality standards in pharmerging countries are worrisome, but Lee Newton of Lonza argues this is not the reality.
The global software consulting company N-Side recently launched an end-to-end clinical trial supply chain management solution to enable “agile” decision making and reduce drug waste.
US FDA announces that a new generic for valsartan will reach the market, after prioritising the review of the product to alleviate shortages resulting from recalled products.
The institutional review board industry sees further consolidation as Advarra acquires Quorum and its research and technology consulting division, Kinetiq.
The pharmaceutical and biotech consultancy has opened a new office in Dublin, Ireland ahead of Brexit, the final outcomes of which remain unknown, says CEO.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
Hugh Pullen, EMVO’s president, explains what the launching of the EMVS means for the industry, and details how a potential no-deal Brexit will impact the system.
France, Germany, and the UK recently formed INSTEX to be able to secure trade despite US sanctions on Iran, a move that has been welcomed by Novo Nordisk.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
The Wasdell Group’s new EU headquarters in Dundalk, Ireland is set to commence operations later this year as part of the company’s “proactive contingency plan” ahead of Brexit.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
August Research is adding clinical trial operations in Georgia and Moldova, expanding the CRO’s reach in Central and Eastern Europe – a less developed market with “fewer competitive trials and lower costs,” says CEO.
The two companies will combine technologies to create solid-dose, needle-free vaccines for a number of infectious diseases and emergent threat pathogens.
The more outsourcing experience a pharma company has, the less important its proximity to contract manufacturing partners becomes, outlines Novo Nordisk VP.
The Indian government seeks to boost local drug production by stipulating that the ‘local content’ of domestic products is 75% and 10% for those that are non-domestic.
Parexel and Eli Lilly are launching a clinical research learning and development program in China as recent reforms have “dramatically” increased the need for new sites in the country.