Search Results for “EU” – Page 35 – media

Novartis’ Lutathera Clears Phase III as Frontline Treatment for Rare Neuroendocrine Cancer

By Tristan Manalac Pictured: Novartis logo on its office in California/iStock, JHVEPhoto Novartis’ radioligand therapy Lutathera (lutetium Lu 177 dotatate) met its primary endpoint in the Phase III NETTER-2 trial in gastroenteropancreatic neuroendocrine tumors, the company announced Monday. NETTER-2 is a randomized and open-label trial that evaluated Lutathera as a first-line option in 222 patients with grade 2 or 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Only those whose cancers were positive for the somatostatin receptor (SSTR) were eligible for enrolment into NETTER-2. When used in combination with high-dose long-acting octreotide, Lutathera led to a significant improvement in progression-free survival (PFS)—the study’s primary endpoint—compared with octreotide alone. In terms of safety, NETTER-2 did not find any new signals of concern and Lutathera’s adverse event profile in the study was consistent with what had been previously established. Novartis did not provide specific efficacy and safety figures, though it promised to do so ...
- Source: drugdu
- 137
- September 28, 2023
Photobiomodulation in sleep has more therapeutic effects for Alzheimer’s disease than in wakefulness

It is well known that sleep is the best medication. However, it is still unknown why the brain recovers better in sleep and whether these processes can be controlled. Recent discoveries have shown that the lymphatic system of the brain is activated during sleep, which contributes to the removal of metabolites, toxins and unnecessary molecules from its tissues. Sleep disturbance contributes to the deposition of metabolites in the central nervous system (CNS). For example, sleep is a biomarker for the development of Alzheimer’s disease. This is due to the fact that the toxic metabolite beta-amyloid is excreted from brain tissue during sleep. Sleep deprivation leads to the accumulation of toxin in the CNS, which over time can lead to the development of Alzheimer’s disease. In this pilot study, the researchers have shown that non-invasive sleep photobiomodulation technology can effectively increase lymphatic excretion of beta-amyloid from the brain tissues of mice ...
- Source: drugdu
- 215
- September 25, 2023
FDA Rejects ARS Pharmaceuticals’ Needle-Free EpiPen Alternative

Agency cites a need for more research to be completed. ARS Pharmaceuticals revealed in a company press release that the FDA issued a complete response letter (CRL) regarding its new drug application (NDA) for neffy, a potential nasal spray alternative to the EpiPen. According to the response, the agency stated that it needed more research before agreeing to approval. The denial comes amid an initial advisory committee vote to approve the treatment back in May. “We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote. In fact, multiple Committee members highlighted the favorable profile of neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response ...
- Source: drugdu
- 202
- September 22, 2023
Researchers discover how neurons die in Alzheimer’s disease

Scientists from the UK’s Dementia Research Institute at University College London (UCL) and VIB-KU Leuven have discovered the cause of the death of neurons in Alzheimer’s disease (AD), opening up potential avenues to develop new treatments for the condition. The researchers found that a programmed form of cell death, known as necroptosis, is initiated when neurons are exposed to amyloid plaques and tau tangles. The researchers created a new model to replicate and connect AD hallmark features – amyloid plaques, tau tangles, and death of neurons – by implanting both healthy human and mouse neurons into the brains of AD mouse models. They discovered that only human neurons displayed Alzheimer’s features, including tau tangles and neuronal cell loss. These findings suggest that humans have specific factors that play in Alzheimer’s that standard mouse models cannot replicate, as their neurons are more resilient to amyloid pathology. Upon further research, the team ...
- Source: drugdu
- 109
- September 22, 2023
Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout. The cuts come after the company’s recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of “all future products,” a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington. “With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients,” the spokesperson said. The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson ...
- Source: drugdu
- 156
- September 19, 2023
Iovance’s PDUFA date for lifileucel pushed due to FDA backlog

