Search Results for “EU” – Page 12 – media

Tau-Focused Asceneuron Adds $100M as Oral Alzheimer’s Drug Advances to Phase 2 Trial

Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
- Source: drugdu
- 140
- July 18, 2024
Delix plans further trials with neuroplastogen after positive Phase I data

Delix Therapeutics is planning to initiate two studies to evaluate patients with major depression investigating its lead neuroplastogen candidate, DLX-001, Delix CMO Dr. Aaron Koenig told Pharmaceutical Technology. Upon the completion of an ongoing Phase I study, the Bedford, Massachusetts-based biotech will take the small molecule into two planned trials—a Phase Ib study and a Phase II study, Koenig said. DLX-001 is a neuroplastogen designed to promote neuroplasticity without giving rise to the deleterious attributes of first- and second-generation psychedelics. “With many psychoactive drugs, you’re talking about the concentrations that you’re able to maintain, continuously engaging the receptor for some period of time. We think that this [DLX-001] has a Cmax-driven effect, meaning that it’s about flipping the switch on the receptor so that downstream effects can then occur,” said Koenig. In May, the company released Phase I data, which demonstrated that treatment with DLX-001 does not produce any psychedelic ...
- Source: https://www.pharmaceutical-technology.com/news/delix-plans-further-trials-with-neuroplastogen-after-positive-phase-i-data/?cf-view
- 91
- July 17, 2024
FDA Grants Fast Track Designation to Sumitomo Pharma’s Novel Treatment for Patients with Relapsed or Refractory Acute Myeloid Leukemia

By Don Tracy, Associate Editor DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability. Image Credit: Adobe Stock Images/Pichitchai The FDA has granted Fast Track Designation to Sumitomo Pharma America’s DSP-5336, an investigational small molecule inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement (MLLr) or nucleophosmin mutation (NPM1m). According to the company, DSP-5336 targets the menin and mixed-lineage leukemia (MLL) protein interaction, which is considered vital in a variety of biological processes, including cell growth and genomic stability.1 “For patients and families facing a diagnosis of relapsed or refractory acute myeloid leukemia, significant unmet medical needs remain—and we share in their urgency to identify and advance new treatment pathways,” said Tsutomu Nakagawa, PhD, president, CEO, SMPA, in a press release. “We are encouraged by FDA’s decision and look forward to working closely ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 87
- July 17, 2024
FDA Approves Arcutis Biotherapeutics’ Zoryve to Treat Patients with Mild to Moderate Atopic Dermatitis

By Don Tracy, Associate Editor Zoryve is a steroid-free, once-daily treatment shown to offer rapid disease clearance and significant itch reduction for patients with mild to moderate atopic dermatitis. The FDA has approved Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.15% for mild to moderate atopic dermatitis (AD) in adults and children over six years of age. According to the company, the treatment is steroid-free and moves quickly to clear the disease, resulting in significant itch reduction. The approval was based on results from three Phase III studies, a Phase II dose-ranging study, and two Phase I pharmacokinetic studies.1 “The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics, vice chair, department of dermatology, UC San Diego School of Medicine, INTEGUMENT study ...
- Source: drugdu
- 73
- July 12, 2024
Diagnostic Test Could Detect Elusive Neuro Disorder Using Tiny Drop of Spinal Fluid

Progressive supranuclear palsy (PSP) is a severe neurological disorder classified under frontotemporal dementia (FTD) that impairs cognition, movement, and behavior. Thought to be caused by an accumulation of tau proteins that damage and kill cells, PSP presents symptoms such as poor balance with frequent backward falls and difficulties moving the eyes vertically. Often misdiagnosed as Parkinson’s disease, PSP progresses more rapidly and does not respond to Parkinson’s treatments. Most individuals with PSP pass away approximately seven years after symptoms begin, and frequently, the disease is only identified posthumously during an autopsy. Unlike Alzheimer’s, there are no tau scans, blood tests, or MRIs that can conclusively diagnose PSP, a fact that has hampered the development of treatments. Now, the discovery of a unique pattern of proteins in the spinal fluid of patients could lead to earlier diagnosis and the development of new treatments for PSP. In a study published in Neurology ...
- Source: drugdu
- 103
- July 10, 2024
Michael J. Fox Foundation and Parkinson’s UK Award $5.2 Million to Mission Therapeutics for Research into Potential Parkinson’s Treatment

