Search Results for “EC” – Page 450 – media

US government announces plan to overhaul organ transplant system

The US government announced a plan Wednesday to overhaul the country’s organ transplant system. The US Department of Health and Human Services’ Health Resources and Services Administration said it will focus on accountability and transparency by seeking more contracts to operate the Organ Procurement and Transplantation Network and sharing data more transparently. The system has only ever been managed by the nonprofit United Network for Organ Sharing, which has been recently criticized for its handling of organs, long waitlists for transplants and the number of deaths among people waiting: about 6,000 per year. There are currently more than 100,000 people in the United States waiting for an organ transplant. In a statement, HRSA Administrator Carole Johnson said that oversight of organ transplants is a “top priority.” “That is why we are taking action to both bring greater transparency to the system and to reform and modernize ...
- Source: drugdu
- 133
- March 23, 2023
MHRA to introduce new UK clinical trials framework

The changes will aim to make it easier to gain approval and to run clinical trials in the UK The Medicines and Healthcare products Regulatory Agency (MHRA) has said it will be introducing a series of measures aimed at streamlining clinical trials approvals in the UK. The changes, which represent the biggest overhaul in UK clinical trials regulation in over 20 years, include a legislative requirement to publicly register clinical trials and share summary results with research participants, as well as guidance to help researchers recruit a diverse cohort of participants. A timeline for completion of an application review within a maximum of 30 days will also be implemented by the MHRA, with a maximum of ten days for a decision to be granted once the regulator has received any final information. Marc Bailey, MHRA chief science and innovation officer, said: “Our world-first COVID-19 approvals showed how ...
- Source: drugdu
- 123
- March 23, 2023
FDA Grants Breakthrough Therapy Designation to Pfizer’s Investigational Alzheimer’s Disease Treatment

Pfizer, a global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational treatment for Alzheimer’s disease, called PF-05217917. This designation is intended to accelerate the development and review of promising drugs that have the potential to address serious or life-threatening conditions. Alzheimer’s disease is a progressive brain disorder that affects millions of people worldwide, causing memory loss and other cognitive impairments. There are currently no approved treatments that can slow or stop the progression of the disease. Pfizer’s PF-05217917 is an antibody that targets the tau protein, which is believed to play a key role in the development and progression of Alzheimer’s disease. The FDA’s decision to grant Breakthrough Therapy designation to PF-05217917 was based on the results of a Phase 2 clinical trial that involved patients with mild to moderate Alzheimer’s disease. The trial showed that ...
- Source: drugdu
- 238
- March 22, 2023
FDA Approves New Drug to Treat Migraine

The U.S. Food and Drug Administration (FDA) has approved a new drug, called Rizaport, for the treatment of acute migraine in adults. Rizaport is a fast-dissolving oral tablet that contains the active ingredient rizatriptan, which belongs to a class of drugs called triptans. Migraine is a neurological condition that affects approximately 39 million people in the United States. It is characterized by recurrent episodes of moderate to severe headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. Triptans are a commonly used class of drugs for the treatment of acute migraine, but they are not effective for all patients and may cause side effects such as dizziness and fatigue. Rizaport, developed by Intec Pharma, offers a new option for the treatment of acute migraine. It is designed to dissolve rapidly on the tongue, allowing for faster onset of action compared to traditional tablet formulations. In ...
- Source: drugdu
- 125
- March 22, 2023
FDA Approves New Treatment for Rare Genetic Disorder

The U.S. Food and Drug Administration (FDA) has recently approved a new treatment for a rare genetic disorder called hereditary angioedema (HAE). The treatment, called Berinert, is manufactured by CSL Behring and is the first and only therapy approved for the treatment of acute attacks of HAE in pediatric patients. HAE is a rare genetic disorder that affects about 1 in 10,000 to 1 in 50,000 people worldwide. It is characterized by recurrent episodes of swelling, or edema, in various parts of the body including the hands, feet, face, and airways. These attacks can be severe and potentially life-threatening, especially when the swelling occurs in the airways, which can lead to difficulty breathing and asphyxiation. Berinert is a human plasma-derived C1 esterase inhibitor (C1-INH) that works by replacing the deficient or malfunctioning C1-INH protein in patients with HAE. The treatment is administered through intravenous infusion and can ...
- Source: drugdu
- 118
- March 22, 2023
Ukraine to clinch first IMF loan to nation at war

