Breaking News on Contract Research, Manufacturing & Clinical Trials

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News in brief

Lonza saw profits and capacity utilisation improve in the first half of 2014 with new pharma and biopharma supply contracts and ongoing restructuring being the key drivers.

Philanthropist Ted Stanley has gifted $650m to the Broad Institute as part of a wider attempt to galvanize research on psychiatric disorders and bring new treatments to market. 

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.

Novasep has received the regulatory nod to manufacture a kinase inhibitor new molecular entity (NME) following pre-approval inspections at two facilities in France.

Global Industry News

Italy to look at drug pricing during EU presidency from in-PharmaTechnologist.com

Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.

Ipca halts API shipments to US following 483 at Indian plant from in-PharmaTechnologist.com

Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

Generics: change in pill shape makes patients 66% more likely to quit from in-PharmaTechnologist.com

Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.

Lilly swaps dry powders for insulin at Indiana site in post-patent shake-up from in-PharmaTechnologist.com

Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose plant in Indiana.

European Pharmacopoeia plans revisions of elemental impurities guideline from in-PharmaTechnologist.com

As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency. 

Spotlight

Petition calls on FDA to amend informed consent requirements

Petition calls on FDA to amend informed consent requirements

The Center for Responsible Science  has asked the US FDA to adopt informed consent rules which ensure that trial participants...

US FDA to set more specific GMP regulations for outsourcing facilities

US FDA to set more specific GMP regulations for outsourcing facilities

Until final regulations are finished, the US FDA has released draft guidance describing the agency’s expectations for...

Parexel taps Middle East, North Africa with Atlas acquisition

Parexel taps Middle East, North Africa with Atlas acquisition

CRO Parexel has shifted its attention overseas with the acquisition of Atlas Medical Services, a provider of...

Trial documents: only 13% of firms are fully paperless, says Veeva

Trial documents: only 13% of firms are fully paperless, says Veeva

Contract research organisations (CROs) have been slow to adopt next-generation means of recording study documents, with only...

Pfizer offers update on risk-sharing deals with Icon, Parexel
Dispatches from DIA

Pfizer offers update on risk-sharing deals with Icon, Parexel

Three years after Pfizer began strategic partnerships with CROs Icon and Parexel, and the companies are still...

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