Drugs
FDA has approved an Arcutis Biotherapeutics supplemental NDA to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, in children aged six to 11 years. Previously, Zoryve was approved for the same indication in people aged 12 years and older.
Drugs
Syndax Pharmaceuticals says new positive data warrants stopping the pivotal AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia. The decision to stop the trial is based on a recommendation from
Drugs
Amplifying the Reagan-Udall Foundation’s just-released report on misinformation, FDA commissioner Robert Califf has outlined a daunting task the agency faces to combat misinformation that is proliferating due to the “power of the Internet, the digitization of our world, and the preponderance of what is commonly referred to
Drugs
FDA has accepted for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2 for treating adults with moderate to severe alopecia areata. The submission is based on data from two pivotal Phase 3 trials (THRIVE-AA1 and THRIVE-AA2), which
Drugs
FDA’s Oncologic Drugs Advisory Committee 10/5 voted 10 to 2 that the CodeBreak 200 confirmatory study, with its progression-free survival primary endpoint, cannot be reliably interpreted as the basis for Amgen’s request to have Lumakras’s (sotorasib) 5/28/21 accelerated approval converted to a full
Drugs
FDA has placed a partial clinical hold on the Innate Pharma lacutamab IND, leading to a pause in patient enrollment in the company’s Phase 2 TELLOMAK and Phase 1b PTCL trials in cutaneous and peripheral T-cell lymphoma. A company statement says the hold follows one fatal case of
Drugs
FDA has granted Invitae a de novo market authorization for its Common Hereditary Cancers Panel for identifying germline variants associated with hereditary cancer. The in vitro diagnostic test focuses on 47 genes already known to contain tens of thousands of genetic variants that increase risk of developing certain cancers, the
Drugs
A Pharmaceutical Cargo Security Coalition alert to drug supply chain members says FDA is looking into fraudulent schemes that appear to be trafficking counterfeit versions of Novo Nordisk’s diabetes drug Ozempic (semaglutide) which is being widely used off-label for weight loss. CBS News says the agency’s action
Drugs
CDER says its NextGen Portal began accepting Over-the-Counter Monograph Order Requests (OMORs) beginning 10/1. The portal allows users to report information to FDA, including certain OTC monograph drug submissions. and submit requests for formal meetings with reviewers and materials related to such meetings. “Before submitting an OMOR,
Drugs
AstraZeneca has submitted both general and specific comments on an FDA draft guidance on QTc information in human prescription drug and biological product labeling. The company’s general comments were: * the guidance does not define what the agency considers to be clinically relevant QTc interval prolongation; * additional guidance is needed
Biologics
The Reagan-Udall Foundation has published Strategies for Improving Public Understanding of FDA-Regulated Products, providing observations, potential strategies, and illustrative tactics for FDA to consider. A foundation announcement (contains links to the report and a virtual public meeting discussing the findings) says the strategies result from the foundation’s
Drugs
FDA has published a draft guidance, Stimulant Use Disorders: Developing Drugs for Treatment, to assist sponsors in developing such treatments. An agency online notice (contains a link to the guidance) says that when it is finalized, the document will be the first to provide FDA’s current thinking on the
Drugs
FDA has granted Noxopharm an Orphan Drug Designation for CRO-67, a drug candidate for treating pancreatic cancer. The designation was based on data that showed that CRO-67 killed tumor cells as well as barrier cells in samples taken from patients who had their tumors surgically removed. The company
Drugs
FDA researchers who conducted a review and meta-analysis of safety outcomes when switching between biosimilars and reference biologics report no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or biosimilar. “The results demonstrate that the incidence
Drugs
A 1/9-1/23 FDA Bioresearch Monitoring Program inspection at a clinical site maintained by Dr. Luis Pena-Hernandez in Atlantis, FL, found objectionable conditions in which Pena-Hernandez did not adhere to the applicable statutory requirements and regulations governing the conduct of clinical investigations and the protection of
Drugs
Biomic Sciences is recalling all lots of ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray products after FDA-conducted testing raised microbial contamination concerns. The contaminants have been identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., and Paenibacillus sp. The products are used as a nasal rinse and
Drugs
A 9/12/22-9/24/22 FDA inspection at the Fresenius Kabi Fenwal International unit in Maricao, PR, found significant deviations from current good manufacturing practice (CGMP) requirements in the manufacture of the firm’s blood pack units with and without in-line leukoreduction filters, Alyx component solutions, Amicus
Drugs
KVK-Tech has recalled one lot (batch number 17853A) of betaxolol tablets as a precautionary measure after a single oxycodone HCl tablet was found on the packaging line during the line clearance after the subject batch was packaged. The company has not received any reports of different tablets in any
Drugs
FDA commissioner Robert Califf says the agency will be increasing a mix of announced and unannounced drug company inspections in India. Califf was interviewed on CNBC-TV18’s The Medicine Box while on his first official visit to the country. Asked about the largest challenge facing India, he said expectations
Drugs
FDA medical reviewers are questioning the validity of the CodeBreak 200 post-marketing study of Amgen’s Lumakras (sotorasib) that is the basis of the company’s request to have the drug’s 5/28/21 accelerated approval converted to a full approval. A briefing document distributed in advance of
Drugs
AdvaMedDx says an FDA 6/22 guidance on a pilot program for oncology drug products used with certain in vitro tests would have benefited from advance notice and opportunity to comment. The association’s 9/28 comment letter says FDA issued the pilot as an immediately-in-effect guidance, thus
Drugs
Pfizer’s Hospira drug unit is recalling several drug lots of 4.2% sodium bicarbonate injection, USP, 5 mEq/10mL vial; 1% lidocaine HCl injection, USP, 50 mg/5mL vial; and 2% lidocaine HCl injection, USP, 100 mg/5mL vial due to the potential presence of glass particulate matter. “There