EMA recommends seven medicines for approval after September meeting
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
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Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
Cecilia Avram details the requirements for pharma companies post-Brexit and provides practical pointers on minimising the disruption to cross-border product availability as new rules come into force.
Gilead is set to acquire Immunomedics for approximately $21 billion, with the transaction anticipated to close in the fourth quarter of 2020.
Valneva has agreed to supply the UK government with 60 million doses of its potential COVID-19 vaccine by the second half of 2021.
The ABPI has said that the new UK-Japan free trade agreement will benefit the pharma industry, providing continuity for life science businesses.
Matt Hancock has announced that the £500 million investment will go towards new COVID-19 testing technologies and increased testing capacity.
Liz Thorn outlines the benefits that in vitro diagnostics can bring to the world in light of the current COVID-19 pandemic.
The Canadian government has agreed that Janssen will supply the country with 38 million doses of its COVID-19 vaccine, while Novavax has agreed to supply 76 million doses if its vaccine.
Nestlé Health Science will acquire Aimmune Therapeutics for a total value of $2.6 billion, extending the former's food allergy portfolio.
The rapid evolution of the COVID-19 situation has created significant barriers to normal operations, from locking down borders to the imposition of restrictions on trade and export – not to mention a surge in demand for many common medicines. Each of these events in isolation can affect production and supply,…
Andrew Dunbar outlines five digital technologies that can help pharma function to the best of its abilities over the course of the COVID-19 pandemic.
The COVID-19 pandemic has had huge knock-on effects on economies around the world. In this article, legal experts from Taylor Wessing explore how the novel coronavirus has hit the life sciences and biotech investment sector and how they see investors behaving as the lockdown and pandemic eases and develops over…
Although steps have been taken to enable the implementation of continuous manufacturing in industry, a lack of global harmonisation in regulations has slowed the adoption of this promising emerging technology. Dave Elder discusses how ICH Q13 seeks to provide a harmonised approach to support this important initiative.
This article explores the reasons behind the introduction of the EU Medical Device (MDR) and In Vitro Diagnostic Devices (IVDR) regulations, the problems that beset them and how COVID-19 finally persuaded the European Commission that a further year’s preparation time for full application of the regulations was necessary.
Sanofi is set to acquire Principia Biopharma Inc. for a total aggregate equity value of $3.68 billion, at $100 per share.