All Drug Development articles – Page 39
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NewsRevised 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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NewsNew Parkinson’s drug formulation “nearly doubles” exposure
Inhibikase Therapeutics’ new drug tablet formulation could potentially facilitate a lower dose of its Parkinson's drug candidate for it to reach therapeutic efficacy.
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NewsGSK shingles vaccine achieves 100 percent efficacy in China trial
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.
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ArticleDivest 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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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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Video
Webinar: Altasciences’ unique project management offering
Discover Altasciences’ unique project and programme management approach and how it can lower your costs and reduce overall development timelines.
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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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Whitepaper
Whitepaper: Are nitrosamines a concern for biologic manufacturers?
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
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Whitepaper
Whitepaper: Navigating nitrosamine impurity testing
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
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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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Whitepaperebook: Benefits of liquid-filled capsules for pharmaceutical development
Discover the benefits of liquid-filled capsules for the formulation of highly potent APIs and drugs that benefit from slow or extended release.
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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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NewsSandoz to file for approval of aflibercept biosimilar
Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.