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Lexicon to face FDA AdComm for Zynquista approval in diabetes and CKD

It looks like Lexicon Pharmaceuticals’ second bid to get US Food and Drug Administration (FDA) approval for Zynquista (sotagliflozin) will be as arduous as the first go around, as the regulatory agency has convened an advisory committee (AdComm) to evaluate its efficacy. The FDA’s Endocrinologic and Metabolic Drugs AdComm will discuss the benefit/risk profile of Zynquista as an adjunct to insulin therapy for glycaemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The AdComm is set to meet on 31 October 2024. Lexicon added that convening of the AdComm will not affect the Prescription Drug User Fee Act (PDUFA) goal date of 20 December 2024 set by the FDA. An AdComm is convened upon request of the FDA to review and evaluate the safety and efficacy data of a therapy. However, the AdComm recommendations are non-binding, with the final decision made by the FDA. The ...
- Source: drugdu
- 80
- August 26, 2024
Leo Pharma’s Timber bet falls flat following Phase III failure

Ayear after hedging its bets on Timber Pharmaceuticals’ dermatology pipeline, Leo Pharma has reported a Phase III failure for the lead asset it acquired at the time. TMB-001, a topical ointment formulation of isotretinoin, came up short in the late-stage trial for patients with moderate to severe congenital ichthyosis. Ichthyosis is an umbrella term for congenital skin conditions that cause dry and scaly skin. In the Phase III ASCEND trial (NCT05295732), Leo stated the therapy did not demonstrate a statistically significant improvement in patients compared to those treated with a vehicle. This meant the primary and key secondary endpoints were not met. The results do not support US regulatory submission, the Danish privately owned company stated in a 21 August press release. There is currently no treatment approved for ichthyosis by the US Food and Drug Administration (FDA). Instead, the condition is managed by hydrating the skin with creams and ...
- Source: drugdu
- 78
- August 26, 2024
CTI announces partnership for oncology drug development

CTI Clinical Trial & Consulting Services (CTI) and Crown Bioscience have announced a strategic partnership aimed at bolstering consulting services for oncology drug development. The collaboration brings together CTI’s clinical and regulatory expertise with Crown Bioscience’s preclinical and translational models, aiming to streamline the transition of oncology compounds from discovery to early-phase global studies. It is set to benefit customers by providing expert guidance that enhances the efficiency of oncology drug development. CTI Global Laboratory Services business development vice-president Ryan Gifford stated: “Crown Bioscience’s leadership in early-phase oncology research and suite of preclinical services complement CTI’s broad spectrum of capabilities. “Together, we can offer enhanced support to our oncology clients and deepen our commitment to advancing cancer research.” The combined expertise is expected to ensure an effective path to clinic, support long-term success in drug development and accelerate the delivery of new oncology treatments to patients. Through the alliance, customers ...
- Source: drugdu
- 68
- August 26, 2024
FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site. The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution. Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release. Regeneron submitted the biologics licence application (BLA) for linvoseltamab under priority review in February this year. The European Medicines Agency (EMA) is still reviewing the therapy in the same indication, and the application to the ...
- Source: drugdu
- 87
- August 23, 2024
Pathalys secures $105m to advance SHPT drug through approval

Pathalys Pharma has secured $105m in a Series B financing round to support its clinical trials, file a new drug application (NDA) with the US Food and Drug Administration (FDA), and accelerate preapproval commercialisation preparations. The company’s lead candidate is upacicalcet, a drug used to treat secondary hyperparathyroidism (SHPT) in patients undergoing dialysis due to chronic kidney disease (CKD). The calcimimetic drug mirrors the action of calcium on tissues, particularly the parathyroid glands. The medication is typically administered during dialysis sessions. Earlier this year, Pathalys launched two identical Phase III studies of upacicalcet, which will both enrol 375 patients. The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30% or more in participants with SHPT and currently on haemodialysis. The funding round, led by TCGX, is set to support these clinical trials, and advance the ...
- Source: drugdu
- 70
- August 23, 2024
Theramex’s Eladynos recommended by NICE for post-menopausal bone disease

