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FDA Approves Stelara Biosimilar Selarsdi to Treat Psoriasis, Psoriatic Arthritis

Davy James Alvotech’s and Teva’s Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis. Image credit: Maria | stock.adobe.com Alvotech’s and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) has been approved by the FDA as a biosimilar to Stelara (ustekinumab), which represents the second approval for a Stelara biosimilar.1 Selarsdi is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US,” Thomas Rainey, ...
- Source: drugdu
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- April 19, 2024
Study reveals how specific nasal cells protect against COVID-19 in paediatric patients

Researchers from University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19. Published in Nature Microbiology, the study used cells donated from healthy participants from Great Ormond Street Hospital, University College London Hospital and the Royal Free Hospital. Researchers focused on the early effects of the SARS-CoV-2 infections using the human nasal epithelial cells (NECs) gathered from children aged up to 11 years, adults aged 30 to 50 years, as well as elderly people aged over 70 years. After using specialised techniques to regrow these cells into the different types usually found in the nose, researchers used single-cell RNA sequencing to identify the genetic networks and functions of thousands of individual cells to identify 24 epithelial cell types. The cell cultures from each age group were then either mock-infected or infected with SARS-CoV-2. After three ...
- Source: drugdu
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- April 19, 2024
ELRIG UK and SRG collaborate to advance life sciences professionals in drug discovery

Both companies will facilitate career progression while advancing the life sciences industry The European Laboratory Research and Innovation Group (ELRIG) UK has announced its partnership with SRG to support life sciences professionals in advancing their careers in drug discovery. Both will help facilitate career progression as well as support the growth of the life sciences industry. As part of the collaboration, ELRIG UK’s community will gain access to career opportunities, while SRG’s specialist talent solutions will be provided to organisations of all sizes to help grow the life sciences sector. More specifically, early career professionals (ECPs) in industry and academia will be able to attend forums and networking events to meet new people and learn the skills needed to help them progress their careers in drug discovery. The volunteer-led community for drug discovery unites academic and biopharma industry experts and thought leaders to share ideas and information through free-to-attend scientific ...
- Source: drugdu
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- April 19, 2024
IND Application for the Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the First-Line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients Approved by NMPA

Shanghai, China, April, 17th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma. Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fourth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in ...
- Source: drugdu
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- April 19, 2024
ANKE Bio and SHIJIAN BIOLOGICAL enter into ADC platform technology licensing cooperation

Recently, Anhui ANKE Bio Engineering (Group) Co., Ltd (hereinafter referred to as “ANKE Bio”, stock code: 300009) signed a license agreement with Shanghai Shijian Biotechnology Co. (“ANKE Bio”). According to the license agreement, ANKE Bio has formally obtained the license of EZWi-Fit®, the ADC technology platform of SHIJIAN BIOLOGY, to develop ADC products. During the license period, ANKE Bio will be responsible for the preclinical research, clinical development and commercial production and sales of the developed products in Greater China, and will pay equity payments (including down payment and milestone payments) and a sales commission as a percentage of net sales to SHIJIAN BIO. Shijian Bio acquires an overseas interest in the ADC product. Shijian Bio is a clinical-stage ADC new drug discovery and development company with an ADC clinical pipeline and comprehensive new drug discovery and development capabilities, and has established a new-generation ADC technology platform, EZWi-Fit®, with its ...
- Source: drugdu
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- April 19, 2024
【EXPERT Q&A】What is the approval process of import and export declaration goods license?

