Search Results for “EC” – Page 401 – media

Cellusion shares pipeline update for eye disease stem cell therapy

Cellusion plans to begin a Phase I/II trial for its bullous keratopathy candidate CSL-001 in 2024, says CEO Shin Hatou. After this, the company will begin a US Phase I/II study for the therapy in 2025, notes Hatou. The Tokyo, Japan-headquartered company aims to submit an investigational new drug (IND) application to the US Food and Drug Administration (FDA) in 2025. Hatou says the company may look to increase funding in the next few years either through further financing rounds or a possible initial public offering. Cellusion would be interested in continuing to work with its current investors and remains open to new investment opportunities to achieve this, he adds. Takuya Kaneko, Cellusion’s chief financial officer (CFO), says that the company aims to launch sales of CSL-001 in Japan by 2027. He says the company is looking for an alliance partner to support the product’s development in the US and ...
- Source: drugdu
- 95
- June 30, 2023
AbbVie, Genmab’s Epkinly shows promise in follicular lymphoma. Will FDA get on board?

Merely a month into an FDA approval, AbbVie and Genmab’s bispecific drug Epkinly has chalked up a positive readout that might enable an expansion in blood cancer, although the exact regulatory path remains unclear. Epkinly significantly beat back tumors in 82% of patients with relapsed or refractory follicular lymphoma in a phase 1/2 trial, the companies said Tuesday. The patients had received a minimum two—and a median three—prior lines of systemic therapy. The median duration of response hasn’t been reached in Epkinly’s study, and investigators are still following patients. The companies also didn’t disclose the complete response rate. Full results from the study will be shared at a future medical meeting. Epkinly snagged an FDA approval for previously treated diffuse large B-cell lymphoma (DLCLC) in May, and AbbVie and Genmab said they will talk to regulators about next steps in FL, an indolent form of lymphoma. If approved in the ...
- Source: drugdu
- 104
- June 30, 2023
FDA Warms Up to Ipsen’s Post-Hoc Analysis for Rare Disease Drug Ahead of Adcomm

By Tristan Manalac https://www.biospace.com/ Despite a risk of bias and false positives, the FDA appears to be open to considering Ipsen’s post-hoc analysis of a Phase III study to support the approval of its investigational therapy palovarotene, proposed for the ultra-rare disease fibrodysplasia ossificans progressive. Ipsen is seeking approval for a once-a-day, 5-mg dose of palovarotene, along with a flare-up regimen consisting of a 20-mg once-daily schedule for the first four weeks followed by 10-mg once-daily for eight weeks, according to the company’s briefing document posted ahead of an Endocrinologic Drugs Advisory Committee meeting scheduled Wednesday. To support its regulatory bid, Ipsen provided data from one Phase II study with multiple open-label extension phases and a single-arm, open-label Phase III study, which used an external natural history control. However, according to the FDA’s briefing material, palovarotene failed its Phase III study, which “crossed the prespecified futility boundary at the second ...
- Source: drugdu
- 104
- June 29, 2023
‘Aging’ immune cell levels could predict how well we respond to vaccines

Cambridge scientists have identified a signature in the blood that could help predict how well an individual will respond to vaccines. The discovery, published today in Nature Communications, may explain why, even among vulnerable patient groups, some individuals have better responses to vaccines than others. During the COVID-19 pandemic, it has become clear that some patients are better protected by vaccination than others. Many studies have shown that SARS-CoV-2 vaccines are less effective in people with weakened immune systems, but also that this effect is not uniform. Vaccination involves priming the immune system to look for—and get rid of—invading pathogens, such as viruses and bacteria. In part, this involves stimulating the production of antibodies uniquely programmed to identify a particular invader. These antibodies are themselves produced by a type of immune cell known as a B cell. One specific subset of B cells is known as age-associated B cells (ABCs). ...
- Source: drugdu
- 98
- June 29, 2023
That essential morning coffee may be a placebo

For many people, the day doesn’t start until their coffee mug is empty. Coffee is often thought to make you feel more alert, so people drink it to wake themselves up and improve their efficiency. Portuguese scientists studied coffee-drinkers to understand whether that wakefulness effect is dependent on the properties of caffeine, or whether it’s about the experience of drinking coffee. “There is a common expectation that coffee increases alertness and psychomotor functioning,” said Prof Nuno Sousa of the University of Minho, corresponding author of the study in Frontiers in Behavioral Neuroscience and Field Chief Editor of the journal. “When you get to understand better the mechanisms underlying a biological phenomenon, you open pathways for exploring the factors that may modulate it and even the potential benefits of that mechanism.” A caffeine kickstart The scientists recruited people who drank a minimum of one cup of coffee per day and asked ...
- Source: drugdu
- 118
- June 29, 2023
Illumina plans layoffs, closure of San Diego facility in push to save $100M a year