Osteoporosis currently affects 3.8 million people in the UK, particularly impacting older women after menopause Theramex’s Eladynos (abaloparatide) has been recommended by the National Institute for Health Care and Research (NICE) for treating bone disease after menopause. More than 14,000 people in the UK seek treatment for osteoporosis after menopause, and these patients will benefit from the drug (if there is a very high risk of fracture) once it becomes available in England on the NHS in three months’ time. Osteoporosis is a bone disease that affects 3.8 million people in the UK. It develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and ...
- Source: drugdu
- 83
- August 23, 2024
eXmoor pharma’s manufacturing facility receives licence from MHRA

The company’s Cell & Gene Therapy Centre can now offer a full range of GMP services Press release: eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, announced it has received a Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP)) licence from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), authorising the manufacture of good manufacturing practice (GMP)-grade cell and gene therapy materials for use in clinical trials. This follows a successful inspection of eXmoor’s Cell & Gene Therapy Centre in Bristol, marking the end of a two-year project to design, build and bring online a 65,000 state-of-the-art advanced therapies manufacturing facility. The licence is a major milestone in eXmoor’s 20-year journey from a consultancy into a full-service, global CGT contract development and manufacturing organisation (CDMO). The Cell & Gene Therapy Centre has been designed in-house by eXmoor as a flexible and scalable manufacturing hub, with integrated ...
- Source: drugdu
- 65
- August 23, 2024
New Microfluidics Method to Speed Up Blood Analyses

Researchers have developed a new method to accelerate and potentially scale up the process of separating particles in fluids, a technique that could prove useful for analyzing cancer cells from blood. This speedier and more precise method of elasto-inertial microfluidics was developed by a team led by researchers at KTH Royal Institute of Technology (Stockholm, Sweden) and involves controlling the movement of tiny particles in fluids by leveraging both the fluid’s elastic properties and the inertial forces arising from fluid movement. The microfluidic device features specially engineered channels that accommodate larger volumes of fluid rapidly, making it ideal for applications requiring quick, continuous particle separation. These channels efficiently sort and line up particles, essential for distinguishing different particle types. This high precision is achieved through the use of specially formulated fluids with high polymer concentrations, giving the fluid viscoelastic properties similar to egg whites that can both flow and rebound. ...
- Source: drugdu
- 86
- August 23, 2024
Genetic Analysis of Lyme Disease Bacteria to Enable More Accurate Diagnostic Tests

Lyme disease is the most prevalent tick-borne illness in North America and Europe, affecting hundreds of thousands of individuals annually. The disease is caused by bacteria from the Borrelia burgdorferi sensu lato group, which are transmitted to humans through the bites of infected ticks. Symptoms typically include fever, headache, fatigue, and a distinctive skin rash. If not treated promptly, the infection can spread to the joints, heart, and nervous system, leading to more severe complications. Now, researchers have conducted a genetic analysis of the bacteria responsible for Lyme disease, potentially leading to advancements in the diagnosis, treatment, and prevention of this tick-borne illness. A research team led by biologists at CUNY Graduate Center (New York, NY, USA) has mapped the complete genetic sequences of 47 strains of Lyme disease-related bacteria from across the globe, creating a valuable resource for identifying the specific bacterial strains that infect patients. This genetic data ...
- Source: drugdu
- 73
- August 23, 2024
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo and Yervoy Combination for Hepatocellular Carcinoma

August 21, 2024 By Don Tracy, Associate Editor Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma. Image Credit: Adobe Stock Images/magicmine The FDA has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for an immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC). According to BMS, acceptance of the sBLA was based on promising results from the Phase III CheckMate-9DW trial, which demonstrated that the combination significantly improved overall survival (OS) compared to Lenvima (lenvatinib) or Nexavar (sorafenib).1 “HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option. With the number of individuals diagnosed with HCC in the United States increasing over ...
- Source: drugdu
- 82
- August 23, 2024

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