Search Results for “Clinical Trial” – Page 59 – media

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
- 109
- May 27, 2024
Innovative Fundus Disease Drug Busilixumab Completes First Injections in Mainland Public Hospitals, Benefiting More Fundus Disease Patients

Recently, Guangdong Provincial People’s Hospital successfully completed the injection of the innovative drug Busiliximab, which is also the first batch of injection of this drug in public hospitals in mainland China. Relying on the “Hong Kong-Macau Pharmaceutical and Device Access” policy, Busiliximab has been approved for urgent clinical use in designated medical institutions in the Greater Bay Area. This new generation of anti-VEGF (vascular endothelial growth factor) drugs in public hospitals will enhance the accessibility of innovative therapies and benefit more patients with fundus diseases. China has more than 40 million patients with endophthalmic disease, and is in urgent need of new drugs to break through the treatment dilemma. The number of patients with fundus diseases in China is increasing, with the potential number of patients with fundus diseases reaching 40 million. The most common of them are diabetic retinopathy and age-related macular degeneration, in addition to many other types ...
- Source: drugdu
- 135
- May 25, 2024
Pharma companies urged to act on antimicrobials to combat drug resistance

A new report from the Access to Medicine Foundation calls for urgent changes in research and development (R&D) to ensure new antibiotics and antifungals reach patients facing drug-resistant infections. The report examines five late-stage antimicrobial projects targeting severe drug-resistant pathogens, revealing that structured advance planning for access and stewardship is not yet standard among companies. Four out of five companies—GSK, Pfizer, Innoviva, and Venatorx—are conducting clinical trials involving children, aiming to improve access for paediatric patients. Despite these efforts, only five low- and middle-income countries (LMICs)—China, India, Mexico, South Africa, and Thailand—have concrete commitments for drug registration. Many of the remaining 108 LMICs with high burdens of targeted diseases lack such commitments. The report underscores the need for partnerships and licensing agreements to enhance access in LMICs. SMEs have pursued wider access through collaborations, like those with the Global Antibiotic Research and Development Partnership (GARDP). However, the report finds that ...
- Source: drugdu
- 128
- May 25, 2024
Allying With Patients to Make Every Cure Possible

To win the battle against rare diseases, drug developers must work hand-in-hand with patients. By Sharon KingMy colleagues and I were privileged earlier this year to meet with a caregiver and a young patient living with a rare form of pediatric cancer, who shared their stories and inspiring words of encouragement for the biopharmaceutical industry. Their message resonated with all who were there: Together we are working toward a world where every cure is possible. It’s a big vision. Every day, more than 400 million people around the world are battling a rare disease. Many of those people are facing a scarcity of treatment options, often limited to drug regimens that haven’t been updated in decades and that do little to cure the illness or even slow down the progression of symptoms. Patient communities have long known that working together is the key to making progress, and they have created ...
- Source: drugdu
- 75
- May 24, 2024
Durect’s Larsucosterol Receives FDA Breakthrough Therapy Designation for Severe Alcohol-Associated Hepatitis

Don Tracy, Associate Editor Moving forward, Durect plans on incorporating feedback from the FDA in the design of a Phase III trial. DURECT Corporation announced that the FDA has granted Breakthrough Therapy Designation (BTD) to larsucosterol, a medication that aims to treat patients with severe alcohol-associated hepatitis (AH). According to the company, the designation is based on positive results from the Phase IIb AHFIRM trial, which demonstrated positive safety and efficacy outcomes, with the first portion of data being announced last year, while additional clinical data is expected to be presented at the. European Association for the Study of the Liver (EASL) Congress next month.1 “We’re pleased with the FDA’s decision to grant Breakthrough Therapy designation to larsucosterol, as it further recognizes its potential to save the lives of AH patients,” said James E. Brown, DVM, President, CEO, DURECT, in a press release. “AH has a high mortality rate and ...
- Source: drugdu
- 75
- May 24, 2024
AstraZeneca Plans $1.5B Manufacturing Site for Global Production of ADC Cancer Drugs