Dive Brief Illumina is laying off staff and closing a facility in San Diego as part of its push to cut its annual spending by $100 million, according to a regulatory filing. The layoffs, which STAT reports will affect 10% of R&D staff, come weeks after Francis deSouza resigned as CEO in the wake of a proxy battle with activist investor Carl Icahn. As well as exiting the San Diego site, Illumina is “evaluating its options” for another California campus in Foster City. The layoffs reportedly affect those two California sites, plus facilities in Wisconsin, Singapore and the United Kingdom. Dive Insight In April, Illumina outlined plans to reduce spending by $100 million this year. The goal was to improve margins and free up cash to invest in high-growth areas. Now, the company has revealed what the plan will mean for its workforce. Layoffs began last week and additional workforce ...
- Source: drugdu
- 105
- June 29, 2023
Eli Lilly experimental obesity drug helped patients lose up to 24% of their weight, study says

Eli Lilly’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday. The phase two trial followed 338 adults who were obese or overweight and either received the pharmaceutical company’s injection, retatrutide, or a placebo each week. Patients who took a 12-milligram dose of retatrutide lost 17.5% of their body weight, or 41 pounds, on average after 24 weeks, compared with 1.6% for those who received the placebo. Patients lost 24.2%, or 58 pounds, on average after 48 weeks. Those who took the placebo lost 2.1% of their body weight after that same time period. The trial’s researchers said average weight loss did not appear to plateau after 48 weeks, suggesting a longer study could show even more. Eli Lilly is currently recruiting patients for ...
- Source: drugdu
- 108
- June 29, 2023
Lisata shares pipeline update of anticancer lead candidate drug

Lisata Therapeutics aims to start a new Phase Ib/IIa trial of its lead candidate drug LSTA1 in glioblastoma later this year. The trial will study LSTA1’s use alongside the standard of care (SOC) versus the SOC and placebo. According to Lisata CEO David Mazzo, added that the company aims to enrol 30 subjects in the active arm in approximately one year. The study will focus on efficacy endpoints such as progression-free survival and overall survival. The trial will take place in the Baltic region, specifically in Estonia and Latvia. This was initially shaped by the company’s collaboration with a research group from Estonia’s University of Tartu Mazzo commented that Lisata aims to have data from this trial ready by mid-2025. The company’s lead candidate LSTA1 is a cyclic peptide that is designed to modify the tumour microenvironment by binding to alpha-V integrins expressed in tumours, per the company’s website. Once ...
- Source: drugdu
- 97
- June 29, 2023
Pfizer Drops Early-Stage Obesity Drug Following Disappointing Phase I Data

By Tristan Manalac Pictured: Pfizer sign on building/Tobias Arhelger/Adobe Stock Pfizer is discontinuing the clinical development of its investigational GLP-1 receptor agonist lotiglipron, which was being developed for obesity and Type 2 diabetes mellitus, the company announced Monday. The decision to cut lotiglipron from Pfizer’s pipeline comes after the company detected heightened concentrations of liver transaminases in patients treated with the investigational drug. Lotiglipron was being evaluated in two Phase I drug-drug interaction studies and one Phase II trial. Pharmacokinetic data from the two Phase I studies also contributed to the candidate’s discontinuation. None of the patients developed liver-related symptoms or similar side effects and neither required medical intervention. Pfizer also did not document signs of liver failure among these patients. The company will present lotiglipron data at an upcoming conference or will submit it for publication in peer-reviewed journals. With lotiglipron’s discontinuation, Pfizer will instead focus on the clinical ...
- Source: drugdu
- 155
- June 28, 2023
Global study shows loneliness can shorten life spans

There is an epidemic of loneliness and isolation today, and the consequences can be deadly, researchers say. Folks who reported that they were socially isolated or felt lonely were more likely to die early from all causes including cancer, according to a sweeping review of 90 studies that included more than 2.2 million people from around the globe. Exactly how loneliness or social isolation affects a person’s health and well-being is not fully understood, but many theories exist, the researchers reported. People who are socially isolated or lonely may be less likely to eat a healthy diet and get regular exercise and more likely to smoke and consume alcohol. In addition, social isolation is linked to inflammation and weakened immune systems. People who are socially isolated may be less likely to receive medical care due to their smaller social networks. Social isolation and loneliness are not one and the same, ...
- Source: drugdu
- 102
- June 28, 2023

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