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FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk

Don Tracy, Associate Editor Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease. GSK’s Arexvy (RSV Vaccine, Adjuvanted) has been approved by the FDA for an expanded indication to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 50-59 years with an increased risk. The approval for this age group was based on encouraging results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of Arexvy in adults aged 50-59, including those with underlying medical conditions. Arexvy was previously approved for adults aged 60 years and older for the same purpose in May 2023. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommended its use through shared clinical decision-making.1 “[This] approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those ...
- Source: drugdu
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- June 12, 2024
Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program

Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion. By Frank VinluanDespite some evidence that cannabis reduces intraocular eye pressure from glaucoma, the ophthalmology community hasn’t embraced its use. One reason cited: The short duration of effect means a patient must smoke or ingest a lot of marijuana to maintain its effect throughout the day. Skye Bioscience’s ambitions to bring glaucoma patients these therapeutic benefits in a twice-daily eye drop have missed the mark. The clinical-stage company is now turning its focus to another drug that targets the same receptor in a different way for a different indication — weight loss. In doing so, Skye aims to show it can compete with ...
- Source: drugdu
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- June 12, 2024
Serac’s imaging agent marks a breakthrough in endometriosis detection

In a significant advancement for endometriosis diagnosis, Serac Healthcare, in collaboration with the University of Oxford, has presented new data showcasing the effectiveness of 99mTc-maraciclatide in imaging the earliest stage of the disease. The DETECT study’s findings, presented by Dr. Tatjana Gibbons at the European Endometriosis Congress, reveal the agent’s potential as a non-invasive diagnostic tool. The study involved imaging the first ten patients with suspected endometriosis using a SPECT-CT camera, followed by laparoscopic surgery to confirm the presence and location of endometriotic lesions. The imaging results aligned with surgical and histological reports, suggesting that 99mTc-maraciclatide could accurately identify superficial peritoneal endometriosis, which accounts for approximately 80% of all diagnoses and is typically only detectable through surgery. David Hail, CEO of Serac Healthcare, expressed optimism about the findings: “The promising initial findings have been further confirmed by more patients in this study indicating the very exciting possibility that maraciclatide has ...
- Source: drugdu
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- June 12, 2024
Boehringer Ingelheim’s survodutide shows promise in liver fibrosis treatment

Boehringer Ingelheim has unveiled promising results from a Phase II trial of survodutide, demonstrating a notable improvement in liver fibrosis among patients. The sub-analysis indicated that up to 64.5% of adults with moderate to advanced scarring (fibrosis stages F2 and F3) experienced an improvement without worsening metabolic dysfunction-associated steatohepatitis (MASH), compared to 25.9% with placebo after 48 weeks of treatment. The findings, presented at the European Association for the Study of the Liver Congress (EASL) 2024 and published in The New England Journal of Medicine, also showed that up to 52.3% of adults treated with survodutide achieved a significant improvement in liver scarring across stages F1 to F3, versus 25.8% with placebo. Dr. Arun Sanyal, Professor of Medicine at Virginia Commonwealth University School of Medicine and Principal Investigator of the trial, said: “I am particularly excited about the findings of the phase 2 trial in survodutide, which demonstrate the potential ...
- Source: drugdu
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- June 12, 2024
Qilu Pharmaceutical’s Three Clinical Studies on Cancer Immunotherapy Presented at ASCO 2024

JINAN, China, June 6, 2024 /PRNewswire/ — The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting convened from May 31 to June 4, 2024 in Chicago, USA, adopting a hybrid format. Among the presented works, three clinical studies from Qilu Pharmaceutical were selected for poster sessions. These studies introduced novel immunotherapeutic agents, specifically QLF31907, a bispecific antibody targeting PD-L1/4-1BB; iparomlimab and tuvonralimab, a MabPair product targeting PD-1/CTLA-4; and iparomlimab, a monoclonal antibody targeting PD-1. The research involved treatments for advanced solid tumors and lymphoma, nasopharyngeal carcinoma, as well as solid tumors characterized by either DNA mismatch repair (dMMR) deficiency or high microsatellite instability (MSI-H). QLF31907, developed by Qilu Pharmaceutical, combines two mechanisms: blockade of PD-L1 to restore T-cell receptor (TCR) signaling, while binding to 4-1BB to provide costimulatory signals essential for T-cell activation. This dual-action mechanism fosters T-cell proliferation and activation, enhancing the anti-tumor immune response. The study, led ...
- Source: drugdu
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- 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
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- June 12, 2024
Abbott wins CE mark for dual-chamber leadless pacemaker

