All articles by Catherine Eckford – Page 53
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NewsProposed non-animal derived reagent Chapter published
USP’s proposed new Chapter , which offers additional information on Bacterial Endotoxins Tests (BETs) using non-animal derived reagents, has been published as a General Announcement in advance of public consultation.
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NewsEli 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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NewsAI/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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NewsPfizer 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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NewsUK 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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NewsGlobal 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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NewsBiopharma 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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NewsCHMP 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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NewsImmunotherapy combo could overcome melanoma anti-PD-1 resistance
A “practice-changing” immunotherapy drug combination demonstrated inhibition of two main immune checkpoints in a trial assessing efficacy in metastatic melanoma.
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NewsCDMO 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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NewsAbbVie gains EU migraine treatment approval
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.
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NewsMultiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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NewsFDA 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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NewsNovo Nordisk makes $1 billion acquisition agreement
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.
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NewsWill Novartis provide new oral option for chronic hives?
If approved, Novartis’ remibrutinib has potential to be the first of a new class of chronic spontaneous urticaria (CSU) treatment in a decade.
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NewsADC oncology therapy market to value over $36b by 2029
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.
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NewsSemaglutide 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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NewsAstraZeneca’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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NewsNew 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.
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NewsAstellas to advance oncology CAR-T therapy
An investment of $50 million by Astellas Pharma in Poseida Therapeutics’ Phase I allogeneic CAR-T product candidate for solid tumour indications is set to advance the cancer immunotherapy field.