Eisai Europe and Biogen have received a positive opinion for the monoclonal antibody therapy to be used as a treatment of adult patients with early Alzheimer’s disease.

Budget Announcement Prompts UK Medicines Manufacturing Skills Centre to Emphasize Need for Skills Development

By Susan Haigney

November 11th 2024

Chancellor of the Exchequer, Rachel Reeves, has announced a £520 million (US$675 million) investment for manufacturing capacity in the United Kingdom, prompting academic and industry leaders to point out that funds should be used to train personnel.

RSV Vaccine Approved for Adults 18–59

By Susan Haigney

October 23rd 2024

Pfizer’s bivalent RSV prefusion F vaccine has been approved by FDA to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

EMA Recommends Several Medicines in October

By Susan Haigney

October 18th 2024

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

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Digitalization of QbD Risk Assessments; Image: photon_photo - stock.adobe.com

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