Latest News in the pharma Industry

Policy & Regulation

CPhI Discover: Remote excipient audits are on the increase, but we must do more to develop novel excipients

CPhI Discover: Remote excipient audits are on the increase, but we must do more to develop novel excipients

4 May 2021

Ahead of the session, Value Added Excipients to Unlock the Potential of APIs, at CPhI Discover on Thursday 18th May – global pharma’s largest ever virtual gathering – we spoke with one of the speakers, Dr Iain Moor...

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Pharma Explained: What is Quality Risk Management & cGMPs?

Pharma Explained: What is Quality Risk Management & cGMPs?

10 Feb 2021

Need clarity on determining your QA from your QbD and your cGMPs? You’re not alone! In our new Pharma Explained series from CPhI, we bring you clear cut definitions from industry experts on a myriad of Pharma Terms, delivered in bitesize video presenta...

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Former FDA Commissioner lays out roadmap for building out excess capacity to deal with pandemic situations

Former FDA Commissioner lays out roadmap for building out excess capacity to deal with pandemic situations

23 Oct 2020

Dr Scott Gottlieb shares insights into COVID-19 vaccine development, the upcoming US election and pharma pricing at the CPhI Festival of Pharma

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Successful MHRA regulatory inspection for Scottish CMO Symbiosis

Successful MHRA regulatory inspection for Scottish CMO Symbiosis

29 Sep 2020

Inspection conducted remotely using video-conferencing and an online private document sharing platform.

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Mylan and development partner win significant EPO ruling related to Copaxone

Mylan and development partner win significant EPO ruling related to Copaxone

15 Sep 2020

Decision clears legal pathway to expand access for patients living with multiple sclerosis in markets across Europe.

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COVID-19 ushers in age of digital, flexible EU pharmaceutical regulation

COVID-19 ushers in age of digital, flexible EU pharmaceutical regulation

8 Sep 2020

The pandemic that has swept over the world in 2020 has caused huge disruption to the European pharmaceutical industry's regulatory procedures and supply chain management. But the crisis has also provided a platform for a learning process for the sy...

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Europe's CHMP recommends suspension of medicines tested by Panexcell over flawed studies

Europe's CHMP recommends suspension of medicines tested by Panexcell over flawed studies

27 Jul 2020

The European Medicines Agency's human medicines committee (CHMP) has recommended the suspension of European marketing authorizations of generic medicines tested by Panexcell Clinical Laboratories at its site in Mumbai, India, citing irregularities in h...

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FDA approves new Dupixent prefilled pen

FDA approves new Dupixent prefilled pen

23 Jun 2020

The prefilled pen supports more convenient self-administration for patients with chronic type 2 inflammatory diseases.

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TraceLink announces results from FDA DSCSA Pilot Program

TraceLink announces results from FDA DSCSA Pilot Program

23 Jun 2020

Key findings demonstrate the value of network solutions to secure and digitalize the pharmaceutical supply chain.

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Chinese CDMOs legislating for the future

Chinese CDMOs legislating for the future

2 Apr 2020

The Chinese pharmaceutical CDMO sector is set for rapid expansion, thanks to major amendments to the country's Drug Administration Law that make outsourcing manufacturing easier

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EMA to only issue electronic medicines certificates during COVID-19 pandemic

EMA to only issue electronic medicines certificates during COVID-19 pandemic

30 Mar 2020

The European Medicines Agency (EMA) said Monday it will only issue electronically signed and authenticated certificates for human and veterinary medicines in place of printed ones so it can continue to provide the documents during the COVID-19 pandemic...

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Helsinn receives European approval of its IV formulation of Akynzeo

Helsinn receives European approval of its IV formulation of Akynzeo

23 Mar 2020

The new formulation offers patients in Europe an alternative route of administration of the only fixed antiemetic combination targeting two distinct CINV pathways in a single dose.

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