By Mike Hollan MTX325 is in Phase I trials and is believed to be able to modify the course of the disease. The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK award a multi-million dollar grant to Mission Therapeutics.1 The $5.2 million grant will be used to advance Mission Therapeutics MTX325, a potentially disease modifying treatment for Parkinson’s. In a press release, Mission Therapeutics’ CEO Anker Lundermose said, “This significant grant, from two of the world’s leading Parkinson’s disease organizations, underlines the huge potential of MTX325 as a disease-modifying treatment for this terrible neurodegenerative illness. It also represents a major endorsement of our mitophagy strategy in human diseases including PD.” The company’s chief scientific officer, Dr. Paul Thompson, PhD,, added, “We have already made excellent progress in healthy volunteers with preliminary data from the ongoing clinical trial showing that MTX325 has a good single dose safety profile, ...
- Source: drugdu
- 106
- July 9, 2024
Hinova Pharmaceuticals receives FDA Fast Track Designation for HP518 for Treatment of AR+ Triple-Negative Breast Cancer (TNBC)

CHENGDU, China, July 5, 2024 /PRNewswire/ — Hinova Pharmaceuticals Inc. (688302.SH), a leading biopharmaceutical company dedicated to developing innovative cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational drug for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC). This designation is intended to expedite the development and review process for drugs that address serious conditions and fill an unmet medical need. About HP518 HP518 is a potent PROTAC AR degrader showing efficacy in AR+ TNBC. In preclinical IND-enabling studies, HP518 has demonstrated promising antitumor activity in AR+ TNBC animal models, showcasing significant tumor reduction and a favorable safety profile. The molecular subforms of TNBC are particularly aggressive forms of breast cancer that lack targeted treatment options, accounting for approximately 15-20% of all breast cancer cases, and are characterized by the absence of estrogen and progesterone receptors ...
- Source: drugdu
- 70
- July 9, 2024
NeuroSense Therapeutics shares positive results of lead candidate in ALS

The neurodegenerative disease currently affects more than 200,000 people worldwide NeuroSense Therapeutics has announced positive mid-stage results of its lead drug candidate, PrimeC, in people living with amyotrophic lateral sclerosis (ALS). The phase 2b PARADIGM study has been evaluating PrimeC, a fixed-dose combination of two US Food and Drug Administration (FDA)-approved drugs, Bayer’s ciprofloxacin, a well-known antibiotic, and Pfizer’s Celebrex (celecoxib), a COX inhibitor used to treat inflammation, in 68 people living with the neurodegenerative disease in Canada, Italy and Israel. Affecting more than 200,000 people globally, ALS is a neurological disorder that affects the motor neurons, the nerve cells in the brain and the spinal cord that control voluntary muscle movement and breathing. Previously granted Orphan Drug Designation by the FDA and the European Medicines Agency, PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic ...
- Source: drugdu
- 77
- July 9, 2024
Hengrui Pharmaceuticals’ Innovative Drug HRS-7249 Injection for the Treatment of Hyperlipidemia Approved for Clinical Trials

Recently, Hengrui Pharmaceuticals’ subsidiary Fujian Shengdi Pharmaceutical Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, which approved HRS-7249 Injection, a Class 1 new drug, to carry out clinical trials for the treatment of hyperlipidemia. Upon inquiry, no similar products have been approved for marketing at home and abroad for the time being. Hypertriglyceridemia (HTG) is a common type of dyslipidemia. Epidemiologic studies have shown that HTG is one of the risk factors for atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis, and is clearly associated with overweight/obesity, insulin resistance/type 2 diabetes mellitus, non-alcoholic fatty liver disease, and chronic kidney disease. Currently, triglyceride-lowering drugs often used in clinical practice have limited reduction of triglycerides and have adverse effects such as hepatic and renal impairment, increased risk of atrial fibrillation, and decreased insulin sensitivity, and safer and more effective drugs are needed for ...
- Source: drugdu
- 99
- July 8, 2024
Hengrui Pharmaceuticals’ Innovative Drug HRS-9813 Tablets for Treatment of Idiopathic Pulmonary Fibrosis Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary Guangdong Hengrui Pharmaceuticals Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, which approved HRS-9813 tablets, a Class 1 new drug, to carry out clinical trials for idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrotic interstitial lung disease of unknown cause, which ultimately leads to hypoxemia, respiratory failure and even death.IPF was included in the first batch of China’s rare disease catalog in 2018, and in recent years, studies have shown that its incidence and prevalence are on the rise globally, and its prognosis is poor, and it is one of the diseases that researchers are currently working to overcome. Currently, there are limited drugs approved for the treatment of IPF at home and abroad, and there are still deficiencies in terms of safety and patient compliance.There is still a huge unmet ...
- Source: drugdu
- 103
- July 8, 2024

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