Search Results for “Clinical Trial” – Page 58 – media

GSK’s Quest to Bring Myeloma Drug Back to the Market Stops for a Data Drop at ASCO

GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.A GSK multiple myeloma drug that was withdrawn from the market is accumulating new clinical data that could support its return — perhaps as an earlier line of therapy. With the latest results, clinicians and GSK executives say they may have figured out how to address a lingering question about how to safely dose the drug, Blenrep. The new data were presented Sunday during the annual meeting of the American Society of Clinical Oncology in Chicago. Blenrep is an antibody drug conjugate (ADC) that targets the BCMA protein on multiple myeloma cells, delivering to them a payload of toxic chemotherapy. There are many multiple myeloma drugs available, but frequent relapse in this ...
- Source: drugdu
- 106
- June 4, 2024
The Crick announces new partnerships with SMEs and MRC for research

The projects will focus on a range of research areas, including Down’s syndrome and ALS The Francis Crick Institute has announced six new partnerships with small and medium-sized enterprises (SMEs) with support from the Medical Research Council (MRC) focused on innovative discovery projects led by Crick researchers. Supported by an MRC Business Engagement Fund Award, as part of UK Research and Innovation, the collaborations will focus on the application of novel cutting-edge technologies, encompassing a diverse range of research to deliver impactful outcomes. Paul Mercer, head of collaboration, the Crick, commented: “We are… excited to be able to develop these research partnerships with SMEs, diversifying the opportunity for development of Crick discoveries through the application of disruptive innovations.” Partners include Perha Pharmaceuticals, Scalable Minds, Broken String Biosciences, Hertility Health, Automata Technologies and Mytos. The projects will focus on a range of research, including pharmacological treatments for congenital heart defects in ...
- Source: drugdu
- 84
- June 4, 2024
FDA Grants Priority Review to Jazz Pharmaceuticals’ Zanidatamab for Multiple Forms of HER-2 Positive Biliary Tract Cancer

Don Tracy, Associate Editor Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer. Jazz Pharmaceuticals announced that the FDA has granted Priority Review to zanidatamab, a bispecific antibody being evaluated for previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). According to the company, the submission was based on positive results from Cohort 1 of the Phase IIb HERIZON-BTC-01 clinical trial, which showed a confirmed objective response rate (cORR) of 41.3%. The FDA assigned the application with a Prescription Drug User Fee Act target action date of November 29, 2024. A Phase III trial, HERIZON-BTC-302, is evaluating zanidatamab in combination with standard-of-care therapy against standard-of-care therapy alone in first-line advanced or metastatic HER2-positive BTC.1 “The priority review designation for zanidatamab underscores the critical ...
- Source: drugdu
- 102
- June 3, 2024
FDA Approves Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma

Davy James Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.The FDA has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who were previously administered at least two lines of systemic therapy that included a Bruton tyrosine kinase (BTK) inhibitor.1 The regulatory action marks the fourth indication for Breyanzi to treat a distinct subtype of non-Hodgkin lymphoma. “With Breyanzi, we are delivering on the promise of cell therapy by offering a definitive treatment option for some of the most difficult-to-treat lymphomas,” Bryan Campbell, senior vice president, head of Commercial, Cell Therapy, BMS, said in a press release. “We are proud of the advances we are making to bring our differentiated CAR T cell therapy to the most patients across indications and lines of therapy to ensure treatment options that ...
- Source: drugdu
- 92
- June 3, 2024
FDA grants priority review to Genentech’s Inavolisib

Genentech, a member of the Roche Group, announced that the USFDA has accepted the company’s new drug application and granted priority review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. The priority review is based on the positive Phase III INAVO120 results, which showed the inavolisib-based regimen more than doubled progression-free survival, reducing the risk of disease worsening or death by 57 per cent compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95 per cent CI: 0.32-0.59, p<0.0001) in the first-line setting. Overall survival (OS) data were immature at the time of primary analysis, but a clear positive trend was observed ...
- Source: drugdu
- 82
- May 31, 2024
Cure Genetics Announced Promising Safety and Efficacy Data of CAR-NKT Product CGC729 for RCC at ASGCT 2024

