Search Results for “FDA” – Page 8 – media

FDA Approves Verona’s Ohtuvayre for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease

Don Tracy, Associate Editor Ohtuvayre is the first inhaled product with a novel mechanism of action for chronic obstructive pulmonary disease to be approved in 20 years. The FDA has approved Verona Pharma’s Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Classified as a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), the treatment combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. According to the company, this marks the first time in 20 years that an inhaled product with a novel mechanism of action has been approved for COPD maintenance.1 “The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” said David Zaccardelli, PharmD, president, CEO, Verona Pharma, in a press release. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre ...
- Source: drugdu
- 69
- July 2, 2024
FDA shares draft guidance on clinical trial diversity action plans

Dive Brief The Food and Drug Administration published draft guidance on Wednesday for diversity action plans intended to increase enrollment of underrepresented groups in clinical trials. A year-and-a-half after Congress passed legislation requiring clinical trial diversity action plans, the agency explained which device trials must meet the requirements and presented a timeline for implementation. The draft is open for feedback for 90 days, giving sponsors a chance to comment on the FDA’s interpretation of legal requirements such as the need to share enrollment goals in the plans. Dive Insight Congress passed a law in 2022 that would require drug- and device-makers to submit diversity action plans to the FDA. Per the law, the FDA was required to publish draft guidance clarifying the format and content of the diversity action plans by Dec. 29, 2023. In the draft, the FDA says that, while the Act “refers to clinical studies broadly,” it ...
- Source: drugdu
- 107
- July 1, 2024
Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy

The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is an inhaled dual inhibitor of phosphodiesterase 3 and phosphodiesterase 4 enzymes and has bronchodilator and non-steroidal anti-inflammatory effects. Verona plans to launch the therapy in Q3 this year. “With substantial funding of up to $650m secured, Verona Pharma is well-positioned to distribute Ohtuvayre in the US, ensuring its availability even beyond 2026,” said Asiyah Nawab, Pharma Analyst at GlobalData. The Ohtuvayre approval was based on the positive results from Phase III ENHANCE-1 and ENHANCE-2 trials (NCT04535986 and NCT04542057). The data from the pooled analysis of the studies showed significant improvements in the symptoms of COPD exacerbations, including dyspnea, breathlessness, cough, sputum, and chest symptoms, in patients with moderate to severe COPD. Ohtuvayre is expected to generate global sales of $1.1bn by 2029, ...
- Source: drugdu
- 86
- June 29, 2024
FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole to Treat Adults with Post-Traumatic Stress Disorder

Don Tracy, Associate Editor Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder. The FDA has accepted Otsuka and Lunbdeck’s supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The sNDA is supported by data from three randomized clinical trials that evaluated the safety and efficacy of the brexpiprazole-sertraline combination in adult patients with PTSD.1 “[PTSD] is one of the most common mental health disorders in the United States. Approximately 13 million adults in the US have PTSD during a given year, and between seven to eight out of every 100 will experience PTSD at some point in their lives,” said John Kraus, MD, PhD, EVP, chief medical officer, Otsuka, in a press release. “This is a significant development, and we look forward to continuing our efforts ...
- Source: drugdu
- 78
- June 28, 2024
FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole to Treat Adults with Post-Traumatic Stress Disorder

Don Tracy, Associate Editor Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder. The FDA has accepted Otsuka and Lunbdeck’s supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The sNDA is supported by data from three randomized clinical trials that evaluated the safety and efficacy of the brexpiprazole-sertraline combination in adult patients with PTSD.1 “[PTSD] is one of the most common mental health disorders in the United States. Approximately 13 million adults in the US have PTSD during a given year, and between seven to eight out of every 100 will experience PTSD at some point in their lives,” said John Kraus, MD, PhD, EVP, chief medical officer, Otsuka, in a press release. “This is a significant development, and we look forward to continuing our efforts ...
- Source: drugdu
- 120
- June 27, 2024
FDA Approves Harmony Biosciences’ Wakix to Treat Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy

Don Tracy, Associate Editor Approval of Wakix marks the first time a non-scheduled treatment option for excessive daytime sleepiness has been approved for patients ages 6 years and older. The FDA has approved Harmony Biosciences’ Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 years and older with narcolepsy. The FDA based the approval on results from a Phase III study conducted by Bioprojet, which evaluated the safety and efficacy of the treatment in patients over 6 years of age. Additionally, Wakix is the first non-scheduled treatment to be approved for EDS in pediatric patients.1 “Following the FDA’s decision to grant priority review, we are very pleased with the Agency’s timely review and approval of Wakix for pediatric narcolepsy patients with excessive daytime sleepiness,” said Jeffrey M. Dayno, MD, president, CEO, Harmony Biosciences, in a press release. “EDS is the primary symptom experienced ...
- Source: drugdu
- 101
- June 26, 2024
FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP

Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. By Frank VinluanA blockbuster Argenx therapy now has an additional FDA approval as a treatment for a rare autoimmune disorder affecting nerves, marking the first new treatment for this condition in decades and a new blockbuster opportunity for this pipeline-in-a-product drug. The disease, chronic inflammatory demyelinating polyneuropathy, or CIDP, develops as the immune system attacks myelin, the protective covering of nerve fibers. CIDP leads to weakness and impairment of motor function, numbness and tingling, and difficulty walking. In many cases, the loss of muscle function requires patients to rely on a wheelchair for mobility. The FDA’s late Friday approval of the Argenx product, Vyvgart Hytrulo, covers the treatment of ...
- Source: drugdu
- 96
- June 26, 2024
FDA Grants Emergency Use Authorization to Roche’s Cobas Liat SARS-CoV-2, Influenza A/B, & RSV Nucleic Acid Test

Don Tracy, Associate Editor The cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab sample. The FDA has granted Emergency Use Authorization (EUA) to Roche’s cobas liat SARS-CoV-2, Influenza A/B & respiratory syncytial virus (RSV) nucleic acid test. According to the company, it is a four-in-one molecular test, defined as an automated multiplex RT-PCR assay that can detect SARS-CoV-2, influenza A, influenza B, and RSV from a nasal swab sample. Additionally, Roche reported that full results can be expected in 20 minutes via a compact analyzer.1 “Diagnostics play a critical role in the fight against respiratory illness,” said Matt Sause, CEO, Roche Diagnostics, in a press release. “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to ...
- Source: drugdu
- 128
- June 14, 2024
Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

SAN FRANCISCO and SUZHOU, China, June 13, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its TOPO1i anti-CLDN18.2 ADC (R&D code: IBI343), for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. Previously, IBI343 has already received FDA approval of its IND application for the treatment of PDAC. At the ASCO 2024 Annual Meeting, Innovent reported the preliminary Phase 1 results of IBI343 in advanced PDAC patients who have received at least one prior line of treatment. In the 6 mg/kg dose group, among the 10 evaluable PDAC patients with CLDN18.2 1/2/3+≥60%, the overall response ...
- Source: drugdu
- 70
- June 14, 2024
FDA Approves Regeneron and Sanofi’s Kevzara to Treat Patients with Active Polyarticular Juvenile Idiopathic Arthritis

Don Tracy, Associate Editor Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics. The FDA has approved Regeneron’s and Sanofi’s approved Kevzara (sarilumab) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing over 138 lbs. According to a joint press release, the approval was based on results of controlled studies and pharmacokinetic data from adults with rheumatoid arthritis (RA), as well as pediatric-specific studies on pharmacokinetics, pharmacodynamics, dosing, and safety.1 “Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, in a press release. “Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable ...
- Source: drugdu
- 138
- June 13, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.