The International Monetary Fund (IMF) says it has reached an agreement with Ukraine on funding worth $15.6bn (£12.8bn). The organisation’s first loan to a country at war is expected to be approved in the coming weeks. It would also be one of the largest financing packages Ukraine has received since Russia’s invasion. The IMF recently changed a rule to allow loans to countries facing “exceptionally high uncertainty”. “Russia’s invasion of Ukraine continues to have a devastating impact on the economy: activity contracted by 30 percent in 2022, a large share of the capital stock has been destroyed, and poverty levels have climbed,” IMF official Gavin Gray said in a statement. “The programme has been designed in line with the new fund’s policy on lending under exceptionally high uncertainty, and strong financing assurances are expected from donors, including the G7 and EU.” Mr Gray also ...
- Source: drugdu
- 245
- March 22, 2023
Google’s rival to ChatGPT launches for over-18s

Google has started rolling out its AI chatbot Bard, but it is only available to certain users and they have to be over the age of 18. Unlike its viral rival ChatGPT, it can access up-to-date information from the internet and has a “Google it” button which accesses search. It also namechecks its sources for facts, such as Wikipedia. But Google warned Bard would have “limitations” and said it might share misinformation and display bias. This is because it “learns” from real-world information, in which those biases currently exist – meaning it is possible for stereotypes and false information to show up in its responses. How do chatbots work? AI chatbots are programmed to answer questions online using natural, human-like language. They can write anything from speeches and marketing copy to computer code and student essays. When ChatGPT launched in November 2022, it had more than one million users within ...
- Source: drugdu
- 138
- March 22, 2023
Roche teams up with Lilly to validate Alzheimer’s blood test

March 22 (Reuters) – Roche (ROG.S) and Eli Lilly and Co (LLY.N) are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval. The effort, unveiled in a statement on Wednesday, comes as Lilly as well as Eisai (4523.T) and Biogen (BIIB.O) are gearing up to sell drugs aimed at slowing the advance of the mind-robbing illness, but their use will require a diagnosis at earlier disease stages than is the norm today. Roche Holding AG would recruit several hundred volunteers with early signs of dementia over the next 18 to 24 months with trial data potentially ready for a U.S. regulatory filing in 2025, Bruce Jordan, leader of Personalized Healthcare Solutions at Roche Diagnostics, told Reuters. The U.S. Food and Drug Administration has asked Roche to recruit a significant number of patients at primary care facilities ...
- Source: drugdu
- 139
- March 22, 2023
All hormonal contraceptives ‘carry small increased risk of breast cancer’

Research finds use of progestogen is associated with a 20-30% higher risk but this falls after no longer taking it All types of hormonal contraceptives carry a small increased risk of breast cancer, according to research establishing a link with progestogen pills for the first time. The use of progestogen is associated with a 20-30% higher risk of breast cancer, data analysis by University of Oxford researchers has established. This builds on previous work showing that use of the combined contraceptive pill, which contains oestrogen and progestogen, is associated with a small increase in the risk of developing breast cancer that declines after stopping taking it. Claire Knight of Cancer Research UK, which funded the study, said the risk was small and should not discourage most people from taking the pill. She said: “Women who are most likely to be using contraception are under the age of 50, where the risk of ...
- Source: drugdu
- 118
- March 22, 2023
Pfizer and Astellas’ Xtandi shows promise in phase 3 prostate cancer study

Pfizer and Astellas have reported positive top line results from a phase 3 trial of their androgen receptor signalling inhibitor, Xtandi (enzalutamide), in non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). The medicine is already a standard of care in the US for metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC), and for one or more of these indications in more than 100 countries. Compared with those indications, nmHSPC represents an earlier stage of disease, in which there is no detectable evidence of the cancer spreading to distant parts of the body, and it still responds to testosterone-lowering treatments. However, some patients remain at a higher risk for BCR following primary treatment, which may result in metastases. The EMBARK trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated daily ...
- Source: drugdu
- 146
- March 21, 2023

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