All Data Analysis articles – Page 2
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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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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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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.
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NewsFormulation research offers step towards digital tablet design
Findings could lead to more robust tablet design and a minimising of the materials used, such as active pharmaceutical ingredients (APIs).
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NewsRoche’s fenebrutinib demonstrates decade-first benefit in multiple sclerosis
New Phase III data presented at ACRIMS suggests the oral BTK inhibitor could become a first-in-class multiple sclerosis therapy.
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NewsCrystallisation research could enhance API drug production
Thermodynamic framework supports rapid assessment of solvents during active pharmaceutical ingredient (API) manufacturing.
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NewsFMT shows promise for enhancing immunotherapy effectiveness in advanced cancer
Phase II data derived from the first randomised trial comparing immunotherapy outcomes post-FMT from immunotherapy responders versus placebo.
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NewsUK ‘gaining pace’ with early-stage trials for advanced therapies
CGT Catapult research shows an increase in phase I/II trials, led by oncology but with clear growth in other disease areas such as inflammation.
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NewsHoth Therapeutics’ topical therapy shines in cancer toxicity trial
Achieves 100 percent response in phase II data highlighting HT-001's potential as a supportive oncology treatment to address a common EGFR therapy burden.
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Biomanufacturing framework could boost microbial production efficiency
Research findings support the design of robust microbial processes for pharmaceutical products.
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NewsJohnson & Johnson’s Caplyta demonstrates phase III promise for depression
Combination therapy comprising of an antidepressant and small molecule drug significantly boosted remission rates in adults with major depressive disorder.
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Yeast research could advance sustainable pharmaceutical bioproduction
Novel approach holds potential to reduce the industry’s dependence on coconut and palm oil extraction for bioproduction of short- and medium-chain fatty acids.
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NewsAI framework could enhance continuous manufacturing, say FDA researchers
Digital twin model offers potential for advanced control during continuous pharmaceutical manufacturing processes.
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NewsEuropean Pharmacopoeia publishes new data quality framework
New general chapter on quality of data 5.38 supports stakeholders with digitalisation during pharmaceutical quality decision-making.
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NewsNovartis chromatography study shows downstream purification benefits
The impurities research illustrates an approach that could offer a simpler and more flexible downstream purification process.
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NewsJ&J’s Rybrevant-Lazcluze combination wins FDA first in lung cancer
US approval of the subcutaneous therapy provides a novel chemotherapy-free frontline option in EGFR-mutated NSCLC.
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NewsAstraZeneca and Daiichi’s Enhertu wins first-in-decade US oncology approval
FDA approval of the drug in combination with Perjeta initiates a $150 million milestone payment to Daiichi Sankyo from AstraZeneca under their joint collaboration.
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NewsCHMP recommends cancer medicines by SFL Pharmaceuticals and Serum Life Science Europe
The EMA’s human medicines committee also recommended approval of drugs by GSK, Moderna, STADA, Lupin Europe and Cytokinetics.
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NewsOff-the-shelf dual-antibody immunotherapy shows myeloma potential
The combination of two J&J biologics demonstrates a significantly improved treatment response for the most aggressive form of multiple myeloma in new phase II data.