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EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Pharmaceutical Technology

The European Commission’s approval comes after the positive opinion of the Committee for Medicinal Products for Human Use. It is also based on the data obtained from the DESTINY-Breast04 Phase III trial, which assessed Enhertu’s safety and efficacy against the physician’s choice of chemotherapy.

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EMA’s CHMP recommends approval of Sandoz’s Hyrimoz biosimilar

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for Sandoz’s citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab) biosimilar.

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The New Frontier in Drug Development: Understanding Biologics and Small Molecules

Cloudbyz

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. The production process is often less complex compared to biologics.

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Cell and gene therapies: why advanced medicines call for specialised logistics

Pharmaceutical Technology

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. Using a similar treatment to target solid tumours could be the industry’s next major milestone. Securing the supply chain. The industry is moving at an unprecedented speed.

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Wellcome funds work on regulating digital mental health tools

pharmaphorum

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? Wellcome has provided funding in the UK to help answer that question. The healthcare charity is providing £1.8 The healthcare charity is providing £1.8

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Innovations in Biosimilars: Insights and Trends from Samsung Bioepis

XTalks

Biosimilars have emerged as an important factor in modern healthcare, reshaping treatment accessibility and affordability. Biosimilars offer a promising pathway to reducing healthcare costs while maintaining the efficacy and safety profiles of their reference products, the originally approved biologic drugs.

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Camallergy’s UK Based Manufacturing Facility Receives cGMP Licences for Peanut Allergy Treatment

The Pharma Data

The new manufacturing facility will handle cGMP production of CA002, the Company’s proprietary peanut allergy treatment, for planned pivotal clinical trials. Camallergy’s manufacturing facility is the only European GMP production facility for peanut oral immunotherapy and is scalable for commercial production.