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Policy & Regulation

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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FDA approves Unidose device for new nasal seizure rescue treatment

FDA approves Unidose device for new nasal seizure rescue treatment

23 Jan 2020

The single-use, ready-to-use, one-step nasal delivery device can deliver a formulation in an emergency situation quickly and easily.

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Lupin could face FDA regulatory action over Tarapur API facility

Lupin could face FDA regulatory action over Tarapur API facility

13 Jan 2020

India’s Lupin Pharmaceuticals warned Monday it could face regulatory sanctions from the US Food and Drug Administration over its Tarapur active pharmaceutical ingredient (API) manufacturing facility.

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2019, the year that got serialization done!

2019, the year that got serialization done!

17 Dec 2019

The past 12 months have been busy as many companies fought to comply with serialization regulations.

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Sartorius Stedim Biotech launches new Sartocheck 5 Plus filter tester

Sartorius Stedim Biotech launches new Sartocheck 5 Plus filter tester

21 Oct 2019

Highest level of data integrity as requested by regulatory authorities.

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FDA approves first  and only medicine in a new class of acute treatment for migraine

FDA approves first and only medicine in a new class of acute treatment for migraine

15 Oct 2019

The approval of Eli Lilly's Reyvow represents the first new class of acute migraine treatment approved by the FDA in more than two decades.

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