Search Results for “EC” – Page 68 – media

Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F

Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells FasTCAR-T GC012F has demonstrated a favorable safety profile in clinical investigator-initiated trials in 60 patients with multiple myeloma and B-cell non-Hodgkin lymphoma SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 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 announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared Gracell’s Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE). Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate ...
- Source: drugdu
- 82
- December 25, 2023
“National Key Laboratory for R&D of New Vaccines for Emerging Infectious Diseases” was launched!

On December 20, the kick-off meeting of “National Key Laboratory for R&D of New Vaccines for New Emerging Infectious Diseases” and the first meeting of the first Academic Committee were held at Sinopharm China Biologicals. Deng Jindong, Vice General Manager of Sinopharm and Chairman of China Bio, and Yang Xiaoming, Chief Scientist and Chief Engineer of Sinopharm, Chief Scientist of China Bio, and Director of the National Key Laboratory for R&D of Novel Vaccines for Newly Emerging Infectious Diseases, formally launched the “National Key Laboratory for R&D of Novel Vaccines for Newly Emerging Infectious Diseases”. Academician Zhao Jia, Academician Chen Xiangmei, Academician Li Zaikun, and Academician Wang Junzhi of the Chinese Academy of Engineering attended the launching meeting. After the launching meeting, the National Key Laboratory of New Vaccine Development for Emerging Infectious Diseases held the first meeting of the first academic committee. The Academic Committee listened to and passed ...
- Source: drugdu
- 83
- December 25, 2023
FDA Grants Priority Review to Genentech’s sBLA for Xolair to Treat Food Allergies

Pharmaceutical Executive Editorial Staff If approved by the FDA, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure, including peanut, milk, and egg allergies. The FDA has granted Priority Review to Genentech’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of allergic reactions, such as anaphylaxis, that may result from an accidental exposure to one or more foods in patients aged 1 year and older with a food allergy. If the FDA approves the application, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure. Roche said it expects the FDA to decide on the approval in the first quarter of 2024. “Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global ...
- Source: drugdu
- 101
- December 22, 2023
Kunming Plasma Products, a subsidiary of China National Pharmaceutical Group (Sinopharm), has been selected for the list of Intelligent Manufacturing Demonstration Factories in 2023.

The announcement, jointly released by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Finance, the State-owned Assets Supervision and Administration Commission of the State Council, and the State Administration for Market Regulation, highlights Kunming Plasma Products’ achievement in intelligent manufacturing by making it to the ‘2023 Intelligent Manufacturing Demonstration Factories’ list. This recognition marks a new milestone in Kunming Plasma Products’ efforts towards intelligent manufacturing and digital factory construction. As a crucial component of China’s ’14th Five-Year Plan’ Intelligent Manufacturing Pilot Demonstration Action, the national-level Intelligent Manufacturing Demonstration Factories and Outstanding Scenes are part of a major national project led jointly by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the State-owned Assets Supervision and Administration Commission of the State Council, the Ministry of Finance, and the State Administration for Market Regulation. The initiative aims to select ...
- Source: drugdu
- 201
- December 22, 2023
【EXPERT Q&A】What documents are needed and what is the specific process for exporting medical equipment?

Drugdu.com expert’s response: Exporting medical equipment requires a thorough understanding of the regulatory requirements of both the exporting and importing countries, and involves several steps and essential documents: 1.Regulatory Compliance Compliance with Exporting Country Regulations: Ensure the medical equipment meets the regulatory standards of the country of origin. Compliance with Importing Country Regulations: Understand and comply with the medical device regulations of the destination country, which may include certifications like CE Marking (for Europe) or FDA approval (for the United States). 2.Essential Documents Export License: Depending on the type of equipment and the destination, an export license may be required. Commercial Invoice: Details the transaction between the exporter and importer. Packing List: Describes the contents and packaging details of the shipment. Bill of Lading or Airway Bill: Used for the shipment of goods. Certificate of Origin: States where the equipment was manufactured. Product Certifications: Documents like CE Certificate or FDA ...
- Source: drugdu
- 170
- December 22, 2023
Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent

