Search Results for “cancer” – Page 71 – media

Pfizer’s RSV vaccine shows benefit in immuno-compromised adults in study

Pfizer said on Monday its respiratory syncytial virus (RSV) vaccine Abrysvo generated a strong immune response in a late-stage study of four groups of adults aged 18 and older with a compromised immune system. A single 120 microgram dose of the vaccine generated strong neutralising antibodies against both subtypes of RSV, called RSV-A and RSV-B, across all groups in the study, Pfizer said. Abrysvo was well-tolerated in the study and showed a safety profile consistent with findings from other studies of the vaccine, it added. The drugmaker plans to submit the data to regulatory agencies for review. The study tested two doses of Abrysvo in 203 adults across four groups – those with a type of lung cancer, end-stage kidney disease, autoimmune inflammatory disorder, and solid organ transplant recipients – all of whom have compromised immunity and are at risk of developing severe RSV-associated disease. Pfizer’s vaccine is currently approved ...
- Source: drugdu
- 91
- August 19, 2024
Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by China’s NMPA

SHANGHAI, Aug. 12, 2024 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials. For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. ...
- Source: drugdu
- 57
- August 19, 2024
Replimune kickstarts Phase III melanoma trial studying RP1 immunotherapy

Replimune has announced the first patient in the Phase III melanoma trial with its lead immunotherapy RP1 or vusolimogene oderparepvec has been dosed and randomised. The IGNYTE-3 study (NCT06264180) will investigate the use of RP1 plus Bristol Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) for patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are ineligible for anti-CTLA-4 therapy. Massachusetts-based biotech Replimune’s CMO Kostas Xynos stated that the trial will serve to, “advance of our planned BLA submission of RP1 in advanced melanoma later this year”. In spite of slowing research, the wider oncolytic virus-based market has been projected to grow from $114mn in 2023 to $2.4bn in 2029 according to GlobalData analyst Kevin Marcaida. Marcaida expects that within this period, Replimune’s RP1 could claim a 74% market share. The IGNYTE-3 trial comes as Replimune continues a downward financial trend. Despite announcing $100m in private placement ...
- Source: drugdu
- 60
- August 16, 2024
International researchers use shear waves to map blood vessel structures

Researchers from King’s College London’s (KCL) School of Biomedical Engineering and Imaging sciences, along with partners at the University of Michigan, the Institut national de la santé et de la recherche médicale in Paris, Norway and Germany, are using shear waves to map blood vessel structures to improve treatments for tumours and other medical conditions. Findings published in Science Advances could improve cancer treatment and potentially improve drug delivery while helping researchers better understand tumours. Michigan and KCL experts developed a new theory using MRI-based elastography imaging to study how shear waves travel through tissue. By analysing them, researchers are able to measure the architecture of blood vessels non-invasively using readily available clinical imaging devices. Shear waves store information about the materials they pass through, including tissue stiffness, which can help diagnose diseases. The method allows researchers to see tiny blood vessels that are usually too small to detect and ...
- Source: drugdu
- 55
- August 16, 2024
US judge denies initial attempt by Novartis to block generic Entresto launch

Novartis’s bid to block the launch of a biosimilar for its best-selling drug Entresto (sacubitril/valsartan) got off to a faltering start, as the drugmaker failed to convince a US court that MSN Pharmaceuticals’ (MSNPI) copycat infringed on a patent. Richard Andrews, district judge for the District of Delaware, ruled the likelihood that Novartis would win the lawsuit was not high enough, meaning a preliminary injunction was not granted. While Andrews stated that stopping MSNPI’s generic launch was not justified, he did order a temporary 72-hour halt while Novartis goes to the US Court of Appeal to seek an injunction, as per a 12 August court document first released by Reuters. The hearing is part of a lawsuit initiated by Novartis to fend off MSNPI’s generic – which received US Food and Drug Administration (FDA) approval last month – to protect sales for its heart failure blockbuster. Novartis’s reference drug was ...
- Source: drugdu
- 59
- August 15, 2024
Hengrui’s Dexmedetomidine Hydrochloride Injection Passed GMP Certification Inspection in Japan

