All news articles – Page 4
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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.
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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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NewsTitanium dioxide-free drotaverine hydrochloride tablets developed
Study findings indicate an alternative coating that would comply with potential future regulation against use of titanium dioxide as a pharmaceutical excipient.
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NewsGSK’s Nucala green lit for COPD in expanded EU approval
The EC's decision opens up the monthly biologic for use by COPD patients with an eosinophils phenotype.
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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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NewsAstraZeneca’s Imfinzi plus chemotherapy earns CHMP nod in gastric cancer
If approved, the regimen would become the first immunotherapy-based perioperative therapy for adults with early gastric and gastroesophageal cancers in Europe.
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NewsNMD Pharma will ‘accelerate’ rare disease drug ignaseclant despite endpoint miss
But phase II data of the small molecule inhibitor for Charcot-Marie-Tooth disease Types 1 and 2 did show it meeting secondary endpoints for functional improvements.
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NewsVetter Pharma outlines plans for new manufacturing site in Germany
The CDMO is also building a new US aseptic clinical production facility in Illinois as it expands its global footprint.
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NewsGenentech gains rights to SanegeneBio’s RNAi pipeline for $1.5bn
Licensing agreement with SanegeneBio set to advance potential breakthrough siRNA medicines.
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NewsUCB wins CHMP favour for first thymidine kinase 2 deficiency treatment
If approved by the European Commission, Kygevvi would provide a new treatment option for eligible patients with the ultra-rare mitochondrial disease in Europe.
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NewsFDA launches PreCheck pilot programme for US pharma manufacturers
The regulator’s new programme aims to create more efficient regulatory review processes for new pharmaceutical manufacturing facilities.
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NewsArdena divests Södertälje drug substance site to Nanologica
The CDMO and CRO’s Swedish API facility will now operate as a Nanologica subsidiary, reverting to its original name Syntagon.
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NewsDr David Berman to join Moderna as Chief Development Officer
Meanwhile, Dr Jacqueline Miller is stepping down as the company's Chief Medical Officer.