Cosentyx is the first intravenous formulation interleukin-17A antagonist to focus on disease. Image Credit: Adobe Stock Images/Seventyfour Novartis officially announced that the FDA approved n intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Currently, Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. “At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience,” said Christy Siegel, ...
Acquisition includes company’s inflammatory disease medicines. Image Credit: Adobe Stock Images/SciePro Amgen revealed in a company press release that it has officially finished its purchase of Horizon Therapeutics for an approximate value of $27.8 billion. According to the company, the acquisition includes: • Alignment with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases. • Strengthening of Amgen’s leading inflammation portfolio by adding first-in-class, early-in-lifecycle medicines such as Tepezza (teprotumumab-trbw), Krystexxa (pegloticase) and Uplizna (inebilizumab-cdon), which treat rare inflammatory diseases. • Leveraging of Amgen’s world-class capabilities in biologics research and development, process development and manufacturing, as well as Amgen’s presence in more than 100 countries around the world. • Generating robust cash flow to support capital allocation priorities, including ongoing investment in innovation while sustaining a commitment to an investment grade credit rating. • Acceleration of revenue growth; expected to be ...
Dive Brief The Food and Drug Administration is expanding a program for accelerating device development to cover neurological and physical medicine technologies. Initially, the voluntary total product life cycle advisory program (TAP) pilot was limited to cardiovascular devices. This week, the FDA Office of Neurological and Physical Medicine Devices also began accepting enrollment requests. Expanding the program to cover cardiovascular, neurological and physical medicine devices is part of a scaling up of the pilot, which enrolled 12 products in its first year. The FDA could enroll up to 45 additional devices over the coming year. Dive Insight The FDA and industry agreed to the TAP pilot in MDUFA V. While the industry initially opposed the advisory program, the FDA secured a chance to show it can “spur more rapid development and more rapid and widespread patient access” by facilitating early engagement and coordination with external stakeholders. A year ago, the ...
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. ...
The company expects to yield a significant number of new medicine launches from the acquisition. Azurity Pharmaceuticals, Inc. broke the news that it has officially acquired Slayback Pharma LLC from existing investors including KKR and Everstone Capital, making it a wholly owned subsidiary. According to Azurity, the acquisition is expected to realize its purpose of serving overlooked patients, hoping to yield a significant number of new medicine launches over the coming years. “I am delighted to announce this combination and the increased potential it brings to do more for overlooked patients,” said Richard Blackburn, CEO, Azurity. “The complementary expertise of the two companies in developing innovative dose forms will result in a strong pipeline of new medicines to meet the needs of patients. We will bring the commercial expertise of Azurity to Slayback’s pipeline and look forward to introducing an even wider range of dose-forms and formulations to meet a ...
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 ...
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 ...
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 ...
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 ...
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 ...
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