Devices
A 12/5-12/14/2024 FDA inspection at Rex Implants in Columbus, OH, found that the company is manufacturing and distributing the REX Mallet, rexpander devices, and Piezoimplant REX BL 2.9 system without an approved PMA or IDE application in place. A 3/12 Warning Letter says the
Devices
Bausch + Lomb has recalled all enVista intraocular lenses (IOLs) due to increasing adverse event reports of toxic anterior segment syndrome (TASS) in conjunction with these IOLs. TASS is a rare, sterile inflammation of the anterior segment of the eye (the area between the cornea and iris) that typically occurs after
Drugs
Axsome Therapeutics says that in the PARADIGM Phase 3 proof-of-concept trial of solriamfetol to treat major depressive disorder with and without excessive daytime sleepiness, the drug failed to meet its primary endpoint in the overall patient population. A company statement says solriamfetol did not demonstrate a statistically significant
Drugs
Compass Therapeutics is announcing statistically significant top-line data on the primary efficacy endpoint from its COMPANION-002 trial, an ongoing Phase 2/3 randomized study of tovecimig in combination with paclitaxel in patients with advanced biliary tract cancer. The trial evaluated tovecimig in 168 patients with unresectable advanced, metastatic
Drugs
FDA has released the form FDA-483 issued following a 2/13-3/6 inspection at SKNV, a Pompano Beach, FL, outsourcing facility. The three inspection observations were: * failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed; * failure to provide adequate containment, segregation,
Devices
An 8/12-9/5/2024 FDA inspection at Next Science LLC in Jacksonville, FL, determined that the firm is illegally manufacturing and distributing adulterated and misbranded wound gels and wound irrigation solutions. A just-released 2/21 Warning Letter says the medical devices are adulterated because the firm does
Drugs
Vanda Pharmaceuticals has filed an NDA for Bysanti (milsaperidone) for treating acute Bipolar I disorder and schizophrenia. The new chemical entity is believed to work by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors, according to the company.
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) for treating adults with muscle invasive bladder cancer (MIBC). The approval covers Imfinzi’s combination use with gemcitabine and cisplatin as a neoadjuvant therapy, followed by durvalumab as an adjuvant monotherapy after radical cystectomy. The approval is based on the results of the
FDA Policy/General
In a move presumably to make it easier to terminate federal employees, president Trump late last week signed an executive order to remove organized union representation from the majority of government agencies, including FDA and other HHS health agencies. Government watchers are predicting that the order will vigorously be challenged
Drugs
Merck says data from its Phase 3 ZENITH trial showed that Winrevair (sotatercept-csrk) significantly reduces the risk of major morbidity and mortality events in adults with pulmonary arterial hypertension. The findings prompted an independent data monitoring committee to recommend early termination of the trial due to overwhelming efficacy, according
Devices
FDA has cleared a TrainHealth 510(k) for its TrainFES [functional neuromuscular stimulator] Advanced device and its use in treating people with sequelae of stroke and spinal cord injury. The device uses smart electrical stimulation that moves the paralyzed limbs of patient to increase both adherence and functional results, the
Devices
An FDA final rule regulating laboratory-developed tests (LDTs) has been vacated by a Texas federal court. Eastern Texas federal judge Sean Jordan ruled 3/31 in favor of plaintiffs American Clinical Laboratory Association and Association for Molecular Pathology, agreeing that the rule is in “excess of [FDA’s] statutory
Biologics
Analysis by Jim Dickinson] CBER director Peter Marks’ shocking resignation 3/28 raises an unexpected challenge to HHS secretary and vaccine skeptic Robert F. Kennedy Jr.’s fitness for office, for coercing it amid the morale-destroying consequences that President Trump’s mass firings are generating inside the agency and
Drugs
Corcept Therapeutics is announcing promising results from its pivotal Phase 3 ROSELLA trial, demonstrating that relacorilant in combination with nab-paclitaxel significantly improves progression-free survival (PFS) in patients with platinum-resistant ovarian cancer. In meeting the trial’s primary endpoint, relacorilant was shown to reduce the risk of disease
Devices
Medtronic is recalling (Class 1) its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device. “The loose material has the potential to become dislodged and cause serious patient adverse health consequences, including injuries caused by delayed therapy, stroke, and death,
Biologics
In a move that may assuage vaccine makers regarding HHS’s potential interference in vaccine reviews and approvals, Bavarian Nordic just gained FDA approval 3/31 for its freeze-dried formulation of Jynneos (smallpox and mpox vaccine, live, non-replicating) for preventing smallpox and mpox [monkeypox] disease in adults 18
Drugs
FDA has issued Milestone Pharmaceuticals a complete response letter on its NDA for Cardamyst (etripamil) nasal spray and its use to convert acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. PSVT is described as a sudden, rapid, and irregular heartbeat (arrhythmia) that originates in the upper
Devices
FDA has granted Visby Medical a de novo marketing clearance for its Women’s Sexual Health Test, a non-prescription at-home diagnostic test for chlamydia, gonorrhea and trichomoniasis. The single-use device includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to
Drugs
FDA is rescheduling a previously planned joint meeting of its Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee. Panel members are scheduled to discuss the findings of completed postmarketing epidemiologic studies that examined the serious risks and predictors of misuse, abuse, addiction, and
Drugs
FDA has approved a Novartis supplemental NDA to expand the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include adults with prostate-specific membrane antigen(PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are delaying taxane-based
Drugs
FDA is notifying NDA and ANDA holders about data integrity and study conduct concerns with bioequivalence studies conducted at contract research organization (CRO) Raptim, which is based in Navi Mumbai, India. An agency notice says that in vitro studies conducted by Raptim are not acceptable, and if any studies were
Drugs
FDA has accepted for review a Liquidia NDA resubmission for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The agency confirmed that the resubmission was a complete Class 1 response to an 8/2024 action letter, which granted