Recently, Kite, a subsidiary of Gilead, announced that it will acquire the biotechnology company Interius BioTherapeutics for US$350 million in cash. This strategic layout marks Gilead’s opening up of a new frontier in the field of cell therapy. Cell therapy, a frontier of innovation in the biopharmaceutical field, is developing at an astonishing pace. While traditional CAR-T therapy has achieved remarkable results in treating hematologic malignancies, it is limited by complex procedures and high costs. Kite’s acquisition of Interius is driven by its pioneering work in in vivo CAR-T therapy. Interius’s in vivo CAR-T technology innovatively eliminates the tedious in vitro steps of traditional therapies, opening up new avenues for the convenience and accessibility of cell therapy and injecting strong technological vitality into Gilead. Interius’s technology platform, leveraging its modularity, can be efficiently adapted to diverse disease areas, enabling scalable production. INT2104, the lead product in its R&D pipeline, is ...
On August 25, local time, it was reported that US President Trump said that he would reduce drug prices to 1/1400 to 1/1500 of the current price, and would deal with the cost figures of US drug prices. Tariffs on medicines will soon be imposed. https://finance.eastmoney.com/a/202508263494050365.html
Yang Sheng, deputy director of the National Medical Products Administration, recently stated that China’s pharmaceutical industry is currently ranked second in the world, with innovative drugsThe number of projects under research accounts for about 30% of the world’s total. Yang Sheng said that to complete the goals and tasks of the 14th Five-Year Plan with high quality and ensure the safety and effectiveness of people’s use of medicines, work should be mainly carried out in three aspects: comprehensively strengthening the bottom line of drug safety, supporting the high-quality development of the pharmaceutical industry throughout the entire chain, and fully guaranteeing the people’s drug needs. In terms of building a solid bottom line for drug safety in all aspects, my country has strengthened dynamic supervision covering the entire life cycle of drugs, established and improved a drug safety risk consultation mechanism, focused on key links such as online drug sales, contract ...
Novartis and BioArctic AB have entered into an option, collaboration, and license agreement to explore a potential new treatment for neurodegenerative disorders. The partnership will apply BioArctic’s proprietary BrainTransporter technology to enhance brain-targeted delivery of therapeutic agents, with the goal of generating a novel drug candidate for evaluation in preclinical and early research stages. How does the Novartis agreement expand BioArctic’s BrainTransporter strategy? Under terms of the deal, BioArctic will receive an upfront payment of $30 million during the initial research collaboration, during which it will generate a drug candidate combining BrainTransporter with a Novartis proprietary antibody. After reviewing the resulting data, Novartis may exercise an option to license the candidate, a step that would trigger additional potential payments to BioArctic of up to $772 million. The Swedish biotech would also be eligible for tiered mid–single-digit royalties on any eventual global product sales. If Novartis chooses to exercise the option, ...
TUESDAY, Aug. 26, 2025 (HealthDay News) — Doctors in China transplanted a genetically modified pig lung into a man, where it functioned for nine days, according to a new study published in the journal Nature Medicine. Researchers at Guangzhou Medical University’s First Affiliated Hospital performed the surgery on a 39-year-old man who had been declared brain-dead after a brain hemorrhage. His family gave consent for the procedure, CNN reported. This is believed to be the first attempt to transplant a pig lung into a human. While scientists see hope in this type of surgery, experts say it could take years before it’s an option for people who need lung transplants. The pig lung used in the transplant had six gene edits that were designed to reduce the risk of rejection. The donor pig was raised in a highly controlled, sterile environment. Doctors also gave the patient several medications to lower ...
