Search Results for “FDA” – Page 6 – media

Johnson & Johnson Submits Supplemental New Drug Application to FDA for Spravato as Monotherapy for Adults with Treatment-Resistant Depression

By Don Tracy, Associate Editor Approval of Spravato would mark the first monotherapy to be available on the market for treatment-resistant depression in the United States.Johnson & Johnson (J&J) has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Spravato (esketamine) as the first and only monotherapy for the treatment of treatment-resistant depression (TRD). According to the company, the sDNA is supported by encouraging data from the Phase IV TRD4005 trial, which evaluated the efficacy, safety, and tolerability of Spravato as a monotherapy. “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Bill Martin, PhD, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine, in a press release. “We’re pleased to build on the more than a ...
- Source: drugdu
- 95
- July 24, 2024
US FDA grants priority review for Pierre Fabre’s EBV+ PTLD

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for Pierre Fabre Pharmaceuticals’ Tabelecleucel (Tab-cel) to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). Tabelecleucel is being developed as a monotherapy for EBV+ PTLD treatment in adult and paediatric patients aged two years and above who have undergone a minimum of one previous therapy. It is an allogeneic, EBV-specific T-cell immunotherapy and acts on EBV-infected cells. The company’s BLA is supported by the outcomes of 430 subjects who received Tab-cel. For patients who have received solid organ transplants, previous therapy typically includes chemotherapy, except in cases where this is deemed inappropriate. No FDA-approved therapies are currently available for this treatment setting. A decision by the US regulator under the Prescription Drug User Fee Act (PDUFA) is anticipated by 15 January 2025. In November 2023, Pierre Fabre Laboratories obtained marketing rights to ...
- Source: drugdu
- 83
- July 22, 2024
FDA Clears Positrigo’s NeuroLF Brain PET System for the Diagnosis of Multiple Brain Disorders

By Don Tracy, Associate Editor Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.The FDA has granted clearance to Positrigo’s NeuroLF brain positron emission tomographic (PET) system, which the company said represents a major advancement in functional brain imaging. The device is designed to diagnose and monitor brain disorders such as Alzheimer disease, brain tumors, epilepsy, and Parkinson disease. As the company’s first brain PET system approved in the United States, Positrigo is currently preparing for global market expansion, with European regulatory approval anticipated later this year.1 “It is not the first device of its kind which receives market clearance in the US, but we believe that our patient-centric and customer-driven design and development efforts over the last couple of years, brought us into the pole position to offer the best imaging solution to address the increased demand ...
- Source: drugdu
- 83
- July 20, 2024
FDA launches new rare disease innovation hub

Anew rare disease innovation hub set up by the US Food and Drug Administration (FDA) aims to expedite the development and approval of orphan drugs. Rare disease clinical trials can be tricky to navigate, especially for conditions with very few patients. Moreover, even after clinical success, some therapies for rare diseases have been dropped by companies due to the high development costs. The FDA’s hub will act as a central point of connection and engagement with the rare disease community, aiding the navigation of FDA-related concerns. It will enhance inter-centre collaboration on scientific, clinical, and policy issues in rare disease product development, said the agency. It also aims to advance novel endpoints, biomarkers, trial designs, real-world evidence, and statistical methods. The hub will be co-led by Dr. Patrizia Cavazzoni, director at the Center for Drug Evaluation and Research (CDER), and Dr. Peter Marks, director at the Center for Biologics Evaluation ...
- Source: drugdu
- 89
- July 20, 2024
FDA Grants Fast Track Designation to Abdera Therapeutics’ Treatment for Extensive-Stage Small Cell Lung Cancer

