Drugs
An FDA report on new safety signals seen in the FDA Adverse Event Reporting System between 7/2023 and 9/2023 includes reports of hair loss, aspiration, and suicidal ideation in some people using the popular GLP-1 receptor agonists like Novo Nordisk’s Ozempic (semaglutide), Wegovy (semaglutide), and Rybelsus
Devices
FDA has cleared a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner. The device offers the “strongest-ever gradient system for a clinically released whole-body MR scanner, making smaller structures in the body visible,” according to the company. It
Drugs
FDA has lifted a partial clinical hold placed on Innate Pharma's Phase 2 TELLOMAK and Phase 1b PTCL trials of lacutamab in cutaneous and peripheral T-cell lymphoma. The hold was ordered 10/2023 following one fatal case of hemophagocytic lymphohistiocytosis (see story). The company now says the
Drugs
FDA should consolidate its recent draft guidance on “Remote Interactive Evaluations (RIE) of Drug Manufacturing and Bioresearch Monitoring Facilities” with similar draft guidances due to an overlap in content and to minimize confusion. In comments submitted to FDA, Pharmaceutical Research and Manufacturers of America (PhRMA) says the RIE guidance should
Drugs
The International Council for Harmonization (ICH) says the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted 12/14/2023 the ICH Q5A(R2) Guideline on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin to take effect 6/14. An
Drugs
An Eagle Hill consultants’ report says FDA has significant opportunities to benefit from further adoption of computer cloud technology if the agency can overcome obstacles identified in the report. The report was produced as part of an agency commitment in PDUFA 7 to “leverage cloud technology to progress regulatory digital
Drugs
The FDA Oncology Center of Excellence (OCE) is taking steps to encourage simplification of cancer clinical trials. Writing in a Comment in Lancet Oncology, researchers with the CDER Office of Oncologic Diseases and OCE say they want “the oncology drug development community to work to find opportunities to bring simplicity
Drugs
A retrospective study conducted by researchers from the FDA Oncology Center of Excellence and the National Institutes of Health found that overall, the representation of participants of racial and ethnic minority groups in studies supporting pediatric exclusivity requests appears to be comparable to the racial distribution of childhood cancers in
Drugs
FDA has granted Geneseeq a breakthrough device designation for its multi-cancer early detection device, CanScan. The device uses “low-depth whole-genome sequencing” on circulating cell-free DNA (cfDNA) from a single peripheral blood draw to extract “genetic and fragmentomic features to detect early cancer signals with 99% specificity
FDA Policy/General
Public Citizen says Dr. Sidney Wolfe, the founder of the Health Research Group in 1971, which later that year became part of Public Citizen, died 1/1 at the age of 86. “Sid invented a new approach of research-based advocacy to get dangerous drugs and devices off the market,
Drugs
FDA has released the form FDA-483 issued following a 12/4-12/8/2023 inspection at the Dr. Reddy’s Laboratories drug testing establishment in Telangana, India. The three inspection observations were: * laboratory records are deficient in that they do not include a complete record of all data obtained
Devices
FDA is updating an ongoing safety alert about reports of elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals from neonatal incubators. The agency says it has determined that new neonatal incubators by Drager (also known as Draeger) do not need to be run for a week before clinical use.
Drugs
Agios Pharmaceuticals says the Phase 3 ENERGIZE study of Pyrukynd (mitapivat) in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia achieved its primary endpoint of hemoglobin response. “Statistical significance was also achieved for both key secondary endpoints associated with change from baseline in FACIT-Fatigue Score and hemoglobin
Drugs
FDA approval of novel drugs was up about 50% in 2023 over 2022, keeping pace with historical levels. An agency announcement lists 55 new drugs and biologics approved in 2023. Some of these products have never been used in clinical practice, FDA says. The listing does not contain vaccines, allergenic
Biologics
FDA has issued a “ Draft Report and Plan on Best Practices for Guidance.” In the document, the agency identifies the best practices for the efficient prioritization, development, review, clearance, issuance, and use of guidance documents. The agency says it is also considering opportunities to further improve its guidance development and
FDA Policy/General
The U.S. House Energy and Commerce Committee’s Republican leadership is investigating FDA’s handling of internal scientific disagreements related to regulatory decisions. In a 1/3 letter to agency commissioner Robert Califf, Committee leaders took issue with the 2021 departure of CBER Office of Vaccines Research and Review
Drugs
FDA has released the form FDA-483 issued following a 12/4-12/12/2023 inspection at Laurus Synthesis Private Limited in Andhra Pradesh, India. The five inspection observations were: * failing to adequately investigate unexpected occurrences; * sampling plans for intermediates are inadequate; * failing to maintain, clean, and store equipment in
Drugs
FDA has released the form FDA-483 with five inspection observations that was issued to Torrent Pharmaceuticals following a 12/5-12/11/2023 at its drug manufacturing facility in Gujarat, India. The five inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch
Drugs
Public Citizen is calling on FDA to change its plan to research the misuse of pharmaceutical products and other substances through an agency-funded program that may use the Researched Abuse, Diversion and Addiction-Related Surveillance program (RADARS). The Public Citizen comment letter asks the agency to clarify who its
Devices
FDA is alerting healthcare providers to not purchase or implant Synovo’s Total Hip System because modifications to the original device design were not cleared by the agency. “Three components of the system, the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, have been significantly modified from
Biologics
Invivyd says it is seeking FDA emergency use authorization for VYD222, which is described as a “broadly neutralizing, half-life extended monoclonal antibody candidate for the pre-exposure prevention of Covid-19 in immunocompromised adults and adolescents.” The submission is based on “positive initial results” from the CANOPY Phase 3
Drugs
FDA has approved an Arcutis Biotherapeutics’ NDA for Zoryve (roflumilast) topical foam, 0.3%, to treat seborrheic dermatitis in individuals age nine and older. A company statement says Zoryve foam provides rapid disease clearance and a significant reduction in itch. The company says it is a once-daily steroid-free