PharmaFocus Today – Page 238 – media

Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023

Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months GC012F is a FasTCAR-enabled B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T therapy being evaluated for hematologic malignancies and autoimmune disease SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 11, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented updated results from the clinical investigator-initiated trial (IIT) of GC012F for treatment of newly diagnosed multiple myeloma (NDMM) as an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place in San Diego, California and online. GC012F demonstrated a 100% overall response rate (ORR) and 95% ...
- Source: drugdu
- 166
- December 15, 2023
BMJ probe questions oversight of UK pharmacy materials on Wegovy amid illegal ad accusations

A BMJ investigation has shone a spotlight on the marketing of semaglutide in the U.K., raising questions about the effectiveness of regulatory oversight of materials on the weight loss and diabetes treatment. Novo Nordisk is the marketing authorization holder for semaglutide, the active ingredient in diabetes drug Ozempic and obesity therapy Wegovy, but the results of online searches for the molecule include pharmacy websites unrelated to the drugmaker. The BMJ looked into whether any of those pages break the rules on the advertising of prescription drugs and how authorities in the U.K. respond to allegations of illegal promotion. A complaint filed by academics in the U.K. and Sweden forms the centerpiece of the report. Writing to the U.K. drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), the academics said they were “appalled” to find Pharmadoctor, a provider of clinical services to pharmacists, was marketing Wegovy “directly to the ...
- Source: drugdu
- 214
- December 15, 2023
After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

After last year’s explosive ruling to overturn the historic abortion ruling reached in Roe v. Wade, abortion access is back up for debate in the Supreme Court. This time, the FDA’s power is on the table, too. The United States’ highest court has agreed to review a Fifth Circuit appeals ruling that restricted access to Danco Laboratories’ abortion pill mifepristone and called the FDA’s regulatory authority into question, an order list (PDF) shows. Specifically, the appeals court’s prior ruling cut down the FDA’s approval for the pill to be delivered by mail, a call the agency made after the Supreme Court overturned Roe v. Wade. It also shrank the time frame the med can be used during pregnancy from 10 weeks to 7 weeks. The Fifth Circuit called the FDA’s approval process for the expanded access flawed and said the agency exceeded its authority. However, the appeals court did dismiss ...
- Source: drugdu
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- December 15, 2023
Discover the Advanced Medical Centrifuge Solutions from Hunan Kecheng Instrument Equipment Co., Ltd.

Hunan Kecheng Instrument Equipment Co., Ltd., a leading manufacturer of medical centrifuges, is delighted to showcase its extensive range of products, including high-speed centrifuges, low-speed centrifuges, refrigerated centrifuges, blood bank centrifuges, and more. Our centrifuges are designed to cater to the needs of hospital laboratories, medical laboratories, and beauty institutions worldwide. Understanding that choosing the right centrifuge can be challenging, our low-speed centrifuges are tailored for hospital laboratories, especially for vacuum blood collection tube separation. We offer a unique solution with an automatic uncapping feature post-centrifugation, enhancing efficiency and reducing manual effort. Our patented rotor design for automatic uncapping includes multiple capacities, catering to different hospital requirements. Our product line includes: TD4K blood card special centrifuge: Ideal for blood type serology, routine blood tests, and immunoassays. TD4B cell smear centrifuge: Extensively used in immune blood laboratories for red blood cell serology and antigen identification. 3-5N urine sediment centrifuge: A ...
- Source: drugdu
- 184
- December 15, 2023
Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune

Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
- Source: drugdu
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- December 14, 2023
AstraZeneca’s Icosavax M&A Deal Helps It Stand Out in Multivalent Vaccines Chase

AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax’s pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults. By FRANK VINLUAN AstraZeneca is already in the respiratory syncytial virus market with two products, including the drug Beyfortus, approved earlier this year. An M&A deal will give AstraZeneca an RSV vaccine candidate based on technology that could help the company compete where new vaccines are going. AstraZeneca is acquiring clinical-stage Icosavax for $800 million up front, the pharmaceutical giant announced Tuesday. Under the deal terms, AstraZeneca will pay $15 for each Icosavax share, which is a nearly 43% premium to the stock’s closing price on Monday. AstraZeneca could pay an additional $5 per share depending on the progress of Icosavax’s vaccine candidates. That payout could bring the value of the deal to $1.1 billion. The vaccines of Seattle-based ...
- Source: drugdu
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- December 14, 2023
Automated Device for Non-Invasive Measurement of Cells’ Electrical Properties to Advance Cancer Diagnosis

