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
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
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
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
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
Drugs
FDA has issued a complete response letter for Zealand Pharma’s dasiglucagon, intended to prevent and treat low blood sugar in children with congenital hyperinsulinism. The Danish drug company says FDA found deficiencies at the firm’s third-party manufacturing facility that are not specific to dasiglucagon. There were no
Drugs
FDA has approved a label update for Kite’s Yescarta (axicabtangene ciloleucel) to include the overall survival primary analysis from the landmark Phase 3 Zuma-7 study that showed a statistically significant improvement for Yescarta in overall survival versus standard of care as second-line treatment with curative intent for
Drugs
FDA says Wipro Unza Singapore Private, Limited, in Winsland House II, Singapore, which is registered with the agency as a manufacturer of over-the-counter drug products, failed to respond to FDA requests for records. A 12/21/2023 Warning Letter says the company failed to respond to two requests
Drugs
FDA has approved Ionis Pharmaceuticals/AstraZeneca’s Wainua (eplontersen) to treat adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis. An Ionis news release says the approval was based on the Phase 3 NEURO-TTRansform trial that showed Wainua demonstrated consistent and sustained benefit halting neuropathy disease progression and improving neuropathy
Drugs
FDA says its review of records submitted by Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi in Avcilar/Istanbul, Turkey, a registered manufacturer of over-the-counter drugs, found significant violations of current good manufacturing practice (CGMP) regulations. A just-released 11/13/2023 Warning Letter says the specific
Drugs
FDA says a 12/5-12/16/2023 Bioresearch Monitoring Program inspection at Siyan Clinical Research, maintained by Anish Shah in Santa Rosa, CA, found objectionable conditions. A 12/12/2023 Warning Letter says Shah failed to ensure that the redacted investigation was conducted according to the investigational plan. “While
Drugs
FDA commissioner Robert Califf says the agency “is already capable of reviewing submissions that include or rely entirely on RWD (real-world data). Enabling advanced data analytics, including RWD, is also incorporated in FDA’s information technology strategy for 2024-2027.” Writing in an FDA Voices Catching Up with Califf
Drugs
FDA has published a guidance, Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drugs and Biological Products, with information about (1) a registry’s fitness for use in regulatory decision-making, focusing on registry attributes that support the collection of relevant and reliable data, (2) linking a
Drugs
FDA has published a guidance, Rare Diseases: Considerations for the Development of Drugs and Biological Products, to assist sponsors in conducting efficient and successful development programs for drugs to treat rare diseases. The document notes that while the statutory requirements for marketing approval for drugs to treat rare and common
Drugs
FDA has published a draft guidance, Master Protocols for Drug and Biological Product Development, with recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submitting documentation to support regulatory review. The document says its primary focus is on randomized umbrella and
Drugs
FDA says it is requiring labeling updates intended to reduce the risk of severe chemical irritation and damage to tissues from intravenous administration of promethazine HCl injection. An agency notice says the injection is indicated to help manage certain allergic reactions, motion sickness, post-operative nausea, and vomiting, and as
Drugs
FDA says a review of business records and other information on Patco Cosmetics in Mumbai, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished over-the-counter drugs. A just-released 12/15 Warning Letter says the specific violations were: * failing to conduct at least
Drugs
FDA says it is investigating counterfeit copies of Novo Nordisk’s Ozempic (semaglutide) injection 1 mg in the U.S. drug supply chain and has seized thousands of units of the product. An agency announcement says FDA and the company are testing the seized products and do not yet have