Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) climbed 93.9% on Oct. 11 after the FDA removed a full clinical hold on studies of the rusfertide, the company's investigational treatment for the blood disorders polycythemia vera and hereditary hemochromatosis. Triggered by a finding of malignant skin tumors in mice treated with the drug disclosed on Sept. 17, the FDA's three-weeks-ago hold had pushed Protagonist shares down by as much as 72%.
Cambridge, U.K.-based Astrazeneca plc has new data from its long-acting COVID-19 antibody combination, AZD-7442, which aims to provide longer protection, potentially for up to a year. Latest data show the intramuscularly injected drug achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild to moderate symptomatic disease.
Nearly two years after confronting an initial complete response letter, Enzyvant Therapeutics Inc. has won FDA approval for a unique treatment for children born without a thymus, an ultra-rare condition leaving them deeply disadvantaged in fighting infections. The product, to be marketed as Rethymic, is the first thymus tissue product approved in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Amgen, Astrazeneca, Beigene, Chemocentryx, Janssen, Takeda.
Allogene Therapeutics Inc. officials took many questions but had few answers during a conference call regarding the FDA’s clinical hold after the report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the phase I/II Alpha2 study.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Denali, Minervax, Ortho Regenerative, Recursion, Y-Mabs.
Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy.
If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients.
LONDON – The World Health Organization (WHO) is recommending the widespread rollout of Glaxosmithkline plc’s Mosquirix (RTS,S), the first malaria vaccine, following real-world evidence it is safe and can be integrated into routine immunization programs and existing malaria control measures.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Pfizer.
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