The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. AstraZeneca aims to open the facility in 2029.Antibody drug conjugates have fast become a big piece of AstraZeneca’s revenue growth. The drugmaker is taking steps to ensure it has the production capacity to meet market demand for these cancer drugs, revealing plans for a $1.5 billion manufacturing site in Singapore to support its global supply of ADC medicines. Construction of the ADC manufacturing facility will receive support from the Singapore Economic Development Board, AstraZeneca said Monday. The company expects to begin design and construction of the facility by the end of this year. Construction of a new drug manufacturing site and receiving the regulatory approvals for commercial production can take several years. AstraZeneca aims to open its new site for ADC production in 2029. An ADC is a cancer therapy made ...
- Source: drugdu
- 75
- May 23, 2024
First Publication of Chiatai Tianqing’s Novel CDK2/4/6 Inhibitor TQB3616 (Cumoxil) Development and Design Strategy

Recently, the team of Chiatai Tianqing and WuXi AppTec disclosed for the first time in Bioorganic & Medicinal Chemistry Letters the molecular design thinking of the novel CDK2/4/6 inhibitor – TQB3616 (Culmerciclib) and R&D history. Small molecule CDK4/6 inhibitors (Palbociclib, Ribociclib, and Abemaciclib) have been successively approved for the treatment of metastatic breast cancer, of which Abemaciclib has shown fewer adverse effects in the clinic attributed to its superior inhibitory activity on CDK4 kinase than on CDK6. Therefore, the research team worked to discover pyrimidine-indazole molecules that are biased to inhibit CDK4 kinase and have some inhibitory activity against CDK2 and CDK6, and TQB3616 was the preferred molecule among such small molecules obtained by SAR screening. It was found that comparing Palbociclib and Abemaciclib, TQB3616 demonstrated different degrees of inhibitory effects on CDK2, CDK4, and CDK6 kinases, and a higher inhibitory capacity for CDK4 kinase [1]. The inhibition of tumor ...
- Source: drugdu
- 72
- May 23, 2024
FDA Grants Accelerated Approval to Amgen’s Imdelltra for the Treatment of Adults with Extensive-Stage Small Cell Lung Cancer

Don Tracy, Associate Editor Imdelltra (tarlatamab-dlle) is the first T-cell engager therapy approved for extensive stage small cell lung cancer. The FDA has granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following treatment with platinum-based chemotherapy. According to the company, the regulatory action was based on the promising response rate and duration of response (DoR) with Imdelltra observed in clinical studies. The action represents the first and only T-cell engager therapy approved by the FDA for ES-SLCS, and Amgen stated that further indications for the use of Imdelltra could soon follow.1 “The FDA’s approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients,” said Jay Bradner, MD, EVP, research and development, chief scientific officer, Amgen, in a press release. “This ...
- Source: drugdu
- 78
- May 21, 2024
CanSinoBio’s Yu Xuefeng was invited to attend the Asia Healthcare Summit Forum

On May 16, the 4th Asia Healthcare Summit (ASGH), jointly organized by the Hong Kong SAR Government and the Hong Kong Trade Development Council, was held at the Hong Kong Convention and Exhibition Centre. Under the theme of “Innovation – Inclusion – Effectiveness”, the forum covered topics such as challenges and opportunities in the global healthcare industry, the latest developments in medical technology and business opportunities in the Asian healthcare industry, aiming to bring together elites in the global healthcare field to explore ways of innovation and development. Dr. Xuefeng Yu, Chairman and CEO of CanSinoBio, was invited to attend the event to discuss the prospects and business opportunities of the Asian healthcare industry with policy makers, healthcare experts, scholars, business leaders and investors from all over the world, and to strengthen the communication and cooperation among global healthcare industry participants. At the conference, Academician Cao Xuetao, Deputy Director of ...
- Source: drugdu
- 77
- May 21, 2024
Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck

Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
- Source: drugdu
- 74
- May 17, 2024

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