Search Results for “FDA” – Page 90 – media

MSD snags European approval for pulmonary arterial hypertension therapy

The European Commission (EC) has granted approval to Merck & Co’s (MSD) Winrevair (sotatercept) to be used as a combination therapy for the treatment of adults with functional class II or III pulmonary arterial hypertension (PAH). The approval was awarded based on data from STELLAR, a Phase III study (NCT04576988) that evaluated 323 adult participants with functional class II or III PAH, as determined by the World Health Organization (WHO), as per the 26 August press announcement, The European approval for the subcutaneously administered therapy follows one from the US Food and Drug Administration (FDA) in March 2024 for the same group of PAH patients. According to GlobalData’s consensus forecasts, Winrevair is expected to generate total sales of $6.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology. Notably, a day before the approval of Winrevair, the FDA granted approval to Johnson & Johnson’s (J&J) Opsynvi (macitentan + tadalafil). ...
- Source: drugdu
- 93
- August 28, 2024
【EXPERT Q&A】What are the advantages of MDSAP medical device system certificate?

Drugdu.com expert’s response: The MDSAP (Medical Device Single Audit Program), also known as the “Medical Device Single Audit Program,” is an audit process recognized and joined by five medical device regulatory agencies from the United States FDA, Australia TGA, Brazil ANVISA, Canada HC, and Japan MHLW. This system certification brings numerous benefits and advantages to medical device manufacturers, primarily in the following aspects: I. Streamlining the Audit Process Reducing Redundant Audits: MDSAP employs a one-time audit process that encompasses the regulatory requirements of multiple countries. Manufacturers need to undergo a single audit to meet market access requirements across participating nations, eliminating the duplication of effort and time waste associated with multiple audits. Unifying Audit Standards: MDSAP certification ensures that a manufacturer’s quality management system and products align with the audit standards and requirements of the five participating countries and regions, facilitating consistency in quality and compliance and simplifying audit procedures ...
- Source: drugdu
- 65
- August 28, 2024
SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

Oxford-based SynaptixBio has been awarded a £2m BioMedical Catalyst grant from Innovate UK to support first-in-human clinical trials of its therapeutic targeting H-ABC, the most severe form of TUBB4A leukodystrophy. In November 2023, SynaptixBio received an earlier grant from Innovate UK to expand its search for rare disease therapies. The company was given a second Orphan Drug Designation from the US FDA in February this year for a therapy targeting Isolated Hypomyelination – a less severe form of TUBB4A leukodystrophy. In the UK, a rare disease is defined as a condition that affects fewer than one in 2,000 in the population and SynaptixBio is the only company licensed to commercialise a treatment for this rare, deadly and currently incurable disease. Currently, there is no cure for TUBB4A-related leukodystrophies, a group of rare neurodegenerative caused by mutations in the TUBB4A gene. The diseases result in disruption to the signals between nerve ...
- Source: drugdu
- 52
- August 27, 2024
Q&A with Oren Gilad, CEO of Aprea Therapeutics

By Mike Hollan Gilad discusses the ways that this method can be used to treat various cancers without putting patients through the side effects of chemotherapy. Precision medicine is gaining momentum in the life sciences industry. It’s also changing the way that researchers are approaching new treatments and therapies. Pharmaceutical Executive spoke with Oren Gilad, PhD, president and CEO of Aprea Therapeutics, about some of the ways that the company is approaching cancer treatment with this new mindset. Pharmaceutical Executive: Can you discuss the concept of synthetic lethality and how it relates to your work? Oren Gilad: Synthetic lethality is a concept where the combination of two genetic mutations leads to cell death, whereas each mutation on its own would not be lethal. Cancer cells often have specific genetic mutations that normal cells do not carry, generally because they exist because a normal mutated to become cancer. So, there’s already ...
- Source: drugdu
- 56
- August 26, 2024
Eisai’s Leqembi deemed too costly for NHS

Though the UK became the first country in Europe to authorize use of Eisai and Biogen’s early Alzheimer’s disease drug, Leqembi (lecanemab), patients in the UK’s National Health Services (NHS) will not gain access to the drug as the anti-amyloid treatment was deemed too costly. As per the 22 August draft guidance consultation released by the National Institute for Health and Care Excellence (NICE), an independent committee found that the cost effectiveness estimates were “considerably above what NICE considers an acceptable use of NHS resources.” The committee cited a lack of evidence on the long-term effects of treatment with Leqembi and the costs of providing treatment infusions, monitoring side effects, and determining when to terminate treatment as uncertainties. According to the guidance, NICE has requested additional information from Eisai and NHS England to address the uncertainties and will consider the additional information alongside stakeholder comments in a second meeting. In ...
- Source: drugdu
- 65
- August 26, 2024
Leo Pharma’s Timber bet falls flat following Phase III failure

