A voluntary recall was issued by Zakah Life for kratom products related to an ongoing salmonella outbreak that has sickened at least 199 people and caused 38 to be hospitalized across 41 states. The recalled Zakah products were Powerful Red Vein Bali Premium Kratom Powder, Super Green Maeng Da powder and premium kratom capsules, and Red Powder Vein Bali Kratom powder, which have expiration dates prior to Jan. 1, 2023, and were shipped across the US.
The FDA requires the use of an approved diagnostic test when taking Merck's Keytruda, or pembrolizumab, or Genentech's Tecentriq, or atezolizumab, to determine PD-L1 levels in patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin. The Dako PD-L1 IHC 22C3 PharmDx and Ventana PD-L1 assays are approved with Keytruda and Tecentriq, respectively, for these patients.
Bristol-Myers Squibb's Opdivo, or nivolumab, received accelerated approval from the FDA as a third-line treatment for patients with small cell lung cancer whose disease has progressed after platinum-based chemotherapy and one or more other lines of therapy. A Phase I/II study showed Opdivo led to a 12% overall response rate among 109 patients and a median duration of response of 17.9 months among 13 responders.
The FDA has informed Mateon Therapeutics that a partial clinical hold has been placed on its study evaluating drug candidate OXi4503, being tested in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. The partial hold is related only to the study arm that involves administration of the 12.2 mg/m2 dose after two reports indicated possible dose-limiting toxicities, although both affected participants recovered after intervention.
The FDA granted orphan drug status to Rafael Pharmaceuticals' CPI-613, being developed in combination with bendamustine to treat patients with peripheral T-cell lymphoma. The drug is being assessed for efficacy, and interim data demonstrated an 86% overall response rate.
The FDA issued a letter to physicians warning them that patients initially supported with SynCardia Systems' Temporary Total Artificial Heart Companion 2 Driver system had higher rates of mortality and stroke, compared with those initially supported with the earlier generation Circulatory Support System Console. Health care providers should consider this warning in treatment decision-making and discussion of device risks and benefits with patients and are advised to return to SynCardia the devices that could be linked to adverse events to help better understand the issue.
The FDA, under its de novo review pathway, has granted Jerusalem-based Brainsway authorization to market the Brainsway Deep Transcranial Magnetic Stimulation System for the treatment of obsessive compulsive disorder. The decision was backed by data from a 100-patient, randomized, multicenter study, which showed 38% of patients responded to treatment with a reduction in Yale-Brown Obsessive Compulsive Scale score, compared with 11% who responded to a sham device.
Health Canada has granted Sweden-based Bonesupport approval for the Cerament G gentamicin-eluting injectable ceramic bone graft substitute. The company is conducting a 230-patient, 30-site US and European trial of its product for standard-of-care management of patients who have open fractures of the tibial diaphysis to support its application for FDA premarket approval.
A 12-week dosing schedule for Regeneron Pharmaceuticals' Eylea, or aflibercept, as a treatment for patients with wet age-related macular degeneration was approved by the FDA. The approval adds to the already available four- and eight-week dosing schedules for the drug.
Alexion's biologics license application for ALXN1210, being developed to treat patients with paroxysmal nocturnal hemoglobinuria, was accepted by the FDA for review under priority status. The agency has set a PDUFA date of Feb. 18.
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