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In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
The first once-per-day oral CGRP receptor antagonist gepant treatment has been approved in the EU as a preventative treatment for both chronic and episodic migraines.
16 August 2023 | By Rapid Micro Biosystems
Watch this webinar with independent microbiology expert Dr Tim Sandle to explore the different technologies, regulatory concerns and validation requirements for automated colony counting methods.
16 August 2023 | By
The MHRA has granted marketing authorisation for a two-component therapy for adults with late-onset Pompe Disease, a rare disorder.
CPHI, the global pharmaceutical exhibition will take place in Milan, Italy from 8-10 October 2024.
Growth of the buccal drug delivery market is driven by the high bioavailability of buccal formulations as well as the ageing population, smoking addiction and increased R&D.
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
Novartis will remove its sickle cell medicine crizanlizumab from the EU/EEA market following a European Commission decision.
The expansion of the CGT manufacturing site in Milan, Italy, will support viral vector development and manufacturing for late-stage clinical and commercial projects.
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
Under a $1 billion acquisition agreement, Novo Nordisk A/S will investigate a potential first-in-class small molecule CB1 receptor blocker as a treatment for obesity.
If approved, Novartis’ remibrutinib has potential to be the first of a new class of chronic spontaneous urticaria (CSU) treatment in a decade.
With antibody-drug conjugates (ADCs) gaining favour as oncology treatments, research shows Daiichi Sankyo, Seagen and Roche are currently three of the market's most important players.
In Novo Nordisk’s landmark trial for cardiovascular outcomes, semaglutide 2.4mg has potential to change how obesity is regarded and treated, headline data suggests.