Drugdu.com expert’s response: The approval process for import and export customs clearance permits typically involves the following steps: Application Preparation: Import and export companies prepare the necessary documents and information, including descriptions of goods, quantities, values, origins, destinations, as well as any required permits or certificates. Submission of Application: The application documents are submitted to the relevant import and export management department or agency. Applications can be submitted online or through traditional mail. Preliminary Review: The import and export management department conducts a preliminary review of the application documents to ensure completeness, accuracy, and compliance with relevant regulations and requirements. Approval: Following the preliminary review, further approval processes are carried out by the import and export management department. The specifics of the approval process depend on factors such as the type of goods, regulatory requirements in the country or region, etc. Issuance of Permit: If the application is approved, the ...
- Source: drugdu
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- April 19, 2024
DUPHAT

Organiser: INDEX Conferences&Exhibitions Time:7 – 9 Jan. 2025 address：Sheik Zayed Road Convention Gate Dubai UAE – United Arab Emirates Exhibition hall: Dubai World Trade Centre Product range: Finished drugs: all kinds of over-the-counter and prescription drugs, various proprietary Chinese medicines, Western medicines, new drugs, specific drugs, biopharmaceuticals, Chinese medicine, herbal raw materials, various raw materials, chemical pharmaceuticals, pharmaceutical intermediates and medical products Raw materials (intermediates) : Vitamins, hormones, sulfonamides, antipyretic analgesics, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western medicine raw materials Excipients and dosage forms: excipients, flow AIDS, enteric materials, antioxidants, sweeteners, penetration enhancers, preservatives, disintegrators, coating materials, surfactants, sunshades, flavors, filter AIDS, stabilizers, lubricants, plasticizers, solvents, flavor straighteners, coloring agents, clarifying agents, PH regulators, etc Pharmaceutical technology: pharmaceutical production equipment and technology, pharmaceutical packaging ...
- Source: drugdu
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- April 19, 2024
Health Advocate Partners with Tava Health to Increase Access to Teletherapy

Mike Hollan Tava’s network of therapists will be added to Health Advocate’s existing network. While the service existed beforehand, the pandemic pushed telehealth into the spotlight. For many patients, it wasn’t just safer to be able to visit a doctor from the comfort of their own home, it was much simpler. This is especially true for patients visiting their regular doctors for recurring conditions. Due to the pre-existing relationship, doctors can often provide the necessary prescriptions based off of a description of symptoms alone. As the pandemic receded, the value of teletherapy remained. Since then, more and more companies are working to expand access to teletherapy services. Health Advocate announced that it has partnered with Tava Health to expand its access to telehealth.1 This partnership will allow members of Health Advocate to access Tava Health’s nationwide network of therapists. These new therapists will be added to Health Advocate’s existing network ...
- Source: drugdu
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- April 18, 2024
Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status

Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression. By Frank Vinluan High placebo responses common in tests of neuropsychiatric drugs makes any clinical trial in major depressive disorder risky. Intra-Cellular Therapies now has data showing its drug met key goals of a pivotal clinical trial, beating a placebo in this indication. The results build the case for expanding the product’s label, which could push its sales into blockbuster territory. According to the preliminary results reported Tuesday, the drug, lumateperone, led to statistically significant and clinically meaningful reductions in scores measured on a widely used rating scale for assessing depression episodes, which was the main clnical trial goal. The drug also met a key secondary ...
- Source: drugdu
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- April 18, 2024
Deep Learning Powered AI Algorithms Improve Skin Cancer Diagnostic Accuracy

Artificial intelligence (AI) algorithms are increasingly being utilized in various clinical settings, such as dermatology. These algorithms are developed by training a computer with hundreds of thousands or millions of images of various skin conditions, each labeled with details like the diagnosis and patient outcomes. Through a process known as deep learning, the computer learns to identify patterns in the images that are indicative of specific skin diseases, including cancers. Once sufficiently trained, the algorithm can suggest potential diagnoses based on new images of a patient’s skin. However, these algorithms do not operate in isolation; they are used under the supervision of clinicians who evaluate the patient, make their own diagnostic assessments, and decide whether to follow the algorithm’s recommendations. Now, a new study led by researchers at Stanford Medicine (Stanford, CA, USA) has found that AI algorithms, which utilize deep learning, can enhance the accuracy of diagnosing skin cancers. ...
- Source: drugdu
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- April 18, 2024

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