All Industry Insight articles – Page 48
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NewsIFPMA reveals new CEO leadership lineup
CEOs from Pfizer, Roche and Daiichi Sankyo will join the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)’s new CEO leadership team.
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NewsPost-approval R&D key in advancing oncology treatments
The Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted in a new report five R&D mechanisms that could facilitate full clinical value of oncology treatments after initial approval from the US Food and Drug Administration (FDA).
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NewsWuXi Biologics proposes spin-off to support bioconjugate development
WuXi Biologics proposed spin-off and a separate HKEX listing of its subsidiary WuXi XDC means the company will be able to better capture the fast-growing global bioconjugate market.
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NewsBispecific antibody approved in Europe for DLBCL
European approval of the bispecific antibody treatment has the potential to change the current standard of care in diffuse large B-cell lymphoma (DLBCL).
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NewsInnovation key for boosting UK biopharma competitiveness
Solutions for technology and government policy to address current challenges and drive economic growth in biopharma and Medtech have been recommended in new reports.
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NewsSustainable pharmaceuticals: what about pine-based painkillers?
UK researchers have developed two of the world’s most common painkillers from a pine-derived compound, meaning new sustainable turpentine-based pharmaceuticals could be on their way.
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NewsBioNTech to support trial access for cancer immunotherapies
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.
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NewsISO publishes standard on bacterial endotoxin testing
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
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NewsFDA releases analysis on drug product quality in 2022
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
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NewsGlobal PAT market expected to exceed $10b in 2032
Digitalisation is a driving factor for the global process analytical technology (PAT) market, according to a report.
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NewsFirst gene therapy approved for Haemophilia A
The first approved gene therapy for haemophilia A reduced the mean annualised bleeding rate from 5.4 bleeds to 2.6 bleeds per year in a clinical study.
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NewsFirst AI-generated small molecule drug enters Phase II trial
Insilico Medicine’s novel AI-generated small molecule inhibitor drug represents a new milestone in pharmaceutical drug development.
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NewsCould obicetrapib facilitate sufficient LDL-cholesterol levels?
Data shared at the National Lipid Association (NLA) Scientific Sessions 2023 demonstrated that obicetrapib with ezetimibe reduced low-density lipoprotein cholesterol (LDL-C) while increasing HDL-C, compared with high-intensity statin monotherapy.
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NewsAlzheimer’s vaccine granted Fast Track designation
The US FDA has given Fast Track designation to an active immunotherapy vaccine that “specifically targets the most toxic forms of amyloid beta (Abeta)”.
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ArticleMicrobiome therapies: a maturing movement
On World Microbiome Day 2023, Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences delve into the current innovative landscape of microbiome-based therapeutics.
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NewsLonza and Vertex to partner to manufacture diabetes cell therapies
The proposed collaboration between Lonza and Vertex Pharmaceuticals will support manufacture of stem cell-derived, fully differentiated insulin-producing islet diabetes cell therapies.
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NewsFDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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NewsHow can real-world evidence support regulatory decision making?
Strategies to further accelerate real-world evidence generation to aid EU regulatory decision-making are needed, states a European Medicines Agency (EMA) report.
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NewsReducing bioburden testing and sterility testing volumes for gene therapies
A reduced sampling plan was recommended in a Biophorum report for reducing required bioburden and sterility testing volumes for gene therapy batch yield.
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NewsGene therapy approved for Duchenne muscular dystrophy
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.