PharmaFocus Today – Page 58 – media

First Patient Enrolled in the US Phase 2 Combination Therapy of Akeso’s Ligufalimab with Azacitidine for Myelodysplastic Syndrome

Akeso has announced the completion of the first patient enrollment in the US for the phase II clinical trial of its innovative CD47 monoclonal antibody, ligufalimab (AK117), in combination with azacitidine for patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). Preliminary studies show that combining AK117 with azacitidine for treating MDS is safe and significantly effective. In response to the urgent need for new therapies among global MDS patients and the evolving market landscape, Akeso has launched an international multicenter Phase II clinical trial. This initiative aims to expedite AK117’s global approval and commercialization process. CD47-targeted drug development for treating MDS shows promising potential. AK117, a next-generation humanized IgG4 anti-CD47 antibody, effectively blocks the CD47-SIRPα interaction to enhance phagocytic activity against tumor cells by phagocytes. Recent data presented at the 65th American Society of Hematology (ASH) Annual Meeting demonstrated that AK117 combined with azacitidine significantly reduces anemia and transfusion requirements ...
- Source: drugdu
- 88
- August 12, 2024
Computational protocol provides cheaper route to manage cholesterol levels

Researchers led by Dr Suman Chakrabarty from S N Bose National Centre for Basic Sciences, Kolkata, an autonomous institute under the Department of Science and Technology, in collaboration with Sarfez Pharmaceuticals, have explored a new frontier in computer-aided drug discovery that can help develop medicines that can prevent harmful protein-protein interactions which can lead to conditions like elevated low-density lipoprotein (LDL) or cholesterol level. Traditionally, scientists have tried to develop small molecules as drugs that would preferentially bind to the protein-protein interaction (PPI) sites and act as competitive inhibitors. However, finding drugs that can effectively block these protein interactions has been difficult because the areas where proteins interact are often large and smooth, with no clear spots for a drug to latch onto. A commonly used alternative approach is to use large peptides or antibodies to inhibit PPIs. But these are often undesirable due to the increased cost, difficulty of ...
- Source: drugdu
- 72
- August 12, 2024
FDA approves first Nalmefene Hydrochloride auto-injector to reverse opioid overdose

The US FDA approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. The agency approved the first nasal spray formulation of nalmefene in May 2023. Drug overdose persists as a major public health issue in the US, with more than 107,000 reported fatal overdoses occurring in 2023, primarily driven by synthetic opioids like illicit fentanyl. Nalmefene and naloxone are two available options to reverse opioid overdose. The FDA has worked to increase the availability and accessibility of both options to encourage harm reduction and reduce overdose death. Nalmefene is an opioid receptor antagonist which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure (hypotension). The newly approved product delivers 1.5 milligrams (mg) ...
- Source: drugdu
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- August 12, 2024
CRISPR-based Casgevy is made accessible in England following NICE guidance

Following positive guidance issued by the National Institute for Health and Care Excellence (NICE), the CRISPR-based gene therapy Casgevy has been made available to patients with transfusion-dependent beta thalassemia (TDT) in England. Today (8 August), NICE released their final draft guidance recommending Casgevy coverage via the NHS. Casgevy was developed by Vertex Pharmaceuticals and CRISPR Therapeutics. The recommendation concerns patients aged 12 and older with severe beta-thalassemia needing blood transfusion, for whom blood and bone marrow transplant is suitable, but no matching donor is available. Consequently, Vertex announced a reimbursement agreement with NHS England making the treatment available beginning today. Casgevy will be accessible through the Innovative Medicines Fund for up to 460 eligible patients, as per NICE. The NICE decision came after an independent committee heard statements on how TDT impacts the lives of patients. TDT is a life-threatening inherited disease in which genetic mutation reduces or prevents production ...
- Source: drugdu
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- August 12, 2024
Henlius to Release Latest Results of HANSIZHUANG and HANQUYOU at ESMO Congress 2024

2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University. HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, ...
- Source: drugdu
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- August 12, 2024
Hengrui Pharmaceuticals’ Innovative Drug Fronachizumab Approved for Clinical Trials for the Treatment of Moderate to Severe Plaque Psoriasis in Children and Adolescents

