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NIH clinical trial for universal influenza vaccine begins

The universal vaccine could protect people against more strains of flu The National Institutes of Health (NIH) has announced that it has begun dosing patients in a phase 1 clinical trial of a new influenza (flu) vaccine candidate, FluMos-v2, to evaluate the vaccine for safety and its ability to elicit an immune response. Designed by researchers at the National Institute of Allergy and Infectious Diseases’s (NIAID) Vaccine Research Center (VRC), FluMos-v2 works to induce antibodies against various influenza strains by displaying part of the influenza virus haemagglutinin (HA) protein in repeating patterns on self-assembling nanoparticle scaffolds, preparing the immune system to recognise and fight the actual virus. Sponsored by NIAID, the trial is expected to enrol 24 healthy individuals, aged 18 to 50 years, to receive two intramuscular injections of the vaccine candidate, 16 weeks apart. The researchers aim to enrol 12 participants in a lower dose group (60mcg per ...
- Source: drugdu
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- September 30, 2023
NICE recommends more genetic testing for links to ovarian cancer

Around 340,000 to 444,000 people in the UK carry one of nine pathogenic gene variants The National Institute for Health and Care Excellence (NICE) has recommended that more people get tested for genes linked to ovarian cancer. The new guideline aims to raise awareness and increase the availability of genetic testing, allowing people to take preventive measures, including surgery, to prevent the development of ovarian cancer. Anyone can carry a gene linked to ovarian cancer, including women, men, transgender people, and non-binary people, which can be passed on to their children. In the UK, around 340,000 to 440,000 people carry one of the nine pathogenic variants – BRCA1, BRCA2, MLH1, MSH2, MSH6, RAD51C, RAD51D, BRIP1 and PALB2 – that cause cancer, 3% of whom know they have a high-risk gene. NICE has recommended that genetic services should test and assess the likelihood of people carrying the genes, including those who ...
- Source: drugdu
- 105
- September 30, 2023
Over half of world’s population not covered by essential healthcare services

The World Health Organization (WHO) and the World Bank have published the 2023 Universal Health Coverage (UHC) Global Monitoring Report, which revealed some alarming statistics concerning out-of-pocket (OOP) health expenditure and the global health service coverage rate. The report showed that only 42 out of 138 countries have achieved progress in expanding UHC service coverage since 2000 while also reducing OOP spending for the population. Alternatively, 108 countries reported worsening to no significant changes in health coverage since 2015, the year when Sustainable Development Goals (SDGs) were adopted. All 108 countries that experienced slow progress in UHC service coverage are low-income countries (LICs) and lower-middle-income countries (LMICs). Despite that, the overall global UHC Service Coverage Index (SCI) score increased from 45 to 68 out of 100 between 2000 and 2021, but no change was reported in the global SCI score between 2019 and 2021. Notably, a significant variation in country-level ...
- Source: drugdu
- 212
- September 29, 2023
Oxford Biodynamics launches prostate screening test

EpiSwitch is designed for men with prostate cancer risk in the UK and is 94% accurate Oxford BioDynamics – a company developing precision medicine tests – has announced that its EpiSwitch Prostate Screening (PSE) blood test will be available to UK patients. The existing PSA test is 55% accurate, and is considered an unreliable test by many doctors, including those in the NHS. The new PSE test has been designed to run alongside the standard PSA test, and combines the PSA score with five proprietary epigenetic biomarkers to predict – with 94% accuracy – the presence (or absence) of prostate cancer. The PSE test has emerged after nearly a decade’s long collaboration between OBD, Imperial College London, University of East Anglia, Imperial College NHS Trust and leading prostate cancer experts across the UK. The development was also part of the wider PROSTAGRAM screening pilot. Mathias Winkler, Consultant Urologist and Surgeon ...
- Source: drugdu
- 118
- September 29, 2023
Will Big Pharma engage in Medicare price negotiations? AZ, BMS say they will

After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines. First up, the companies need to tell CMS by Sunday whether they’ll participate in the process or exit the Medicare and Medicaid programs entirely. In a statement to Fierce Pharma, an AstraZeneca representative said the company plans to “participate in the process outlined by CMS to communicate the value of Farxiga to people covered by Medicare” as part of its commitment to ensuring access. BMS plans to begrudgingly participate in the process, a spokesperson told Fierce Pharma in an emailed statement. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid,” the spokesperson said. “That is ...
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- 108
- September 29, 2023
As chemotherapy shortage ebbs and flows, attention shifts to long-term solutions

