Search Results for “Clinical Trial” – Page 101 – media

Spikevax approved for use in children aged 6 months to 5 years

Spikevax, the COVID-19 vaccine from Moderna, has today been authorized for use in children aged 6 months to 5 years. The vaccine has been authorized in this new age group after it has been found to meet our standards of safety, quality and effectiveness, with no new safety concerns identified. This followed advice from the Commission on Human Medicines, which carefully reviewed the evidence. This is the second COVID-19 vaccine to be authorized in this age group; the Pfizer/BioNTech vaccine (Comirnaty), was authorized in Great Britain for infants and children aged 6 months to 4 years on 6 December 2022. For this age group, the vaccine is given as a primary series of two 25-microgram injections in the upper arm or in the thigh, approximately one month apart. In reaching their decision, the MHRA’s experts carefully reviewed data from an ongoing clinical trial involving 6,388 children aged 6 months to ...
- Source: drugdu
- 130
- May 11, 2023
Life Bio, Forge to develop gene therapies for aging-linked diseases

Life Biosciences has announced a cGMP manufacturing collaboration with Forge Biologics for advancing the development of new gene therapies to treat aging-related diseases. This partnership aims to help advance the company’s partial epigenetic reprogramming platform for aging-related diseases, such as its lead programme that targets the ophthalmic indications. Through the alliance, Forge Biologics will provide cGMP manufacturing, toxicology, adeno-associated virus (AAV) process development, and analytical services to Life Biosciences. Life Biosciences will use the platform processes of Forge Biologics, including the HEK293 suspension Ignition Cells and per adenovirus helper plasmid. The company stated that all the development and AAV manufacturing works will take place at Forge Biologics’ 200,000ft2 gene therapy facility, called Hearth, located in Columbus, Ohio, US. Life Biosciences CEO Jerry McLaughlin said: “We are delighted to be working with the Forge team, whose expertise in gene therapy manufacturing is unmatched. “We believe we’re on the cusp of revolutionising ...
- Source: drugdu
- 117
- May 11, 2023
Researchers evaluate the dual-therapeutic effect of gene therapy in mouse model of osteosarcoma

Reviewed by Lily Ramsey, LLM Investigators at Brigham and Women’s Hospital and collaborating institutions evaluated the dual-therapeutic effect of gene therapy in a clinically relevant model for common form of bone cancer. With a worldwide incident rate of 3.4 cases per million people per year, osteosarcoma is one of the most common bone cancers affecting children and adolescents. The current gold standard treatment option requires extensive surgical intervention and chemotherapy that leads to a poor prognosis and decreased quality of life. Due to the aggressive nature of the disease, the surgical intervention usually involves total reconstruction of the limbs or, in most cases, amputation. Researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, in collaboration with investigators at University College Dublin (UCD), Massachusetts Institute of Technology (MIT), and Trinity College Dublin (TCD), have identified a potential therapeutic target and developed a unique delivery ...
- Source: drugdu
- 142
- May 9, 2023
The safety and efficacy of FINLAY-FR-2/1A, a new protein-based COVID-19 vaccine

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for the coronavirus disease 2019 (COVID-19) pandemic, has claimed more than 6.92 million lives and infected over 765 million individuals. Most COVID-19 vaccines target the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) to prevent the binding of SARS-CoV-2 to the host angiotensin-converting enzyme 2 (ACE-2) receptor. Background Preclinical studies associated with FINLAY-FR-2 (Soberana 02), a protein subunit vaccine conjugated with the tetanus toxoid carrier protein, have confirmed its effectiveness, with similar results obtained in Phases I, II, and III clinical trials. These trials have shown that FINLAY-FR-1A (Soberana Plus), an RBD dimer without conjugation, has increased neutralization capacity in COVID-19 convalescent individuals. Additionally, when this protein-based vaccine was introduced as the third dose to FINLAY-FR-2, it induced the production of anti-RBD immunoglobulin G (IgG) antibodies. Several countries, including Iran, Cuba, Venezuela, Belarus, Mexico, and Nicaragua, have approved FINLAY-FR-2 and FINLAY-FR-1A vaccines ...
- Source: drugdu
- 124
- May 9, 2023
Researchers use skull-implantable ultrasound to help deliver chemotherapy to the brain

