Evotec has announced a collaboration with the Crohn’s & Colitis Foundation to advance drug discovery and develop new therapies for IBD, which includes Crohn’s disease and ulcerative colitis. The collaboration between Evotec and the foundation’s IBD therapeutics incubator programme aims to translate academic research into medical innovations for patients with IBD, a debilitating chronic medical condition. The programme fosters partnerships between the foundation, academic researchers and industry partners. The partnership will leverage Evotec’s end-to-end integrated research and development platform to advance the development of drugs for fibrosis and impaired intestinal barrier function, two significant unmet medical needs for IBD patients. Evotec chief business officer Dr Matthias Evers stated: “Mission-driven foundations like the Crohn’s & Colitis Foundation are an essential part of the healthcare ecosystem as they drive medical progress in areas of significant unmet need that would otherwise not be pursued. “As we join forces within the foundation in this ...
Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches. But 2024 represents a fresh opportunity for the pharma giant, Bourla said. “In essence, you should expect 2024—after all the changes in the setup that we did in year ’23—to be a year of execution,” he told the JPM audience. Pfizer will attempt to execute, in part, by leveraging its recent $43 billion buyout of antibody-drug conjugate specialist Seagen, Bourla explained. Further, the company hopes to advance its presence in respiratory syncytial virus (RSV), where Pfizer recently launched its vaccine Abrysvo. Still, Bourla was frank about the challenges Pfizer faced in 2023. “The year for us, we missed our internal projections. And also we missed the expectations ...
Recently, the FUTURE series of studies has brought good news again. The results of the FUTURE-SUPER clinical trial led by the team of Prof. Zhimin Shao and Prof. Zhonghua Wang from the Affiliated Cancer Hospital of Fudan University have been announced, which fully confirmed the effectiveness and safety of the first-line precision treatment based on the “Fudan typing”, and is about to change the clinical practice of the treatment of TNBC. The results of the study will be announced in 2023. The results of the study were first announced at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023, which attracted the attention of scholars around the world, and on January 9, 2024, the study was published in The Lancet Oncology, the top international oncology journal, with an impact factor as high as 51.1 under a fast-track system. The clinical study is also another landmark achievement of the ...
BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company located in Guangzhou, China, is hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approved the application for Phase Ib/II clinical trial of BAT7104 injection in combination with BAT4706 injection for the treatment of advanced malignant tumors. BAT7104 is a bispecific antibody against PD-L1 and CD47 developed by BIO-THERA and is intended to be developed for the treatment of tumors.BAT7104 activates macrophages to phagocytose tumor cells by blocking the CD47/SIRPα pathway; BAT7104 relieves tumor cells from inhibiting T-cells through the PD-L1/PD-1 pathway by blocking the PD-L1/PD-1 pathway, achieving adaptive immunity and solid immunity. inhibition, realizing the combined anti-tumor effect of adaptive and intrinsic immune systems. Through affinity differentiation design, ...
Traditional methods of blood testing require invasive procedures administered by medical professionals, and can be time-consuming as well as expensive. Not everyone has the time, access, and financial means to get laboratory results for blood work, however, billions of women globally have their period every single month. Until now, menstrual samples had never previously been explored as a diagnostic source for health information. Now, for the first time, a safe and simple technology allows menstrual blood samples to be used as an alternative to traditionally collected venous blood draws. This breakthrough provides an opportunity for testing important biomarkers for millions of menstruating women across the world. Qvin (Menlo Park, CA, USA) has proved the clinical relevancy of menstrual blood for several important biomarkers. The company’s Q-Pad technology uses menstrual blood to gain health insights in a non-invasive, convenient manner and can be used for testing anywhere in the world. The ...
A hybrid in vitro diagnostics (IVD) solution for multiplexed point-of-care testing (xPOCT) can perform both molecular and immunoassays from several body fluids on a single platform. The hybrid and scalable technology aims to deliver lab-comparable test results in a single patient encounter, significantly reducing the diagnostic timeline. Picodya’s B-Matrix diagnostic system is the world’s first POC hybrid solution that can run IVD tests, both immunoassays and molecular assays on the same device at lab-comparable quality, on multiple patient samples, simultaneously within minutes. The B-Matrix is designed to minimize turnaround time, and deliver better outcomes while lowering costs. The B-Matrix is powered by Picodya’s proprietary PicoFluidic technology which enables the system to operate at high capacity testing for a panel of markers simultaneously, using just pico volumes of reagents and controls. This allows for ultra-fast results within as quickly as 15 minutes and at a fraction of the cost for comparable ...
AcelRx Pharmaceuticals wants to put a tough few years behind it. After failing to crack the pain market, the biotech has shifted its focus to a pipeline led by a blood thinner and adopted a new name, Talphera, to reflect the revised strategy. The value of AcelRx has fallen sharply in recent memory, dropping 62% over the past year and 98% over the past five years to leave the company with a market cap of below $15 million. The five-year time frame covers the period after the approval of the sublingual pain drug Dsuvia. AcelRx won approval in 2018 but failed to turn the opioid into a major product, generating sales of $1.8 million in 2022. Alora Pharmaceuticals acquired the drug for $1.1 million last year, moving AcelRx away from its earlier focus on pain. Following the transaction, AcelRx’s goals were to win approval tforhe pre-filled ephedrine syringe, Fedsyra, and ...
The Medicines and Healthcare products Regulatory Agency (MHRA) has set out a regulatory roadmap to enable safe access to medical technology, including artificial intelligence (AI) and diagnostics. The Roadmap Towards the Future Regulatory Framework for Medical Devices will support the development of new regulations that will prioritise patient safety and help ensure individuals continue to have access to the devices they need without delay, while enhancing the UK’s position as “a world-leading environment for medical technology innovators,” the MHRA said. The roadmap is also set to offer “significant new opportunities for patients and healthcare” by enhancing the UK’s ability to benefit from advancing medical technology such as implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease. Dr Laura Squire, the MHRA’s MedTech regulatory reform lead and chief officer of healthcare, quality and access, said: “Today’s exciting medical technology advances offer important new opportunities for ...
GlaxoSmithKline (“GSK”) announced that NMPA has recently approved Nucala® (Mepolizumab injection) for the maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above. Nucala® is the first targeted human anti-interleukin-5 (IL-5) monoclonal antibody biologic in China for this indication. Asthma is a major health burden in China, where approximately 46 million adults suffer from asthma. About 6% of them have severe asthma, which can cause an increased risk of acute exacerbations requiring hospitalization and even potentially fatal asthma attacks. The daily lives of people with severe asthma are severely affected and treatment is costly. In China, 15.5% of people with asthma have experienced an exacerbation requiring hospitalization in the past 12 months. The Guidelines for the Prevention and Management of Bronchial Asthma (2020 edition), developed by the Chinese Medical Association’s Section of Respiratory Diseases, cites an unmet need for treatment of this disease in ...
Dive Brief The Food and Drug Administration has categorized an urgent medical device correction from Johnson & Johnson’s Megadyne as a Class I event. Megadyne contacted customers last month to restrict the use of four electrode products in children under the age of 12 years. The products are staying on the market with a narrower label. The J&J unit took the action after receiving reports of burn injuries that could be particularly harmful to children. Megadyne has received reports of 99 injuries and no deaths, according to the FDA’s Monday recall notice. Dive Insight The electrode pads help direct currents from certain instruments used during surgery through the patient’s body to prevent the risk of energy concentrating in one area and burning the patient, according to the FDA. Megadyne sent an urgent field safety notice about the burn risk in June, leading to a Class I notice from the FDA ...
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