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FDA Issues Refusal to File Letter to Theratechnologies for sBLA Seeking Approval of Intramuscular Administration of Trogarzo

Davy James Trogarzo (ibalizumab-uiyk) is currently approved in combination with other antiretroviral therapy for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen. The FDA has issued a refusal to file letter (RTF) to a supplemental Biologics License Application (sBLA) filed by Theratechnologies Inc. for an intramuscular (IM) method of administration for maintenance dosing of Trogarzo (ibalizumab-uiyk).1 The CD4-directed post-attachment HIV-1 inhibitor is approved in combination with other antiretroviral therapy (ART) for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current ART regimen.2 The RTF followed a preliminary review of the sBLA by the FDA, which found that the application did not include data the agency required to establish a pharmacokinetic bridge between IM administration and intravenous (IV) administration of Trogarzo. “While we are disappointed to receive this letter from the FDA, we were aware that the approval of this ...
- Source: drugdu
- 112
- March 2, 2024
New digital iTalkBetter app significantly improves speech in stroke patients

Aphasia is a language disorder caused by some form of brain damage, including stroke Researchers from the Neurotherapeutics Group at University College London’s Queen Square Institute of Neurology have developed a new digital app that significantly improves speech in stroke patients. Supported by Wellcome and funded by the National Institute for Health and Care Research (NIHR), the iTalkBetter app provides speech therapy for people living with aphasia, a language disorder. Caused by some form of brain damage, including stroke, severe head injury and brain tumours, aphasia can lead to difficulties with speech or language. The NHS currently provides around 12 hours of speech and language therapy, with further face-to-face therapy available via some charities or privately. However, most aphasia patients are undertreated with therapy. The new app offers practice for over 200 commonly used words, games to maintain engagement and an integrated speech recogniser to analyse speech in real time ...
- Source: drugdu
- 91
- March 2, 2024
‘Top-down’ treatment strategy dramatically improves outcomes for Crohn’s patients

Researchers from the University of Cambridge have revealed a ‘top-down’ treatment strategy involving Janssen’s Remicade (infliximab) straight after diagnosis significantly improved outcomes for patients with Crohn’s disease. Affecting around one in 350 people in the UK, Crohn’s disease is a life-long condition caused by inflammation of the digestive tract, which can lead to flares of inflammation and progressive bowel disease damage as the condition worsens. Sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, with support from the National Institute for Health and Care Research (NIHR), the PROFILE trial recruited 386 Crohn’s disease patients from 40 hospitals across the UK. Despite the biomarker not proving useful in selecting treatments for individual patients, patients were randomly assigned to one of two treatment groups, which were given a different treatment strategy: ‘accelerated step-up’ or ‘top-down’. The accelerated step-up group treatment approach involved patients starting Remicade if their disease ...
- Source: drugdu
- 130
- March 2, 2024
Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification from the NMPA

Shanghai, China, 29th February 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis，pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA)，bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and ...
- Source: drugdu
- 138
- March 2, 2024
The marketing application for new indications of Anrotinib hydrochloride capsule and anti-PD-L1 “Behmosubaisumab (TQB2450 injection)” of Zhengda Tianqing has been accepted.

Recently, Anrotinib Hydrochloride Capsules and anti-PD-L1 “Behmosubaisumab (TQB2450 Injection)” developed by Zhengda Tianqing have submitted a new indication application to the Center for Drug Evaluation of the State Drug Administration (CDE), which has been accepted, with the indications of non-microsatellite patients who have previously failed to receive or cannot tolerate the first- or second-line chemotherapy regimens. Recurrent or metastatic endometrial cancer that is not microsatellite highly unstable (non-MSI-H) or non-DNA mismatch repair defective (non-dMMR), or intolerant. Bemosumab is an innovative, fully humanized anti-PD-L1 monoclonal antibody with a new sequence developed by AstraZeneca.In April 2022, Bemosumab in combination with amrutinib hydrochloride capsules for the treatment of recurrent or metastatic endometrial cancer was included in the Breakthrough Therapeutic Classification by the CDE.In January 2023, Bemosumab’s application for marketing in the first-line treatment of recurrent or metastatic endometrial cancer in combination with amrutinib hydrochloride capsules was formally accepted by the CDE.The application was ...
- Source: drugdu
- 143
- March 2, 2024
AstraZeneca’s “CD19/CD3 dual antibody” receives clinical approval in China

