Nearly four years after the COVID-19 pandemic closed government offices and sent federal employees home to work remotely, the U.S. FDA is returning to some semblance of normalcy, with its drug and biologics centers expanding in-person face-to-face industry meetings to include all PDUFA and BsUFA meeting types, beginning Jan. 22.
Calliditas Therapeutics AB’s full approval from the U.S. FDA for Tarpeyo (budesonide) delayed release capsules in immunoglobulin A nephropathy (IgAN) revived speculation about competitor Travere Therapeutics Inc. which, like Calliditas, has gained accelerated approval for its prospect.
Glaukos Corp. brought home a nice year-end gift for investors with a broad U.S. FDA approval for the Idose TR. Indicated for use in patients with primary open-angle glaucoma or ocular hypertension across the full range of disease severity, the device/drug combo provides continuous release of a prostaglandin analog that reduces intraocular pressure via a titanium device implanted through a corneal incision for up to three years.
The FDA has awarded orphan drug designation to Ocelot Bio Inc.'s lead candidate OCE-205 for the treatment of ascites due to all etiologies except cancer. Ocelot Bio plans to initiate clinical studies of OCE-205 in refractory ascites next year.
Given the challenges of generating chemistry, manufacturing and control information on the compressed timelines used in the EMA’s Priority Medicines scheme and the U.S. FDA’s breakthrough therapy designation program, the two regulators published a joint question-and-answer document discussing quality and good manufacturing practice aspects of applications for both programs, which are aimed at speeding development of innovative products to address unmet medical needs.
The data package for Filsuvez (birch triterpenes), a topical gel aimed at treating partial thickness wounds, satisfied U.S. reviewers the second time around. Chiesi Group said the FDA approved the treatment Dec. 19 for use in patients 6 months and older with rare blistering skin diseases junctional epidermolysis bullosa and dystrophic epidermolysis bullosa.
South Korea’s GC Biopharma Corp. has gained U.S. FDA approval for its immune-deficiency plasma drug, Alyglo (immune globulin intravenous, human-stwk; IVIG-SN 10%), five months after refiling its BLA and before its PDUFA date of Jan. 13, 2024.
Avstera Therapeutics Corp. has received FDA clearance of its IND application for HDAC6 inhibitor AVS-100. Avstera intends to initiate a phase Ia/b trial in the first half of 2024 to evaluate AVS-100 alone and in combination with pembrolizumab in locally advanced or metastatic solid tumors.
Nrx Pharmaceuticals Inc. has announced FDA clearance of its IND application for the use of NRX-101 (lurasidone hydrochloride/D-cycloserine) for the treatment of complicated urinary tract infections (cUTI).
Shares of Checkpoint Therapeutics Inc. dropped 44.8% Dec. 18 on news that the U.S. FDA issued a complete response letter (CRL), delaying potential approval of PD-L1 antibody cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma. The FDA had accepted in March the BLA, seeking use for treating patients who are not candidates for curative surgery or radiation, setting a Jan. 3, 2024, PDUFA date.
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