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FDA approves Roche’s immunotherapy assay to support treatment decisions in lung cancer

31 October 2016 | By Niamh Louise Marriott, Digital Content Producer

The US Food and Drug Administration (FDA) has approved Roche’s PD-L1 assay as a diagnostic to identify PD-L1 expression levels in patients considering treatment with Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC)…

European Pharmaceutical Review - Issue 5 2016
European Pharmaceutical Review - Issue 5 2016
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Issue #5 2016 – Digital edition

20 October 2016 | By European Pharmaceutical Review

In this issue: Biosimilars, Informatics, Ingredients, PAT, HPLC, Microbiology, Product Showcase, Regulation, and much more...

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Antibiotics: resist the resistance

15 September 2016 | By Niamh Louise Marriott, Digital Content Producer

European Pharmaceutical Review caught up with Destiny Pharma’s CEO, Dr Love, for an exclusive interview to discuss why the pharmaceutical industry needs to radically change its approach to antibiotics in order to combat the threat of bacterial resistance…

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Destiny’s SA trial shows fast acting antibiotic too quick for disease resistance

5 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The two-stage clinical trial studied the safety, tolerability, and efficacy of intra-nasally applied exeporfinium chloride gels. Part 1 yielded safety data in eight volunteers and allowed progression to Part 2 in 48 healthy volunteers with colonised nasal Staphylococcus aureus (SA) bacteria. Part 2 was double-blinded, placebo controlled, and investigated two…

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Roche’s cancer immunotherapy drug has longer OS vs. chemotherapy

1 September 2016 | By Niamh Louise Marriott, Digital Content Producer

Roche’s study for tecentriq (atezolizumab) met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events…

Characterising therapeutic antibodies and ADCs using mass spectrometry
Characterising therapeutic antibodies and ADCs using mass spectrometry
article

Characterising therapeutic antibodies and ADCs using mass spectrometry

24 August 2016 | By

Since the 1970s, the advent of biotechnology has resulted in the development and commercialisation of many therapeutic proteins, including antibodies and antibody fragments, for the treatment of human diseases. Examples include antibody treatments for autoimmune diseases (for example, adalimumab [Humira®] for rheumatoid arthritis), cancers (such as trastuzumab [Herceptin®] for breast…

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Biomarker breakthrough could improve Parkinson’s treatment

16 August 2016 | By University of Florida

Scientists have found that using magnetic resonance imaging reveals areas where Parkinson’s disease causes progressive decline in brain activity, a biomarker discovery which will help to evaluate new experimental treatments to slow or stop the disease’s progression...

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Combining soft-tissue cancer drugs improves survival

21 July 2016 | By Niamh Louise Marriott, Digital Content Producer

Scientists discovered that adding a novel monoclonal antibody therapy to traditional chemotherapy increased survival by nearly a year in patients with advanced sarcoma, a lethal soft-tissue cancer.