Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The post FDA slaps partial hold on Biogen, InnoCare MS drug appeared first on.

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FDA Side effects Biopharma Prospecting 69

pharmaphorum

OCTOBER 27, 2022

There has been somewhat better news for GSK for another of its top pipeline prospects – renal anaemia drug daprodustat – although that also came with disappointment. GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million, including around €23 million upfront. Daprodustat backed.

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Legacy MEDSearch

OCTOBER 25, 2023

Theranica , a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio ® , a Remote Electrical Neuromodulation (REN) device for the treatment of migraine.

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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. More recently, the FDA granted approval of Roctavian in June 2023.

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Legacy MEDSearch

JULY 19, 2023

VAPOR 2 is a prospective, multicenter, single-arm study that will treat 235 patients with intermediate-risk, localized prostate cancer at up to 30 U.S. The therapy is designed to ablate cancer cells while protecting surrounding structures, lessening the likelihood of life-altering side effects common with other prostate cancer treatments.

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Medical Side effects Patients Recruitment 52

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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