AI remained one of the main talking points at CTS Europe, as the roadmap for generative AI was mapped out. In 2022, the launch of the generative Artificial Intelligence (AI) platform ChatGPT broke the record for the fastest-growing consumer application in history. Following the rapid adoption of AI technologies, the pharma sector is now exploring the capabilities and challenges of generative AI as it remains one of the key trends in the industry. However, despite the recent progress in the use of AI in real-world situations, we are still in the early stages of the AI roadmap, research director at GlobalData Josep Bori, at the recently concluded Clinical Trial Supply (CTS) Europe 2024 meeting. Generative AI is a technology capable of generating text, images or other data using generative models, often in response to prompts. Explaining how generative AI works, Bori said: “AI is trying to optimise the output to ...
March 4), according to the CDE official website, Lundbeck’s clinical trial application for Class 1 chemical drug Lu AF28996 capsules has been accepted. Currently, the drug is undergoing Phase I clinical trials overseas. Parkinson’s disease is a neurological dysfunction disease with complex symptoms and difficult early diagnosis. It is common in middle-aged and elderly people. At present, the main treatment for Parkinson’s disease is drug therapy, with the purpose of reducing symptoms, delaying the progression, and improving the patient’s quality of life. Lu AF28996 is a dopamine D1/D2 receptor agonist developed by Lundbeck Pharmaceuticals. It is a relatively new anti-Parkinson therapy and is currently undergoing Phase I clinical trials overseas. Among them, a study to evaluate the safety, tolerability, etc. of Lu AF28996 in Parkinson’s patients is expected to be completed in 2025. This time, the approval of Lu AF28996’s clinical trial application in China is expected to bring a ...
Hainan Shuangcheng Pharmaceuticals was approved by the State Drug Administration to issue Drug Registration Certificate to Octreotide Acetate Injection. Basic drug information 1, drug name: octreotide acetate injection 2、Dosage form: Injection 3、Specifications: 1ml:0.1mg (C₄₉H₆₆₁₀O₁₀S₂) 4、Registration Classification: Class 4 chemical drugs 5、Drug Approval Number: State Drug License H20243223 6、Prescription drug/over-the-counter drug: prescription drug 7、Listed Licensee: Hainan Shuangcheng Pharmaceutical Co. 8、Manufacturer: Hainan Shuangcheng Pharmaceutical Co. 9, Production Address: Haikou City, Xiuying District, No. 16 Xingguo Road Approved indications Octreotide acetate injection is indicated for the control of symptoms and reduction of plasma levels of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in patients with acromegaly who are unable or unwilling to undergo surgery or radiation therapy. Treatment of patients with acromegaly who are unable or unwilling to undergo surgery, or treatment of patients with intermittent acromegaly for whom radiation therapy has not yet taken effect; alleviation of symptoms ...
The non-invasive tool can also improve patient stratification and monitor disease progression Researchers from King’s College London (KCL) have developed a deep learning framework for a non-invasive brain-age prediction tool for the early diagnosis of neurological diseases. The study built and made available a set of models for clinical use after training multiple brain models from a variety of magnetic resonance image (MRI) types. Neurological disorders, such as Alzheimer’s disease, strokes, multiple sclerosis and Parkinson’s disease, are conditions that affect the brain as well as the nerves found throughout the human body and spinal cord. By comparing patients’ brain ages against their chronological ages, numerous neurological and psychiatric conditions can be identified, helping to predict future health outcomes for patients. Researchers collected over 81,000 patients’ head MRI examinations from Guy’s and St Thomas’ NHS Foundation Trust and King’s College Hospital NHS Foundation Trust between 2008 and 2019. After pre-training models, ...
Don Tracy, Associate Editor Teens to be included in both placebo and open label studies for QRX003, a potential treatment for Netherton syndrome. Today, Quoin Pharmaceuticals announced that the FDA has given approval to include teenagers aged 14 years and older in two ongoing clinical trials for QRX003, a potential treatment for Netherton syndrome (NS). According to a press release, this marks the first time that teen patients with NS will have the opportunity to participate in clinical trials under an Investigational New Drug Application (IND). Additionally, the studies will accommodate teens currently on off-label systemic therapy, with the focus of generating comprehensive data for QRX003’s development.1 “We are very pleased to announce this exciting development, not just for Quoin’s clinical program, but for the Netherton community as a whole,” said Michael Myers, BSc, PhD, CEO, Quoin, in a press release. “We are frequently petitioned by parents and caregivers that ...
