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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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FDA grants first approval for multiple sclerosis biosimilar
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.
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Divest to invest: the new normal in biopharma?
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.
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Eli Lilly therapeutic shows potential in thyroid cancer
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.
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AI/ML to drive bioprocess containers market
The biopharma industry will see more customisation in the design of bioprocess containers in the next five years, a market report has predicted.
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Pfizer maternal RSV vaccine approved
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.
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UK medicines manufacturing to get innovation boost
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.
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Global RNA therapy clinical trials market to reach $3.5 billion by 2030
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.
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Biopharma sees strong Q2 2023 market cap growth
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.
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CHMP to review MAA for geographic atrophy treatment
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.
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CDMO to manufacture SARS-CoV-2 intranasal vaccine
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.
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FDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
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Semaglutide demonstrates cardiovascular benefit
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.
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AstraZeneca’s tezepelumab and dapagliflozin accepted for use in Scotland
The Scottish Medicines Consortium (SMC)’s acceptance means eligible patients across the UK can now benefit from AstraZeneca's Tezspire (tezepelumab) for severe asthma and Forxiga (dapagliflozin) for chronic heart failure.
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New vaccine development centre to strength UK’s capabilities
The UK’s new vaccine development and evaluation centre will target pathogens for which a vaccine does not exist or could be improved, supporting pandemic preparedness.
