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FDA approves CellTrans’ Lantidra as first cellular therapy to treat type 1 diabetes

The US Food and Drug Administration (FDA) has approved CellTrans’ Lantidra (donislecel) as the first cellular therapy to treat patients with type 1 diabetes. The authorisation specifically applies to adults who are unable to meet their target blood glucose levels because they have repeated episodes of severe low blood sugar (hypoglycaemia), despite intensive disease management and education. Almost 1.9 million people in the US have type 1 diabetes, according to the American Diabetes Association. The condition requires lifelong care, including the regular administration of insulin, either through multiple daily injections or continuous infusion using a pump. However, some patients have trouble managing the amount of insulin needed every day, and dosing becomes difficult. These patients may also develop hypoglycaemia unawareness, where they are unable to detect that their blood glucose is dropping and may not have a chance to treat themselves. Lantidra, which is administered initially as a single infusion, ...
- Source: drugdu
- 125
- July 3, 2023
Lantidra wins FDA approval as first-ever type 1 diabetes cell therapy

The US Food and Drug Administration (FDA) has announced that Lantidra, a cellular therapy for type 1 diabetes (T1D), has become the first treatment of its kind to be approved. Lantidra is an allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells. The approval applies to adults with ‘brittle’ T1D – those unable to reach target glycated haemoglobin (average blood glucose levels) due to repeated severe hypoglycaemic episodes, despite intensive diabetes management and education. T1D accounts for roughly 5%-10% of all diabetes cases. Within this population, an even smaller group, approximately three out of every 1,000 people with T1D, suffer from ‘brittle’ disease. The therapy works by essentially replacing the body’s insulin-producing beta cells in the pancreas. This is achieved through allogeneic islet beta cells that secrete insulin, administered as a single infusion into the hepatic (liver) portal vein. While this is generally sufficient, an additional infusion ...
- Source: drugdu
- 203
- July 3, 2023
Sanofi outlines five-pronged approach to reel in €10B in vaccine sales by 2030

While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. Boasting prophylactic prospects in respiratory syncytial virus (RSV), pneumococcal disease and flu—including a clutch of promising mRNA candidates—the French pharma feels confident its shots can deliver billions of dollars by the end of the decade. By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday. Much of that momentum hinges on Sanofi’s pipeline, where the company is targeting an “accelerated pace of innovation” in a bid to launch at least five innovative phase 3 vaccine programs by 2025. “When developing new vaccines, our scientists can now choose from nine distinct platforms—probably the largest number in the industry,” Thomas Triomphe, Sanofi’s executive vice president of vaccines, said of the company’s future immunization prospects. And despite big things on the horizon—principally in the form of ...
- Source: drugdu
- 106
- July 3, 2023
Missed trial protocols, fabricated emails and failed endpoint mar BioXCel’s Alzheimer’s agitation readout

A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. As BioXCel unveiled its phase 3 data for its orally dissolving dexmedetomidine (originally Pfizer’s Precedex) formulation in Alzheimer’s-related agitation, the company also disclosed some serious trial missteps in an Securities and Exchange Commission (SEC) filing. After the FDA in December inspected a trial site that enrolled about 40% of study participants, the agency found three big red flags relating to adherence of the trial’s framework, the filing says. For one, the investigator failed to follow the informed consent plan for four trial subjects, chief medical officer Robert Risinger, M.D., told investors on a conference call. In “certain instances” the investigative plan wasn’t followed and sufficient case histories weren’t maintained for some patients. For example, the site reported a serious adverse event for one patient outside of ...
- Source: drugdu
- 103
- July 2, 2023
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
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
- 144
- 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
- 118
- 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
- 151
- 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
- 115
- July 1, 2023

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