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UK ‘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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Genentech doubles investment in North Carolina manufacturing facility
The East Coast expansion is part of the biopharma firm’s $50 billion investment in its US manufacturing and R&D capabilities.
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Europe marks key milestone in adopting Critical Medicines Act
EU Parliament agrees clear priorities for future negotiations on the act, including investing in pharma manufacturing capacity.
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EU concludes major free trade agreement with Mercosur countries
European pharma industry acknowledges the progress made, particularly with partial tariff reductions, but said further provisions could have been achieved.
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ReiThera on vaccines and remaining nimble around emerging threats
As vaccines are buffeted by political pressures, the CDMO discussed its growth approach and some of its key collaborations.
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Sentynl 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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Novartis 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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Chemical 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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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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Europe 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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AstraZeneca 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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CHMP 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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Europe edges closer to formalising new ‘Pharma package’ industry rules
Progress made in the region’s approach to critical medicines and antibiotics as the EU Council and EU Parliament agree a new deal.
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Pfizer boosts its obesity plans with $2bn GLP-1 YaoPharma deal
The move builds on its recent billion-dollar acquisition of the obesity-focused biopharma company Metsera.
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Gamida Cell wins cell therapy first in severe aplastic anaemia from FDA
The US approval for the Ayrmid company’s novel transplant option Omisirge adds to its existing licence in haematological malignancy.
