Drugs
Eisai and Biogen say that Eisai has initiated a rolling submission BLA for lecanemab-irmb (Eisai/Biogen’s Leqembi) subcutaneous autoinjector for weekly maintenance dosing. Leqembi is indicated for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of the disease (known as early Alzheimer’
Drugs
Parenteral Technologies is petitioning FDA to “publish a statement of enforcement expressly prohibiting the further use of misleading, confusing, and inadequate directions for over-the-counter single-ingredient liquid acetaminophen products for 2-3 years of age, 24-35 pound infants.” The petition calls for the removal and no further
Drugs
FDA has extended by three months its review of an Ascendis Pharma NDA due to the company’s submission of additional information requested by the agency for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism. Because the late cycle submission constituted a major amendment, FDA has now extended the review action
Drugs
An 11/20-11/22/2023 FDA inspection at the Grupo Quimico SRL contract testing laboratory in Montevideo, Uruguay, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/30 Warning Letter says the specific violations were: * failing to ensure that laboratory records
Drugs
FDA has cleared a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respiratory infections and covers 21 viral and bacterial targets. It was previously authorized under an emergency use authorization as the QIAstat-Dx Respiratory SARS-CoV-2 Panel. “The
Drugs
A 10/30-11/20/2023 FDA inspection at Westwood Laboratories in Azusa, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/17 Warning Letter says the four specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure of
Drugs
United Therapeutics is asking FDA to withdraw its tentative approval of a Liquidia Technologies NDA for Yutrepia (treprostinil) and issue a complete response letter for the application. The 5/10 petition says that LGM Pharma, which United says is Liquidia’s sole active pharmaceutical ingredient (API) supplier, is the subject
Drugs
A California federal court has dismissed with prejudice a putative shareholders’ class action suit against AcelRx Pharms alleging that the company made false or misleading statements in marketing materials for its opioid pain killer Dsuvia (sufentanil) sublingual tablets to expand the target market, putting the company at risk for FDA
Drugs
FDA has approved a Baxter expanded indication for Clinolipid (lipid injectable emulsion) for use in pediatric patients, including preterm and term neonates. The proprietary mixed oil lipid emulsion is used to provide calories and essential fatty acids in parenteral (intravenous) nutrition when oral or enteral nutrition is not possible, insufficient
Drugs
Novo Nordisk says it will seek FDA approval by the end of the year for Mim8, its next-generation Factor 8a mimetic bispecific antibody that is intended to deliver sustained hemostasis for once-weekly or once-monthly prophylaxis for hemophilia A patients, with and without inhibitors. “Administered subcutaneously, Mim8 bridges
Drugs
FDA has granted Merus a breakthrough therapy designation for petosemtamab for treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following treatment with platinum-based chemotherapy and an anti-programmed cell death receptor-1 or anti-programmed death ligand 1 antibody. The
Drugs
FDA has issued Eugia Pharma Specialties (an Aurobindo subsidiary) a seven-item Form-483 following a 5/3-concluded inspection at its sterile drug manufacturing facility in Rajasthan, India. The agency says the company’s procedures designed to prevent microbiological contamination of drug products are not followed, and they do
Drugs
FDA has accepted for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The agency has set a user fee review action target date of
Drugs
FDA has granted SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer (SCLC). The drug was previously granted orphan drug status for SCLC and pancreatic cancer 7/23 and February of this year, respectively. The company says the drug, an
Drugs
FDA has granted Novartis a breakthrough therapy designation for Scemblix (asciminib) for treating adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Novartis says the designation was based on positive data from the Phase 3 ASC4FIRST study, in which Scemblix met both primary endpoints with
Drugs
RAPT Therapeutics has decided to close and unblind two Phase 2 trials of zelnecirnon (RPT193) following FDA clinical holds due to a serious adverse event reported in February. The Phase 2b trial of zelnecirnon (RPT193) in atopic dermatitis and a Phase 2a trial in asthma were halted by FDA after
Drugs
The Biotechnology Innovation Organization (BIO) says FDA should consider including greater discussion on the rationale for its draft guidance on the collection of race and ethnicity data in clinical trials and clinical studies for FDA-regulated medical products. In a comment letter, it says the discussion should include the consequences,
Drugs
FDA commissioner Robert Califf told a Senate Appropriations Committee hearing 5/8 that the agency is advising against enriched enrollment studies for opioid products going forward. Califf had been asked by Senator Joe Manchin (D-WV) what the agency’s position is following a 4/2023 advisory committee meeting that
Drugs
CDER director Patrizia Cavazzoni says the reorganization of FDA’s Office of Regulatory Affairs regarding inspection activities will create a “unified compliance discipline and program that will reside within the Center and work hand in hand with the Office of Regulatory Affairs and the inspectorate.” Providing an online update to
Drugs
FDA has granted Avidity Biosciences a breakthrough therapy designation for delpacibart etedesiran (AOC 1001) and its use in treating myotonic dystrophy Type 1 (DM1). The investigational treatment is “designed to address the root cause of DM1, an underrecognized, progressive and often fatal neuromuscular disease with no approved therapies,” the company
Biologics
As directed by a presidential Executive Order, FDA, EPA and the Department of Agriculture have developed a joint regulatory plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. An FDA statement (includes a link to the plan) says the plan “incorporates processes and timelines
Drugs
FDA has responded to a Kaiser Permanente petition submitted more than 14 years ago (12/2009) asking the agency to revise its standards, procedures, and guidelines for developing, implementing, and evaluating risk evaluation and mitigation strategies (REMS). The FDA response says Kaiser specifically asked the agency to: * increase the transparency