The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.

EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC

By Feliza Mirasol

March 10th 2025

The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.

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EMA Approves TAKHZYRO for Additional Subcutaneous Administration Option to Treat Hereditary Angioedema

By Feliza Mirasol

March 7th 2025

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

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Symbiosis Reports Successful Completion of FDA Inspection of Scotland Facilities

By Patrick Lavery

March 6th 2025

The inspection focused on fill/finish of ongoing commercial supplies of an adeno-associated virus viral vector biologics product for a major pharmaceutical client in the United States.

Isometric View of a Pharmaceutical Factory - Industrial Design for Prints, Cards, Posters, and Digital Graphics | Image Credit: © Anna– Stock.Adobe.com

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

By Aimee Penko

March 5th 2025

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

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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