Core Insights - Genmab has decided to halt the development of its experimental antibody therapy aimed at treating cancer, which was in late-stage trials [1] Company Summary - The Danish drugmaker Genmab announced the cessation of its late-stage trials for the antibody therapy [1]

Ultragenyx Pharmaceutical said on Monday that its experimental drug for a type of genetic bone disease did not meet the main goal in late-stage studies. ...

Core Insights - 60 Degrees Pharmaceuticals, Inc. announced a study revealing that 24% of 50 patients with chronic fatigue were infected with Babesia, a parasite linked to babesiosis, suggesting a potential connection between Babesia infection and prolonged recovery times in chronic fatigue patients [1][2][9] Group 1: Study Findings - The study conducted by North Carolina State University involved 50 participants who reported chronic diseases and potential exposure to arthropod vectors, with all participants experiencing fatigue for at least six months [5] - The findings support the hypothesis that Babesia infection may be associated with chronic diseases, particularly in prolonging recovery times for patients suffering from chronic fatigue [2][4] Group 2: Ongoing Research - The B-Free Chronic Babesiosis Study is currently evaluating the efficacy and safety of the ARAKODA regimen (tafenoquine) over 90 days for resolving severe fatigue in chronic babesiosis patients, with enrollment taking place at the Icahn School of Medicine at Mount Sinai in New York [3][9] - The study's results highlight the need for further prospective controlled studies to better understand the relationship between Babesia infection and chronic diseases [4] Group 3: Babesiosis Overview - Babesiosis is a tick-borne illness caused by Babesia parasites, leading to symptoms such as fevers, chills, and fatigue, with severe cases posing life-threatening risks, especially to the elderly and immunosuppressed [7] - The incidence of babesiosis is rapidly increasing, particularly in the Northeast, with an estimated minimum annual incidence of at least 25,000 cases in the U.S., although the actual number may be significantly higher [7][8] Group 4: Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA (tafenoquine), for malaria prevention in 2018 [10] - The company collaborates with prominent research and academic organizations in the U.S. and Australia, and is headquartered in Washington, D.C. [10]

PONTE VEDRA, FL / ACCESS Newswire / December 29, 2025 / Every industry has its forgotten corners. In anticoagulation, those corners turned into entire neighborhoods. ...

Core Viewpoint - Danish drugmaker Novo Nordisk has significantly reduced the prices of its obesity drug Wegovy in certain provinces of China, nearly halving the costs [1] Company Summary - Novo Nordisk has implemented a price reduction strategy for Wegovy, targeting specific regions in China to enhance accessibility [1]

Core Viewpoint - Zevra Therapeutics has entered into an exclusive expanded access distribution agreement with Uniphar to provide Niemann-Pick Disease Type C (NPC) patients access to MIPLYFFA (arimoclomol) in select territories outside of Europe [1][3] Company Overview - Zevra Therapeutics is a commercial-stage company focused on therapies for rare diseases, aiming to address unmet needs in this community [14] - The company has developed MIPLYFFA, the only treatment shown to halt disease progression in NPC, with FDA approval received on September 20, 2024 [4][5] Product Information - MIPLYFFA is indicated for use in combination with miglustat for treating neurological manifestations of NPC in patients aged 2 years and older [5] - The drug has demonstrated a durable effect, halting disease progression as measured by the NPC Clinical Severity Scale over a one-year trial [4] - MIPLYFFA has shown long-term clinical outcomes with over 5 years of patient experience across more than 270 NPC patients [4] Distribution Agreement - The agreement with Uniphar aims to expand access to MIPLYFFA, leveraging Uniphar's expertise in global distribution and supply chain management [3][16] - This partnership is expected to initially address a select patient population while Zevra continues to prepare for its U.S. commercial launch and potential EU approval [3] Clinical Significance - MIPLYFFA increases the activation of transcription factors that regulate lysosomal expression and has been shown to reduce unesterified cholesterol in NPC fibroblasts [4] - The pivotal phase 3 trial results indicate significant clinical benefits, although the full clinical significance of these findings is not yet fully understood [4] Regulatory Status - MIPLYFFA is currently approved in the U.S. and is under review by the European Medicines Agency for marketing authorization in Europe [3][4]

白云山(00874)公布，近日，公司分公司广州白云山医药集团股份有限公司白云山制药总厂收到国家药 品监督管理局签发的《药品补充申请批准通知书》。 白云山制药总厂注射用头孢呋辛钠于2006年5月在国内正式上市，并于2025年4月3日向国家药品监督管 理局递交一致性评价申请，于2025年4月11日获得受理。 头孢呋辛钠为第二代头孢菌素，对大多数革兰氏阴性菌、革兰氏阳性菌敏感，具有抗菌谱广、肾脏毒性 较低、对β内酰胺酶稳定的优势，临床广泛用于治疗唿吸道感染、泌尿系统感染及外科感染。注射用头 孢呋辛钠被列入国家基本药物目录(2018)，属于国家医保乙类品种(2025)。 白云山制药总厂的注射用头孢呋辛钠通过仿制药一致性评价，有利于提升该药品的市场竞争力。 ...

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it has entered into an exclusive licensing agreement with ASK Pharm for its proprietary pan-RAS (ON) inhibitor AN9025. Under the terms of the agreement, ASK Pharm will obtain exclusive rights to develop, manufacture, and commercialize ...

近日，新华制药（000756）磷酸奥司他韦干混悬剂获国家药品监督管理局批准正式上市，并视同过评。 新华制药方面表示，该产品为该公司首个成功获批上市的口服型抗流感仿制药物，这一成果标志着公司 在口服抗流感治疗领域达成了产品线"从无到有"的实质性突破，填补了企业在该细分市场自主产品的空 白，为公司整体治疗领域的战略布局补上了关键的一环。 同时，对于新华制药的另一层意义在于，伴随集中采购的推进以及基层医疗需求的增长，磷酸奥司他韦 干混悬剂有望成为儿童流感防治的主力剂型。该产品需配制成混悬液使用，故而消化道反应相对较少， 其配备的给药器可通过液体抽取方式精准控制给药剂量，对于低龄儿童而言，用药更为灵活便捷，是儿 童流感预防与治疗的优选方案。 磷酸奥司他韦作为一种选择性的流感病毒神经氨酸酶抑制剂，能够有效抑制甲型和乙型流感病毒的传 播，适用于成人和2周龄及以上儿童的甲型和乙型流感治疗，以及适用于1岁及1岁以上人群的甲型和乙 型流感的预防。 据了解，磷酸奥司他韦是世界上第一种获批的抗流感病毒药物，由美国生物制药公司吉利德科学的科研 团队研制，后与瑞士罗氏制药合作完成临床开发及商业化，于1999年获得美国FDA批准上市，商 ...

Other drugmakers seem to be too far behind to disrupt this duopoly, at least for now.The weight loss market has garnered plenty of headlines over the past two years. Yet, to date, and despite plenty of pipeline candidates, only two brands dominate this field. One of them is Wegovy, a medication marketed by Novo Nordisk (NVO 0.30%), and the other is Zepbound, which was developed by Eli Lilly (LLY +0.07%). These two are the undisputed leaders in this therapeutic area, and they could soon solidify their lead w ...