Drugdu.com expert’s response: Medical Device Class I Product Filing Process I. Pre-Filing Preparation Confirm Product Classification Ensure the product falls within the scope of the Class I Medical Device Product Catalog or the In Vitro Diagnostic Reagent Classification Sub-Catalog. If the product is outside these catalogs, apply to the National Medical Products Administration (NMPA) for classification determination. Filing can proceed only after confirmation as a Class I medical device. Prepare Filing Documents The following core materials must be submitted (subject to local regulatory requirements): Filing Form: Completed and stamped with the enterprise’s official seal or signed by the legal representative. Enterprise Qualification Documents: Business license duplicate. Legal representative’s identification. Product Technical Documents: Product Technical Requirements (prepared per the Guidelines for Drafting Technical Requirements for Medical Devices), specifying functional and safety indicators, as well as testing methods. Product Inspection Report (self-tested or commissioned testing, including product information, testing basis, and results). Instructions for Use and Label Samples (compliant ...
The FDA has updated the label for Amgen’s Repatha (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) linked to uncontrolled low-density lipoprotein cholesterol (LDL-C). The expanded indication removes the prior restriction that patients must already have diagnosed cardiovascular disease (CVD), broadening access to individuals considered to have an elevated risk.1 What Milestones have Shaped Repatha’s Label Expansion Over the Years? “Far too many adults at risk of cardiovascular disease are not achieving their LDL-C goals, despite it being one of the most modifiable risk factors for a heart attack or stroke,” said Murdo Gordon, EVP, global commercial operations, Amgen, in a press release. The FDA also extended the approval of Repatha to include it as a standalone therapy for patients with homozygous familial hypercholesterolemia (HoFH), a rare inherited condition that causes dangerously high cholesterol levels. The agency further underscored that Repatha should be prescribed in ...
By Dennis Thompson HealthDay ReporterMONDAY, Aug. 25, 2025 (HealthDay News) — Hidden fat deposits packed around abdominal organs like the stomach, intestines and liver could be increasing people’s risk of heart disease, a new study says. Excessive amounts of this hidden fat — also called visceral fat — is tied to faster aging of the heart, researchers report in the European Heart Journal. This fat can’t be seen from the outside, and some people can have large amounts of visceral fat even if they have a healthy weight, researchers noted. “Our research shows that ‘bad’ fat, hidden deep around the organs, accelerates aging of the heart,” senior researcher Dr. Declan O’Regan, a professor at the MRC Laboratory of Medical Sciences at Imperial College London, said in a news release. “But some types of fat could protect against aging — specifically fat around the hips and thighs in women,” he added. ...
According to a report from Southern Finance on August 26, Walvax BioAccording to news, recently, the 23-valent pneumococcal polysaccharide vaccine (hereinafter referred to as “23-valent pneumococcal vaccine”) produced by Yuxi Watson Biotechnology Co., Ltd. , a subsidiary of Walvax Biotechnology Holdings, completed its first export delivery to El Salvador, marking the first time that Walvax Biotechnology has exported 23-valent pneumococcal polysaccharide vaccine to El Salvador.The product has officially launched in the Latin American market. As the world’s first preservative-free 23-valent pneumococcal polysaccharide vaccine, it is suitable for children over 2 years old and high-risk adults. Global sales have exceeded 14 million doses. https://finance.eastmoney.com/a/202508263494831241.html
LEO Pharma recently announced that the FDA has approved ANZUPGO (delgocitinib) Cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults. Delgocitinib is a pan-JAK inhibitor that simultaneously inhibits JAK1, JAK2, JAK3, and TYK2, suppressing the signaling of proinflammatory cytokines (such as IL-4, IL-13, and IL-23) and alleviating skin inflammation and itching. Degatinib cream is the world’s first topical JAK inhibitor specifically used to treat moderate to severe chronic hand eczema and is expected to become a new treatment option for CHE patients. Principles and R&D progress Hand eczema is the most common hand skin disease, presenting as a variety of lesions including erythema, papules, blisters, scaling, hyperkeratosis, and fissures. Most patients with hand eczema develop the condition into a chronic condition. Chronic hand eczema (CHE) refers to hand eczema that persists for more than three months or recurs two or more times within a ...
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