PharmaFocus Today – Page 115 – media

FDA Approves Amneal’s Naloxone Hydrochloride Nasal Spray as an OTC Treatment for Opioid Overdose

Don Tracy, Associate Editor Company aims to provide affordable emergency treatment from overdoses of heroin, fentanyl, and prescription opioids. Amneal Pharmaceuticals announced that the FDA has approved its OTC Naloxone Hydrochloride (HCI) nasal spray for use in counteracting opioid overdoses. As a generic of Narcan, this nasal spray has also been shown to neutralize overdoses caused by heroin, fentanyl, and prescription opioids. With Naxolone officially available, the company stated that this action provides another affordable option to prevent overdoses, which causes more death in people under the age of 50 years than any other cause.1 “With today’s launch, Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription. Our business is deeply rooted in a commitment to helping others. By enhancing access to naloxone nasal spray, we hope to get this affordable emergency treatment into the hands ...
- Source: drugdu
- 76
- April 26, 2024
GLP-1/GIP Dual-Target Receptor Agonist (THDBH120 for Injection) Clinical Trial Approval for Weight Loss Indication Declaration

Tonghua Dongbao Pharmaceutical Co. (hereinafter referred to as the “Company”, “Tonghua Dongbao”), a wholly-owned subsidiary of Tonghua Dongbao Zixing (Hangzhou) Biomedicine Co., Ltd. has recently obtained the clinical trial approval for THDBH120 for weight loss indication from the Center for Drug Evaluation (CDE) of the State Drug Administration. THDBH120 for injection for the indication of weight loss drug clinical trial approval notice. The approval of the clinical application for THDBH120 for weight loss indication for injection signifies that the company’s GLP-1 pipeline in the field of overweight and obesity treatment has also stepped into the phase of clinical trials, which is of milestone significance. In the future, the Company will accelerate the research and development progress of THDBH120 for injection in diabetes indication and weight loss indication, and further explore and tap the potential of other indications to maximize the value of the product. THDBH120 for injection has a huge ...
- Source: drugdu
- 95
- April 26, 2024
Investors anticipate “bounce-back” in European private investment

The Swiss biotech ecosystem suffers from a “weak public market”, said Francesco de Rubertis, a cofounder at Medicxi Ventures. Despite this, De Rubertis and other experts at the recently concluded Swiss Biotech Day conference, anticipated an improvement in the investment market in the months to come. The conference, held in Basel 22–23 April, gathered experts from around the world to discuss trends in the pharmaceutical sector. At the “Decoding Swiss Biotech – the Investors perspective” session, panellists highlighted changes in the investment market and shared predictions for 2024 and onwards. Nicholas Riddle, the managing director of healthcare investment banking at JP Morgan, forecasts an uptick in the number of pharmaceutical initial public offerings in Europe this year. Riddle added, “It has been a pretty terrible time for private companies in the last several years. However, we are starting to see a bit more engagement from both European funds, who have ...
- Source: drugdu
- 71
- April 26, 2024
Spatial Tissue Analysis Identifies Patterns Associated With Ovarian Cancer Relapse

High-grade serous ovarian carcinoma is the most lethal type of ovarian cancer, and it poses significant detection challenges. Typically, patients initially respond to surgery and chemotherapy, but the cancer often returns. Now, researchers have used spatial analysis of tissue samples to uncover patterns that could indicate whether patients with this form of ovarian cancer are likely to experience early recurrence following treatment, potentially guiding future therapeutic strategies. Researchers at Cedars-Sinai (Los Angeles, CA, USA) conducted spatial protein analyses on ovarian cancer tissue samples to identify patterns correlated with early cancer relapse soon after treatment. The study involved 42 patients and examined both primary and recurrent tumors using imaging mass cytometry, which allows for the detailed spatial examination of protein presence within tissues. Their key findings highlighted the role of plasma cells in the tumor’s immune response. The study found that the location of plasma cells and their relationship with nearby ...
- Source: drugdu
- 81
- April 25, 2024
Unique Autoantibody Signature to Help Diagnose Multiple Sclerosis Years before Symptom Onset

Autoimmune diseases such as multiple sclerosis (MS) are thought to occur partly due to unusual immune responses to common infections. Early MS symptoms, including dizziness, spasms, and fatigue, often resemble other conditions, complicating diagnosis, which heavily relies on detailed brain MRI evaluations. MS can severely impair motor control, but advancements in treatment can slow down its progression and help maintain functions such as walking. Notably, around 10% of MS patients begin producing a distinctive set of antibodies against their own proteins years before symptoms appear. These autoantibodies have been found to bind to both human cells and common pathogens, possibly explaining why immune attacks on the brain and spinal cord occur in MS. Now, researchers have identified a unique autoantibody signature in about 10% of MS patients that appears years before the onset of clinical symptoms, raising hopes for early detection via a simple blood test and earlier treatment initiation. ...
- Source: drugdu
- 84
- April 25, 2024
FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. By Frank Vinluan Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ. The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer. BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce ...
- Source: drugdu
- 77
- April 25, 2024
FDA Approves Novartis’ Lutathera for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors

Davy James Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. The FDA has approved Novartis’ Lutathera (lutetium Lu 177 dotatate) to treat patients aged 12 years and older with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. The regulatory action makes Lutathera the first therapy specifically approved to treat GEP-NETs in a pediatric patient population.1 “Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new hope to young patients living with this rare cancer,” Tina Deignan, Novartis therapeutic area head, Oncology US, said in a press release. “Radioligand therapies (RLTs) have extraordinary potential to shape the future of cancer care. With this approval, we have taken another vital step toward fulfilling that vision, strengthening our commitment to researching and developing the RLT platform across multiple cancer types and treatment settings.” NETs, which are ...
- Source: drugdu
- 139
- April 25, 2024
Positive Results from Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) in Patients with Giant Cell Arteritis

On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019). Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, “Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to ...
- Source: drugdu
- 77
- April 25, 2024
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018

Shanghai, China, April 23, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the first subject was dosed for a phase 1 clinical trial of HLX6018 (NCT06310746), a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company. HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases, and it was recently approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). Currently, no product targeting GARP/TGF-β1 has been approved for marketing globally. Fibrosis is a pathological process characterised by persistent tissue scars which attributed to excessive deposition of extracellular matrix (ECM). This condition can be induced by a variety of stimuli such as infections, autoimmune reactions, radiation, and tissue injury. Common fibrosis-related diseases include IPF, non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, chronic kidney disease (CKD), myocardial infarction (MI), etc. Among them, IPF is a chronic, progressive interstitial ...
- Source: drugdu
- 119
- April 25, 2024
Boehringer Ingelheim and Ochre Bio partner on liver disease in deal worth over $1bn

Chronic liver disease and associated cirrhosis account for one million deaths every year Boehringer Ingelheim and Ochre Bio have partnered to discover and develop novel, first-in-class regenerative treatments for chronic liver disease (CLD), including late-stage metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. The partnership aligns with Boehringer’s drive to improve outcomes for patients living with interconnected cardiovascular, renal and metabolic diseases. Accounting for approximately one million deaths per year, CLD and associated cirrhosis cause significant morbidity, loss of health-related quality of life and economic burden. As CLD progresses, the liver’s natural ability to regenerate and repair diminishes, resulting in serious complications such as liver failure or liver cancer. Under the terms of the agreement, Ochre will receive up to $35m in upfront and near-term research-based milestone payments, as well as possible milestones for clinical, regulatory and commercial success plus tiered royalties, with an overall deal value with the potential to exceed $1bn. ...
- Source: drugdu
- 92
- April 25, 2024

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