Archives: 2019-11-01

Data suggest gene, cell therapy trial initiations in Europe lag behind North America

Medical science has moved on from the one-size-fits-all approach to the era of personalized medicine. European authorities approved the world’s first-ever gene therapy — GSK’s Strimvelis, a treatment for an inordinately rare inherited disorder characterized by a ravaged immune system, in 2016. So far, the EMA has granted the greatest number of marketing authorizations for

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Milk from Teeth: Dental Stem Cells Can Generate Milk-Producing Cells

Stem cells of the teeth can contribute to the regeneration of non-dental organs, namely mammary glands. According to a new study from researchers at the University of Zurich, dental epithelial stem cells from mice can generate mammary ducts and even milk-producing cells when transplanted into mammary glands. This could be used for post-surgery tissue regeneration

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Novartis’ Zolgensma gene therapy study halted by FDA on animal safety concerns

he Food and Drug Administration has halted a clinical trial of Novartis’ Zolgensma gene therapy due to a safety concern found in an animal study, the company said Wednesday. The hold affects the Novartis (NVS) clinical trial known as STRONG, which was testing a higher dose of Zolgensma administered by spinal injection to older children

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European Commission Approves Bavencio-Inlyta for First-line Treatment of Advanced Kidney Cancer

The European Commission (EC) has approved a combination regimen of Bavencio (avelumab) injections plus Inlyta (axitinib) tablets for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC), the most common type of kidney cancer. The combination can be used in patients regardless of their predicted prognosis and PD-L1 status. The EC’s decision followed a positive recommendation issued in September by the Committee for Medicinal

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BRAF/MEK inhibitor therapy induces response in metastatic melanoma with rare BRAF mutations

Combination therapy with BRAF and MEK inhibitors conferred significant PFS benefit compared with BRAF inhibitor monotherapy among patients with metastatic melanoma with rare BRAF mutations or translocations, according to results of an international, retrospective study published in Journal of Clinical Oncology. “Patients with rare BRAF mutations may respond to targeted therapy, however, efficacy seems to be lower compared with patients

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AffyImmune Therapeutics Announces IND Approval for a First-in-Man Trial of Affinity-Tuned CAR-T cells for Patients with Advanced, Refractory Thyroid Cancer

AffyImmune Therapeutics, an emerging leader in CAR-T therapies, today announced FDA approval of the company’s investigational new drug (IND) application for AIC100, an affinity-tuned CAR-T cell that received Orphan designation for advanced thyroid cancer. The trial: Phase I study of AIC100 in relapsed and or refractory advanced thyroid cancer and anaplastic thyroid cancer, is sponsored by Weill

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RESTORE 1st Advanced Therapies Science Meeting 25th-26th November 2019, Berlin

RESTORE-Health by Advanced Therapies invites you to join the First Advanced Therapies Science Meeting (ATSM), an EACCME® accredited event, which will be held at the Maritim Hotel, Stauffenbergstraße in Berlin from the 25th – 26th November 2019. Advanced Therapies are one of the most recent and significant advances in medicine. They include gene and cell

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Stem cell therapy approved for MS patients in Scotland

MULTIPLE sclerosis campaigners have hailed a “huge step forward” for patients in Scotland after a stem cell therapy was recommended for use on the NHS for the first time. Haematopoietic stem cell transplantation (HSCT) has been described as a “game-changer” for MS after an international clinical trial showed that it could reboot patients’ immune systems and halt the progress

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