A German court has dealt the first blow against CureVac amid the company’s heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. The German Federal Patent Court ruled that one of eight CureVac patents involved in the litigation is invalid, the company said in a Tuesday release. The patent in question covers a process that improves the expression of mRNA in cells, Juve Patent reports. The ruling came as a surprise to CureVac, which noted that the court in April issued a preliminary opinion in favor of the patent’s validity. Still, CureVac believes its “pioneering role in mRNA technology and continuing innovation in the field made essential contributions to safe and efficacious COVID-19 vaccines,” CEO Dr. Alexander Zehnder said in a statement. The company will “continue to defend our claim for recognition and fair compensation and will take appropriate action by appealing this decision,” Zehnder added. CureVac’s appeal ...
- Source: drugdu
- 92
- December 21, 2023
Smartwatches prove effective in detecting heart arrhythmias in children

A recent study published in the journal Communications Medicine discusses how smartwatches can facilitate the diagnosis of arrhythmias in children. Background Smartwatches and other wearable devices are becoming increasingly popular and allow users to constantly monitor their health, leading to their value for medical diagnosis becoming well-recognized. While the utility of these devices for adults has been widely researched, including for cardiac health monitoring and reducing the time needed to detect symptomatic rhythms, little is known about how they can be used to monitor child health indicators. Palpitations and abnormalities in cardiac rhythms are a leading cause of referrals in pediatric cardiology. However, existing non-invasive methods like patch rhythm monitors are not always effective in diagnosing arrhythmias, as symptoms often present infrequently, and children cannot wear monitors for as long as adults. Invasive methods such as implantable loop monitors (ILR) allow long-term monitoring. However, this approach may not be ideal ...
- Source: drugdu
- 107
- December 20, 2023
Fluorescence Microscopy Combined with AI Enables Detection of Tumors at Early Stage

Detecting cancer in the body or monitoring it during therapy is typically a time-consuming process, often conducted in later phases when signs become obvious. Researchers engaged in cancer research are continuously seeking reliable and sensitive techniques to detect a developing tumor at a very early stage and to closely monitor the success or failure of cancer therapy. Therefore, a breakthrough in early cancer diagnosis is a significant advancement. Researchers have now achieved a breakthrough with the development of a test for early diagnosis of cancer. Researchers at the Paul Scherrer Institute (Würenlingen, Switzerland) have demonstrated that changes in the organization of the cell nucleus of certain blood cells can reliably indicate the presence of a tumor in the body. Using fluorescence microscopy, the team examined the chromatin of these blood cells – DNA packaged into a complex structure. They analyzed about 200 different characteristics, including the external texture, the packing ...
- Source: drugdu
- 110
- December 20, 2023
GSK tees up AstraZeneca rivalry with positive Jemperli-Zejula readout in endometrial cancer

On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. This time, the company is touting results for its PD-1 inhibitor Jemperli and PARP inhibitor Zejula, which could become a threat to a rival therapy at AstraZeneca. Adding Jemperli and Zejula to chemotherapy significantly extended the time before tumor progression or death in patients with primary advanced or recurrent endometrial cancer that’s mismatch repair proficient or microsatellite stable (pMMR/MSS), GSK said Monday. The results came from the second part of the phase 3 RUBY trial. The trial also showed that the Jemperli-Zejula-chemo regimen was better at delaying disease worsening than chemo alone in the overall population, regardless of genetic stability. But GSK appears to think that the combo has more value in the pMMR/MSS subgroup. Patients with pMMR/MSS endometrial cancer have few treatment options, Hesham Abdullah, GSK’s head of oncology R&D, said in ...
- Source: drugdu
- 197
- December 20, 2023
Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples

Microfluidics, which are miniature devices that control the flow of liquids and facilitate chemical reactions, play a key role in disease detection from small samples of blood or other fluids. Commonly known examples include at-home Covid-19 test kits, which use basic microfluidic technology. However, more complex microfluidic applications often require chemical reactions at precise temperatures. Typically, these advanced devices are produced in clean rooms and include heating elements made of expensive materials like gold or platinum, making the manufacturing process costly and challenging to scale. Researchers have now made a breakthrough by employing 3D printing to build self-heating microfluidic devices, potentially paving the way for the creation of affordable and efficient tools that could detect various diseases. Scientists at the Massachusetts Institute of Technology (MIT, Cambridge, MA, USA) innovatively utilized multimaterial 3D printing to fabricate microfluidic devices with integrated heating elements. This development allows for precise temperature control of fluids ...
- Source: drugdu
- 84
- December 19, 2023

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