Search Results for “Clinical Trial” – Page 86 – media

Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 196
- October 10, 2023
Catheter ablation beats drugs in J&J retrospective study of AFib heart failure risk

Dive Brief Catheter ablation is better than antiarrhythmic drugs at cutting heart failure risk as a second-line treatment for atrial fibrillation patients, according to a retrospective study funded by Johnson & Johnson. The study, which was published in Heart Rhythm O2, compared the incidence of heart failure in a claims database to evaluate whether patients who have previously tried an antiarrhythmic drug should receive catheter ablation or a different medicine. Across a dataset of more than 18,000 patients, people who received catheter ablation had a 57% lower risk of developing heart failure than their counterparts on antiarrhythmic drugs. Dive Insight In 2019, a randomized clinical trial funded by the National Institutes of Health and medtech companies including J&J’s Biosense Webster found catheter ablation is no better at reducing the composite risk of death and major cardiovascular events than antiarrhythmic drugs. However, the trial linked ablation to a lower risk of ...
- Source: drugdu
- 140
- October 9, 2023
Emergex and VIC to develop infectious disease therapies in the Gulf

Emergex Vaccines has signed a Memorandum of Understanding (MoU) with the Vaccine Industrial Company (VIC) to develop and commercialise T cell-priming immune set-point candidates against infectious disease therapies. The territories included in the agreement were Saudi Arabia and other specified territories, such as GCC member states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE), other Middle Eastern territories and specified regions. As per the deal, VIC will have an equity share in Emergex, contingent on the Saudi Arabian government’s support for Phase II/III clinical trials of Emergex’s T cell-priming candidates. These are beings studied for dengue, Covid-19, and others, including the add-on therapies related to these indications. In June, Emergex reported positive data from the Phase I trial of its T cell-priming immune set-point candidate, DengueTcP, for treating dengue. The results showed that the therapy was well tolerated in healthy volunteers. The company also reported positive data for CoronaTcP, a ...
- Source: drugdu
- 93
- October 9, 2023
Lokavant receives $8 million from investment giant, Mitsui to expand AI platform

Clinical trial platform company, Lokavant, has received an $8 million strategic investment from global trading and investment giant, Mitsui & Co. Ltd. The investment will be used to expand its AI-optimized platform across the Asia-Pacific (APAC) region. Lokavant entered Japan’s established clinical research market through one of its earliest customers, CMIC Group, the country’s largest contract research organization (CRO). Now with the backing from Mitsui, the company is poised to open a new APAC headquarters in Tokyo. The investment has come about following a year of efforts between the two companies which saw Mitsui’s extensive due diligence of the clinical trials landscape. Encouraged by Lokavant’s clinical trial intelligence technology and proven track record in Japan with current customers, Mitsui has vowed to offer operational support, including business development, staffing, and product localization to help expand Lokavant further in APAC after an initial focus on Japan. The regional headquarters will serve ...
- Source: drugdu
- 117
- October 8, 2023
Sanofi, Teva Ink Deal to Develop Inflammatory Bowel Disease Treatment

Collaboration to focus on ulcerative colitis and Crohn’s disease. Image Credit: Adobe Stock Images/SciePro Sanofi and Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd., announced in a company press release plans to partner on development and commercialization of TEV’574, currently in Phase IIb clinical trials for the treatment of ulcerative colitis and Crohn’s disease, two types of inflammatory bowel disease. Under terms of the collaboration, Teva will receive an initial payment of $500 million with the potential to earn up to $1 billion in development and launch milestones. “This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth strategy,” said Richard Francis, president, CEO, Teva, in the aforementioned release. “This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A. We are honored to partner with Sanofi to bring their proven capabilities, leadership, ...
- Source: drugdu
- 117
- October 7, 2023
Already Partnered With Nvidia and Eli Lilly, Iambic Adds $100M for AI Drug Discovery

Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024. By FRANK VINLUAN Drug discovery isn’t only about finding new targets. There’s still plenty of opportunity to find better ways to hit targets that are already drugged, according to Tom Miller, CEO of startup Iambic Therapeutics. Understanding how a molecule interacts with a known disease target enables drug hunters to design molecules that could be superior alternatives for patients. Miller notes that a molecule’s ability to bind to a target protein while leaving related proteins unaffected improves its safety. It’s also important to understand how the distribution of a molecule across tissues in the body affect efficacy. Iambic’s drug discovery research employs ...
- Source: drugdu
- 221
- October 6, 2023
Novo Nordisk Foundation commits €127m for new cell therapy facility

The Novo Nordisk Foundation has announced that it has committed up to €127m in funding to develop and manufacture a new cell therapy facility, Cellerator, in Denmark, to help fight chronic diseases. The new Novo Nordisk Foundation, Cellerator, will be used for the final development steps of animal research and upscaling new cell therapies for testing in humans. This will help to accelerate treatments for people with diseases including chronic heart failure, Parkinson’s disease, kidney disease, type 1 diabetes and several forms of cancer. Cell therapies work by transplanting living cells into patients to treat diseases. It’s estimated that one in three adults suffers from multiple chronic conditions. In the US alone, it’s been calculated that out of 58 million deaths in 2005, chronic disease was responsible for 35 million. The funding follows a report prepared for the European Federation of Pharmaceutical Industries and Associations, which came to the conclusion ...
- Source: drugdu
- 104
- October 6, 2023
FDA clears Krystal Biotech’s IND for Type 1 AATD treatment KB408

The US Food and Drug Administration has approved Krystal Biotech’s Investigational New Drug (IND) for a Phase I clinical trial of the investigational alpha-1 antitrypsin deficiency (AATD) treatment KB408. Earlier this month, the FDA granted orphan-drug status for KB408 in AATD. The first patient in the planned Phase I trial is expected to receive treatment in Q1 2024. The Phase I trial, involving adult patients with AATD and the PI*ZZ genotype, will assess the safety, tolerability, and efficacy at three planned dose levels. AATD is a rare genetic disorder that occurs when there is insufficient production or impaired functionality of the alpha-1 antitrypsin (AAT) protein. Low AAT levels result in damage to lung tissue, leading to chronic obstructive pulmonary disorder (COPD). KB408 is a gene therapy consisting of a modified herpes simplex virus 1 (HSV-1) derived vector, which delivers two full-length copies of the SERPINA1 gene to enable AAT expression. ...
- Source: drugdu
- 139
- October 4, 2023
Ariceum doses first patient with satoreotide

by John Pinching The treatment targets extensive stage small cell lung cancer and aims to boost therapeutic impact Ariceum Therapeutics, a company developing products for the treatment of specific cancers, has announced that the first patient has been dosed with its satoreotide therapy. The treatment targets extensive stage small cell lung cancer (ES-SCLC), while the research is taking place at the Murdoch University Health Center in Australia. Ariceum’s broader open label phase 1b trial will analyse the tolerability and safety of the ‘theranostic pair’ of somatostatin receptor antagonists, ga-satoreotide trizoxetan and lu-satoreotide tetraxetan, among patients with ES-SCLC. The central aim of the research is to establish a recommended phase 2 dose and schedule in due course. ‘Theranostics’ is the system of incorporating two paired drugs: the first, a diagnostic agent to identify cells that exhibit a particular biomarker, and the second, a therapeutic drug which subsequently acts on those cells. ...
- Source: drugdu
- 202
- October 3, 2023
MIT study reveals why certain immunotherapies do not always work

A new Massachusetts Institute of Technology (MIT) study has revealed a potential explanation as to why certain immunotherapies for cancerous tumours do not always work as predicted. If validated in clinical trials, the findings could help doctors identify cancer patients who would benefit the most from drugs known as checkpoint blockade inhibitors. Checkpoint blockade inhibitors work by stimulating immune cells to destroy tumours in the body’s T cell response. In previous studies, findings have shown that these drugs work effectively in patients whose tumours have a large number of mutated proteins. However, 50% of patients who received the US Food and Drug Administration-approved checkpoint blockade inhibitor, pembrolizumab, did not respond well or only showed short-lived responses, despite their tumours showing high mutational burden. In a study of mice, the researchers revealed that measuring the diversity of mutations within a tumour generated a more accurate prediction as to whether immunotherapy treatment ...
- Source: drugdu
- 105
- October 1, 2023

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