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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
- 89
- 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 Today (8 August), NICE released their final draft guidance recommending Casgevy coverage via the NHS.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
- 76
- 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
- 97
- 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
- 79
- 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
- 57
- 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
- 66
- 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
- 68
- 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
Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank VinluanA Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize its ...
- Source: drugdu
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- August 10, 2024
Novartis’ kidney disease drug Fabhalta receives US FDA approval

Novartis announced that the US FDA has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g (1). Fabhalta specifically targets the alternative complement pathway of the immune system. When overly activated in the kidneys, the complement system is thought to contribute to the pathogenesis of IgAN (1-4). This indication is granted under accelerated approval based on the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study measuring reduction in proteinuria at 9 months compared to placebo. It has not been established whether Fabhalta slows kidney function decline in patients with IgAN. The continued approval of Fabhalta may be contingent upon verification and description of clinical benefit from the ongoing Phase III APPLAUSE-IgAN study, evaluating whether Fabhalta slows disease ...
- Source: drugdu
- 97
- August 10, 2024

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