By Don Tracy, Associate Editor The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors. The FDA has granted Fast Track Designation to Abdera Therapeutics’ ABD-147, a next-generation precision radiopharmaceutical therapy designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed following platinum-based chemotherapy. According to the company, ABD-147 implements advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, which is a protein commonly found on neuroendocrine tumors but rarely expressed on the surface of normal cells or tissues.1 “Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” said Lori Lyons-Williams, president, CEO, Abdera Therapeutics, in a press release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are ...
- Source: drugdu
- 107
- July 19, 2024
FDA Grants Fast Track Designation to Sumitomo Pharma’s Novel Treatment for Patients with Relapsed or Refractory Acute Myeloid Leukemia

By Don Tracy, Associate Editor DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability. Image Credit: Adobe Stock Images/Pichitchai The FDA has granted Fast Track Designation to Sumitomo Pharma America’s DSP-5336, an investigational small molecule inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement (MLLr) or nucleophosmin mutation (NPM1m). According to the company, DSP-5336 targets the menin and mixed-lineage leukemia (MLL) protein interaction, which is considered vital in a variety of biological processes, including cell growth and genomic stability.1 “For patients and families facing a diagnosis of relapsed or refractory acute myeloid leukemia, significant unmet medical needs remain—and we share in their urgency to identify and advance new treatment pathways,” said Tsutomu Nakagawa, PhD, president, CEO, SMPA, in a press release. “We are encouraged by FDA’s decision and look forward to working closely ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 86
- July 17, 2024
FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
- Source: drugdu
- 97
- July 16, 2024
After AdCom rejection, FDA rebuffs Novo Nordisk’s once-weekly insulin

The US Food and Drug Administration (FDA) has rejected the biologics licence application (BLA) for Novo Nordisk’s once-weekly insulin icodec for the treatment of diabetes mellitus. The company did not disclose the details of the complete response letter (CRL) issued by the FDA. But did share that the CRL outlined concerns related to the “manufacturing process and the type 1 diabetes (T1D) indication”. Novo Nordisk also added that the company did not expect to fulfil the requests detailed in the CRL by the end of this year, and consequently will not be refiling the BLA for insulin icodec until next year, at the earliest. The BLA rejection news comes two months after the FDA Endocrinologic and Metabolic Drugs Advisory Committee (AdCom) voted against the approval of insulin icodec for T1D. In a 7-4 vote, the panel found that insulin icodec’s benefits do not outweigh its risks, especially the elevated risk ...
- Source: drugdu
- 93
- July 13, 2024
FDA Approves Arcutis Biotherapeutics’ Zoryve to Treat Patients with Mild to Moderate Atopic Dermatitis

By Don Tracy, Associate Editor Zoryve is a steroid-free, once-daily treatment shown to offer rapid disease clearance and significant itch reduction for patients with mild to moderate atopic dermatitis. The FDA has approved Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.15% for mild to moderate atopic dermatitis (AD) in adults and children over six years of age. According to the company, the treatment is steroid-free and moves quickly to clear the disease, resulting in significant itch reduction. The approval was based on results from three Phase III studies, a Phase II dose-ranging study, and two Phase I pharmacokinetic studies.1 “The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics, vice chair, department of dermatology, UC San Diego School of Medicine, INTEGUMENT study ...
- Source: drugdu
- 73
- July 12, 2024
Arcutis bags FDA approval for atopic dermatitis cream after delay

Arcutis has won its third US Food and Drug Administration (FDA) approval for Zoryve (roflumilast) cream in two years, with the latest indication meant for adults and some children with atopic dermatitis. The FDA has approved the once-daily topical cream for mild to moderate atopic dermatitis in patients aged six years and older. Zoryve, a phosphodiesterase-4 (PDE4) inhibitor, was approved as a cream in July 2022 for the treatment of plaque psoriasis for patients aged 12 and older, and October 2023 for children aged 6-11 with psoriasis. The initial date for the label expansion in atopic dermatitis was set for 7 June 2024, but the decision was delayed by several days, with Arcutis releasing a statement on 9 June saying there had been no request for new information from the regulator at the time. The approval is supported by positive data from three Phase III studies, a Phase II dose-ranging ...
- Source: drugdu
- 68
- July 12, 2024

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