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Macrophage cell therapy: a new hope for chronic liver disease patients

Drug Target Review

The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.

Therapies 116
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Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…

The Pharma Data

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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AstraZeneca’s Lynparza recommended by the EMA for HRD-positive advanced ovarian cancer

The Pharma Data

This came after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the recommendation based on a positive opinion of the PAOLA-1 Phase 3 trial which was published in The New England Journal of Medicine. .

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FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. This indication was approved under accelerated approval based on tumor response rate and duration of response.

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Loxo Oncology at Lilly Announces Publication of Pirtobrutinib (LOXO-305) Phase 1/2 Data in The Lancet

The Pharma Data

The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020. About the BRUIN Phase 1/2 Trial.

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Merck’s KEYTRUDA® (pembrolizumab) Receives Two New Approvals in Japan

The Pharma Data

KEYTRUDA is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial. 0.80; p=0.0002) and doubled median PFS (16.5 months [95% CI, 5.4-32.4] months [95% CI, 6.1-10.2])

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FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

The Pharma Data

Patent Trial and Appeal Board (PTAB) had instituted inter partes review (IPR) against U.S. DAXI was evaluated in three Phase III trials, with the median time to loss of none or mild wrinkle severity was 24 weeks and the median time to return to baseline wrinkle severity was about 28 weeks. On October 14, Liquidia announced the U.S.

FDA 52