European Pharmaceutical Review
NOVEMBER 18, 2022
The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. The most common side effects observed were initial insomnia, irritability and dyskinesia. The efficacy and safety profile of Upstaza has been shown across clinical trials and compassionate use programmes.
pharmaphorum
JULY 1, 2022
billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.
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pharmaphorum
JANUARY 3, 2023
The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. .
Pharmaceutical Technology
SEPTEMBER 8, 2022
Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. Patient education and medication adverse effect counselling. Patient monitoring for safety and efficacy. Dispensing of speciality pharmaceuticals and shipping coordination. Prior authorisation assistance.
pharmaphorum
DECEMBER 28, 2022
billion buyout of Principia Biopharma. That could give the drugs an advantage over CD20-targeting therapies like Roche’s Ocrevus (ocrelizumab) that inhibit B cells across the board, leaving patients prone to infections and other side effects.
European Pharmaceutical Review
JULY 20, 2023
Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. For cell and gene therapy, a “big issue” she stated, was the complexity of manufacturing.
Clarivate
OCTOBER 19, 2023
Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects).
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