Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Capricor, EMD Serono, Gyroscope, Imara, Knight, Metacrine, Regenxbio, Sarepta, Therapeuticsmd.
Tricida Inc. executives were not surprised when the FDA issued a complete response letter for veverimer to treat chronic metabolic acidosis. Despite an Aug. 22 PDUFA date, the company had received an FDA notification on July 16 that there were deficiencies that would preclude discussion of labeling and postmarketing requirements and commitments.
HONG KONG –Stempeutics Research Pvt Ltd. received the green light from the Drug Controller General of India (DCGI) to launch its Stempeucel therapy to treat critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aligos, Editas, Exelixis, HHS, Kazia, Merck, Turning Point.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Astrazeneca, Biomarin, Genmab, Kazia, Miragen, Opthea, Vertex.
Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates.
Novartis AG won FDA clearance for the anti-CD20 monoclonal antibody Kesimpta (ofatumumab) in relapsing forms of multiple sclerosis (MS) in adults, with a label that includes clinically isolated syndrome and relapsing-remitting as well as active secondary progressive disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Gene Technologies, Amidebio, Axsome, Bristol Myers Squibb, Carsgen, Kubota, Lidds, Polaryx, Samsung Bioepis.
An FDA rejection of Galapagos NV's rheumatoid arthritis (RA) drug filgotinib, announced Aug. 18, was "disappointing and unexpected," CEO Onno van de Stolpe said, adding that "there is so much more" to his company's story and pipeline. Gilead Sciences Inc., the Belgian company's partner and a substantial backer of both the drug and the pipeline, said it would "evaluate the points raised" by the CRL, but continued to believe in the drug.
Biomarin Pharmaceutical Inc.’s complete response letter (CRL) for Roctavian (valoctocogene roxaparvovec; Valrox) gene therapy for severe hemophilia A shocked the company, its investors and analysts mere days before its Aug. 21 PDUFA date. Now an approval and launch for what would have been the first approved hemophilia gene therapy is likely pushed back roughly two years.
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