Search Results for “FDA” – Page 97 – media

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
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
- 101
- June 27, 2024
【EXPERT Q&A】Simaglutide API is exported to Thailand, which registration qualifications need to be met and the registration process for drug registration in Thailand (preparation manufacturers are local enterprises in Thailand)

Drugdu.com expert’s response: 1.Registration Qualification Requirements ①Pharmaceutical Business License: To export Semaglutide API to Thailand, it is first necessary to ensure that your enterprise possesses a Pharmaceutical Business License, which is the basic qualification for drug export. ②GMP Certification: GMP certification refers to the certification of a pharmaceutical production quality management system. For the export of Semaglutide API to Thailand, your enterprise must also obtain GMP certification to ensure the quality and safety of the product. ③Pharmaceutical Quality Management System Certification: In addition to the above two qualifications, pharmaceutical quality management system certification is also necessary. This will help guarantee the quality of product sales and service in the Thai market. ④Pharmaceutical Liability Insurance: To safeguard the rights and interests of consumers, your enterprise should also consider purchasing pharmaceutical liability insurance. 2.Thai Drug Registration Process (Assuming the Formulation Manufacturer is a Local Enterprise in Thailand) ①Submission of Registration Application: ...
- Source: drugdu
- 141
- June 26, 2024
Portable Device Analyzes White Blood Cell Activity to Monitor Cancer Patients’ Health

Chemotherapy and similar treatments aimed at eliminating cancer cells often adversely affect patients’ immune cells. Each year, this results in tens of thousands of cancer patients suffering from weakened immune systems, making them susceptible to potentially fatal infections. Physicians are tasked with balancing the dosage of chemotherapy—enough to kill cancer cells but not so much as to dangerously reduce the patient’s white blood cell count, leading to neutropenia. This condition not only impacts health but can also lead to social isolation between chemotherapy sessions. Traditionally, monitoring of white blood cells has been limited to blood tests. Now, a new at-home white blood cell monitor offers doctors the ability to remotely monitor their patients’ health more comprehensively. This device, which avoids blood draws, uses light to scan the skin at the top of the fingernail and employs artificial intelligence (AI) to identify critically low levels of white blood cells. Based on ...
- Source: drugdu
- 117
- June 25, 2024
Sarepta’s Elevidys secures US label expansion for DMD

Just a week after Pfizer revealed a Phase III trial failure for its mini-dystrophin gene therapy for Duchenne muscular dystrophy (DMD), Sarepta has announced that it has scored a US label expansion for its DMD gene therapy Elevidys (delandistrogene moxeparvovec-rokl). As per the 20 June press release, the US Food and Drug Administration (FDA) has expanded Elevidys’ label to include DMD patients with a confirmed mutation in the DMD gene who are at least four years of age. Based on its functional benefits, Elevidys was granted traditional approval for ambulatory patients and accelerated approval for the non-ambulatory population. However, according to the announcement, which drove Sarepta’s shares up 36%, further progression on the approval track hinges on validated clinical benefits from a confirmatory study. When the therapy’s durability came into question, particularly in a non-ambulatory population, Sarepta CEO Douglas Ingram said in an investor call held on 21 June, that ...
- Source: drugdu
- 151
- June 25, 2024
Philips launches stent system to restore blood flow in blocked veins

Dive Brief Philips has launched its Duo Venous Stent System in the U.S. to treat patients with blockages in their veins, the company said Wednesday. The implant, which won approval in December, is designed to address the root cause of chronic deep venous disease and comes in two forms for use in different types of veins. Philips acquired the device in its 2022 takeover of Vesper Medical. The company paid 227 million euros upfront for Vesper to expand its image guided therapy business. Dive Insight The Duo Venous Stent System is a portfolio of self-expanding stents mounted on disposable delivery devices. Vesper designed the stents to increase the diameter of obstructed veins. Restoring blood flow could improve quality of life by alleviating symptoms of venous disease, which include pain, swelling and discoloration of skin. Philips tracked improvements on observational quality-of-life endpoints in a trial of the device. Using data from ...
- Source: drugdu
- 123
- June 17, 2024
Avidity Bio’s RNA Therapy Flashes Early Signs of Treating a Muscular Dystrophy’s Root Cause

