News – Page 7
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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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NewsRois appoints Kimberlee Steele as Chief Commercial Officer
She joins the Madrid-headquartered contract development and manufacturing organisation from SHL Medical.
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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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NewsRottendorf and Corealis collaborate on OSD manufacturing
The two CDMOs sign an alliance to offer an integrated early-development offering and accelerated commercial pathway.
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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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NewsFresenius Kabi and Phlow onshore US epinephrine manufacturing
The collaboration covers the essential medicine's active pharmaceutical ingredients (APIs) and finished doses.
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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.
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NewsLilly acquires CAR-T therapy biotech Orna Therapeutics for $2.4bn
Agreement with Orna Therapeutics includes potential best-in-class, immune-targeting in vivo CAR-T therapies.
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NewsBMS partners with Evinova to strengthen clinical development using AI
Aims to shorten medicine development timelines, improve likelihood of trial success and reduce clinical trial costs.