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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
- 105
- 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
- 90
- 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
- 121
- 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
- 87
- 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
- 81
- 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
- 81
- June 7, 2024
India’s DCGI approves Orchid Pharma’s API Enmetazobactam

Orchid Pharma has secured approval from the Drugs Controller General of India (DCGI) to manufacture and market its new chemical entity (NCE), the active pharmaceutical ingredient (API) Enmetazobactam. The DCGI also approved the production and marketing of the finished dosage form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable. The antibiotic drug combination is specifically indicated for complicated urinary tract infections (cUTI), including the treatment of acute pyelonephritis. Other indications comprise hospital-acquired pneumonia (HAP), ventilator-associated pneumonia, and bacteremia when associated with or suspected to be linked to either cUTI or HAP. Orchid Pharma’s new combination drug addresses the urgent need for effective treatments against severe infections caused by resistant bacteria, a critical concern in the global health community’s fight against antimicrobial resistance (AMR). The United Nations and the World Health Organization have declared AMR to be a “silent pandemic”, attributing to five million deaths in 2019. The company ...
- Source: drugdu
- 119
- June 7, 2024
Resolution unveils data for liver disease treatment at EASL 2024

Resolution Therapeutics Limited, in collaboration with the University of Edinburgh, has presented compelling clinical data at the EASL Congress 2024 in Milan, Italy, showcasing the significant potential of macrophage cell therapy for treating advanced liver cirrhosis. The MATCH Phase 2 study, led by Dr Paul Brennan from the University of Dundee and Professor Stuart Forbes, has revealed that autologous non-engineered macrophages are safe and effective for patients with liver cirrhosis, showing a marked improvement in patient survival and transplant-free survival over thirty months post-randomisation. Professor Forbes – a founder of Resolution Therapeutics and Professor of Transplantation and Regenerative Medicine at the University of Edinburgh – reflected: “We are greatly encouraged by the data from the MATCH Phase 2 study and this long-term follow-up study. We will continue monitoring patients with the aim of reporting further data at the AASLD meeting in November 2024.” Resolution has also introduced a proprietary discovery ...
- Source: drugdu
- 84
- June 7, 2024
Sanofi’s Sarclisa shows significant promise in treating myeloma

Sanofi’s Sarclisa, a novel treatment for multiple myeloma, has demonstrated a substantial improvement in progression-free survival for patients ineligible for transplant. The phase 3 IMROZ study revealed that Sarclisa (also known as isatuximab), combined with a VRd regimen, reduced the risk of disease progression or death by 40% compared to VRd alone. The study, which was presented at the American Society of Clinical Oncology (ASCO) annual meeting, marks a significant advancement in the treatment of newly diagnosed multiple myeloma (NDMM). The full data, published in the New England Journal of Medicine, will inform future regulatory submissions. Professor Graham Jackson, a haematologist and advisor for Myeloma UK, highlighted the importance of the findings: “Effective first-line treatment is essential in managing and delaying disease progression for newly diagnosed multiple myeloma patients. He added: “The significant progression-free survival demonstrated in the IMROZ study reinforces the potential of isatuximab-VRd to improve outcomes for newly ...
- Source: drugdu
- 80
- June 7, 2024
Phase III Trial Data Presented at ASCO Show Imfinzi Improves Survival in Limited-Stage Small Cell Lung Cancer

Don Tracy, Associate Editor Results of the ADRIATIC trial indicated that treatment with Imfinzi after standard-of-care concurrent chemoradiotherapy improves overall survival and progression-free survival in patients with limited-stage small cell lung cancer.AstraZeneca announced a significant milestone from the ADRIATIC trial, which is evaluating the safety and efficacy of Imfinzi (durvalumab) for the treatment of limited-stage small cell lung cancer (LS-SCLC) in patients who haven’t progressed following concurrent chemoradiotherapycCRT. According to the company, the trial found that administration of Imfinzi after standard-of-care cCRT greatly improves overall survival (OS) and progression-free survival (PFS) compared to placebo. These results were presented at the 2024 American Society of Clinical Oncology Annual Meeting during the Plenary Session.1 “The ADRIATIC results represent a breakthrough in limited-stage small cell lung cancer, a highly aggressive disease where recurrence rates are high and only 15 to 30 per cent of patients survive five years,” said David R. Spigel, chief ...
- Source: drugdu
- 129
- June 6, 2024

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