Avidity Biosciences’ RNA therapy for facioscapulohumeral muscular dystrophy has preliminary clinical data showing it knocked down expression of a gene that causes this rare disease. More details will be presented at a medical conference this week. By Frank VinluanAn experimental RNA therapy from Avidity Biosciences has early clinical trial results showing it reduced by half the expression of a gene at the root of a rare, inherited form of muscular dystrophy with no FDA-approved therapies. Furthermore, patients in the study are showing signs of regaining muscle function. Based on these initial results announced Wednesday, Avidity said it plans to accelerate the start of additional cohorts in the Phase 1/2 study that could support an application seeking regulatory approval in this disease, facioscapulohumeral muscular dystrophy (FSHD). More details about the data are coming soon. Avidity plans to present the preliminary results during the Annual FSHD Society International Research Congress meeting, which ...
- Source: drugdu
- 71
- June 14, 2024
Chiatai Tianqing and China Resources Pharmaceutical Commercial signed a strategic cooperation agreement

On June 7, Chiatai Tianqing Pharmaceutical Group and China Resources Pharmaceutical Commercial signed a strategic cooperation agreement in Tianjin. Based on the principle of resource sharing, complementary advantages and common development, the two parties will carry out in-depth cooperation in the fields of pharmaceutical research and development, production, sales and circulation, and jointly help the sustainable development of China’s pharmaceutical industry. Chiatai Tianqing’s commercial director Qi Tianze and CR Pharmaceuticals Commercial Deputy General Manager Dong Hao signed the agreement on behalf of the two parties. As one of the leading pharmaceutical companies in China, Chiatai Tianqing has always been committed to researching and developing innovative drugs, improving drug quality and meeting patients’ needs. With strong R&D strength and market competitiveness, the company has won wide recognition and trust. As an important pillar industry of China Resources Group, China Resources Pharmaceutical Commercial has a comprehensive pharmaceutical distribution network and market channels, ...
- Source: drugdu
- 91
- June 14, 2024
Abbott ramps up over-the-counter CGM race with new sensors

Dive Brief Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration. One product is the company’s Lingo device, sold as a wellness product for people who do not have diabetes. The other is Abbott’s new Libre Rio device, which is intended for adults with Type 2 diabetes who do not use insulin, posing a direct challenge to Dexcom’s Stelo device. After Lingo was cleared last week, RBC Capital Markets analyst Shagun Singh wrote the over-the-counter nod could offer a more than $1 billion sales opportunity for Abbott. Dive Insight Abbott had discussed plans to bring Lingo to the U.S. after releasing it in the U.K. last year. The device, which can be worn on the upper arm for 14 days, tracks glucose to help people understand how their bodies react to different foods, exercise and stressors. Abbott received FDA ...
- Source: drugdu
- 121
- June 12, 2024
Kangpu Biopharmaceuticals to Present Results from Phase 2a of KPG-818 in SLE at EULAR 2024

HEFEI, China, June 10, 2024 /PRNewswire/ — Kangpu Biopharmaceuticals today announced that a poster tour presentation highlighting the Phase 2a clinical data of KPG-818 in patients with Systemic Lupus Erythematosus (SLE) will be presented at the upcoming Annual European Congress of Rheumatology EULAR 2024, taking place in Vienna, Austria, June 12-15, 2024. Poster tour presentation details: Abstract Title: KPG-818, a Novel Cereblon Modulator in Patients with Systemic Lupus Erythematosus: Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study Abstract number: POS0057 Abstract authors: Robert Levin, et al. Poster tour title: Clinical Poster Tours: Systemic lupus – Of old and new therapies Poster tour date and time: Wednesday, June 12, 2024, 15:30 – 16:30 CEST Poster tour location: Hall C The Phase 2a trial is a multicenter, randomized, double-blind, placebo-controlled study, to assess the safety and tolerability, pharmacokinetics, and preliminary efficacy of KPG-818 in patients with SLE, and to select dosing ...
- Source: drugdu
- 88
- June 12, 2024

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