All Industry Insight articles – Page 2
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NewsFirst mRNA COVID-19/flu combination vaccine set for European approval
CHMP backs Moderna’s mCombriax vaccine for adults aged 50 and over.
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NewsNovo Nordisk expands oral GLP-1 manufacturing capacity in Ireland
Near €500 million investment will increase the firm’s capacity to produce tablet versions of its obesity and diabetes medicines.
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NewsCharles River Laboratories parts ways with its CDMO business
Aims to further strengthen and broaden its portfolio in order to drive long-term growth, greater efficiency and operational excellence.
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NewsLipid nanoparticle discovery could increase drug delivery efficiency
Study findings offer potential to accelerate development of RNA-based medicines.
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NewsNovartis to site fifth radioligand therapy manufacturing facility in Texas
Investment to support production of radiopharmaceutical cancer therapies and forms part of Novartis’ planned $23 billion investment in its US capabilities.
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NewsNovo Nordisk strikes $2.1bn oral obesity biologic deal with Vivtex
Drug delivery partnership to advance next-generation oral therapies and help Novo Nordisk expand its obesity and diabetes portfolio.
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NewsGSK acquires TGF-beta protein firm 35Pharma for nearly $1bn
Acquisition will help GSK scale its pipeline for respiratory, immunology and inflammatory diseases.
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NewsAbbVie invests $380m in Illinois to expand US API manufacturing
Decision forms part of the pharma company’s plan to commit $100 billion to its R&D capabilities in the US over the next decade.
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ArticleApplying AI to enhance drug formulation and development
AI/ML is not replacing formulation scientists or process engineers; it is just amplifying their expertise.
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NewsFDA drafts new ultra-rare disease therapy guidance
Agency’s planned framework is the first to support the approval process for new ultra-rare disease treatments.
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NewsGilead adds to cell therapy portfolio with $8bn acquisition of Arcellx
Deal builds on the companies’ 2022 collaboration over CAR T therapy anito-cel.
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NewsEU court dismisses pharma call to annul disputed wastewater rules
Ruling leaves “important legal questions regarding the validity of the Directive unresolved”, according to industry association EFPIA.
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NewsLilly's Omvoh demonstrates long-term potential in Crohn’s
New late-stage data shows the drug enabled the majority of IBD patients to stay steroid free over three years of Omvoh treatment.
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NewsDaiichi Sankyo picks Dr John Tsai to head up R&D
The ex-Novartis drug development head will lead the pharmaceutical company’s global R&D operations.
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NewsFDA policy sets new clinical trial requirements for drug approvals
The default standard would see US drug and biologic approvals require a single, robust pivotal study plus confirmatory evidence, instead of two trials.
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NewsJohnson & Johnson invests $1bn in US cell therapy manufacturing
New Pennsylvania plant forms part of the pharma company’s $55 billion commitment to expand its US manufacturing footprint before the end of the decade.
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NewsPfizer’s Braftovi improves progression-free survival in colorectal cancer
A triple therapy combination of the drug could offer a “potentially practice-changing treatment option”, according to new late-stage data.
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NewsGSK wins dual EU approval for its ultra-long-acting biologic Exdensur
The European Commission’s decision covers the treatment’s use in severe asthma and chronic rhinosinusitis.
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NewsOrsellinic acid produced in E. coli for first time
Study findings could provide an alternative production platform for rhododendron-derived drugs with potent anticancer and anti-HIV properties.
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NewsAmgen wins new European approval for Uplizna in generalised myasthenia gravis
The EC decision clears a new first-in-class approach to manage the rare autoimmune condition.