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FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

Don Tracy, Associate Editor Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy. The FDA has approved an expanded indication for Gilead’s Vemlidy (tenofovir alafenamide), to treat chronic hepatitis B virus (HBV) infection in pediatric patients aged six years and older who weigh at least 25 kg and have compensated liver disease. In 2016, the medication was initially approved for adults with chronic HBV and compensated liver disease, with an extended use approved in 2022 for children aged 12 years and above. Approval for the expanded indication was based on positive results stemming from Gilead’s Phase II clinical trial (Trial 1092) after 96 weeks, showing safety and efficacy in younger children. According to the study data, participants experienced progressive increases in the rates of virological suppression compared to those administered a placebo.1 “Chronic hepatitis B ...
- Source: drugdu
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- April 2, 2024
Innovative Blood Collection Device Overcomes Common Obstacles Related to Phlebotomy

The discomfort associated with traditional blood draws leads to a significant issue: approximately 30% of diagnostic tests prescribed by physicians are never completed by patients. This avoidance is often due to the fear of pain from needle sticks and a reluctance to visit medical facilities where there’s a perceived risk of encountering illness. Now, a virtually pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system solves the problem of the physical pain of a traditional blood draw, making it easier, cheaper, and faster to potentially receive a diagnosis. RedDrop Dx’s (Fort Collins, CO, USA) innovative blood collection device, RedDrop One, aims to enhance blood collection technology and patient care practices. With its user-centric design, RedDrop One eliminates many of the drawbacks associated with traditional blood collection methods, allowing for the collection of larger blood volumes more efficiently and with significantly less discomfort for the patient. This device is ...
- Source: drugdu
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- April 2, 2024
Upgraded Syndromic Testing Analyzer Enables Remote Test Results Access

QIAGEN (Venlo, the Netherlands) has released the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade. This represents a significant advancement from the initial QIAstat-Dx Analyzer 1.0, offering enhanced capabilities for the accurate, rapid, and cost-effective identification of complex syndromes. The system, which is designed for laboratory settings, incorporates economical, disposable cartridges that integrate sample preparation with all necessary reagents on board. Leveraging multiplex real-time PCR technology, it can identify and distinguish between various pathogens, delivering results within approximately one hour. Additionally, the system enables the display of cycle threshold (Ct) values and amplification curves, providing deeper analytical insights beyond those achievable with endpoint PCR or alternative methodologies. A key feature of this upgraded system is the introduction of the QIAstat-Dx Operational Module PRO, which is equipped with a 64-bit processor and 4GB of RAM. This enables the Remote Results Application, a pioneering tool in syndromic testing that allows for the ...
- Source: drugdu
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- April 2, 2024
89bio wins EMA priority status for MASH candidate pegozafermin

The European Medicine’s Agency (EMA) has granted priority medicines (PRIME) status to 89bio’s pegozafermin, a drug being evaluated to treat patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with advanced forms of fibrosis. The EMA’s PRIME scheme is designed to expedite the development of medicines that meet an unmet need, such as rare diseases. The agency upgraded the scheme last year to enhance scientific advice and regulatory package preparation for sponsors of the scheme. 89bio’s pegozafermin was granted PRIME status based on positive data from the company’s Phase IIb ELIVEN trial (NCT04929483), according to a 27 March press release. The randomised trial saw three doses of the drug administered either once weekly or biweekly in 192 patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis (F4). Patients in the biweekly 44mg and once-weekly 30mg treatment groups saw significant one-stage fibrosis improvement without MASH worsening. MASH resolution without worsening ...
- Source: drugdu
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- April 2, 2024
J&J reportedly eyeing Shockwave Medical for takeover

Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of medical device company Shockwave Medical, as first reported by the Wall Street Journal (WSJ) on 26 March. The WSJ cited people familiar with the matter who claimed that a finalised deal could be around the corner pending successful acquisition talks. However, the report also noted that another suitor could emerge to merge with Santa Clara, a California-based medical device manufacturer. WSJ did not mention the valuation of the potential acquisition. This is not the first time Shockwave has been involved in acquisition rumours, as Bloomberg reported that Boston Scientific was eyeing Shockwave for a takeover in April 2023. Since the publication of the WSJ report, Shockwave’s stock price has increased by 3.8%. Shockwave has a market cap of $12.3bn. As per a 15 February press release, Shockwave has commenced the ...
- Source: drugdu
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- April 2, 2024
Hengrui’s Clinical Application for New Drug Indicated for Psoriasis Approved

