Latest News in the pharma Industry

Policy & Regulation

WuXi STA’s new drug product manufacturing facility passes first European MPA GMP Inspection

WuXi STA’s new drug product manufacturing facility passes first European MPA GMP Inspection

27 Mar 2019

CDMO positioned to empower more customers to develop innovative drugs faster and more efficiently.

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TraceLink submits an interoperable blockchain network solution for FDA DSCSA Pilot Project Program

TraceLink submits an interoperable blockchain network solution for FDA DSCSA Pilot Project Program

12 Mar 2019

Trace Histories is a purpose-built distributed ledger solution for ensuring patient safety by 2023 DSCSA deadline.

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Recipharm achieves new ISO 45001 certification to support sustainability efforts

Recipharm achieves new ISO 45001 certification to support sustainability efforts

28 Feb 2019

ISO 45001 developed to improve employee safety, reduce workplace risk and create better working conditions globally.

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Preservative-free multidose dispenser approved across Europe for glaucoma treatment

Preservative-free multidose dispenser approved across Europe for glaucoma treatment

26 Feb 2019

Aptar Pharma working closely with Santen Pharmaceutical to improve patient safety, achieve dosing accuracy and maintain product integrity.

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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’.

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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.

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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.

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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.

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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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