Latest News in the pharma Industry

Policy & Regulation

Brexit - the EU FMD's painful problem

Brexit - the EU FMD's painful problem

7 Feb 2019

Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.

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FDA approves first generic Advair Diskus

FDA approves first generic Advair Diskus

4 Feb 2019

Mylan's Wixela Inhub is the first FDA-approved therapeutically equivalent generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or COPD.

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UK and Russia sign MoU on regulatory co-operation on medicines

UK and Russia sign MoU on regulatory co-operation on medicines

29 Jan 2019

Medicines regulators of the UK and Russian set out key principles to support their collaboration on improving public health.

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FDA approves first generic version of Sabril tablets

FDA approves first generic version of Sabril tablets

17 Jan 2019

Approval of generic vigabatrin tablets granted to Teva Pharmaceuticals USA.

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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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Sanofi's formulation patents on multibillion-dollar Lantus are Invalidated by US PTE

Sanofi's formulation patents on multibillion-dollar Lantus are Invalidated by US PTE

16 Dec 2018

Mylan achieves key milestone to provide US diabetes patients with more affordable generic version of Sanofi's Lantus insulin glargine vials.

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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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