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Organovo: 3D printed liver tissue to challenge current toxicity models

'3D printed heads' but Organovo's printing platform uses real cells to create living tissue for preclinical testing

A 3D printed human liver system could offer better informed risk-based decisions earlier in the drug development process than with current in vitro models, according to developers Organovo.

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News in brief

Drug developers should add their early-stage discoveries to an open-source database or pay a fine to cut wasted time duplicating results, say researchers.

A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.

EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.

Lonza has not been asked to pay back taxes after abandoning plans to expand its biologics plant in Hopkinton, Massachusetts last year.

Global Industry News

US FDA approves first needle-free flu vaccine delivery system from in-PharmaTechnologist.com

For the first time ever, the US FDA has approved a needle-free injection system to deliver the seasonal flu vaccine.

Eisai sues FDA for ‘losing one year’ of marketing to generics rivals from in-PharmaTechnologist.com

Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.

Cell line development set to get faster says Horizon Discovery from BioPharma-Reporter.com

CRISPR gene editing will make cell line development cheaper and faster according to Horizon Discovery, which says that new tech has application in both biomanufacturing and preclinical disease modelling.

Frogs, fungus and falsified data - Indian firm falls foul of US FDA from in-PharmaTechnologist.com

Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.

India changes course, calls for bar codes for mono cartons in April from in-PharmaTechnologist.com

Nearly a month after India pushed back its deadline indefinitely  for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade  (DGFT) has set a new deadline of April 2015.

Novartis invests $35m in stem cell tech company with option to acquire from BioPharma-Reporter.com

Novartis has invested $35m (€26.3m) for a 15% stake in Israel-based Gamida Cell, which offers stem cell expansion technologies and therapeutics.

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...