FDA
In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported.
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After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.
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Loqtorzi is the first programmed death receptor-1 from China to be approved by the U.S. regulator, and the first for patients with recurrent or metastatic nasopharyngeal carcinoma across all lines of treatment.
Following an FDA rejection and a previous discontinuation in psoriasis, Eli Lilly’s anti-IL-23 antibody has finally won an approval in ulcerative colitis, joining a crowded inflammatory bowel disease market.
Santhera Pharmaceuticals and partner Catalyst Pharmaceuticals got the FDA’s greenlight for their Duchenne muscular dystrophy drug Agamree, which is expected to launch in the first quarter of 2024.
The oncology company added a fifth indication for its isocitrate dehydrogenase 1 inhibitor, securing the greenlight for treating patients with IDH1-mutated relapsed or refractory myelodysplastic syndromes.
Even after the runaway success of mRNA vaccines against COVID-19, the pathway to approval for upcoming would-be mRNA therapeutics has yet to be laid out.
The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.
A Discussion with IQVIA’s Michelle Gyzen Sr. Director, Regulatory Affairs and Drug Development Solutions
The label for the achondroplasia drug, which promotes endochondral bone growth, now covers children under five years of age with the rare genetic disease causing the most common form of dwarfism.
While Merck lost out to Pfizer earlier this year in snapping up Seagen, this week the company closed a deal worth a potential $22 billion with Daiichi Sankyo—further evidence of the industry’s insatiable appetite for ADC technology.
Following a delay and an initial rejection, UCB’s IL-17A/IL-17F blocker bimekizumab was approved for moderate-to-severe plaque psoriasis, which will now be marketed with the brand name Bimzelx.