SUZHOU, China, May 23, 2024 /PRNewswire/ — On May 10, 2024, Cure Genetics announced the safety and efficacy data of their CAR-NKT product, CGC729, for patients with relapsed and refractory metastatic renal cell carcinoma (R/R mRCC) in an oral presentation at the 27th Annual Meeting of the American Society for Gene & Cell Therapy (ASGCT) in Baltimore. This marked the first-in-human trial using CAR-NKT therapy for R/R mRCC, demonstrating a good safety profile and encouraging anti-tumor activity. This phase I dose-escalation clinical trial was conducted at Fudan University Shanghai Cancer Center using a single-arm, 3+3 design to evaluate the safety and efficacy of CGC729 at three dose levels (DL1: 5 x 106/m2; DL2: 1.5 x 107/m2; DL3: 4.5 x 107/m2) in the treatment of R/R mRCC patients who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and received a single infusion of ...
- Source: drugdu
- 111
- May 30, 2024
GlobalData

Innovent Biologics has unveiled Phase III (DREAMS-2) results for mazdutide, indicating superiority over dulaglutide in glycaemic control for type 2 diabetes (T2D) patients in China. “With its potential to revolutionise T2D treatment, mazdutide’s success could not only reshape the landscape of diabetes therapeutics in China but also underscores the growing demand for innovative solutions amidst the escalating prevalence of T2D in the region,” says GlobalData. Mazdutide is reportedly the only glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist to reach Phase III stage of development (China) for type 2 diabetes (T2D) globally. DREAMS-2 (NCT05606913) Phase III study compared the efficacy and safety of mazdutide and dulaglutide in Chinese subjects with T2D, who have inadequate glycemic control with metformin monotherapy or combination therapy of metformin with other oral drugs. The primary endpoint was successfully met, showing the robust glucose-lowering efficacy of mazdutide. The key secondary endpoints showed mazdutide’s superior ...
- Source: drugdu
- 78
- May 29, 2024
GlobalData

Great progress has been made in the management of female infertility since the introduction of assisted reproductive technology, predominantly in vitro fertilisation (IVF). However, despite the improvements made in the space, challenges associated with the treatment remain. The development of non-injectable fertility medications represents a significant unmet need, according to key opinion leaders (KOLs) interviewed by GlobalData. Dr Shireen Mohammad, Senior Cardiovascular & Metabolic Disorders Analyst at GlobalData, comments, “KOLs have described the level of unmet need in this market as moderate. While injectable gonadotropins are commonly used in IVF, they require subcutaneous or intramuscular injections, which can be inconvenient, painful, and stressful for patients. Therefore, the development of non-injectable alternatives could offer significant benefits in terms of patient convenience, compliance, and the overall treatment experience.” Linzagolix choline, developed by Kissei Pharmaceutical, is an orally administered gonadotropin-releasing hormone (GnRH) receptor antagonist currently in Phase III clinical trials in the US, ...
- Source: drugdu
- 92
- May 28, 2024
Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients

Multiple sclerosis (MS) is a chronic neurological condition for which there is currently no cure. It affects around three million people globally and ranks as the second most common cause of disability among young adults. The urgent need for improved treatments has led to extensive research into various viruses associated with MS, with the Epstein-Barr Virus (EBV) emerging as a significant risk factor for the disease. It remains unclear why certain individuals with MS exhibit an abnormal immune response to EBV, which typically causes no symptoms in most people. Now, a novel blood test has been developed that measures the immune response to EBV, providing new avenues for basic research into EBV’s role in MS and potential applications in clinical trials aimed at targeting the virus. Researchers at Trinity College Dublin (Dublin, Ireland) conducted studies measuring the immune response of MS patients to EBNA-1, a component of EBV that resembles ...
- Source: drugdu
- 117
- May 28, 2024
Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients

Multiple sclerosis (MS) is a chronic neurological condition for which there is currently no cure. It affects around three million people globally and ranks as the second most common cause of disability among young adults. The urgent need for improved treatments has led to extensive research into various viruses associated with MS, with the Epstein-Barr Virus (EBV) emerging as a significant risk factor for the disease. It remains unclear why certain individuals with MS exhibit an abnormal immune response to EBV, which typically causes no symptoms in most people. Now, a novel blood test has been developed that measures the immune response to EBV, providing new avenues for basic research into EBV’s role in MS and potential applications in clinical trials aimed at targeting the virus. Researchers at Trinity College Dublin (Dublin, Ireland) conducted studies measuring the immune response of MS patients to EBNA-1, a component of EBV that resembles ...
- Source: drugdu
- 124
- May 27, 2024

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