Latest News in the pharma Industry

Policy & Regulation

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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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

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

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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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FDA approves Pharming's new facility for expanded Ruconest production

FDA approves Pharming's new facility for expanded Ruconest production

10 Mar 2020

Netherlands-based specialty pharmaceutical company Pharming has received US Food and Drug Administration (FDA) approval for its new biologics facility in the Netherlands which it says will ensure sufficient manufacturing capacity for its acute heredita...

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Potential first-in-class treatment reaches significant milestone

Potential first-in-class treatment reaches significant milestone

2 Mar 2020

The US Food and Drug Administration (FDA) accepts for review Pfizer and Eli Lilly's Biologics License Application (BLA) for tanezumab — a non-opioid treatment for patients with chronic pain due to moderate-to-severe osteoarthritis.

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Novartis receives EC Approval for next-gen anti-VEGF treatment for wet AMD

Novartis receives EC Approval for next-gen anti-VEGF treatment for wet AMD

21 Feb 2020

Beovu is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on 3-month dosing intervals immediately after the loading phase.

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FDA approves only triple-combination tablet with Jardiance

FDA approves only triple-combination tablet with Jardiance

31 Jan 2020

Trijardy XR is a once-daily therapy combining three well-established treatments in one pill.

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