PharmaFocus Today – Page 116 – media

AbbVie’s Telisotuzumab Vedotin (Teliso-V) Included in CDE’s List of Breakthrough Therapeutic Varieties

Recently, the Center for Drug Evaluation (CDE) of the State Drug Administration formally included AbbVie’s clinically developed sterile lyophilized powder for infusion, Telisotuzumab Vedotin (Teliso-V), into the list of breakthrough therapeutic drug varieties for the treatment of advanced/late stage c-Met protein (OE) with high expression of c-Met protein (OE) with disease progression occurring during or after platinum-based drug therapy. metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq) non-small cell lung cancer (NSCLC) patients. About Telisotuzumab Vedotin (Teliso-V) Teliso-V is an investigational first-in-class antibody-coupled drug (ADC) targeting the c-MET protein in patients with tumors overexpressing c-Met, a receptor tyrosine kinase that is overexpressed in many solid tumors, including NSCLC. Its efficacy safety as monotherapy in previously treated patients with c-Met overexpressing NSCLC will be further evaluated in the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868) For more information on the Teliso-V clinical trial, please visit https://clinicaltrials.gov/. Currently, there ...
- Source: drugdu
- 145
- June 13, 2024
2024 ASCO | Benmelstobart monotherapy research results in gynecologic oncology and other areas updated

The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago from May 31 to June 4, local time. Chiatai Tianqing’s recently launched Class 1 innovative biologic Benmelstobart announced a number of research results at the meeting, covering the fields of digestive and gynecological oncology. Benmelstobart monoclonal antibody is an innovative humanized anti-PD-L1 monoclonal antibody with a new sequence, which was just approved for marketing in May 2024. The first approved indication is for the first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SLC) in combination with amilotinib hydrochloride capsule, carboplatin and etoposide. Endometrial cancer is one of the most common gynecologic malignancies and its incidence is on the rise worldwide. Most patients with endometrial cancer are diagnosed at an early stage and have a good overall prognosis, with a 5-year survival rate of 95%. Once localized spread or distant metastasis occurs, the 5-year survival rate ...
- Source: drugdu
- 150
- June 13, 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
- 146
- June 12, 2024
Noninvasive Technology Detects Rare Cancer Cells in Blood

Historically, analyzing circulating tumor cells (CTCs) required invasive methods like blood draws, which often missed rare CTCs or multicellular CTC clusters (CTCCs) known for their high metastatic potential. Now, a groundbreaking technology offers a new way for researchers to monitor and understand the spread of cancer within the body. A collaborative effort between researchers at Northeastern University (Boston, MA, USA) and Dartmouth College (Hanover, NH, USA) has led to the development of an innovative device known as “diffuse in vivo flow cytometry” (DiFC). This technology facilitates the noninvasive detection and counting of rare cancer cells circulating in the bloodstream. By utilizing highly scattered light to probe large blood vessels, DiFC overcomes the shortcomings of traditional tests to enable the noninvasive analysis of larger peripheral blood volumes and detection of rare cancer cells. The team’s pioneering two-color DiFC system can simultaneously identify two distinct populations of cancer cell in real time ...
- Source: drugdu
- 141
- June 12, 2024
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
- 115
- 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
- 102
- 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
- 120
- 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
- 145
- 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
- 124
- 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
- 113
- June 12, 2024

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