Search Results for “Clinical Trial” – Page 85 – media

Novo Nordisk Strikes Deal for Late-Stage Hypertension & Kidney Disease Drug

The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes. By FRANK VINLUAN Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease. The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion. The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney ...
- Source: drugdu
- 219
- October 18, 2023
FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The FDA has 49 committees and panels oriented around various therapeutic areas and modalities. As regulatory submissions increasingly include digital components, the agency wants to ensure it is adequately informed about these technologies. It’s adding a digital health advisory committee charged with providing that perspective. The FDA expects the new advisory committee will become fully operational in 2024. It will discuss technologies such as artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. In addition, topics covered by this new committee could include decentralized clinical trials, patient-generated health data, and cybersecurity. The committee will consist of a core nine voting members, including the chair. Members serve terms of up ...
- Source: drugdu
- 200
- October 17, 2023
Interest in RNA Editing Accelerates as Therapies Approach the Clinic

By Gerard Platenburg Pictured: RNA/iStock, Artur Plawgo Based on the significant progress made over the last few decades with RNA therapeutics, RNA editing is widely considered the next generation of promising medicines in this field. RNA therapies have made significant progress over the last few years, with an increasing number of FDA approvals beginning in 1998 with Vitravene for CMV retinitis, followed by Macugen for macular degeneration in 2004 and Spinraza for spinal muscular atrophy in 2016. There have also been multiple siRNA-based drugs, including Onpattro for polyneuropathy of hereditary transthyretin-mediated amyloidosis in 2018. And finally, in 2020, perhaps the most well-known products in the RNA space were introduced: the mRNA-based COVID-19 vaccines. All of these demonstrate the strength of RNA therapies and their potential impact on diseases with high unmet need. RNA therapeutics are indeed elegant approaches to altering RNA and thus protein expression, opening the potential to target ...
- Source: drugdu
- 134
- October 17, 2023
FDA Approves Pfizer’s Ulcerative Colitis Drug, $6.7B Arena Buy Pays Off

By Connor Lynch Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis The FDA has greenlit Pfizer’s ulcerative colitis drug etrasimod, marketed as Velsipity, based on Phase III results published in The Lancet, the company announced Friday. Pfizer’s Elevate UC Phase III registrational program, consisting of the Elevate UC 52 and Elevate UC 12 clinical trials, examined the safety and efficacy of a 2-mg daily dose of the oral medication for patients intolerant to or who had failed on trials of a conventional, biological, or Janus kinase inhibitor therapy. Both studies “achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of Velsipity,” Pfizer said in Friday’s announcement. In the Elevate 52 UC trial, 27% of patients achieved clinical remission, compared to 7% of patients receiving a placebo at week 12, and by week 52 it was 32% versus 7%. In the Elevate 12 UC ...
- Source: drugdu
- 104
- October 17, 2023
Mount Sinai researchers receive NIH grant to compare new treatment options for sickle cell disease

The Mount Sinai Health System has received a $12,180,625 grant from the National Heart, Lung and Blood Institute to compare new treatment options for sickle cell disease and determine which work best for specific patients. Jeffrey Glassberg, MD, Director of the Mount Sinai Sickle Cell Program, said, “Sickle cell traditionally has been a neglected disease, but it benefited from a flurry of innovation over the last decade and there are now three new medications approved for the disease.” “While this is welcome news, clinicians now have a new challenge. No studies have compared the drugs to each other or looked at their use in combination, so there’s very little information to help decide which of the new drugs are best for which patients.” The study, known as REAL (Registry Expansion Analyses to Learn) Answers, is a collaboration among 10 sickle cell centers across the United States that will implement a ...
- Source: drugdu
- 159
- October 14, 2023
Elligo Health Research expands Study Marketplace with Syneos Health