On February 28, 2010, AbbVie and OSE Immunotherapeutics, an immunotherapeutics company, announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to address serious chronic inflammatory diseases, which is currently in preclinical studies. OSE-230 is a first-of-its-kind monoclonal antibody designed to activate the G protein-coupled receptor (GPCR) target ChemR23, which may provide a novel mechanism for relieving chronic inflammation by regulating macrophage and neutrophil function. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said: “This collaboration underscores our commitment to expanding our immunology portfolio, with the ultimate goal of raising the standard of care for patients suffering from inflammatory diseases worldwide. We look forward to applying our expertise in immunology drug development to advance the development of OSE-230. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, said: “We are pleased to partner with AbbVie, a global leader in the development and commercialization of ...
Organiser: American pharmaceutical association Time:16 – 18 April 2024 address:655 West 34th Street New York, NY 10001-1188 USA Exhibition hall: Javits Convention Center, NYC Product range: Analytical instruments, automation and process control, batch processing systems/equipment, biological process equipment, packaging equipment, process equipment and parts, pilot plant equipment and custom components, tablet/capsule filling machine facility engineering and maintenance, environmental treatment and equipment, clean room equipment; Processing systems, control systems, automation instruments, pharmaceutical packaging materials, containers, etc About Interphex: The New York Biopharmaceutical Exhibition (Interphex) is one of the largest pharmaceutical exhibitions in North America. Held since 1979, it is the most trusted life science show in North America across both chemical and biopharmaceutical fields. Exhibitors meet decision buyers from the world’s top pharmaceutical companies through the exhibition.
Today (1st March), the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the PM8002 injection applied by Biotheus is planned to be included in the breakthrough therapy category, and the indication is the first-line treatment of inoperable locally advanced/recurrent metastatic triple-negative breast cancer with albumin-bound paclitaxel for combined injection. Public information shows that PM8002 is an anti-PD-L1/VEGF bispecific antibody independently developed by Biotheus. BioNTech has reached a cooperation agreement of more than US$1 billion with Biotheus to obtain the development, production and commercialization rights of this product worldwide (except Greater China). PM8002 is a bispecific antibody drug candidate consisting of a humanized anti-PD-L1 mono-antibody (VHH) fused to an anti-VEGF-A IgG1 antibody containing an Fc-silent mutation. This design can enrich PM8002 molecules into the tumor environment and reduce the systemic side effects caused by systemic VEGF blockade. According to an earlier press release fromBiotheus, PM8002 ...
Davy James The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act. The FDA has approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) for the treatment of complicated urinary tract infections (cUTIs), including the kidney infection pyelonephritis, in patients aged 18 years and older.1 The FDA also granted Allecra with a five-year marketing exclusivity extension for the β-lactam/β-lactamase inhibitor combination through the Generating Antibiotic Incentives Now Act (GAIN Act), which is legislation that incentivizes the development of new anti-infective treatments. “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals. I extend my sincere congratulations to my colleagues Omar Lahlou and Patrick Velicitat for their leadership and oversight throughout this whole process,” Iain Buchanan, supervisory board member of Allecra Therapeutics, said in a press release. “As ...
Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved by the State Drug Administration, which authorizes the company to carry out the clinical trial of adelberizumab in combination with SHR-A1811 for the treatment of breast cancer. According to the data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world’s number one malignant tumor and is the most common malignant tumor in women. Statistics show that in 2020, there were about 2.26 million newly diagnosed cases of female breast cancer and 685,000 deaths worldwide, ranking first in female malignant tumor morbidity and mortality. The incidence and mortality rates of breast cancer worldwide vary according to regional distribution. In China, the 2020 China Cancer data show that the incidence rate of breast ...
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