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USFDA approves Novasep facilities for kinase inhibitor contract

Novasep's Chasse-sur-Rhone, France site will produce the API

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

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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.

Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe. 

Timescales and sourcing comparator biologics are the biggest challenges for biopharmas running biosimilars studies, says an expert.

Global Industry News

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.

MonosolRx finds new licensee for oral film delivered ondansetron from in-PharmaTechnologist.com

MonosolRx has found a new US licensee for its oral film ondansetron product, Zuplenz, signing up Galena BioPharma nearly four years after previous partner Strativa handed the drug back.

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. 

Brazilian JV looks to tap plant-based manufacturing system for biosimilars from BioPharma-Reporter.com

Biologic manufacturer PlantForm and PharmaPraxis have established a joint venture to develop, manufacture and commercialize biosimilar versions of six key biopharma treatments.

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1 from in-PharmaTechnologist.com

Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.

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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