Latest News in the pharma Industry

Policy & Regulation

EU FMD - time is running out!

EU FMD - time is running out!

13 Nov 2018

Companies that have left it too late to implement their own solution will have to rely on support from providers, whose resources are already in high demand as the deadline approaches.

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Concept Life Sciences extends GLP accreditation to support regulatory studies

Concept Life Sciences extends GLP accreditation to support regulatory studies

10 Nov 2018

Accreditation ensures quality and integrity of non-clinical laboratory studies to support pharmaceutical and biotech industries.

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Proprietary nasal delivery formulation of diazepam reaches NDA

Proprietary nasal delivery formulation of diazepam reaches NDA

7 Nov 2018

The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.

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Sandoz pulls the plug on US biosimilar rituximab

Sandoz pulls the plug on US biosimilar rituximab

4 Nov 2018

Company will focus on robust biosimilar portfolio for unmet access and sustainability needs.

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Symbiosis secures FDA viral vector process approval

Symbiosis secures FDA viral vector process approval

5 Oct 2018

Strengthens the CDMO's position as a centre of excellence as part of the viral vector drug development supply chain.

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New oral treatment for metastatic melanoma receives EU authorisation

New oral treatment for metastatic melanoma receives EU authorisation

24 Sep 2018

Encorafenib in combination with binimetinib demonstrated 14.9 months median progression-free survival compared with vemurafenib monotherapy (7.3 months).

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NMPA approves fruquintinib capsules for metastatic colorectal cancer

NMPA approves fruquintinib capsules for metastatic colorectal cancer

13 Sep 2018

Fruquintinib - innovative medicine that has not previously been launched in China or internationally - provides a new therapeutic approach for metastatic colorectal cancer patients.

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The 6-month FMD countdown - are you ready?

The 6-month FMD countdown - are you ready?

21 Aug 2018

With only 6 months left in which to become EU FMD-compliant, how can companies make the best use of their now limited options?

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Protecting the links between the UK and the EMA

Protecting the links between the UK and the EMA

14 Aug 2018

Now less than a year away from when the UK officially leaves the EU, the main goal remains the same - maintaining access to new drugs for patient health.

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TraceLink announces Russia compliance solution

TraceLink announces Russia compliance solution

13 Aug 2018

Company helps customers navigate and company with "one of the most complicated track and trace regulations in the world".

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A new era for migraine patients

A new era for migraine patients

6 Aug 2018

EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.

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Breast cancer device receives FDA approval

Breast cancer device receives FDA approval

3 Aug 2018

The first non-radioactive, dual-tracer for sentinel lymph node biopsy approved in the US.

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