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Microbiome drug to be tested in IBS clinical trial

Drug Discovery World

EnteroBiotix, a Glasgow, UK based biotechnology company, has dosed the first patient in a clinical trial designed to evaluate EBX-102-02 for the treatment of irritable bowel syndrome (IBS). The primary objective of the study is to assess the safety and tolerability of EBX-102-02.

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EC grants approval for Calliditas’ Kinpeygo to treat IgA nephropathy

Pharmaceutical Technology

The treatment is indicated for IgAN patients at risk of quick disease progression risk with a urine protein-to-creatinine ratio (UPCR) ?1.5g/gram. An orphan medicinal product, Kinpeygo is the first and only therapy to receive approval for IgAN. This 3.87mL/min/1.73 mL/min/1.73 m2 in those who received placebo.

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US FDA accepts BLA for Henlius’ biosimilar HLX02

Pharmaceutical Technology

Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA. Henlius president Jason Zhu said: “Henlius independently developed HLX02 in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the FDA, and other international biosimilar guidelines. “It

Medicine 130
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Leading speciality pharmacies in pharma

Pharmaceutical Technology

Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time.

Pharmacy 113
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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. Cell and gene therapies are currently at the forefront of immunotherapy cancer research, and a few approved therapies are already making a difference to disease outcomes for patients.

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Orphan drugs and where to launch them: The keys to Europe’s forgotten territories

Pharmaceutical Technology

Historically, the pharmaceutical industry has failed to meet the needs of this patient population. The commercial investment required to research and develop an innovative drug, prove its safety and efficacy, and bring it to market is staggering. But where does this leave patients outside of these preferred markets?

Drugs 147
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Metastatic uveal melanoma drug granted MHRA Innovation Passport 

Drug Discovery World

iOnctura, a clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, has been awarded the innovative medicine designation, the Innovation Passport, for roginolisib, for the treatment of metastatic uveal melanoma by the Medicines & Healthcare products Regulatory Agency (MHRA).

Drugs 52