PharmaFocus Today – Page 373 – media

A Future Without Screening Colonoscopies?

Kerry Dooley Young April 05, 2023 US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening. Most recently, Guardant Health, Inc, announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test. Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC. If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years. “They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, ...
- Source: drugdu
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- April 12, 2023
‘This Is a First’

Marcia Frellick April 07, 2023 Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Researchers have found for the first time that COVID infection has crossed the placenta and caused brain damage in two newborns, according to a study published online today in Pediatrics. One of the infants died at 13 months and the other remained in hospice care at time of manuscript submission. Lead author Merline Benny, MD, with the division of neonatology, department of pediatrics at University of Miami, and colleagues briefed reporters today ahead of the release. “This is a first,” said senior author Shahnaz Duara, MD, medical director of the Neonatal Intensive Care Unit at Holtz Children’s Hospital, Miami, explaining it is the first study to confirm cross-placental SARS-CoV-2 transmission leading to brain injury in a newborn. Both infants negative for the virus at birth ...
- Source: drugdu
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- April 12, 2023
GSK outlines deal to send cell therapies back to Adaptimmune

The pharma is handing back two experimental cancer medicines amid a retreat from cell therapy research. GSK has outlined a deal to send two cancer immunotherapies back to biotechnology company Adaptimmune Therapeutics, a move that follows the larger drugmaker’s recent decision to stop investing in cell and gene therapy research. Adaptimmune announced last October that it would regain rights to the two programs, each of which are in development for solid tumors. On Tuesday, the biotech revealed terms of the agreement. It will get about $37 million in cash from GSK, and receive all materials, data and trial sponsorship responsibilities related to the drugs later this year. The agreement will formally end a partnership between GSK and Adaptimmune that dates back to 2014. That year, the two began working on a program called lete-cel, which works by genetically modifying cells to detect NY-ESO, a protein expressed on several ...
- Source: drugdu
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- April 12, 2023
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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- April 7, 2023

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