It’s been about 10 months since FDA inspectors rebuked a production plant in India that made popular platinum-based chemotherapies, kicking off a chain reaction of drug shortages that continues to jeopardize cancer care in the U.S.While the White House recently announced that overseas importations and other efforts have increased U.S. supplies of carboplatin and cisplatin, not all clinics are able to access the drugs, according to the American Society of Clinical Oncology’s (ASCO’s) chief medical officer Julie Gralow, M.D. Even as supplies recover around the country, a “certain set” of cancer clinics are still unable to get their hands on the medicines, Gralow said in an interview. The disparity in availability reflects the disproportionate impact the shortage has had on patients based on factors such as location or socioeconomic status, Gralow added. It’s often smaller sites that can’t secure the drugs. While bigger hospitals may have them, those sites often ...
- Source: drugdu
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- September 29, 2023
Alto Reports Positive Phase II PTSD Data After Mid-Stage MDD Win

By Tristan Manalac Pictured: Cracked figure of a head symbolizing distress/iStock, designer491 Alto Neuroscience on Tuesday announced that its investigational drug ALTO-100 showed a favorable efficacy and safety profile in a Phase IIa trial in patients with post-traumatic stress disorder. The study also demonstrated that Alto’s precision psychiatry approach could lead to better outcomes for post-traumatic stress disorder (PTSD) patients. In a subgroup of patients defined by a certain cognitive profile, treatment with ALTO-100 reduced scores in the clinician-administered PTSD scale for DSM-5 (CAPS-5) by 17.5 points. In contrast, the candidate improved CAPS-5 scores by only 12.9 points in patients without this cognitive profile. The difference was statistically significant, indicating that the company’s approach could identify potential drug responders by looking at patients’ neurobiological profiles, according to Alto’s announcement. In addition, in the biomarker-defined patients, ALT-100 elicited a clinical response rate of 46% compared to only 26% in those without ...
- Source: drugdu
- 170
- September 29, 2023
mRNA Vaccine Manufacturing Comes to Africa

By Clemence Manyukwe Pictured: The first BioNTainer arrives in Rwanda/BioNTech German biotech company BioNTech has said it will start manufacturing vaccines in Africa within 18 months after completing a manufacturing facility in Rwanda, a milestone the company stated it expects to reach by the end of this year. The company is also planning to set up plants in two other African countries, South Africa and Senegal, as part of what it describes as an effort to democratize access to novel medicines around the globe. “Core to BioNTech’s business practices is to improve the health of people worldwide,” a company spokesperson told BioSpace in an email. To launch its manufacturing presence in Africa, BioNTech introduced its BioNTainer, a flexible container solution delivering turnkey mRNA manufacturing facilities for scalable mRNA vaccine production. “The BioNTainer was developed to help ensure sustainable, equitable access to mRNA-based medicines in countries and regions where they are ...
- Source: drugdu
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- September 29, 2023
Short-term exposure to air pollution may increase stroke risk

Short-term exposure to air pollution may be linked to an increased risk of stroke, according to a meta-analysis published in the September 27, 2023, online issue of Neurology®, the medical journal of the American Academy of Neurology. Short-term exposure was defined as occurring within five days of the stroke. Ahmad Toubasi, MD, study author, University of Jordan in Amman, said, “Previous research has established a connection between long-term exposure to air pollution and an increased risk of stroke. However, the correlation between short-term exposure to air pollution and stroke had been less clear. For our study, instead of looking at weeks or months of exposure, we looked at just five days and found a link between short-term exposure to air pollution and an increased risk of stroke.” The meta-analysis involved a review of 110 studies that included more than 18 million cases of stroke. Researchers looked at pollutants such as ...
- Source: drugdu
- 215
- September 29, 2023
Siemens Healthineers buys Aspekt to bolster radiation oncology services

Dive Brief Siemens Healthineers has acquired Aspekt Solutions to strengthen the service offering at its Varian cancer therapy unit. Neither party disclosed the value of the deal. Aspekt supports radiation oncology sites — the type of health centers that use Varian devices — with services such as dosimetry consulting, clinic management, technology evaluation and staffing. Varian sees the acquisition as complementary to its Advanced Oncology Solutions unit, which provides professional and clinical services to improve the implementation of its technologies. Dive Insight Varian, a provider of radiation oncology equipment and software, pitches its AOS unit as enabling sites to adopt technologies, improve quality and expand capacity. The unit collaborates with radiation oncology sites to simplify data entry, optimize databases, reduce variation between dosimetrists and train staff on safety. In doing so, Varian aims to address challenges such as the rising cost of care and staff shortages. “Through our AOS offerings, ...
- Source: drugdu
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- September 29, 2023

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