PharmaFocus Today – Page 312 – media

Gates Foundation and Wellcome to fund late-stage trial of tuberculosis vaccine candidate

The Bill & Melinda Gates Foundation and Wellcome have joined forces to fund the late-stage development of what could be the first tuberculosis (TB) vaccine in over a century. TB is a bacterial infection spread by inhaling tiny droplets from the coughs or sneezes of an infected person. Despite being both curable and preventable, the disease continues to affect around ten million people every year, and 1.6 million people died from it in 2021, almost entirely in low and middle-income countries. The only TB vaccine in use today, bacille Calmette-Guérin (BCG), was first used in 1921. It helps protect babies and young children against severe systemic forms of TB, but offers limited protection against pulmonary TB – a form of active TB – among adolescents and adults. The Gates Foundation and Wellcome will invest around $550m to support the phase 3 trial of the M72/AS01E (M72) vaccine, which will be ...
- Source: drugdu
- 119
- July 2, 2023
CDC recommends RSV vaccines from Pfizer, GSK for adults 60 and older

The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors. Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their health-care providers to decide if taking a shot is right for them. The CDC said the shots are expected to be available to the public this fall, when respiratory syncytial virus – along with Covid and the flu – typically begins to spread at higher levels. “These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate,” the CDC said in a statement. The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but ...
- Source: drugdu
- 108
- July 2, 2023
AstraZeneca’s STRIDE shows improved outcomes for liver cancer patients

AstraZeneca has announced impressive results for its STRIDE regimen, delivering significantly improved outcomes for advanced liver cancer patients. The treatment regimen was evaluated in the ongoing HIMALAYA Phase III study (NCT03298451), conducted with 1324 hepatocellular carcinoma (HCC) patients. Participants were randomised to receive either STRIDE or sorafenib, one of the tyrosine kinase inhibitors that comprise the current standard of care for various liver, kidney, and thyroid cancers. After four years of follow-ups, AstraZeneca announced that STRIDE reduced the risk of death by 22% compared to sorafenib, with 25.2% of patients alive at the four-year mark compared to 15.1% with sorafenib. While a one-in-four survival rate may not be comparable, advanced-stage HCC carries a poor prognosis. Five-year survival rates for the condition are only 7%, one of the lowest across all oncology, so even minor improvements in overall survival can make a major difference. Despite this improvement, adverse events recorded during ...
- Source: drugdu
- 209
- July 2, 2023
FDA seeks feedback on technologies that can enable healthcare at home

Dive Brief The U.S. Food and Drug Administration is asking for public input on the transition to at-home care and how it can support enabling technologies. As part of its push to advance health equity, the FDA has posed a series of home-care questions to the medtech industry, including a query about how it can support the development of devices for use in non-clinical care settings. Other questions cover how digital health technologies can support home-based healthcare, the device design attributes that facilitate use outside of clinical settings and methods for generating data to inform regulatory reviews. Dive Insight The development of remote patient-monitoring devices and other connected medical technologies has made it possible to treat more patients at home. In theory, home care can help reduce costs and risks associated with spending time in healthcare facilities and lessen burdens on patients. The COVID-19 pandemic accelerated uptake and validation of ...
- Source: drugdu
- 117
- July 2, 2023
Has COVID-19 changed the future of pharmaceutical regulation?

Has COVID-19 revolutionized the future of regulation of medicine development and authorization or are we simply responding to an unprecedented global pandemic? Our Head of Regulatory Affairs and Enhanced Services, Harriet Edwards, delves deep on how the pandemic changed the industry we work in today. COVID-19, or SARS-CoV-2, has undoubtedly changed the world as we know it, affecting daily life, health, and economics to an unprecedented degree. Due to the widespread and devastating impact of this previously unknown virus, there has been a massive effort from the pharmaceutical industry to rapidly develop a vaccine to protect the population. As a consequence of the increasingly evolving threat of COVID-19, developers and regulators have had to respond accordingly, learning about the virus while attempting to develop and regulate treatments concurrently. This article aims to examine whether COVID-19 (SARS-CoV-2) has changed the future of regulation through identifying and discussing the notable regulatory milestones ...
- Source: drugdu
- 145
- July 2, 2023
FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use

