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Moderna cancer vaccine takes positive step

Company’s candidate, in combination with MSD’s Keytruda, receives PRIME designation Moderna has announced that mRNA-4157/V940 – its investigational cancer vaccine – in combination with Keytruda, Merck’s anti-PD-1 therapy, has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA). It concerns the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection. The vaccine mRNA-4157/V940 stimulates an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumour. The EMA awarded the PRIME scheme designation following positive data emerging from the phase 2b KEYNOTE-942/mRNA-4157-P201 clinical trial. The results from this research will be shared at the American Association for Cancer Research (AACR) in mid-April. PRIME is a regulatory system run by the EMA that provides support for the development of medicines that target unmet medical needs. Through PRIME, the EMA offers proactive and early ...
- Source: drugdu
- 112
- April 12, 2023
FDA approves controversial new Alzheimer’s drug

On April 4th, 2023, Pharmaceutical Technology reported that the FDA has approved a new treatment for Alzheimer’s disease called Aduhelm. The drug, developed by Biogen, is the first new Alzheimer’s treatment to be approved in nearly two decades. However, the approval has been controversial, with some experts questioning the drug’s efficacy and high cost. Aduhelm targets a protein called beta-amyloid, which is believed to play a role in the development of Alzheimer’s disease. The drug has been shown to reduce the buildup of beta-amyloid in the brain, but some experts have raised concerns about the drug’s efficacy and potential side effects. The drug is also very expensive, with an estimated cost of $56,000 per year per patient. This has led some experts to question whether the drug is worth the cost. Despite the controversy, the approval of Aduhelm is seen as a significant development in the fight against ...
- Source: drugdu
- 165
- April 12, 2023
Pfizer and Moderna’s COVID-19 vaccines offer lasting protection

Study finds on April 7th, 2023, Pharmaceutical Technology reported that a new study has found that Pfizer and Moderna’s COVID-19 vaccines offer lasting protection against the virus. The study, which was published in the New England Journal of Medicine, found that people who received either vaccine had robust and persistent antibody and T cell responses against SARS-CoV-2, the virus that causes COVID-19, even six months after receiving the second dose. The study followed 2,500 healthcare workers who received either the Pfizer or Moderna vaccine and found that their immune responses remained strong over time. The researchers noted that while antibody levels did decline over time, the levels were still high enough to provide protection against the virus. The findings are significant because they suggest that the vaccines are likely to provide long-term protection against COVID-19. The study also provides reassurance that the vaccines are effective against new variants of ...
- Source: drugdu
- 175
- April 12, 2023
US health officials aim to ‘transform’ Alzheimer’s disease research with $300 million data platform

The US National Institute on Aging is moving forward with efforts to build a real-world Alzheimer’s disease database as part of its aim to improve, support and conduct more dementia research. Last month, the agency, part of the National Institutes of Health, posted a notice of the grant for the six-year database project, setting its earliest start date as April 2024. The NIH confirmed Tuesday that plans are underway to fund the Alzheimer’s disease and Alzheimer’s disease-related dementias’ real-world data platform. The National Institute on Aging intends to commit $50 million per year, starting in fiscal year 2024, to fund one award. The nonprofit Alzheimer’s Association is among those planning to apply for the grant. “The newly-announced NIA funding for a large-scale Alzheimer’s disease research database is truly exciting and a very important step forward for our field, and the Alzheimer’s Association will apply for ...
- Source: drugdu
- 146
- April 12, 2023
FDA takes only drug for premature birth off the market

On Thursday, the US Food and Drug Administration announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth that had been the only medication approved for the condition. The FDA says that the drug is not effective and that the benefits of taking it do not outweigh the risks. “It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Dr. Robert Califf said in a statement. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of ...
- Source: drugdu
- 128
- April 12, 2023
New study shows SARS-CoV-2 infection accelerates the progression of dementia

