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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
- 207
- 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
- 112
- 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
- 106
- 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
- 123
- 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
- 111
- 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
- 217
- 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
- 121
- 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
- 148
- 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
- 123
- 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
- 116
- July 1, 2023

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