All articles by Catherine Eckford (European Pharmaceutical Review) – Page 3
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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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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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NewsLeftover bread could support sustainable pharmaceutical manufacturing
The use of microbial-derived hydrogen could lead to carbon-negative, fossil-free bioproduction of pharmaceuticals.
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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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NewsRecipharm sells manufacturing site to Scinai in biologics collaboration
Recipharm forms a long-term partnership with the Israeli biopharma and CDMO covering early development through to commercial supply.
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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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NewsSanofi’s Beyfortus shows infant benefit beyond first RSV season
The biologic enabled a significant reduction in RSV-related hospitalisations in infants through a second RSV season.
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NewsNovartis bolsters the case for Vanrafia’s full approvals in IgA nephropathy
Phase III results will support the firm’s planned filings for traditional approvals later in 2026, following last year’s US and China accelerated approvals.
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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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NewsSanofi selects Dr Belén Garijo as new CEO
The company veteran will return to lead the pharma firm, taking over from Paul Hudson.
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NewsDr Veit Bergendahl to join Rentschler Biopharma as Chief Operating Officer
New operations lead brings over twenty years of biopharma experience to the CDMO’s Laupheim and Milford sites.
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NewsFujifilm Biotechnologies inaugurates expanded £400m UK biomanufacturing site
The CDMO’s investment in the North-East based site expansion supports UK production of medicines and vaccines.
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NewsEMA opens consultation for Annex 15 GMP guidelines
Proposal guideline by EMA anticipated to replace Eudralex Volume 4: Annex 15 Qualification and validation.