Revised Annex 1 now effective
The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
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The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.
In the first-ever efficacy trial of GSK’s Shingrix in China, no cases of shingles (herpes zoster) were reported after administration of the vaccine, new data shows.
Subin Baral, EY Global Deals Leader for Life Sciences, a partner at Ernst & Young LLP, shares exclusive insight on how strategies such as specialisation can help life science companies secure future growth and the key role divestments and spin-outs have on ensuring this strategic focus.
The first randomised trial comparing efficacy of a highly selective RET-kinase inhibitor with multikinase inhibitors (MKIs) in advanced medullary thyroid cancer (MTC) has delivered promising results.
The biopharma industry will see more customisation in the design of bioprocess containers in the next five years, a market report has predicted.
The US Food and Drug Administration (FDA) has authorised an RSV vaccine for pregnant individuals, which in one study, reduced the risk of severe LRTD by 81.8 percent within 90 days after birth.
A multi-million investment is set to enhance UK medicines manufacturing in three key areas: intracellular drug delivery, digitalisation and automation and nucleic acid medicines.
Research states that the rising success rate of RNA-based COVID-19 vaccines and demand for personalised medicines is driving the global RNA therapy clinical trials market.
Johnson & Johnson have been shifted from the top position in the market capitalisation ranking for the first time, due to Eli Lilly having the largest growth during Q2 2023, research shows.
Iveric Bio's marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
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.
Lilly expands its portfolio of treatments for cardiometabolic diseases with acquisition of Versanis Bio and Sigilon Therapeutics.
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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.