The possible common pathomechanisms linking multiple sclerosis and post-COVID-19 brain involvement (A). Proposal of a new codename regarding post-COVID-19 cognitive sequelae (B). Credit: Journal of Alzheimer’s Disease Reports (2023). DOI: 10.3233/ADR-220090 Infection with SARS-CoV-2 has a significant impact on cognitive function in patients with preexisting dementia, according to new research published in the Journal of Alzheimer’s Disease Reports. Patients with all subtypes of dementia included in the study experienced rapidly progressive dementia following infection with SARS-CoV-2. Since the first wave of COVID-19, neurologists have noticed both acute and long-term neurological syndromes and neuropsychiatric sequelae of this infectious disease. Insights into the impact of COVID-19 on human cognition has so far remained unclear, with neurologists referring to “brain fog.” A group of researchers driven to gain a better understanding of and dissipate this fog investigated the effects of COVID-19 on cognitive impairment in 14 patients with preexisting dementia (four with Alzheimer’s disease [AD], five with vascular dementia, three ...
- Source: drugdu
- 164
- April 7, 2023
Sanofi, BARDA break ground on another flu vaccine plant at Pennsylvania campus

[Sanofi and the Biomedical Advanced Research and Development Authority have broken ground on a new formulation and fill facility at the company’s Swiftwater, Pennsylvania, campus. The plant is part of a third major manufacturing investment for BARDA at the site as part of a contract which was signed in 2019 to increase domestic production capabilities. (Photo by Chesnot/Getty Images)] Sanofi and the Biomedical Advanced Research and Development Authority (BARDA) are expanding their capacity to manufacture flu shots. They are breaking ground on a two-story formulation and filling facility at the company’s sprawling campus in Swiftwater, Pennsylvania. Sanofi will fill syringes and vials using isolator barrier technology as well as single-use technology to provide flexibility. This is the third major manufacturing investment for BARDA at the site as part of a contract signed in 2019 to increase domestic production capabilities for pandemic flu vaccines. The contract supports the ...
- Source: drugdu
- 146
- April 7, 2023
Mediterranean diet linked to greater biodiversity and food security, study finds

Dr. Priyom Bose, Ph.D. By Dr. Priyom Bose, Ph.D.Apr 5 2023 Reviewed by Danielle Ellis, B.Sc. To combat the double burden of non-communicable diseases and climate change, adopting sustainable and healthy diets and transitioning to sustainable food systems is essential. To support food security and sustainable development, the Mediterranean diet (MD) has been widely recognized as a healthy nutrition and biodiversity resource. A recent Advances in Nutrition study explored biodiversity and analyzed food-plant diversity differences between the Western diet and the MD. Background The global population is expected to rise to 10.9 billion by the end of the century. The Food and Agriculture Organization (FAO) estimates that food production must increase by almost 50% to meet consumers’ demands. Rapid population growth is often considered a threat to sustainable development, as it stresses natural resources. The existing agro-food system has also been cited as a key driver of climate change and environmental ...
- Source: drugdu
- 169
- April 6, 2023
GSK will have to pay additional royalties to AstraZeneca on cancer drug Zejula

[GSK already has concerns with cancer drug Zejula, which is under scrutiny as a member of the PARP inhibitor class. Not the company has taken a loss in court as it will have to surrender added royalties to AstraZeneca for the drug which rolled up sales of 463 pound sterling ($571 million) last year. (GSK)] When Emma Walmsley took over as CEO at GSK in 2017, one of her first moves was to beef up the company’s oncology portfolio with a $5.1 billion acquisition of cancer specialist Tesaro and its newly approved drug Zejula. The ovarian cancer treatment generated 463 pound sterling ($571 million) in 2022, representing a 17% increase from the previous year. So far, so good, right? Well, not exactly. After losing a patent case in court on Wednesday, GSK will have to surrender a portion of its sales of Zejula to Tesaro’s partner on ...
- Source: drugdu
- 159
- April 6, 2023
Immunomodulators boost vaccine response and reduce inflammation, finds study

Adjuvants—ingredients that help boost the immune response in vaccines—have been used in vaccines for decades. But inducing a stronger immune response can result in more unwanted side effects, like swelling at the injection site or fever and body aches. Researchers at the Pritzker School of Molecular Engineering (PME) at the University of Chicago have found that adding small molecules called immunomodulators to vaccine adjuvants gives them the ability to better regulate the body’s response to vaccines. “If you think of adjuvants as a megaphone that stimulates the immune system, then you can think of immunomodulators as a sound mixer,” said Jeremiah Kim, a graduate student and co-lead author of the paper. “We’re able to selectively tune the immune response to reduce negative side effects.” In models, adding immunomodulators to a flu vaccine increased antibody response, and adding them to a typhoid vaccine reduced inflammation. The results were published in ACS Central Science. Graduate student Matthew Rosenberger was also a ...
- Source: drugdu
- 150
- April 6, 2023

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