Latest News in the pharma Industry

Policy & Regulation

Sirio Pharma receives sports nutrition production licence approval

Sirio Pharma receives sports nutrition production licence approval

18 Feb 2019

The approval enables Sirio to add special sports nutrition ingredients into products and covers six functional classes for ‘protein supplementary’, ‘speed & power’, ‘endurance’, ‘energy control’, ‘energy supplementary’, and ‘post-exercise recovery’.

Read more 
All Recipharm facilities ready for EU serialisation, regardless of Brexit

All Recipharm facilities ready for EU serialisation, regardless of Brexit

15 Feb 2019

The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers.

Read more 
Post-EU FMD deadline - 'business as usual'?

Post-EU FMD deadline - 'business as usual'?

12 Feb 2019

Partner connectivity will be an immediate and ongoing challenge beyond the deadline and several pharma companies are likely to break agreements with current suppliers through breach of contract clauses.

Read more 
FDA approves first Nanobody-based medicine for adults with aTTP

FDA approves first Nanobody-based medicine for adults with aTTP

10 Feb 2019

Cablivi is the first US approval for Sanofi's new rare blood disorders franchise.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more