Dive Brief The U.S. Food and Drug Administration has written to healthcare providers to emphasize its current indications and instructions for use of NuVasive’s limb-lengthening system. NuVasive paused shipments of its Precice devices for lengthening limbs in 2021 but resumed the sale of some products later that year after showing that its titanium-based devices may be free of the problems associated with stainless steel implants. The FDA said it continues to monitor the safety of the titanium implants and, having expanded the use of the devices to children in a recent 510(k) clearance, is reminding healthcare providers of its position on the products. Dive Insight The FDA in March gave 510(k) clearance to NuVasive to market its Precice Intramedullary Limb Lengthening System for use in the femur and tibia of children aged 12 years and up. Having lowered the minimum age for using the device, the FDA wrote to healthcare ...
- Source: drugdu
- 120
- July 1, 2023
Scientists use designer tubulins to crack the tubulin code

Tubulin is a protein that plays a crucial role in the structure and function of cells. It is the main component of microtubules, which are long, hollow fibers that provide structural support, help the cell divide, give it its shape, and act as tracks for moving molecular cargo around inside the cell. There are two types of tubulin: alpha-tubulin and beta-tubulin. Together, they form dimeric (two-part) building blocks, spontaneously assembling into microtubules that undergo further continuous cycles of assembly and disassembly. The tubulin code To fine-tune microtubules, the dimers undergo various post-translational modifications (PTMs), which are chemical modifications that occur after they are synthesized, and can affect their structure, activity, and interactions with other molecules. Two important PTMs take place on the unstructured tail of alpha-tubulin: Polyglutamylation, which adds chains of glutamate amino acids, and detyrosination, which removes the final tyrosine amino acid. These PTMs, among others, are found together ...
- Source: drugdu
- 113
- July 1, 2023
Loneliness linked with elevated risk of cardiovascular disease in patients with diabetes

Loneliness is a bigger risk factor for heart disease in patients with diabetes than diet, exercise, smoking and depression, according to research published June 29 in the European Heart Journal,. “The quality of social contact appears to be more important for heart health in people with diabetes than the number of engagements,” said study author Professor Lu Qi of Tulane University School of Public Health and Tropical Medicine, New Orleans. “We should not downplay the important of loneliness on physical and emotional health. I would encourage patients with diabetes who feel lonely to join a group or class and try to make friends with people who have shared interests.” “Loneliness and social isolation are common in today’s societies and have become a research focus during the last years, especially driven by the COVID-19 pandemic and the continuous digitalization of society,” state Kahl and colleagues in an accompanying editorial. Loneliness refers ...
- Source: drugdu
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- July 1, 2023
Pandemic ‘fear of missing out’ had mental health consequences for older adults, study shows

During the COVID-19 pandemic, fear of missing out (FOMO) on social activities may have negatively affected the mental health of adults at high risk of serious disease, according to a new study from Rice University and Baylor University. “Fear of missing out and depressive symptoms during the COVID-19 pandemic” was published June 29 in Social and Personality Psychology Compass and is authored by Angie LeRoy, an assistant professor of psychology and neuroscience at Baylor; Vincent Lai, a Ph.D. student at Rice; Arya Tsay-Jones, who participated in the research as a Rice undergraduate; and Chris Fagundes , a professor in Rice’s Department of Psychological Sciences. The acronym “FOMO”—short for the “fear of missing out” one might feel about not being able to take part in events or experiences that could make one’s life better—refers to a phenomenon that has become more mainstream in the last decade as social media use has ...
- Source: drugdu
- 117
- July 1, 2023
FDA rejects Alvotech’s Humira biosimilar for the third time

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Humira biosimilar AVT02, further delaying the company’s plans to launch the drug in a landmark year. The agency rejected the drug’s biologics licence application (BLA) over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland, according to Alvotech’s press release on 28 June. While the FDA did not make a note of any other deficiencies in the BLA, issues related to the Reykjavik facility need to be resolved to facilitate the drug’s potential approval. This marks the second time that the FDA has rejected AVT02’s BLA this year. In April, the regulator issued a CRL to Alvotech, which also noted the deficiencies seen in the company’s Reykjavik plant. Prior to that, the company received a CRL from the FDA over deficiencies in the plant in September 2022. Alvotech plans to resubmit ...
- Source: drugdu
- 107
- July 1, 2023

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