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FDA Committee Votes Against Approval of Lykos Therapeutics’ MDMA Treatment for PTSD

Don Tracy, Associate Editor In a majority vote, the Psychopharmacologic Drugs Advisory Committee cited concerns regarding the data presented for MDMA as a treatment for post-traumatic stress disorder. The FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) has voted against recommending Lykos Therapeutics’ New Drug Application (NDA) for midomafetamine (MDMA) capsules for use in combination with psychological intervention for the treatment of post-traumatic stress disorder (PTSD) in adults. The committee voted 2-to-9 against the efficacy of the treatment, and voted 1-to-10 against the benefits outweighing the risks, stating its doubts that MDMA-assisted therapy is effective in treating PTSD.1 “We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Amy Emerson, CEO, Lykos Therapeutics, in a press release. As a basis of their ...
- Source: drugdu
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- June 11, 2024
ITM gains $204.6m investment for radiopharmaceutical pipeline

ITM Isotope Technologies Munich (ITM) has secured an investment of €188m ($204.6m) aimed at bolstering its radiopharmaceutical pipeline. Global investment company Temasek spearheaded the funding round with contributions from entities managed by BlackRock, the Qatar Investment Authority (QIA), ATHOS and Carbyne. The funding will be channelled towards advancing and broadening ITM’s radiopharmaceutical pipeline, supporting the development platform and commercially launching its Phase III lead candidate, ITM-11 (n.c.a.177Lu-edotreotide). The asset is currently under evaluation in two Phase III trials, COMPETE and COMPOSE, for the treatment of gastroenteropancreatic neuroendocrine tumours. The investment will enable ITM to bolster its manufacturing capabilities for Lutetium-177 (177Lu) and expand its production to include other high-value medical radioisotopes such as Actinium-225 (225Ac). As part of the expansion, the company will also supply the in-demand medical radioisotopes to its extensive global network and utilise them to diversify its radiopharmaceutical therapy pipeline. This strategy is designed to address a ...
- Source: drugdu
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- June 11, 2024
GSK acquires Elsie to unlock oligonucleotide therapeutics

GSK has acquired Elsie Biotechnologies for $50m to unlock the potential of oligonucleotide therapeutics. Elsie Biotechnologies has been at the forefront of oligonucleotide therapeutic development, focusing on increasing potency, reducing toxicity, and optimising delivery to harness the potential of the modality fully. The acquisition is set to enhance GSK’s research and development (R&D) in gene modulation. Elsie Biotechnologies offers technologies that can modulate gene expression. This feature is particularly valuable for targeting therapeutic areas that are not responsive to traditional small-molecule drugs or biologics. The integration of Elsie’s technologies for the discovery, synthesis and delivery of oligonucleotide into GSK’s R&D framework is expected to advance the company’s platform capabilities significantly. The move follows a successful initial partnership between the two companies which began in July 2023 and allowed GSK to assess and validate Elsie’s technology. GSK’s use of AI and machine learning, combined with data from Elsie’s platform, aims to ...
- Source: drugdu
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- June 11, 2024
Osteal raises $50m to bring joint infection drug/device combo to market

Osteal Therapeutics has raised $50m in Series D financing, as the orthopaedic infection treatment specialist turns its eyes to a regulatory submission for its lead candidate VT-X7. Medtech giant Zimmer Biomet led the round with participation from existing investors, including Johnson & Johnson Innovation, among others. The funds, which follow $23m raised in Series C financing in late 2023, will be used for a new drug application (NDA) to the US Food and Drug Administration (FDA) for VT-X7. Proceeds will also go towards advancing the US-based company’s musculoskeletal portfolio, according to a 5 June press release. Osteal has designed VT-X7 for the treatment of periprosthetic joint infection. The condition is a complication of joint replacement surgery in which bacteria infiltrate the joint implant. This causes biofilms, a layer of microorganisms that are hard to treat. VT-X7 is a drug/device combination product, consisting of antibiotic drugs vancomycin hydrochloride and tobramycin sulfate ...
- Source: drugdu
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- June 11, 2024
RINVOQ® (upadacitinib) Now Available in the U.S. for the Treatment of Pediatric Patients Two Years of Age and Older with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis

On June 4, AbbVie announced that the U.S. FDA approved the use of RINVOQ® (upadacitinib) for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who have had an insufficient response to, or are intolerant of, one or more tumor necrosis factor (TNF) inhibitors. In addition, a new dosage form of RINVOQ® LQ (upadacitinib) oral solution, based on weight-based dosing, is now available in the U.S. for the pediatric population. Dr. Roopal Thakkar, Senior Vice President, Global Therapeutic Areas and Chief Medical Officer of AbbVie, said: “RINVOQ has always been an important addition to the treatment of a wide range of rheumatic diseases, helping adult patients achieve meaningful disease control. Now, AbbVie is proud to offer RINVOQ in tablets and oral solution for our younger patients. Nearly 300,000 children and adolescents in the U.S. have some form ...
- Source: drugdu
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- June 11, 2024
Q&A with Bobby Azamian