The agreement builds on the companies’s existing partnership Elligo Health Research has announced it is expanding its IntElligo Study Marketplace platform with Syneos Health. The platform aims to make sales, site selection and application processes more transparent and efficient for clinical trial sponsors, clinical research organisations and sites, while also tracking progress. As part of the agreement, Syneos will utilise Study Marketplace to expand access to clinical trials, increase efficiencies for sites and sponsors across over 500 of Elligo’s US site networks and cover a broad range of therapeutic areas. Launched in 2022 by the healthcare-enabling research organisation, Study Marketplace is a one-stop platform that aims to accelerate participation in clinical research and allows sites to manage their entire pipeline process on a single, user-friendly portal. Updated in June this year, IntElligo Study Marketplace allows sites to easily access and browse available studies and study documents, apply for those of ...
- Source: drugdu
- 150
- October 13, 2023
Bayer christens $250M cell therapy ‘launch facility’ in Berkeley

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.Bayer on Tuesday opened its first Cell Therapy Launch Facility in Berkeley, California, which is expected to create capacity to bring cell therapies to patients worldwide. Bayer has invested $250 million to build the plant, which will initially crank out materials for late-stage clinical trials across 100,000 square feet of space, the drugmaker said in a release. The plant is also equipped to support the potential commercial launch of BlueRock’s experimental cell therapy for Parkinson’s disease, bemdaneprocel. At the moment, BlueRock says planning is underway for its phase 2 study of bemdaneprocel, which is expected to start enrolling patients in the first half of 2024. The plant features flexible, modular space ...
- Source: drugdu
- 140
- October 12, 2023
ABVC BioPharma obtains patent for MDD treatment in Taiwan

ABVC BioPharma has obtained a patent in Taiwan for the use of PDC-1421 in ABV-1504, an asset that treats major depressive disorder (MDD). PDC-1421 is an extract of Radix Polygala. In April 2023, the company received a patent for the same treatment in the US. Data from the latest studies showed that PDC-1421 should be given orally as a capsule for a minimum of 25 days. Doses ranged from once to three times per day. ABVC CEO Dr Uttam Patil stated: “These patents grant ABVC the right to exclude others from using, offering or selling PDC-1421 throughout the US and Taiwan until the year 2040. “As our patent map steps into global coverage, we eagerly await the results of patent applications in the European Union, China, Japan and more.” ABV-1504 is an inhibitor of norepinephrine transporter. The company has concluded Phase II clinical trials of ABV-1504 containing PDC-1421 and intends ...
- Source: drugdu
- 157
- October 11, 2023
FDA Blocks Alnylam’s Bid to Expand Onpattro Label

By Tristan Manalac Pictured: Alnylam headquarters in Cambridge, Massachusetts/iStock, hapabapa The FDA on Monday denied approval of Alnylam Pharmaceuticals’ siRNA therapy Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis. In its Complete Response Letter (CRL), the regulator said that Alnylam had not provided enough evidence of the therapy’s benefit in the proposed indication. At the same time, the FDA did not flag any problems with patisiran’s clinical safety, drug quality, manufacturing processes or study conduct. “The CRL indicated that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established,” according to the company’s announcement. In light of the rejection, Alnylam will no long work toward an expanded label for Onpattro in the U.S. Monday’s CRL runs counter to the recommendations of the FDA’s own panel of external advisers. In September 2023, the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in ...
- Source: drugdu
- 107
- October 11, 2023
Compound found to inhibit influenza virus replication by targeting host enzyme

How can the propagation of influenza viruses be stopped? For a new approach in the therapy of influenza infections, Prof. Hiroki Kato from the Institute of Cardiovascular Immunology at the University Hospital Bonn (UKB) and the Cluster of Excellence ImmunoSensation2 of the University of Bonn receives an Open Philanthropy grant of 2.2 million US dollars. Together with his team, he found a compound that inhibits the body’s own methyltransferase MTr1 and thus prevents the replication of influenza viruses. The funded project now aims to identify further MTr1 inhibitors with influenza-inhibiting activity that could be considered for clinical trials in the near future. When a virus enters our body, it binds to the host cell and introduces its genetic information in form of ribonucleic acid (RNA). Using these blueprints, the host cell is now forced to produce numerous new viruses. “This is because viruses have evolved various mechanisms, including modifications of ...
- Source: drugdu
- 93
- October 11, 2023

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