Effective monitoring of cancer cells is crucial for physicians in guiding treatment and managing the disease, potentially reducing cancer-related mortality. Non-invasive diagnostic platforms that measure the electrical properties of cancer cells show promise for early detection of drug resistance and metastasis in cancer. Earlier studies have found that the type of cancer and its drug resistance status can be understood from cellular permittivity and conductivity data. As a result, there is a growing need for analytical methods that can quickly measure these electrical properties of cells. Electrorotation (ROT) is one method that can capture these cellular properties by analyzing permittivity and conductivity based on how a cell moves in an electric field. This method characterizes cell types and states by profiling their frequency-dependent rotational movement under a modulated electric field. However, traditional ROT methods have limitations, primarily the cumbersome process of capturing, measuring, and replacing cells, which reduces the throughput ...
- Source: drugdu
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- December 14, 2023
HPV DNA Test Using Lymphatic Fluid Collected After Surgery Could Predict Risk of Cancer Recurrence

Head and neck cancer, previously linked to heavy drinking and smoking, has seen a significant shift due to human papillomavirus (HPV). In fact, HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) has become the most prevalent HPV-related cancer, surpassing cervical cancer, with increasing cases globally. Despite treatments, up to 30% of head and neck cancer patients face recurrences, often due to elusive cancer cells that treatments miss. Recently, the focus has shifted to liquid biopsy for detecting cancer recurrences post-treatment. Liquid biopsies search for cancer indicators in body fluids like blood and urine. Now, a new study has found that liquid biopsy of lymphatic fluid, which is commonly thrown away post-surgery, could be key in tailoring treatments for HPV-driven head and neck cancer. The groundbreaking study by researchers at University of Pittsburgh (Pittsburgh, PA, USA) and Washington University School of Medicine in St. Louis (WUSTL, St. Louis, MO, USA) revealed that HPV ...
- Source: drugdu
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- December 14, 2023
CanSino Biologics completed the first subject enrollment in Phase I clinical trial of its component diphtheria-tetanus and pertussis combined vaccine for adolescents and adults

Recently, CanSino Biologics’ adsorbed acellular (component) diphtheria-tetanus combination vaccine (hereinafter referred to as “Tdcp for adolescents and adults”) officially launched Phase I clinical trials and completed the enrollment of the first subject. Tdcp for adolescents and adults is suitable for people aged 6 years and above. It is a booster vaccine for adolescents and adults. This randomized, blinded, controlled phase I clinical trial will initially evaluate the safety and immunogenicity of the vaccine. Whooping cough, diphtheria and tetanus, also known as diphtheria, are serious diseases caused by bacteria. Since the protective effect of immunity triggered by the main antigen of pertussis gradually decreases after vaccination, the incidence and mortality of pertussis gradually increase in the post-vaccination population. The domestic market is in urgent need of a DPT vaccine with longer-lasting immune protection and higher safety. Major developed countries have included this vaccine in their regular vaccination plans, but there is ...
- Source: drugdu
- 145
- December 14, 2023
CanSinoBIO Kicks-off the Polio VLP Vaccine Cooperation

December 1, 2023 – CanSino Biologics Inc. (“CanSinoBIO” or “the Company”) kicked off its innovative Polio VLP Vaccine Cooperation that aims to eradicate polio worldwide today as representatives from The Bill & Melinda Gates Foundation (the foundation) visited the facility. Dr. Xuefeng Yu, Chairman and CEO, Dr. Shoubai Chao, Chief Operating Officer, Dr. Tao Zhu, Chief Scientific Officer, and Ms. Jing Wang, Chief Commercial Officer and representatives from CanSinoBIO gave warm welcome to the foundation delegation. Dr. Xuefeng Yu expressed his gratitude to the foundation for their support over the past years that enabled CanSinoBIO to play a vital role in the global polio eradication efforts. CanSinoBIO is committed to continuously focusing on this fight against the vaccine-preventable disease and make a greater impact on global public health. CanSinoBIO has been actively participating in the World Health Organization (the WHO) polio eradication strategy to eliminate the disease, and has been ...
- Source: drugdu
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- December 14, 2023

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