Dive Brief Abbott said Thursday it has received a CE mark for its dual-chamber leadless pacemaker, clearing the company to start selling the system in Europe. The Aveir DR system has two synchronized leadless pacemakers, one for the right atrium and another for the right ventricle, setting it apart from single-chamber devices such as Medtronic’s Micra. Abbott has identified the device, which won approval in the U.S. in 2023, as a product that can help its cardiac rhythm management business achieve sales growth of at least around 6% to 7%. Dive Insight Abbott named Aveir as a driver of the 7.5% organic sales growth reported by its rhythm management unit in the first quarter. CEO Robert Ford said on an earnings call in April that Aveir “rapidly captured market share” in the single-chamber pacing segment after its U.S. authorization last year. Ford cited the longer-lasting battery and ability to upgrade ...
- Source: drugdu
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- June 11, 2024
CISA warns of cybersecurity risks in Baxter products

Dive Brief The Cybersecurity and Infrastructure Security Agency posted two notices last week regarding vulnerabilities in Baxter products that could allow unauthorized users to compromise machines or access credentials. The notices outline cyber risks in a Baxter Welch Allyn patient monitor and a Baxter Welch Allyn configuration tool. The notice for the configuration tool stated that Baxter found “no evidence to date of any compromise of personal or health data,” while the notice for the patient monitor said that no known public exploitation “specifically targeting this vulnerability has been reported to CISA at this time.” Baxter, which posted cybersecurity bulletins on its website on May 30, declined to comment on how the vulnerabilities were identified and whether they were found due to a breach or cyberattack. Dive Insight The CISA posted notices outlining two separate issues with the Baxter products. One notice covered the use of a default encryption key ...
- Source: drugdu
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- June 11, 2024
FDA Committee Votes Against Approval of Lykos Therapeutics’ MDMA Treatment for PTSD

Don Tracy, Associate Editor In a majority vote, the Psychopharmacologic Drugs Advisory Committee cited concerns regarding the data presented for MDMA as a treatment for post-traumatic stress disorder. The FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) has voted against recommending Lykos Therapeutics’ New Drug Application (NDA) for midomafetamine (MDMA) capsules for use in combination with psychological intervention for the treatment of post-traumatic stress disorder (PTSD) in adults. The committee voted 2-to-9 against the efficacy of the treatment, and voted 1-to-10 against the benefits outweighing the risks, stating its doubts that MDMA-assisted therapy is effective in treating PTSD.1 “We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Amy Emerson, CEO, Lykos Therapeutics, in a press release. As a basis of their ...
- Source: drugdu
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- June 11, 2024
ITM gains $204.6m investment for radiopharmaceutical pipeline

ITM Isotope Technologies Munich (ITM) has secured an investment of €188m ($204.6m) aimed at bolstering its radiopharmaceutical pipeline. Global investment company Temasek spearheaded the funding round with contributions from entities managed by BlackRock, the Qatar Investment Authority (QIA), ATHOS and Carbyne. The funding will be channelled towards advancing and broadening ITM’s radiopharmaceutical pipeline, supporting the development platform and commercially launching its Phase III lead candidate, ITM-11 (n.c.a.177Lu-edotreotide). The asset is currently under evaluation in two Phase III trials, COMPETE and COMPOSE, for the treatment of gastroenteropancreatic neuroendocrine tumours. The investment will enable ITM to bolster its manufacturing capabilities for Lutetium-177 (177Lu) and expand its production to include other high-value medical radioisotopes such as Actinium-225 (225Ac). As part of the expansion, the company will also supply the in-demand medical radioisotopes to its extensive global network and utilise them to diversify its radiopharmaceutical therapy pipeline. This strategy is designed to address a ...
- Source: drugdu
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- June 11, 2024

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