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Biopharmaceuticals

Case Study: Franz Ziel’s utilisation of Enzyme Indicators using Fractional Kill Time method

3 June 2024 | By

An EJPPS published study on Enzymatic Indicators in Vaporized Hydrogen Peroxide Decontamination Cycles: Application-related Research focusing on Fractional Kill Time (FKT) and Reverse Fractional Kill Time (RFKT) Studies

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Oligonucleotide ALS therapy approved in EU

31 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

The European Commission (EC) has granted Biogen its third rare disease treatment approval in the European Union.

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Ophthalmology acquisition to advance tri-specific antibody

30 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

A novel late-phase clinical candidate for diabetic macular edema and neovascular age-related macular degeneration will be developed as part of the proposed agreement.

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Pioneering AAV gene therapy for Krabbe disease

30 May 2024 | By Catherine Eckford (European Pharmaceutical Review), Dr Maria Escolar (Forge Biologics)

Dr Maria Escolar, Chief Medical Officer, Forge Biologics, explores the advantages of the company’s novel AAV gene therapy for Krabbe disease, which could help to overcome some of the immune and safety challenges the gene therapy sector is facing.

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Pharma Horizons: Cell and Gene Therapy

30 May 2024 | By European Pharmaceutical Review

This report is dedicated to exploring some of the latest innovations in the cell and gene therapy space, from development and quality control, through to manufacturing and clinical trials.

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LBP-immunotherapy could benefit oncology patients

29 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

New data for a microbiome-based therapeutic together with an immune checkpoint inhibitor has shown “encouraging clinical benefits” in advanced cancers.

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Two novel biosimilars approved in EU and US

29 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.

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New Phase III data for hidradenitis suppurativa biologic released

24 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

The IL-17A and IL–17F inhibitor demonstrated positive efficacy and safety in adults with moderate-to-severe hidradenitis suppurativa, new data shows.

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Progressing personalised cell therapies in oncology

23 May 2024 | By Dr Imran Khan (J&J Innovative Medicine)

Dr Imran Khan, PhD, Vice President, Medical Affairs, Hematology, Johnson & Johnson Innovative Medicine discusses the major benefits and current challenges of CAR-T cell therapies, as well as the potential of the company’s novel BCMA-targeted treatment for multiple myeloma.

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European Commission grants first-of-a-kind biosimilar approval

22 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.

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Novel biologic could offer ulcerative colitis symptomatic remission

21 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

Johnson & Johnson’s selective IL-23 inhibitor demonstrated clinically meaningful improvements compared to placebo in ulcerative colitis, new study data shows.

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AstraZeneca announces $1.5b ADC manufacturing facility

20 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

The new manufacturing facility for antibody drug conjugates (ADCs) will be designed to have zero carbon emissions when operational, AstraZeneca stated.

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FDA approves Amgen T-cell engager for small cell lung cancer

17 May 2024 | By Caroline Peachey (European Pharmaceutical Review)

Amgen’s Imdelltra™, previously known as tarlatamab, is approved for the treatment of adult patients with advanced small cell lung cancer.

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New EVP, Teva Global Operations appointed

16 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

The new Executive Vice President of Teva Global Operations will bring “significant experience at every stage of the manufacturing and supply process” to his new role, the company asserted.

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Ensuring sterility of a novel anti-VEGF bispecific antibody

15 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

Safety of the compounded biologic was confirmed following 28-day storage in two different polypropylene syringe types, research shows.

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Biopharmaceuticals