Search Results for “EHR” – Page 6 – media

Pfizer Hemophilia Gene Therapy Meets Phase 3 Goals, But Its Success Matters More to Sangamo

Pfizer’s hemophilia A gene therapy reduced annualized bleeding rates in a Phase 3 clinical trial, setting the stage for discussions with regulators. However, the market for such one-time treatments is uncertain, as uptake of commercialized hemophilia gene therapies remains slow. By Frank Vinluan A Pfizer gene therapy for hemophilia A reduced bleeding rates in patients with the inherited blood disorder, meeting goals of its Phase 3 study. The preliminary results announced Wednesday are measures taken at 15 months in a study that will follow patients for up to five years, meaning the one-time treatment’s durability remains an open question. The pharmaceutical giant now plans to meet with regulators to discuss next steps for the therapy. In hemophilia A, insufficient levels of a clotting protein called factor VIII make patients susceptible to frequent bleeding events. Treatment includes regular infusions of this clotting protein to prevent these events. The Pfizer gene therapy, giroctocogene fitelparvovec, delivers ...
- Source: https://medcitynews.com/author/fvinluan/
- 114
- July 27, 2024
Telix raises $398m to advance kidney and brain cancer radiotherapies

Not long after pulling a last-minute plug on a $232m initial public offering (IPO) on Nasdaq, Telix Pharmaceuticals has raised $398m (A$600m) via the issue of convertible bonds. The bonds, which are convertible into ordinary shares, will yield a 2% – 2.75% interest, the radiopharmaceutical specialist said in a 23 July press release. The maturity date is set for five years from now, at the end of July 2029. Australia-based Telix said it intends to list the convertible bonds on the Official List of Singapore Exchange Securities Trading Limited (SGX-ST). While Telix had been planning on going public on Nasdaq earlier this year, the company U-turned on the IPO citing market conditions at the time. Telix had been on course to raise $232m in the listing, though the company maintained that the decision was not “predicated on the need to raise capital”. Instead, the convertible bonds bring low-cost financing to ...
- Source: drugdu
- 63
- July 25, 2024
Tau-Focused Asceneuron Adds $100M as Oral Alzheimer’s Drug Advances to Phase 2 Trial

Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
- Source: drugdu
- 140
- July 18, 2024
Prioritised investments from pharma companies shaping competitive pipeline landscape of bronchiectasis

Recent studies have allowed the unexplored field of bronchiectasis to be further investigated by shedding light on the mechanisms behind the disease’s pathophysiology. In recent years, bronchiectasis has garnered a significant amount of attention, with pharmaceutical companies prioritising their investments in the development of promising pipeline agents to treat the disease through various mechanisms of action (MOAs). Pharmaceutical companies involved in the field of bronchiectasis include Insmed, Boehringer Ingelheim, Sanofi, Renovion, Armata Pharmaceuticals, Chiesi, CSL, BioAegis Therapeutics, and Reistone Biopharma, all of which are shaping the competitive landscape of the field, according to GlobalData. Current research focuses on disease mechanisms, such as inflammation, further uncovering potential targets for pharmaceutical companies. Such targets include neutrophil-mediated inflammation components but also general inflammation components, such as interleukins and bacteriophages. Interestingly, the pipeline landscape is filled with Phase I and Phase II agents, with only Insmed’s brensocatib in Phase III. These pipeline agents have ...
- Source: drugdu
- 91
- July 15, 2024
OLYMVAX Trivalent Influenza Virus Cracking Vaccine (MDCK Cells) Clinical Trial Application Accepted