Mike Hollan The Tarsus Pharmaceuticals CEO discusses the ways that his company is finding solutions that may have been overlooked. Bobby Azamian, CEO and chairman at Tarsus Pharmaceuticals, is focused on finding new treatments for diseases that he believes have been overlooked. He spoke with Pharmaceutical Executive about his approach to finding ways to treat the root causes of chronic diseases. Pharmaceutical Executive: Can you explain your mission at Tarsus? Bobby Azamian: My career mission has been to try and unlock solutions to big chronic diseases. I started as a scientist and then became a physician internist, where I saw a lot of big chronic diseases and realized that we don’t have many definitive therapies for those. We don’t have treatments that really address the root causes for a lot of those big diseases. That really motivated me to become an entrepreneur, so I started out investing in early-stage venture ...
- Source: drugdu
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- June 7, 2024
Astellas Confirms FDA Acknowledgement of Zolbetuximab Resubmission

Mike Hollan The drug had previously been submitted, but required resubmission due to production issues. FDA acknowledged that Astellas has resubmitted zolbetuximab for a Biologics License Application (BLA).1 The drug is a first-in-class claudin 18.2-targets monoclonal antibody and is designed to treat various forms of gastric cancer. According to a press release issued by Astellas, FDA has set November 9, 2024, as its new target action date. The drug had been previously submitted, but had to be resubmitted after Astellas received a complete response letter from FDA in January, 2024. While the agency did not state any issues with the clinical data, efficacy, or safety of the drug, it required resubmission due to third-party manufacturing deficiencies. Astellas resubmitted the drug on May 9, 2024, but only just announced confirmation from FDA. In a press release, Astellas’ senior vice president and head of immuno-oncology development Moitreyee Chatterjee-Kishore, PhD, MBA, said, “Astellas ...
- Source: drugdu
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- June 7, 2024
AI Tool Predicts Cancer Patients’ Response to Immunotherapy

Immune checkpoint inhibitors are a form of immunotherapy drug that enables immune cells to target and destroy cancer cells. At present, the Food and Drug Administration has approved two predictive biomarkers for identifying patients who might benefit from immune checkpoint inhibitors. The first biomarker is tumor mutational burden, which measures the number of mutations in the DNA of cancer cells. The second biomarker is PD-L1, a protein found on tumor cells that inhibits the immune response and is targeted by some immune checkpoint inhibitors. However, these biomarkers are not always reliable in predicting a patient’s response to immune checkpoint inhibitors. Recent machine-learning models utilizing molecular sequencing data have demonstrated potential in predicting responses, but this data is costly and not routinely collected. Researchers have now created an artificial intelligence (AI) tool that uses standard clinical data, such as results from a basic blood test, to predict if a patient’s cancer ...
- Source: drugdu
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- June 7, 2024
New DNA Testing Method Offers Faster and More Accurate Pathogen Identification

The Polymerase Chain Reaction (PCR) is widely regarded as the definitive method for target DNA sequence amplification, testing, and analysis. In this traditional PCR process, the DNA sample undergoes heating to separate into single strands, which then serve as templates for synthesizing new DNA strands through enzymatic action. Despite its effectiveness, this method can be cumbersome, slow, and costly. Now, researchers have introduced an alternative DNA testing method that could potentially replace traditional PCR, paving the way for broader applications in medical diagnostics. Developed at Case Western Reserve University (Cleveland, OH, USA), this new technique or reaction is named AMPLON (Amplifying DNA with Multiarm Priming and Looping Optimization of Nucleic Acid). It enables comparison of DNA from diseased cells with that from healthy ones, enhancing understanding of disease progression and treatment approaches. AMPLON uses multiple extensions along the DNA strand, significantly enhancing the speed and accuracy of DNA synthesis at ...
- Source: drugdu
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- June 7, 2024
Merck opens $195.7m expanded distribution centre in Germany

German science and technology company Merck KGaA has announced the opening of its expanded Life Science distribution centre at Schnelldorf, which involved an investment of €180m ($195.7m). With this investment, the facility has almost doubled in size, adding 25,000m² to its area. The development bolsters the company’s capacity to meet the surging global demand for critical drugs and contribute to public health significantly. The newly expanded site now features a manual down-filling operation and an extra distribution area for a wide array of products destined for laboratories and research institutions worldwide. The Schnelldorf centre’s workforce comprises 470 specialists including engineers, and manufacturing and distribution experts. The site expansion is part of the company’s multi-year investment programme in the life science business sector. The company has announced projects worth more than €2bn since 2020. They span Europe, China and the US, reflecting the company’s strategic focus on enhancing industrial capacity and ...
- Source: drugdu
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- June 7, 2024

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