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
Devices
FDA has cleared an Abanza 510(k) for its WasherCap Mini fixation system for soft tissue repair, including meniscal root repair and anterior cruciate ligament reconstruction. “The WasherCap Mini is the first suture and tape fixation device that offers surgeons a knotless, bidirectionally tension-adjustable solution — regardless of bone quality,
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
FDA Policy/General
Just as the dust is barely settled from recent firings of about 1,000 FDA probationary staff and the subsequent rehiring of 200 CDRH reviewers, the Trump administration issues a memo asking agencies like FDA to “undertake preparations to initiate large-scale reductions in force (RIFs), consistent with applicable law.
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
FDA has released the form FDA-483 issued following an 11/11-11/19/2024 inspection at the firm’s vaccine manufacturing facility in Incheon, South Korea. The form’s specific inspection observations were: * failure to have in writing and/or follow responsibilities and procedures for quality units to ensure
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.
Biologics
FDA has accepted for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy for treating adults with recurrent respiratory papillomatosis (RRP). PRGN-2012 is designed to “elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11,” the company says.
Biologics
A 6/7-6/12/2024 FDA inspection at Sperm Bank, Inc., doing business as Fertility Center of California in San Diego, CA, documented significant deviations from regulations for human cells, tissues, and cellular and tissue-based products. A 2/14 Warning Letter says specific deviations of concern were: * failure
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
Drugs
Emalex Biosciences says its lead candidate drug ecopipam, a novel dopamine-1 receptor antagonist, met its primary and secondary endpoints in a Phase 3 Tourette syndrome study. Company officials say they plan to meet with FDA to discuss submitting an NDA later this year for ecopipam to treat patients with
Devices
FDA has cleared Tandem Diabetes Care’s next-generation automated insulin delivery algorithm, Control-IQ+ technology (Control-IQ+), for use in people with Type 2 diabetes ages 18 and older. The technology was previously 510(k) cleared for use in Type 1 diabetes. The Type 2 version includes enhancements to
Drugs
Ascent Consumer Products is recalling one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System following a confirmed test result of microbial contamination involving Staphylococcus aureus (S. aureus). “Use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System contaminated with S. aureus can result in blood infections