The US Food and Drug Administration (FDA) is feeling the strain on its resources and has had to delay the priority review of Iovance Biotherapeutics’s lifileucel to 2024. The Prescription Drug User Fee Act (PDUFA) action date for the priority review of the Biologics License Application (BLA) for lifileucel has been postponed from 25 November 2023 to 24 February 2024. However, Iovance was quick to add that the reason for pushing the date was the FDA’s “insufficient resources” and that it was working with the agency to expedite the review for a potentially earlier approval date. The company also added that the FDA reported no major review issues, no concerns regarding the status of the confirmatory trial, and had no plans to hold an advisory committee meeting. The markets viewed the news favourably, as Iovance’s stock rose by more than 15% in pre-market trading. The company’s market cap stands at ...
- Source: drugdu
- 102
- September 19, 2023
Click Expands to Substance Use Disorder With Indivior Digital Therapeutics Pact

Click Therapeutics, a developer of prescription digital therapeutic products, is adding substance use disorder to its pipeline through a new partnership with addiction medicines maker Indivior. Like other products in the Click pipeline, the new substance use disorder treatment, codenamed CT-102, will be a mobile software app. This app will be designed to work alongside drugs used to treat addiction. The Indivior portfolio includes the opioid addiction products Sublocade and Suboxone. Click said the partnered app will combine evidence-based behavioral therapy with tailored interventions intended to have an effect on the brain. Privately held Click is part of a cohort of companies developing software as treatments for various medical conditions. The company has mapped the entire brain to discover faulty brain circuits that are implicated across a variety of diseases. To treat these diseases, the company designs apps that present users with tasks that have the effect of retraining and ...
- Source: drugdu
- 180
- September 12, 2023
FDA fast tracks Mendus’s acute myeloid leukaemia vaccine vividencel

The US Food and Drug Administration (FDA) has granted fast track designation to Mendus’s cancer vaccine vividencel for the treatment of acute myeloid leukaemia (AML). The FDA’s decision was based on results from the Phase II ADVANCE II trial (NCT03697707), which investigated the vaccine’s use as a maintenance monotherapy in patients with AML in complete remission. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews. In June, the Swedish company, which was previously known as Immunicum, presented comprehensive immunomonitoring data at the European Hematology Association’s 2023 hybrid congress. According to Mendus, the vaccine led to increased levels of activated, cancer-killing T cells and reduced levels of immune-suppressive T cells in the majority of the patients in the Phase II ADVANCE II study. Prior to this, the company published data on the drug’s effects on measurable residual ...
- Source: drugdu
- 167
- September 12, 2023
UK rejoins EU’s Horizon Europe science programme

The UK has re-joined the EU’s Horizon Europe science research programme after the country’s post-Brexit absence and long-stalled talks. British scientists will now be able to apply for grants and bids to take part in Horizon Europe projects, based on the UK Government’s 7 September announcement. As an EU member state at the time, the UK was part of the EU’s past Horizon 2020 research funding programme. This programme has since been succeeded by Horizon Europe, which uses its budget of €95.5bn to support research across the region. The programme not only offers funding for research but also provides a chance for collaboration across Europe and beyond such as Armenia, Israel, and New Zealand. “The UK’s decision to re-join the Horizon Europe funding programme will be welcomed warmly by researchers across the EU and Great Britain today,” said Dr. Harshil Patel, head of scientific development at Seqera Labs after the ...
- Source: drugdu
- 201
- September 11, 2023
【Expert Q&A】How do I get started in the pharmaceutical intermediates business?

Entering the pharmaceutical intermediates business is a challenge that requires a wide range of specialized knowledge and experience, especially if you don’t have an extensive network in this field. Here are some suggestions to help you get started and succeed in your business: I. Basic Preparation Market Research: Understand industry trends, target customers, competitors, and market demand. Financing and Budget: Ensure you have enough capital to operate, including for production, sales, and marketing. Licensing and Compliance: Know and adhere to all relevant laws and regulations, including obtaining necessary permits and certifications. II. Technology and Production R&D Capability: Have or partner with reliable R&D institutions to develop and improve products. Quality Control: Establish strict quality control procedures. Supply Chain Management: Find reliable raw material suppliers and establish robust logistics and inventory management systems. III. Sales and Marketing Sales Team: Establish or hire an experienced sales team. Online Marketing: Utilize websites, social ...
- Source: drugdu
- 262
- September 7, 2023
Licensing and Compliance market research pharmaceutical intermediates

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