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The Patient-Centered Outcomes Core has developed a new tool kit to provide resources to support the capture of patient-reported outcome (PRO) measures in diverse study populations. The post October 2, 2023: Patient-Centered Outcomes Core Develops Tool Kit to Promote Health Equity in PROs appeared first on Rethinking Clinical Trials.
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Continued development of the use of complex innovative trial designs. Continue development of the use of Real-World Evidence. Orientation.
This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government. According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC).
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.
The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atezolizumab).
University of Newcastle researchers in Australia have developed a saliva test to evaluate glucose levels in diabetic patients. The test involves the use of testing strips that contain a glucose biosensor with electronic elements in the test’s transistor, like inks, that allow for mass printing of the test strips at low cost.
Researchers at Massachusetts Institute of Technology (MIT) have designed the world’s first digital fabric fiber that contains digital devices which can sense, analyze and store health data, and use it to infer a person’s activity and state of health. This would generate exciting new possibilities for digital health applications.
Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.
The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials.
For generic drug manufacturers, stability testing is a critical step in the development process. Container Closure System : How will the drug interact with its packaging? Learn more about the importance of stability testing in generic drug development: [link] This is particularly important for drugs that are sensitive to light.
For Cold Spring Harbor Laboratory (CSHL) Research Professor Alexander Krasnitz, the answers may lie deep within vast databases and hospital archives containing hundreds of thousands of tumor samples. Maybe, but where would that key fit? How can we trace cancer's ancestral roots to modern-day solutions?
Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a Single Patient Use Glass Fliptop Vial.
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The product was approved for use in adults, and the Pediatric Research Equity Act (PREA)-required pediatric studies were deferred.
UK biotech Inspira Pharmaceuticals has emerged from stealth mode with a deal with Vectura to develop an inhaled therapy for COVID-19 that could be ready for human testing within 12 months. . “One area of research we are particularly excited about is the ability of IPX formulations to degrade biofilms,” McGoldrick told us.
Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. deliesschef. About REALM-DCM.
Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs. Containment challenges.
Microbiota restoration therapy is a key innovation area in immuno-oncology Microbiota restoration therapy can be composed of human faecal material containing viable gut flora from a patient or donor, and include a diluent and a cryoprotectant. By means of geographic reach, the Spanish National Research Council holds the top position.
The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. Regulatory concerns remain Overall, microbiome research has not advanced as much as expected, which is partly due to safety issues, says Hota.
Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.
Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. New doors were opened in the 2000s with the development of genome editing, such as CRISPR-Cas9, which introduces molecular tools to change existing DNA. Collaboration and integrated manufacturing.
Successful TIL therapy depends on the infusion product containing tumour-reactive T cells that, on infusion, generate an anti-tumour immune response that causes disease regression. Improvement to the TIL product itself is an area of intense research. to more than 10%.
It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR. PREVNAR 20 has been developed on the basis of Pfizer’s approved PREVNAR 13 vaccine.
per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D).
Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.
While it has been known for about five decades now that patients with Parkinson’s disease have a higher likelihood of developing melanoma than the general population, the exact reasons for this were unknown. Now, thanks to a study funded by the National Institutes of Health Intramural Research Program, scientists have discovered that ?-synuclein,
The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease. The idea of ‘genetic superheroes’ and precision medicine is captivating for researchers, but the concept can be abstract and distant for participants. First, start co-development with participants early on in the process.
TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.
Tokyo, Japan – Researchers from Tokyo Metropolitan University have developed a new carbon capture system which removes carbon dioxide directly from the atmosphere with unprecedented performance.
The list includes companies that provide a range of services, including but not limited to: · New product/health plan innovation research. Pricing research. The document contains detailed information on the suppliers and their product offerings, alongside their contact details to aid your purchasing or hiring decision.
Data generated through high-throughput omics approaches paired with clinical patient records can give rise to remarkably robust datasets to inform and guide disease insights and development of targeted therapeutics. Generation of strong research dataset cohorts must begin with high-quality clinical samples.
Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.
KEYTRUDA is an anti-PD-1 therapy developed by Merck, while Padcev has been developed by Astellas and Seagen. The combination therapy can be used to treat la/mUC patients who do not qualify for cisplatin-containing chemotherapy. Results showed that patients treated with Padcev along with KEYTRUDA achieved a confirmed ORR of 68%.
A report released Thursday by the University of California at Los Angeles researchers said that 66 percent of Los Angeles health-care workers who responded to an online questionnaire (not a randomized sample) said they would delay taking a vaccine. The results of trials were announced in press releases rather than peer-reviewed papers.
Research shows how mosquito genetics, combined with expanding habitats due to climate change , may accelerate the risk of Zika virus outbreaks, emphasizing the urgency of targeted vector control strategies. The WHO contained a Marburg virus outbreak in Tanzania in early 2024 with nine cases and six deaths.
The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation.
Streamlined development, flexibility in manufacturing, and improved product quality at reduced costs, while gaining access to capabilities and capacity are some of the factors fuelling the pharmaceutical solid dosage contract manufacturing market. Growth of oral solid dosage contract manufacturing in the pharmaceutical industry.
Experts from Servier and Genuity Science recently spoke on a webinar about using genomics data to drive drug development in heart failure and identify new targets for novel therapeutics. The reverse could also be true whereby the development of coronary artery disease may impact heart rate. HFrEF vs. HFpEF.
The document contains detailed information on the suppliers and their products, alongside contact details to aid your purchasing or hiring decisions. The post Leading API chemical companies in contract marketing appeared first on Pharmaceutical Technology.
The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision.
Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. Single- and multi-nation funding opportunities flooded in.
A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. extractables and leachables).
FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC). But for now, we wait.
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