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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
- 203
- September 22, 2023
CDMOs SK pharmteco, Oxford Biomedica make cell and gene therapy manufacturing M&A plays

It’s a boom time in the cell and gene therapy market, with manufacturers making moves to secure a larger piece of the pie. Wednesday, two CDMOs revealed acquisitions that will bolster their production capabilities and increase their global presence. Korean manufacturer SK pharmteco has taken a controlling stake in the Philadelphia-based Center for Breakthrough Medicines (CBM) for an undisclosed sum. Meanwhile, England’s Oxford Biomedica said it is in talks with Institut Mérieux to buy out its subsidiary, ABL Europe, for 15 million euros ($16 million). SK’s move comes after it invested $350 million in CBM in January of last year. As part of the agreement, SK had an option to increase its stake, which it exercised, becoming its largest stockholder. CBM was established in 2019 at a former GSK site. The prior funding allowed CBM to begin building end-to-end manufacturing capabilities. SK boasted that the site will be the world’s ...
- Source: drugdu
- 105
- September 22, 2023
Merck KGaA links with BenevolentAI and Exscientia to expand AI capabilities

Merck KGaA has announced two new strategic partnerships with Benevolent AI and Exscientia to support its artificial intelligence (AI)-driven drug discovery plans. Benevolent and Exscientia plan to leverage Merck KGaA’s expertise in oncology and neuroinflammation under the collaboration. As part of the agreement, the companies have collectively selected three potential first-in-class and best-in-class targets. The partnership will focus on finding viable small molecule candidates for development that Merck KGaA will choose for further preclinical and clinical development. In this deal, announced on 20 September, BenevolentAI will be eligible for payments of up to $594 million, including a low double-digit million-dollar immediate payment. Further payments will be made according to future discovery, development and commercial milestones. Also, the London, UK-based company could receive tiered royalties on net sales of any commercialised products. BenevolentAI is already collaborating with AstraZeneca and Eli Lilly for AI-driven drug discovery. In May, BenevolentAI announced intentions to ...
- Source: drugdu
- 117
- 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
kICR researchers develop new test to help identify future cancer treatments

Researchers from the Institute of Cancer Research’s (ICR) Centre for Cancer Drug Discovery have developed a new test, RKD2, which makes the early stages of drug discovery for cancer more efficient. Funded by Cancer Research UK, the researchers created an investigative procedure that can help scientists identify new biologically active compounds to be used to develop effective medications. Fragment-based drug discovery uses various techniques to screen libraries of compounds, or fragments, with a low molecular weight. During the initial stage, scientists introduce a potential anti-cancer target and see which fragments interact with it. Previously, researchers could only determine that ‘yes, an interaction occurred’ or ‘no, there was no interaction’. However, it was difficult to apply this to weak interactions, and the team could not rule out nonspecific interactions. The new RKD2 test allows researchers to quantify interactions by determining their strength, identifying those that are truly active and worth following ...
- Source: drugdu
- 146
- September 22, 2023
FDA Rejects ARS’ Epinephrine Nasal Spray Despite Adcomm Support

By Tristan Manalac Pictured: FDA signage outside its office in Maryland/iStock, hapabapa The FDA on Tuesday turned down ARS Pharmaceuticals’ application for its epinephrine nasal spray neffy for the treatment of type I allergic reactions in adults and children weighing at least 30 kg. In its Complete Response Letter (CRL), the regulator asked ARS to conduct an additional pharmacokinetic and pharmacodynamic study that evaluates repeated neffy doses compared with repeat administrations of an epinephrine injection in participants with allergen-induced allergic rhinitis. According to the company’s announcement on Tuesday, the FDA is making this request despite aligning with ARS in August 2023 regarding the need to conduct this study as a post-marketing requirement. The regulator and the company have also already settled on the final physician’s labeling for the product. In May 2023, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16-6 that neffy’s risk-benefit profile was favorable in adults. The ...
- Source: drugdu
- 120
- September 22, 2023
Taysha Drops Gene Therapy Candidate as FDA Again Calls for Study Changes

