Search Results for “Clinical Trial” – Page 55 – media

【EXPERT Q&A】How long does it take to register three types of medical devices in Russia?

Drugdu.com expert’s response: The registration process for Class III medical devices in Russia typically requires a period of 24 months or more. Based on official requirements and information from reference articles, here is a detailed explanation and summary of the registration timeline: Medical Device Classification: According to the Russian medical device classification standards, Class III medical devices fall into the high-risk category, requiring a more stringent registration and review process. Registration Process: The registration process includes appointing a Russian authorized representative, product classification identification, submitting technical documentation for medical devices, conducting system audits (if applicable), and undergoing RZN evaluation. Registration Timeline: Initial Review: Once the application materials are complete, the registration agency will submit the application to the Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor). The initial review may take several weeks to several months to confirm the completeness and compliance of the application documents. Detailed Review and Evaluation: ...
- Source: drugdu
- 98
- July 3, 2024
Parkinson’s UK awards ICL £100,000 to develop small drugs for Parkinson’s disease

Parkinson’s UK has awarded nearly £100,000 to researchers at Imperial College London (ICL) to develop a new drug for Parkinson’s disease (PD) through the charity’s drug accelerator award grant scheme. Researchers will use a computer-based programme to simulate good targets for new drugs to slow the progression of the neurological disease and improve the success of clinical trials. Affecting around 153,000 people in the UK, PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. In the process of drug development, the more information that researchers have when planning a clinical trial, including simulating how a drug might work, the more likely it is to be successful when being trialled in people and compared to other available treatments. Using simulation, researchers aim to test the best way to target GPNMB, a protein that has been linked to PD. Previous ...
- Source: drugdu
- 73
- July 2, 2024
Biotech fund Curie.Bio augments reserves with $380m to boost startups

Biotech startup incubator Curie.Bio has secured $380m in funding for its latest investment pool aimed at nurturing early-stage companies advancing towards clinical trials. The fundraising round – which boosts Curie.Bio’s total funds raised to nearly $1bn – specifically targets Series A investments in companies within its accelerator programme, focusing on advancing companies towards clinical proof-of-concept studies. The Massachusetts-based biotech investor launched with $520m in its pocket in February 2023, with investments from GV, ARCH Venture Partners, and Leaps by Bayer. The investor operates through two parts: one provides seed-stage funding to startups, while the other offers essential services to help advance scientific projects. Amid macroeconomic pressures, private biotech venture financing saw a significant downturn in 2022 and 2023. During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, as investors became more cautious and focused on existing portfolios. Curie.Bio was started by Alexis Borisy, Zach ...
- Source: drugdu
- 95
- July 1, 2024
The Financial Potential of Convertible Notes in the Pharmaceutical Sector

These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. By Jaylon M. ReynoldsIn the realm of biotech and pharmaceuticals, fundraising often plays a pivotal role in driving innovation and progress. Biotech and pharmaceutical companies, whether private startups or established public firms, frequently turn to convertible notes as a strategic financial instrument. These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. Convertible notes are utilized, structured, valued, and accounted for in various ways within the context of the biotech and pharmaceutical industries. Private companies For burgeoning private biotech and pharmaceutical firms, navigating the journey from research and development to commercialization can be financially demanding. Convertible notes offer a flexible financing solution, providing companies with the necessary capital to fuel their operations ...
- Source: drugdu
- 65
- 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
- 83
- 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
- 77
- June 28, 2024
Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease

The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. By Frank VinluanA Novo Nordisk drug for hypertension and chronic kidney disease has failed a pivotal study, a setback to the Danish pharmaceutical giant’s effort to bring patients a new therapy with potential safety and efficacy advantages over currently approved medications in the drug class, including a product marketed by Bayer. Novo Nordisk did not release specific details about the Phase 3 results for the drug, ocedurenone. The company said Wednesday that an independent data monitoring committee recommended stopping the trial after a prespecified interim analysis. Ocedurenone is a small molecule designed to block the mineralocorticoid receptor. When overactivated, this receptor can contribute to ...
- Source: drugdu
- 97
- June 28, 2024
Chen Jining, Secretary of Shanghai Municipal Party Committee, met with Paul Han, CEO of French Sanofi Group

Chen Jining, Secretary of the Municipal Party Committee of Shanghai Municipality, met with Paul Han, CEO of Sanofi Group of France, and his delegation on the morning of June 26th. Chen Jining said that biomedicine is one of the three leading industries that Shanghai focuses on. We actively play the role of reform and opening up the test bed, around basic research, clinical trials, approval and supervision, health insurance, introduced a series of early and pilot implementation of policies and initiatives, to more competitive innovation advantages, industrial advantages, market advantages and comprehensive cost advantages, the whole chain to promote biomedical science and technology innovation and industrial development, and effectively promote people’s health and well-being. Sanofi is a leading global pharmaceutical and healthcare enterprise, welcome to grasp the opportunity of Shanghai’s industrial transformation, further increase the investment layout in Shanghai, and put more innovative R&D and manufacturing in Shanghai. We will ...
- Source: drugdu
- 94
- 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
- 118
- June 27, 2024
Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease

The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. By Frank Vinluan A Novo Nordisk drug for hypertension and chronic kidney disease has failed a pivotal study, a setback to the Danish pharmaceutical giant’s effort to bring patients a new therapy with potential safety and efficacy advantages over currently approved medications in the drug class, including a product marketed by Bayer. Novo Nordisk did not release specific details about the Phase 3 results for the drug, ocedurenone. The company said Wednesday that an independent data monitoring committee recommended stopping the trial after a prespecified interim analysis. Ocedurenone is a small molecule designed to block the mineralocorticoid receptor. When overactivated, this receptor can contribute to ...
- Source: drugdu
- 102
- June 27, 2024

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