According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia. AZD0486 (TNB-486) is a new, fully human CD19xCD3 IgG4 bispecific antibody, originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for US$1.265 billion and also obtained its clinical-stage drug TNB-486. According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal “OncLive” in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs. Currently, AZD0486 has entered the Phase ...
- Source: drugdu
- 94
- March 2, 2024
Pharmtech Ingredients 2024

Organiser: ITE Time:19 – 21 November 2024 address：Crocus Expo IEC, Krasnogorsk, 65 -66 km Moscow RingRoad ,Russia Exhibition hall: Crocus- Expo IEC Product range: Pharmaceutical machinery: preparation production equipment, pharmaceutical water equipment, equipment, Chinese medicine treatment equipment, refrigeration equipment, etc Packaging equipment materials: aluminum plastic packaging machine, filling machine, tablet machine, labeling machine, inkjet machine, anti-counterfeiting printing and packaging production line, bar code composite technology equipment, self-adhesive printing and packaging equipment, plastic packaging products, packaging container filling and sealing machine, packaging machine, bag packaging machine, multi-functional bottle packaging machine, glass packaging products and medicinal packaging materials production facilities standby Laboratory equipment/Analytical testing: laboratory equipment and devices, laboratory consumables, chemical reagents, biochemical/analytical instruments, biotechnology analytical testing instruments, pharmaceutical testing equipment, food analytical testing instruments, pharmaceutical industry analytical instruments, etc Fluid equipment: sanitary pumps, valves, fluid engineering, pipes and fittings, microfiltration, ultrafiltration, etc Clean system: clean air conditioning equipment, clean studio/desk, clean equipment, ...
- Source: drugdu
- 182
- March 1, 2024
【EXPERT Q&A】How to apply for Biologics License Application (BLA)?

Drugdu.com expert’s response: The Biologics License Application (BLA) is a licensing application for biologic products, typically managed and approved by the United States Food and Drug Administration (FDA). BLA submission is required to obtain approval for the sale of biologic products in the U.S. market. The following are the key aspects to consider and the required documents for BLA submission: 1.Clinical Trial Data: Detailed clinical trial data must be provided in the BLA submission, including study design, trial results, safety, and efficacy data. These data should adhere to FDA’s requirements for clinical trial design and reporting. 2.Product Quality Control: Information on product quality control, including manufacturing processes, quality control methods, stability data, etc., needs to be provided. These data ensure that the manufacturing process and quality of the product comply with FDA requirements. 3.Nonclinical Data: Relevant nonclinical data, such as animal model studies, toxicology data, etc., should be provided to assess ...
- Source: drugdu
- 151
- February 29, 2024
World’s First Low-Cost, High-Throughput, Near-Patient Molecular Diagnostic Test System Dramatically Reduces Wait Times

It is important for doctors to rapidly and accurately identify prevalent respiratory pathogens like COVID-19, influenza A and B, RSV-A, and RSV-B for administering prompt, tailored treatment to infected individuals. In a significant advancement, a near-patient test system using automation technology detects pathogens with unrivaled speed and cuts the typical waiting time of 24 to 48 hours to just one to two hours without the need for expensive biosafe laboratories. Fast MDx Limited (Middlesex, UK) and Festo (London, UK) have jointly designed and developed the world’s first, low-cost, high-throughput, near-patient molecular diagnostic test system that will provide clinicians with earlier, more informed results, allowing each patient to receive a faster, personalized clinical pathway. The Fast MDx system comprises everything necessary for testing, including sample tubes, swabs, and even electronic result transmission to the originating hospital, clinic, or doctor’s office. The system incorporates Fast MDx’s latest, ultra-fast, NGx2 4-Channel qPCR thermal ...
- Source: drugdu
- 109
- February 29, 2024
Simple Measurement Predicts Risk of Rapid Progression of Chronic Kidney Disease

Chronic kidney disease (CKD) is increasingly becoming a major health issue worldwide. For those diagnosed with CKD, the rate of disease progression can vary, with some individuals experiencing a rapid deterioration in kidney function. Healthcare providers need to spot patients who are newly diagnosed with CKD and are at a heightened risk of rapid disease progression. Early identification can allow for timely interventions that could slow down, or in some cases, prevent the progression of the disease. Now, researchers have made a breakthrough by discovering a simple method to identify individuals at high risk for rapid CKD progression, an advancement that could greatly enhance prevention and treatment strategies. In a comprehensive study, a team of researchers from Aarhus University (Aarhus, Denmark) examined the precise risk of rapid CKD progression utilizing data from Danish health registers. This study provides valuable insights for medical professionals on identifying patients who are more likely ...
- Source: drugdu
- 97
- February 29, 2024

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