By Connor Lynch Pictured: FDA sign in its headquarters/iStock, Grandbrothers Taysha Gene Therapies has decided to drop its lead experimental AAV-based gene therapy candidate after the FDA reiterated calls for the company to put the treatment through a randomized, double-blind placebo-controlled trial. The Dallas-based company announced on Tuesday that it would no longer be developing its TSHA-120 treatment for giant axonal neuropathy (GAN) based on the FDA’s Type C meeting feedback regarding the therapy’s potential pathway. “FDA continues to recommend a randomized, double-blind, placebo-controlled trial as the optimal path to demonstrate efficacy in TSHA-120,” the company said in a statement. Taysha noted in the announcement that the FDA “provided a potential path for a single-arm trial with an external control group matched with to-be treated patients by multiple prognostic factors and recommended longer term follow up to account for potential bias.” CEO Sean Nolan said in a statement that the ...
- Source: drugdu
- 190
- September 22, 2023
J&J starts trial of pulsed field ablation catheter with mapping feedback

Dive Brief Johnson & Johnson has begun a clinical trial of another investigational pulsed field ablation (PFA) device, opening a new front in its pursuit of a potentially significant cardiovascular opportunity. The treatment of the first patients with the Omnypulse catheter comes months after J&J posted data on Varipulse, another PFA device to treat atrial fibrillation. J&J also has a PFA and radiofrequency dual energy device in late-phase development. Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data to support mapping. Analysts have identified the combination of PFA and mapping, which J&J sees as a key feature of its systems, as a threat to Abbott’s electrophysiology unit. Dive Insight It has been only three weeks since Boston Scientific notched a milestone in the race for the first-generation PFA market with positive clinical trial results. Boston Scientific and Medtronic are leading the way. Stifel analysts ...
- Source: drugdu
- 616
- September 21, 2023
New NIH plan outlines HSV research framework with four strategic priorities

In response to the persistent health challenges of herpes simplex virus 1 (HSV-1) and HSV-2, today the National Institutes of Health released the Strategic Plan for Herpes Simplex Virus Research. An NIH-wide HSV Working Group developed the plan, informed by feedback from more than 100 representatives of the research and advocacy communities and interested public stakeholders. The plan outlines an HSV research framework with four strategic priorities: improving fundamental knowledge of HSV biology, pathogenesis, and epidemiology; accelerating research to improve HSV diagnosis; improving strategies to treat HSV while seeking a curative therapeutic; and, advancing research to prevent HSV infection. HSV-1 and HSV-2 are among the most common viral infections in the United States. HSV can cause recurring blisters or sores. In severe cases HSV may lead to life-threatening or long-term complications, typically in the central nervous system. There are no licensed preventive HSV vaccines, and there is no cure. Up ...
- Source: drugdu
- 237
- September 21, 2023
Tribunal upholds £130M fine after UK authorities probed 10,000% price hike

Auden Mckenzie and Actavis UK—now known as Accord-UK—will remain on the hook to pay hefty fines for their roles in introducing costly price hikes on hydrocortisone tablets.In a judgment published Monday, the U.K.’s Competition Appeal Tribunal (CAT) upheld previous findings by the country’s Competition and Markets Authority (CMA) that multiple drugmakers had charged “excessive and unfair prices” for generic hydrocortisone over the course of 10 years. Hydrocortisone tablets treat adrenal insufficiency, including serious conditions such as Addison’s disease. In the U.K., the medicine is funded by England’s National Health Service. The tribunal’s decision comes a little more than two years after CMA doled out fines worth more than 260 million pounds sterling ($360 million) to more than 10 pharmaceutical companies. The punishment followed a long-running investigation by the U.K. into the steep cost of hydrocortisone. From 2008 to 2016, the med’s price grew by 10,000%, costing taxpayers hundreds of millions ...
- Source: drugdu
- 176
- September 21, 2023

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