Recently, Hengrui Pharmaceuticals has received the GMP certificate issued by Japan Pharmaceuticals and Medical Devices Agency (PMDA) for its preparation production site located at No. 38, Huanghe Road, Lianyungang, and the company’s Dexmedetomidine Hydrochloride Injection has successfully passed the GMP compliance inspection by PMDA. This is the company’s quality management system again recognized by international authoritative institutions after the API dexmedetomidine hydrochloride PMDA site inspection was passed, which is conducive to the company to further strengthen the internationalization strategy and enhance the competitiveness in the global market. Japanese GMP certification is one of the authoritative certifications in the field of international drug production, and the inspection is characterized by rigor, meticulousness and attention to details.2023 In September, two qualification inspectors of Japan PMDA conducted a GMP on-site inspection for several days on Hengrui Pharmaceuticals’ Dexmedetomidine Hydrochloride Injection production line at the preparation production site located at No. 38 Huanghe Road, ...
- Source: drugdu
- 63
- August 15, 2024
Pfizer touts positive topline data for RSV vaccine Abrysvo

Pfizer has announced positive topline results from a pivotal late-stage study of its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults who are immunocompromised and at risk of developing severe RSV-associated lower respiratory tract disease (LRTD). As per the 12 August press release, Abrysvo was found to be well tolerated in the substudy B portion of the pivotal Phase III MONeT study (NCT05842967). While substudy B evaluated two 120 µg dose doses of Abrysvo, Pfizer reported that a single 120 µg dose of the vaccine led to “strong neutralizing” responses against RSV-A and RSV-B. The safety profile of Abrysvo was consistent with that of previous studies. “Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said senior vice president and CSO, Vaccine ...
- Source: drugdu
- 67
- August 14, 2024
An Upcoming White House Decision May Jeopardize Americans’ Access to Life-Saving Drugs

The White House might soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. By Katie AdamsThe White House could soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. Typically, when patients receive copay assistance from pharmaceutical companies, the amount paid by the manufacturer helps reduce the patient’s out-of-pocket costs. But with copay accumulators, the assistance from the drugmaker is not counted toward the patient’s maximum limit on out-of-pocket expenses. In September of last year, Judge John D. Bates of the U.S. District Court for the District ...
- Source: drugdu
- 71
- August 13, 2024
KCL and UCL scientists develop accurate AI brain imaging model for research

Researchers from King’s College London have developed a new artificial intelligence (AI) brain imaging model in collaboration with University College London (UCL) which is realistic and accurate enough to use in medical research. Published in Nature Medicine Intelligence, the three-dimensional, synthetic images of the human brain could help support research to predict, diagnose and treat brain diseases including dementia, stroke and multiple sclerosis. According to Brain Research UK, there are an estimated 11 million people in the UK who are living with a neurological condition. Among the most common are Alzheimer’s disease, epilepsy and stroke. In collaboration with the London Medical Imaging and AI Centre for Value-Based Healthcare and NVIDIA data scientists and engineers, researchers trained the AI model in weeks as opposed to months using the NVIDIA Cambridge-1 supercomputer. The model is able to produce 3D, high-resolution images that have all the characteristics of real human brains, including correct ...
- Source: drugdu
- 73
- August 13, 2024
First Patient Dosed of Phase 2 Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein in Combination with Serplulimab Plus HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in a phase 2 clinical trial (NCT06349980) of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fifth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in 2022. From which, hepatocellular carcinoma (HCC) is the predominant pathological type of PLC, which accounts for between 75% and 85% of liver cancer cases. Due to its insidious onset, lack of symptom in its early stage, and quick progression, PLC usually has ...
- Source: drugdu
- 111
- August 12, 2024

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