Recently, Hengrui Pharmaceuticals’ subsidiary, Suzhou Shengdia Bio-pharmaceutical Co., Ltd. has received a Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration, agreeing to conduct a clinical trial for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to less than 18 years old, who are suitable for systemic therapy or phototherapy. Psoriasis is a chronic, relapsing, immune-mediated inflammatory skin disease that most often involves the scalp, knees, elbows, hands and feet. The prevalence of psoriasis ranges from 0.09% to 11.4% of the global population [1][2], and the prevalence of psoriasis in our country is about 0.5% [3]. About 80%-90% of psoriasis cases are of the common type of psoriasis (plaque psoriasis) and 10%-20% of cases are of moderate to severe psoriasis involving more than 5% of the body surface area (BSA) [4]. It is estimated that approximately 1/3 of adults with psoriasis ...
- Source: drugdu
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- August 12, 2024
Hengrui Pharmaceuticals’ Innovative Anti-inflammatory Drug SHR-1819 for the Treatment of Prurigo nodularis Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary, Guangdong Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, agreeing to conduct a clinical trial of SHR-1819 Injection for patients with Prutigo nodularis (PN). PN is a chronic, inflammatory skin disease clinically characterized by episodes of intense itching and multiple nodular lesions. The main clinical symptom is intense, recurrent itching accompanied by uncontrollable scratching, which leads to hyperkeratosis of the skin to the point of forming dome-shaped nodules.1 PN leads to the development of psychological disorders in patients who face a significant reduction in quality of life, reduced sleep quality, and anxiety and depression. According to Frost & Sullivan, the number of PN patients in China will be approximately 2 million in 2022 and is expected to reach 2.1 million in 2030. To date, there is no standard diagnosis and treatment program for PN, ...
- Source: drugdu
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- August 12, 2024
Nutraceutical brand Aurelle Health launches in India

Aurelle Health, a D2C Nutraceutical brand aimed to prioritise women’s hormonal health, has been launched in India. Taking its lineage from Balaxi Pharmaceuticals, the inception of the brand is based on the statistics that 1 out of every 5 Indian women suffer from hormonal issues like Polycystic Ovary Syndrome (PCOS). The brand further aims to educate women about their hormone health. As part of the launch phase, the company has introduced products across four categories – hair health, skin health, gut health and weight management. The novel products namely Clear Canvas, Mane and Maintain, Gut Health and Tone it Down, claim to be non-GMO, clinically proven, sugar-free and vegan. Paridhi Maheshwari, Founder, Aurelle Health explains that the brand incorporates her journey through PCOS, along with her experience in the pharmaceutical industry. Aurelle products are currently available on their website, Amazon and in select skin/hair clinics. The products are slated to ...
- Source: drugdu
- 68
- August 10, 2024
What effect does X-ray inspection have on pharma products?

Mike Pipe, Head of Global Sales, Mettler-Toledo Mettler-Toledo Safeline X-rayX-ray technology is an effective way of inspecting pharmaceutical products for a range of factors, among them being certain kinds of contaminants, fill levels, damaged or missing components, and damaged packaging. Without a doubt, the pharma sector is waking up to how useful X-ray inspection can be, and how it can improve matters of cost, efficiency and waste. The European Medicines Agency (EMA) has issued rules regulating the exposure of drugs to X-rays, in its document “The Use of Ionising Radiation in the Manufacture of Medicinal Products” (3AQ4a). This guidance advises that irradiation may be used for microbial decontamination, sterilisation or other treatments in the manufacture of medicinal products and that manufacturers doing so should refer to the Guide to Good Manufacturing Practice (Volume IV of “The Rules Governing Medicinal Products in the European Union”) and in particular to Annex 12, ...
- Source: drugdu
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- August 10, 2024
ImmunityBio Launches Study to Evaluate Combination of Anktiva, AdHER2DC Cancer Vaccine for Endometrial Cancer

By Don Tracy, Associate Editor The study aims to explore Anktiva as a potential cornerstone of future immunotherapy treatments for endometrial cancer and other forms of the disease. ImmunityBio has initiated a clinical trial to evaluate the combination of Anktiva, their IL-15 superagonist, with the investigational AdHER2DC cancer vaccine, a product of the National Cancer Institute (NCI), as a potential treatment for endometrial cancer. According to the company, the purpose of the trial is to assess the safety and efficacy of this combination therapy in patients with HER2-positive endometrial cancer. The trial comes amid Anktiva’s recent FDA approval for treating BCG-unresponsive non-muscle invasive bladder cancer.1,2 “We are pleased to partner with the NCI on this important cancer control study involving Anktiva, which has demonstrated in clinical trials that activation of memory T cells may help deliver long-duration response well beyond that of checkpoint inhibitors alone,” said Patrick Soon-Shiong, MD, executive ...
- Source: drugdu
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- August 10, 2024

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