MedCity News

MARCH 22, 2024

Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease.

Side effects 119

Side effects FDA Patients Biopharma 119

pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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FDA Side effects Biopharma Marketing 98

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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Side effects Safety Biopharma Recruitment 98

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. billion buyout of Principia Biopharma.

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FDA Side effects Biopharma Prospecting 75

European Pharmaceutical Review

OCTOBER 19, 2023

billion deal, in which Eli Lilly agreed to acquire two of POINT Biopharma Global’s late-stage radioligand therapies for oncological indications. This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

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Food and Drug Administration Manufacturing Side effects Doctors 105

Pharmaceutical Technology

OCTOBER 13, 2022

Myovant Sciences has rejected an acquisition offer from Sumitovant Biopharma and its wholly owned subsidiary, Sumitomo Pharma. The drug won its original FDA approval in May last year to treat heavy menstrual bleeding that accompanies uterine fibroids in premenopausal women.

Food and Drug Administration 52

Food and Drug Administration Pharma Side effects FDA 52

European Pharmaceutical Review

JULY 20, 2023

More recently, the FDA granted approval of Roctavian in June 2023. She stated that some of the key concerns were around viral safety, immunogenicity and the fact that long term side effects are unknown. This included the EC’s approval of Roctavian in August 2022, which was the first gene therapy for haemophilia A.

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Consulting Manufacturing Side effects Safety 74