News – Page 10
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News
AbbVie licenses novel bispecific antibody from RemeGen for $5bn
New deal strengthens AbbVie's oncology portfolio, adding a new class of cancer therapeutics to its inventory.
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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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NewsSentynl secures US-first approval for rare Menkes disease
The US biopharma company can now offer a new treatment option for eligible paediatric patients with the genetic disease.
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NewsSanofi wins EU approval for its type 1 diabetes biologic Teizeild
The European Commission’s decision will make the product the first disease-modifying treatment to be available for the condition in Europe.
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NewsNovartis to site its fourth US radioligand manufacturing facility in Florida
The new Winter Park plant advances the pharma company’s $23 billion commitment to enhance its US radioligand medicine manufacturing capabilities.
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NewsEndotoxins research supports recombinant reagent use for pharma QC
Replacing LAL reagents with animal-free alternatives addresses industry commitments to improve QC practices’ ethics and sustainability.
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NewsAstraZeneca hires Rick Suarez to lead its biopharma efforts in the US
His appointment comes as the pharma company AstraZeneca seeks to hit $80 billion revenue target by 2030.
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NewsLilly acquires inflammatory firm Ventyx Biosciences for $1.2bn deal
The deal brings it access to oral therapies targeting inflammatory-mediated conditions, including cardiometabolic, neurodegenerative and autoimmune diseases.
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NewsChemical assessment in Europe to be streamlined under new legislation
The European Commission’s new framework aims to improve safety assessment of chemicals to better protect human health and the environment.
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News
Amgen acquires UK cancer biotech Dark Blue Therapeutics for $840m
Gains access to the company’s small molecule-targeted protein degraders to expand its oncology pipeline.
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NewsEndotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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US oral GLP-1 first as Novo Nordisk launches Wegovy pill
The obesity drug’s new formulation gains an important opportunity to define the market before regulators finish assessing Lilly’s rival orforglipron.
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NewsSamsung gains first US manufacturing site through $280m GSK deal
The CDMO will acquire the pharma company’s Human Genome Sciences facility in Maryland.
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NewsGeneric manufacturer safety records revealed by new consumer app
News organisation ProPublica’s Rx Inspector tool connects FDA information on factory location and regulatory records to individual generic drugs.
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NewsAlnylam invests $250m to boost RNAi manufacturing in the US
Will add its enzymatic ligation platform, now accepted on the FDA’s emerging technology programme, to its Norton, Massachusetts site.
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NewsChitose and Fujifilm Biosciences sign biopharma manufacturing alliance
The deal will see the companies combine their respective work on CHO-MK cells and GMP-manufactured culture media.
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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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NewsEurope makes progress in its bid to tackle medicine shortages
And as the Critical Medicines Act advances, so too does the Biotech Act, with the moves attracting mixed support from the region’s pharma industry.
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NewsBicycle Therapeutics strikes uranium deal for sustainable radiopharmaceuticals
UK biotech commits to scale up of 228Th extraction and a long-term supply agreement to facilitate production of thousands of doses of 212Pb for cancer therapies annually.