Drugs
FDA says it has ordered testosterone product makers to change their drug labeling to remove a warning about risk of adverse cardiovascular outcomes in men using them for hypogonadism. An agency notice says the warning can be removed based on findings from the Testosterone Replacement Therapy for Assessment of Long-
Drugs
Zevra Therapeutics says it has signed an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million. The proceeds are intended to support the commercial launches of Miplyffa And Olpruva, and “advancing our pipeline of product candidates to address unmet needs within the rare disease community,
Drugs
Praxis Precision Medicines says it will continue a clinical trial despite an interim analysis that recommended Study 1 of the Essential3 program evaluating ulixacaltamide in essential tremor be stopped for futility because it is unlikely to meet the primary efficacy endpoint under the parameters set by its statistical model. An
Drugs
FDA has sent a Warning Letter to Granules about its finished dosages and pharmaceutical formulation intermediates manufacturing facility in Gagillapur, near Hyderabad, India. The Hindu reports that the Warning Letter follows an 8/29-9/6/2024 agency inspection that resulted in six observations on a form FDA-483. The
Drugs
The Senate Health Education Labor & Pensions committee has announced a 3/6 confirmation hearing to review the nomination of Johns Hopkins surgeon and public policy researcher Marty Makary (see earlier story) as the next FDA commissioner. Makary was selected to correct FDA’s course, according to president Trump, who
Drugs
FDA has released the form FDA-483 issued following an 11/12-11/20/2024 inspection at the Zhejiang Huahai Pharmaceutical Co. active pharmaceutical ingredient (API) manufacturing facility in Linhai, Taizhou Zhejiang, China. The seven inspection observations were: * failure of laboratory records to include complete test data derived from all
Drugs
FDA has granted fast-track designation for Adicet Bio’s ADI-001 for the potential treatment of adults with systemic sclerosis. ADT-001 is described as an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy targeting CD20 to treat autoimmune diseases. FDA has granted it fast-track
Drugs
FDA has released the 19-page form FDA-483 issued following an 11/4-11/15/2024 inspection at Exela Pharma Sciences, a Lenoir, NC, outsourcing and sterile drug manufacturing facility. The form’s 15 inspection observations were: * failure of written records of investigations into unexplained discrepancies to always include
Drugs
FDA has cleared a Visby Medical 510(k) for its point-of-care respiratory health test. The Visby Medical Respiratory Health Test is described as a rapid polymerase chain reaction test that detects and differentiates between upper respiratory infections caused by influenza A & B, and SARS-CoV-2 (Covid-
Drugs
FDA has released the form FDA-483 issued following a 2/11-2/17 inspection at the Piramal Pharma Limited API (active pharmaceutical ingredient) manufacturing facility in Navi Mumbai, Maharashtra, India. The six inspection observations were: * failure to have in writing and fully follow the responsibilities and procedures applicable to
Drugs
FDA has released the form FDA-483 issued following a 7/16-7/26/2024 inspection at the Indoco Remedies sterile and non-sterile drug manufacturing facility in Vasco Da Gama, Goa, India. The seven inspection observations were: * procedures describing the handling of written and oral complaints related to drug
Drugs
AstraZeneca says data from interim analysis of its SERENA-6 Phase 3 trial showed that camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) “demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS)” in
Drugs
FDA has cleared a Google 510(k) for its Loss of Pulse Detection feature and its use on the Pixel Watch 3. The feature can detect when someone wearing the watch has experienced a loss of pulse (the heart stops beating due to primary cardiac arrest, respiratory or circulatory failure,
Drugs
CDER acting director Jacqueline Corrigan-Curay says that in FY 2024, the Center “continued its robust efforts to ensure that safe and effective prescription and nonprescription medications are available to improve the health of people in the United States.” In the Center’s 10th yearly drug safety report, she particularly
Drugs
One in six oncology patients in Phase 2 clinical trials receive treatments that are eventually approved by FDA, two Canadian researchers write in the Journal of the National Cancer Institute, adding that this represents a higher therapeutic value than Phase 1 trials. The researchers say the proportion improved to one
Drugs
FDA has accepted for review a Regeneron Pharmaceuticals BLA resubmission for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The agency has set a review action target date of 7/30. “Acceptance of the BLA resubmission follows the achievement of an
Drugs
GenBioPro, which manufactures a generic form of the abortion medication mifepristone, has petitioned a Texas federal court to be added to the defendants in the first legal fight over the procedure since Donald Trump became president again. The Hill reports that Missouri et. al. v FDA is a revamped version
Drugs
A California federal court has held that the FDA monograph covering therapeutic over-the-counter shampoo products preempts state law putative class action claims about disclosures, warnings, and the product’s safety and efficacy. The case involved a shampoo containing the active ingredient coal tar, a component of which is
Biologics
Two stakeholders have submitted specific, line-by-line, technical comments on an FDA draft guidance on protocol deviations for clinical investigations of drugs, biological products, and devices. The comments were submitted by Labcorp and AstraZeneca.
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment. The submission also seeks approval for its continued adjuvant use in combination with standard-of-care radiotherapy with or
Drugs
FDA has removed a risk evaluation and mitigation strategies (REMS) program for clozapine, which required healthcare professionals to report results of absolute neutrophil count (ANC) blood tests before pharmacies dispense the drug. The decision to remove the REMS is in line with an 11/20/2024 joint meeting of the
Drugs
FDA has released the form FDA-483 issued following a 5/30-6/7/2024 inspection at the AstraZeneca drug manufacturing facility in Frederick, MD. The four inspection observations were: * drug substance upstream manufacturing systems have unmitigated risk in the assurance of process performance and product quality; * procedures in support