Today (March 29), according to the official website of CDE, Guangdong Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as “Hengrui Pharmaceutical”) class 1 new drug SHR-1139 injection indicated for psoriasis application obtained approval. Psoriasis is a chronic inflammatory skin disease that is stimulated by environmental factors, genetic control, and immune media. According to relevant data, there are more than 7 million psoriasis patients in China. Fhstrilin predicts that China’s psoriasis market will increase to US $ 9.5 billion in 2030, with a compound annual growth rate of 27.1%. Globally, the number of patients with psoriasis is on the rise. At present, biopharmaceuticals have gradually become one of the mainstream therapies of psoriasis in China. Related drugs are mainly focused on targets such as TNF-α and IL families. Hengrui Pharmaceutical also deployed psoriasis therapy drugs, of which Fu Niqizumab (SHR-1314) targets IL-17A targets. Following the CDE acceptance of the listing of ...
- Source: drugdu
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- April 2, 2024
March 29, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA made several updates to the Mammography Quality Standards Act and Program section on the FDA Website to enhance user experience and provide the most up-to-date information, including reordering and renaming the landing pages so the information is easier to find and updating and deleting old data to provide the public with current information. On Thursday, the FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve the public—especially retailers—by providing this key information in a single location, with easy-to-use search capabilities. The database, which can be accessed here. The database will be updated on a monthly basis. On Wednesday, the FDA authorized marketing of the Medline Autologous Regeneration of ...
- Source: drugdu
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- April 2, 2024
Altamira Therapeutics partners with Univercells Group on nanoparticle-delivered mRNA vaccines

Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform Altamira Therapeutics, a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets has announced that it has entered into a collaboration agreement with Univercells Group to evaluate the use of the Company’s proprietary SemaPhore platform for the delivery of mRNA vaccines. Univercells is a global life sciences company creating platforms for developing and manufacturing biologics, including mRNA vaccines and therapeutics, in a simple, scalable and cost-efficient way. Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform. Should the experiments prove successful, Univercells and Altamira intend to discuss and negotiate a commercial agreement for the development and manufacturing of nanoparticle-based mRNA vaccines using Univercells’ production platform. Covadonga Pañeda, PhD, Altamira’s ...
- Source: drugdu
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- April 2, 2024
Novo Nordisk to acquire Cardior Pharmaceuticals to strengthen pipeline in cardiovascular disease

The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. Martin Holst Lange, executive vice president for Development at Novo Nordisk said, “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development. We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to ...
- Source: drugdu
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- April 2, 2024
Cambodia Phar-Med Expo 2024

Organiser: Minh Vi Exhibition & Advertisement Services Co., Ltd. Time:28 – 30 August 2024 address：Diamond Island Phnom Penh Cambodia Exhibition hall: Diamond Island Convention & Exhibition Center Product range: Medical equipment and equipment: medical aid equipment, rehabilitation physiotherapy equipment, medical vehicle, bed, table, medical aid equipment, surgical equipment, preventive medical equipment, examination equipment, monitoring equipment, treatment equipment, inspection and analysis equipment, special surgical equipment, first aid equipment, surgical equipment, diagnostic equipment and supplies, analysis and control, Monitoring equipment, corrective equipment, ophthalmic instruments and equipment, ENT equipment, dental supplies and equipment, radiological medicine equipment, medical reagents and equipment, prosthetics and rehabilitation equipment, medical and health products and equipment, disinfection and sterilization equipment, traction, diagnostic equipment, treatment equipment, inspection and analysis equipment, etc Medical institutions and laboratory technical equipment: laboratory furniture, laboratory automation and accessories, optical instruments and equipment, dressings, wound care materials, catheters, medical experimental analysis and diagnostic instruments, biopharmaceutical instruments, cell biology ...
- Source: drugdu
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- April 2, 2024

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