Search Results for “EC” – Page 232 – 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
- 67
- July 2, 2024
NPMA went to Sinopharm to hold a symposium on drug supervision and high-quality development

On June 24, Yuan Lin, Director of Drug Safety of State Drug Administration, and his delegation went to Sinopharm for investigation, Zhao Bingxiang, Deputy Secretary of Party Committee and General Manager of Sinopharm, hosted the reception, and the two sides held a symposium on drug regulation and high-quality development. The meeting was presided over by Zhou Le, Deputy Director of the Department of Drug Administration. Director Yuan Lin and relevant comrades of the Department of Drug Registration and the Department of Drug Administration listened to the special reports on children’s medicines, vaccines and blood products, special medicines, traditional Chinese medicines injections and formula granules, and drug business of Sinopharm Group’s scientific and technological research and development, industrial manufacturing, and trading and circulation subsections, focusing on the research and development of medicines, manufacturing, supply management, quality assurance, informationization construction, modernization and logistics construction, and so on. Informatization construction, modern logistics construction ...
- Source: drugdu
- 71
- July 1, 2024
UCL begins first UK deep brain stimulation study for children with rare epilepsy

Lennox-Gastaut syndrome affects up to 5% of children living with paediatric epilepsy A new study sponsored by University College London (UCL) has begun, making it the UK’s first ever deep brain stimulation (DBS) trial for children with epilepsy. In collaboration between Great Ormond Street Hospital, UCL, King’s College London, the University of Oxford and Amber Therapeutics, the Children’s Adaptive Deep brain stimulation for Epilepsy Trial (CADET) pilot intends to recruit three additional patients living with Lennox-Gastaut syndrome (LGS). Affecting around 50 million people worldwide, epilepsy is a neurological condition where sudden bursts of electrical activity in the brain cause seizures or fits. Affecting up to 5% of children with paediatric epilepsy, LGS is a rare and severe form of epilepsy that is characterised by repeated seizures that begin early in life. The study will investigate the safety of a cranially-mounted DBS device called the Picostim with software called DyNeuMo-1, manufactured ...
- Source: drugdu
- 73
- July 1, 2024
IHI’s new funding round to include topics on CVD and arthritis

The initiative’s proposals aim to tackle current challenges in health research and innovation The Innovative Health Initiative (IHI) has launched a new call for proposals, which include topics on cardiovascular disease (CVD) and arthritis, as part of the total budget worth €96.5m to tackle challenges in health research and innovation. As part of the total budget, Horizon Europe, the EU’s research and innovation programme, has contributed €47.6m, while an additional €40.9m comes from the IHI’s industry members, as well as €8.1m from IHI contributing partners. Dr Niklas Blomberg, executive director, IHI, commented: “This call for proposals is an excellent opportunity to be part of ambitious projects tackling major challenges in health research and innovation.” The IHI aims to identify and create models, interventions and best practices to improve the management of CVD in Europe’s cities, covering healthcare delivery, individual lifestyle changes and the living environment. It will include five pilot ...
- Source: drugdu
- 96
- July 1, 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
Sarclisa Combination Improves Progression-Free Survival in Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma

Don Tracy, Associate Editor Reportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma. Results from the IMROZ Phase III trial show that Sanofi’s Sarclisa (isatuximab-irfc) in combination with standard-of-care therapy comprised of lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death by 40% compared to a solo VRd regimen in patients with newly diagnosed transplant-ineligible multiple myeloma (MM). According to the company, the data represents the first time an anti-CD38 monoclonal antibody combined with VRdsupported a significant improvement in progression-free survival (PFS) for these patients. “The significant progression-free survival (PFS) benefit observed with Sarclisa combination therapy compared to VRd is important and encouraging for patients with newly diagnosed multiple myeloma. Effective frontline therapy has the potential to modify the course of the disease, which ...
- Source: drugdu
- 65
- July 1, 2024
Semi-Automated System Rapidly Identifies Pathogenic Genetic Variant Causing Rare Diseases

Many patients with rare diseases (50-75%) do not receive a diagnosis after genomic sequencing, often due to insufficient information on the variants identified. Reassessing data over time with new genetic insights can improve diagnostic rates. However, reanalyzing genetic data in clinical laboratories is often hampered by time and resource limitations. Now, a novel semi-automated system enables rapid reanalysis of unresolved rare disease cases by regularly comparing patient genomic data with the latest global research findings, aiming to identify elusive disease-causing genetic variants. Developed by Mayo Clinic researchers in 2022 (Rochester, MN, USA), the system, named RENEW (REanalysis of NEgative Whole-exome/genome data), incorporates an advanced filtering system that scans new genetic data to identify the variants responsible for a patient’s condition. A recent study demonstrated RENEW’s effectiveness, providing likely diagnoses for 63 out of 1,066 previously undiagnosed cases. RENEW can review each of the 5,741 prioritized genomic variants in about 20 ...
- Source: drugdu
- 83
- June 29, 2024
Eli Lilly, OpenAI Strike Collaboration Agreement Seeking to Discover New Antimicrobials to Fight Drug-Resistant Bacteria

Don Tracy, Associate Editor The collaboration with OpenAI is part of Lilly’s strategy to combat drug-resistant pathogens through its Social Impact Venture Capital Portfolio. Eli Lilly and Company and OpenAI have agreed to terms on a deal to leverage generative artificial intelligence (AI) for discovering new antimicrobials to combat drug-resistant bacteria. According to Lilly, antimicrobial resistance (AMR) poses a significant risk throughout the world, especially in low- and middle-income countries. Additionally, the misuse and overuse of antimicrobials in humans, animals, and plants are the primary influences for developing drug-resistant pathogens, amplifying AMR in the process.1 “Our collaboration with OpenAI represents a groundbreaking step forward in the fight against the growing but overlooked threat of antimicrobial resistance,” said Diogo Rau, EVP, chief information and digital officer, Lilly, in a press release. “Generative AI opens a new opportunity to accelerate the discovery of novel antimicrobials and the development of custom, purpose-built technologies ...
- Source: drugdu
- 103
- June 29, 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
- 83
- June 29, 2024
The Lancet sub-journal publishes clinical phase 1b/2 results of the next-generation CD20 antibody MIL62 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma

Recently, eClinical Medicine, a sub-journal of The Lancet, published the results of a phase 1b/2 study of recombinant humanized monoclonal antibody MIL62 injection in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma, led by Prof. Yuankai Shi of Cancer Hospital, Chinese Academy of Medical Sciences. The study was designed to evaluate the efficacy and safety of MIL62 in combination with lenalidomide in the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common pathological subtypes of non-Hodgkin’s lymphoma (NHL) and are inert lymphomas. In China, FL accounts for about 8% of B-cell NHL, while MZL accounts for about 12%. Early progression in patients with inert lymphoma is directly related to poor prognosis, with approximately 20% of patients experiencing disease recurrence or progression within 24 months of diagnosis (POD24). These patients typically have a poor prognosis, ...
- Source: drugdu
- 105
- June 29, 2024

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