Ayear after hedging its bets on Timber Pharmaceuticals’ dermatology pipeline, Leo Pharma has reported a Phase III failure for the lead asset it acquired at the time. TMB-001, a topical ointment formulation of isotretinoin, came up short in the late-stage trial for patients with moderate to severe congenital ichthyosis. Ichthyosis is an umbrella term for congenital skin conditions that cause dry and scaly skin. In the Phase III ASCEND trial (NCT05295732), Leo stated the therapy did not demonstrate a statistically significant improvement in patients compared to those treated with a vehicle. This meant the primary and key secondary endpoints were not met. The results do not support US regulatory submission, the Danish privately owned company stated in a 21 August press release. There is currently no treatment approved for ichthyosis by the US Food and Drug Administration (FDA). Instead, the condition is managed by hydrating the skin with creams and ...
- Source: drugdu
- 67
- August 26, 2024
Pathalys secures $105m to advance SHPT drug through approval

Pathalys Pharma has secured $105m in a Series B financing round to support its clinical trials, file a new drug application (NDA) with the US Food and Drug Administration (FDA), and accelerate preapproval commercialisation preparations. The company’s lead candidate is upacicalcet, a drug used to treat secondary hyperparathyroidism (SHPT) in patients undergoing dialysis due to chronic kidney disease (CKD). The calcimimetic drug mirrors the action of calcium on tissues, particularly the parathyroid glands. The medication is typically administered during dialysis sessions. Earlier this year, Pathalys launched two identical Phase III studies of upacicalcet, which will both enrol 375 patients. The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30% or more in participants with SHPT and currently on haemodialysis. The funding round, led by TCGX, is set to support these clinical trials, and advance the ...
- Source: drugdu
- 65
- August 23, 2024
Johnson & Johnson Set to Acquire V-Wave Ltd

By Don Tracy, Associate Editor The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.Johnson & Johnson (J&J) has reached a definitive agreement to acquire V-Wave Ltd., a private company specializing in cardiovascular implants for heart failure patients. The acquisition is expected to integrate V-Wave into Johnson & Johnson MedTech. V-Wave was recently granted FDA Breakthrough Device Designation and CE mark approval for the Ventura Interatrial Shunt technology, which treats heart failure with reduced ejection fraction (HFrEF). The deal is expected to close by the end of this year.1 “We are excited to welcome V-Wave to Johnson & Johnson MedTech and to take another meaningful step toward transforming the standard of care for cardiovascular disease. We recognize the importance of identifying more diverse and effective treatments for heart failure, and our recent ...
- Source: drugdu
- 69
- August 22, 2024
Eli Lilly Drug Reduces Risk of Diabetes Onset, Building Case for Broader Use of the Therapy

In a Phase 3 study, Eli Lilly’s tirzepatide led to a 94% reduction in the risk that obese or overweight prediabetes patients progress to type 2 diabetes. Lilly was already planning to expand use of the blockbuster metabolic disorders drug to sleep apnea and heart failure. By Frank Vinluan The longest clinical trial to date for a blockbuster Eli Lilly metabolic disorder drug now has data showing the treatment delayed progression to type 2 diabetes in patients who are obese or overweight, results that continue to build the case of broader health benefits for the therapy. The preliminary results announced Tuesday come from a clinical trial designed to test once-weekly injections of tirzepatide in prediabetes participants. In addition to being overweight or obese, participants also had at least one weight-related complication, excluding diabetes. The main goal of the placebo-controlled study is assessing tirzepatide’s effect on weight. At the highest of three ...
- Source: drugdu
- 71
- August 22, 2024
Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut

Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. By Frank VinluanWhen the FDA approves a drug, passing that regulatory bar of safety and efficacy puts it on the path toward likely reimbursement by government and commercial payers. The same has not been true for digital therapeutics. A proposal from the Centers for Medicare and Medicaid Services signals a change in federal thinking about such technologies, which could pave the way for broader coverage of novel digital medicines. For the first time, CMS’s proposed physician fee schedule, a comprehensive annual listing of the fees that Medicare uses to pay doctors, now includes digital therapeutics. The proposal does not cover all digital therapeutics under multiple benefit categories, as the Digital Therapeutics Alliance (DTA) had asked nearly a year ago. ...
- Source: drugdu
- 68
- August 21, 2024

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