Many cancer therapies do not produce the hoped-for results. A common reason for this is that the tumors develop resistance to the medications. This is the case, for example, with alpelisib, a drug that has been approved for use in Switzerland for the past few years as a treatment for advanced breast cancer. A research group at the Department of Biomedicine of the University of Basel has now discovered that the loss of the neurofibromin 1 (NF1) gene leads to a reduced response to alpelisib. The researchers also found that the dietary supplement N-acetylcysteine restores the sensitivity of cancer cells to this treatment. The findings have been published in the journal Cell Reports Medicine on April 11. Loss of gene triggers resistance At the moment, patients with advanced and metastatic breast cancer lack effective treatment options. The PI3K signaling pathway is often overactive in breast cancer due to mutations promoting tumor ...
US health officials released data Tuesday showing how chlamydia, gonorrhea and syphilis cases have been accelerating, but doctors are hoping an old drug will help fight the sexually transmitted infections. Experts believe STDs have been rising because of declining condom use, inadequate sex education and reduced testing during the COVID-19 pandemic. Millions of Americans are infected each year. Rates are highest in men who have sex with men, and among Black and Hispanic Americans and Native Americans. “Sexually transmitted infections are an enormous, low-priority public health problem. And they’ve been a low-priority problem for decades, in spite of the fact that they are the most commonly reported kind of infectious disease,” said Dr. John M. Douglas Jr., a retired health official who lectures at the Colorado School of Public Health. To try to turn the tide, many doctors see promise in doxycycline, a cheap antibiotic that has been sold for more than ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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