Biopharma FDA Side effects 
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.
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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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.
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.
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.
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.
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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