The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria. If approved, Emblaveo would be among the first beta-lactam/beta-lactamase inhibitor combos cleared for use in Europe.
Asieris Pharmaceuticals Co. Ltd plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia.
In a recent study led by Soman Abraham from Duke University, investigators observed that an increase in nociceptive sensory nerves in urinary tract biopsies from patients with recurrent urinary tract infections (rUTIs) was linked to elevated nerve growth factor (NGF) from monocytes and mast cells. This overgrowth of nerve cells appeared to cause lingering symptoms after rUTIs.
With a second batch of phase Ib data from the trial testing RGLS-8429 in hand from Regulus Therapeutics Inc., Wall Street is looking forward to results from the third cohort in midyear and weighing prospects with the compound in autosomal dominant polycystic kidney disease. Screening of the fourth cohort will start during the second quarter. Meanwhile, the company has begun to mull a pivotal phase II trial that would launch in the middle of next year, and may help with accelerated approval by the U.S. FDA.
Dimerix Ltd. announced a AU$20 million ($US13.22 million) capital raise following the news that its lead candidate, DMX-200, was successful in a prespecified interim analysis of the efficacy endpoint in its pivotal phase III trial in focal segmental glomerulosclerosis, a rare kidney disease.
In a recent study led by Soman Abraham from Duke University, investigators observed that an increase in nociceptive sensory nerves in urinary tract biopsies from patients with recurrent urinary tract infections (rUTIs) was linked to elevated nerve growth factor (NGF) from monocytes and mast cells. This overgrowth of nerve cells appeared to cause lingering symptoms after rUTIs. These findings, appearing in the March 1, 2024, online edition of Science Immunology, have the potential to provide a new approach to managing symptoms of rUTIs that would reduce unnecessary antibiotic usage.
Hun-taek Kim founded Tiumbio Co. Ltd. in 2016 after spending more than two decades at a major chemical and life science firm, SK Chemicals Co. Ltd. “The prospects for our three major assets are very bright, and the probability of failure is low,” CEO Kim told BioWorld. “We’re looking for a breakthrough in rare diseases – to develop new treatments for [niche] markets with large unmet demand.”
Wall Street got what it wanted from Vera Therapeutics Inc. with atacicept in IgA nephropathy (IgAN) and rewarded shares of the Brisbane, Calif.-based firm (NASDAQ:VERA), pushing them to close Jan. 25 at $25.31, up $8.29, or 49%.
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.
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