By Sean Whooley Leave a Comment [Screenshot from video provided by Nortwestern Medicine] Northwestern Medicine shared results from a first-in-human clinical trial for a skull-implantable ultrasound device that supports chemotherapy delivery. The device opened the blood-brain barrier to repeatedly permeate large, critical regions of the human brain. This enabled the delivery of chemotherapy injected intravenously. With the patient awake, a four-minute procedure opens the blood-brain barrier and patients go home after a few hours. Results from the Northwestern study demonstrated both a safe and well-tolerated treatment. Some patients even reached up to six cycles of chemotherapy treatment. The paper published on May 2 in The Lancet Oncology. More about the chemotherapy study The researchers say this marks the first study to successfully quantify the effect of ultrasound-based blood-brain barrier opening on the concentrations of chemotherapy in the human brain. Opening the blood-brain barrier led to approximately a four-to-six-fold increase in drug concentrations ...
- Source: drugdu
- 112
- May 7, 2023
Algorithm generates 128-fold increase in antibodies

In a recent article published in the journal Nature, researchers used a classical concept in computational linguistics to design a new algorithm, LinearDesign, which optimized the structural stability and codon usage of messenger ribonucleic acid (mRNA) sequences. For instance, using this algorithm, researchers could optimize mRNA sequences encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein and use it in mRNA-based coronavirus disease 2019 (COVID-19) vaccines. Background All vaccines based on the relatively new mRNA technology suffer from common limitations, such as mRNA instability and rapid degeneration, which, in turn, lead to poor protein expression and, subsequently, compromised immunogenicity and druggability of all mRNA vaccine products. It also critically hinders the storage, distribution, and efficacy of all mRNA vaccines, including COVID-19 and varicella-zoster virus (VZV) vaccines. Therefore, there is an urgent need for a principled mRNA design algorithm that simultaneously optimizes stability and codon usage of encoding mRNA sequences to ...
- Source: drugdu
- 237
- May 5, 2023
Bristol Myers Squibb and Tubulis partner in deal worth over $1bn

The agreement is aimed at developing differentiated ADCs for solid tumours Bristol Myers Squibb (BMS) and Tubulis have announced an agreement aimed at developing differentiated antibody-drug conjugates (ADCs) for solid tumours. ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones. Under the terms of the licensing agreement, the German biotech will receive an upfront payment of $22.75m from BMS and will be eligible for future payments of over $1bn plus royalties. In exchange, BMS will gain exclusive rights to Tubulis’ Tubutecan payloads and P5 conjugation platform for the development of a selected number of highly differentiated ADCs to treat solid tumours. ...
- Source: drugdu
- 140
- May 5, 2023
ChatGPT outshines physicians in quality and empathy for online patient queries

By Neha Mathur In a recent study published in JAMA Internal Medicine, researchers evaluated the ability of ChatGPT, an artificial intelligence-based chatbot assistant, to respond to patient questions posted on a publically accessible social media forum. Background Owing to the quick expansion of digital health care, more and more patients have begun to raise queries on social media forums. Answering these questions is not just time-consuming but tedious for healthcare professionals. AI assistants, like ChatGPT, could help address this additional work and help draft quality responses, which later clinicians could review. About the study In the present cross-sectional study, researchers randomly drew 195 exchanges in response to a patient question asked over Reddit’s r/AskDocs, a publically accessible social media forum, in October 2022. Then, a team of licensed healthcare professionals generated a new chatbot session using the original full text of the question to which a physician responded and then evaluated the ...
- Source: drugdu
- 139
- May 5, 2023
Seres’s Bacteria in a Pill Becomes First FDA-Approved Oral Microbiome Therapy

Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy. A capsule filled with bacteria is now FDA approved for treating a serious and potentially deadly type of gut infection, making the Seres Therapeutics drug the first oral microbiome therapy to receive the regulatory go-ahead for patients. The infection is caused by Clostridioides difficile (C. difficile or C. diff), a bacterium that’s part of the diverse microbial community in the intestines. When the gut microbiome is disrupted, C. diff can proliferate, releasing toxins that cause frequent diarrhea, abdominal pain, and fever. In severe cases, the infection leads to organ failure and death. Antibiotics can treat C. diff infection, but these bacteria can develop resistance, leading to a recurrence of the infection. When that happens, patients have limited treatment options. According to Centers for Disease Control and Prevention data cited by Seres, about 156,000 cases of ...
- Source: drugdu
- 169
- May 2, 2023
‘Eat, sleep, console’ reduces hospital stay and need for medication among opioid-exposed infants

Researchers have found the “Eat, Sleep, Console” (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and 63% less likely to receive medication as part of their treatment, compared to newborns cared for with FNAST. ESC prioritizes non-pharmacologic approaches to care, such as a low-stimulation environment, swaddling, skin-to-skin contact and breastfeeding. ESC also encourages parental involvement in the care and assessment of their infants. These findings are based on the hospital outcomes of a large and geographically diverse group of opioid-exposed infants. A two-year follow-up study of a subset of infants is ongoing. The current findings are published in the New England Journal of Medicine. “Medical care for newborns who were ...
- Source: drugdu
- 129
- May 2, 2023

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