Recently, the State Drug Administration website announced that it agreed to accept OLYMVAX’s application for clinical trials of trivalent influenza virus lysate vaccine (MDCK cells), which is also the first cell-based trivalent influenza vaccine to be declared for clinical use in China. Influenza vaccination is an effective means of preventing influenza and reducing the burden of influenza-associated severe illness and death. Divided from the components of the vaccine and the types of preventive viruses, the influenza vaccines currently available in China include trivalent influenza vaccine and tetravalent influenza vaccine. Trivalent influenza vaccine mainly prevents H1N1 and H3N2 subtypes of Influenza A, as well as Influenza B Victoria lineage viruses, while tetravalent influenza vaccine is based on trivalent influenza vaccine, with added prevention against Influenza B Yamagata lineage viruses. OLYMVAX’s quadrivalent influenza virus lysate vaccine (MDCK cells) has been approved by the State Drug Administration for the issuance of the Notice ...
- Source: drugdu
- 123
- July 9, 2024
New AI Transparency Rule Should Drive Higher Quality Tools & More AI Adoption

Micky Tripathi, head of The Office of the National Coordinator for Health Information Technology (ONC), thinks his office’s recent rule on AI transparency will do a good job of empowering both providers and tech developers. “I think it’s going to spur more adoption of AI-based tools in healthcare delivery, and hopefully, it’s going to establish a sort of mechanism for driving higher quality AI-based tools,” he stated during an interview this month at the Reuters Digital Health conference in San Diego. In December, the ONC finalized a new rule that instated transparency requirements for the use of AI in healthcare settings. It requires healthcare AI developers to provide more data about their products to customers, which could aid providers in determining AI tools’ risks and effectiveness. Under the new rule, AI vendors must share information about how their software works and how it was developed. That means disclosing information about ...
- Source: drugdu
- 116
- May 30, 2024
With M&A Deal, Click Therapeutics’ Digital Prospects in Metabolic Disease Get Better

Click Therapeutics is acquiring the assets of Better Therapeutics two months after that digital therapeutics developer announced it would lay off all employees and shut down. Better’s main asset is AspyreRx, an FDA-authorized mobile app for type 2 diabetes. By Frank VinluanDigital therapeutics developer Click Therapeutics is building up its prospects in cardiometabolic disorders by acquiring the assets of Better Therapeutics, a company whose technology platform yielded one FDA-authorized product and could serve as a springboard for a range of drug and digital treatment pairings. Better’s FDA-authorized prescription digital therapeutic, named AspyreRx, is a type 2 diabetes mobile app that helps patients modify behaviors in order to change the course of their disease. Artificial intelligence enables the software to personalize treatment plans to each patient. AspyreRx secured FDA authorization last summer, but Better struggled to commercialize the product on its own. Payer coverage decisions on the app were pending as ...
- Source: drugdu
- 73
- May 29, 2024
Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. By Frank Vinluan Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world. The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter. Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events ...
- Source: drugdu
- 73
- May 2, 2024
GlobalData

Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
- Source: drugdu
- 132
- April 20, 2024
Simple PCR Assay Accurately Differentiates Between Small Cell Lung Cancer Subtypes

Small cell lung cancer (SCLC), a rapidly progressing neuroendocrine malignancy, exhibits low survival rates. Despite its molecular and clinical heterogeneity, SCLC is presently treated as a single entity, without the use of predictive biomarkers, which leads to poor patient outcomes. Recent research has proposed dividing SCLC into four subtypes—labeled “A”, “N”, “P”, and “I”—each characterized by distinct molecular signatures and treatment vulnerabilities. Initially, this classification relied on gene expression (RNA-seq) data. Further studies indicated that the same categorization could be recapitulated through the use of a reduced-representation bisulfite sequencing (RRBS) methylation profile. Although this classification system effectively predicts treatment responses, including to immunotherapy, in retrospective analyses, both RNAseq and RRBS techniques are too labor-intensive and slow for quick treatment decisions in an aggressive malignancy. Now, a pilot study published in the journal Cancer Cell has demonstrated the feasibility of a simple PCR assay to accurately differentiate between SCLC SCLC subtypes. ...
- Source: drugdu
- 87
- April 10, 2024

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