A salmonella outbreak related to precut melons has spread to two more states and sickened 10 more people, bringing the number of cases to 70 across seven states. The FDA and CDC recently warned the public of the precut cantaloupe, watermelon and fruit salad mix linked to the outbreak that have been distributed to 22 states.
The FDA approved the inclusion of new evidence from a late-stage study that Novartis' Cosentyx, or secukinumab, slows progression of joint structural damage at week 24 in patients with active psoriatic arthritis.
Acurx Pharmaceuticals' ACX-362E, being developed to treat patients with Clostridium difficile infection, received qualified infectious disease product status from the FDA. The company intends to launch an early-stage clinical trial of the candidate in the fourth quarter.
CytoDyn submitted to the FDA protocol amendments for a Phase II study of PRO 140 in patients with graft-versus-host disease, which includes switching pretreatment conditioning to reduced intensity conditioning from aggressive myeloablative conditioning. The revision also includes switching to open-label design from a blinded 1-to-1 randomized placebo-controlled design and a 50% increase in the PRO 140 dose.
FDA's Antimicrobial Drugs Advisory Committee will meet Aug. 8 to discuss two new drug applications for Paratek Pharmaceuticals' qualified infectious disease product- and fast-track-tagged omadacycline, in oral and IV formulations, for the treatment of patients with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. The candidate achieved the primary endpoints of three late-stage studies for both indications.
A regulator in Poland granted Moleculin Biotech approval to begin a Phase I/II clinical trial of its experimental drug Annamycin, indicated for relapsed or refractory acute myeloid leukemia. The approval will allow Moleculin to start patient recruitment, with the study expected to begin later this year.
The first US implantation of Neovasc's Reducer refractory angina treatment device was performed in an FDA-approved compassionate-use case at Henry Ford Hospital in Detroit. The system increases oxygenated blood perfusion to the cardiac muscle's ischemic areas by altering blood flow in the circulatory system.
The Dynacord suture has been launched in the US by Johnson & Johnson through its subsidiary DePuy Synthes for use in soft tissue repair. The suture, which is available on Healix Advance anchors, will be fully released in the third quarter.
The FDA has granted Medtronic 510(k) clearance to market its Kyphon HV-R bone cement for fixation of pathological fractures of sacral vertebra with sacroplasty or sacral vertebroplasty. This expanded indication grants health care providers additional options for the treatment of sacral insufficiency fractures.
Follow-on funding pulled in $73.1 million for ObsEva, which recently reported that its candidate OBE2109, or linzagolix, met the primary endpoint in the Phase IIb EDELWEISS study for endometriosis-associated pain indication. The company also has Phase III PRIMROSE 1 and 2 trials of the candidate for uterine fibroid-associated heavy menstrual bleeding.
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