media – Page 6 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Takeda and Protagonist seek FDA approval for rusfertide to treat PV

Takeda and Protagonist Therapeutics have jointly submitted a new drug application (NDA) seeking approval from the US Food and Drug Administration (FDA) for rusfertide to treat adults with polycythemia vera (PV). The first-in-class, subcutaneously administered hepcidin mimetic peptide, rusfertide is intended to regulate iron homeostasis and red blood cell production to help manage haematocrit levels in PV patients. The NDA follows positive results from the 32-week primary analysis and 52-week evaluation of the Phase III global placebo-controlled, randomised VERIFY trial. In this trial, rusfertide achieved the primary endpoint and all four key secondary endpoints. The study found that patients treated with the therapy alongside standard of care (SoC) therapy achieved a notably higher response rate than those given a placebo with SoC. The application also includes findings from the earlier Phase II REVIVE study. Rusfertide has received breakthrough therapy designation from the FDA, recognising its potential to offer substantial improvement ...
- Source: drugdu
- 54
- January 7, 2026
Aktis Oncology kicks 2026 IPO cycle off with $210m target

The IPO class of 2026 is likely to receive its first incumbent, after Aktis Oncology set its sights on a public listing that could see proceeds of around $210m. The cancer treatment-focused biotech first revealed plans for an IPO in mid-December, but the figure touted then was around the $100m mark. In an updated registration statement with the US Securities and Exchange Commission (SEC), Aktis is offering 11,775,000 shares of common stock at a price between $16 and $18 per share. The company would trade under the ticker “AKTS” on the Nasdaq Global Market. If the listing goes ahead at the midpoint of that range, Aktis anticipates raising $181.7m in proceeds. If underwriters take up their 30-day option, that value would rise again to $209.6m. Aktis’ pipeline focuses on radiopharmaceuticals, a type of drug that uses a radioactive isotope with a targeting molecule to destroy cancer cells. The biotech specifically ...
- Source: drugdu
- 54
- January 7, 2026
Rongjiekang RT2831 bispecific antibody drug receives Orphan Drug Designation from the US FDA

Nanjing Rongjiekang Biotechnology Co., Ltd.’s independently developed innovative drug RJK-RT2831 recently received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation will facilitate access to relevant policy support for RJK-RT2831’s subsequent research, development, registration, and commercialization in the United States, including research funding, tax breaks for clinical research expenses, exemption from prescription drug user fees, and accelerated market approval. The Nanjing Rongjiekang RT2831 project is a bispecific nanobody drug targeting specific antigens on the surface of malignant hematological tumor cells. It has demonstrated excellent safety and efficacy potential in non-clinical studies. Currently, the project is undergoing Phase I clinical trials in China. There remains a significant unmet medical need for patients with acute myeloid leukemia (AML), and RJK-RT2831 holds promise for providing AML patients with novel treatment options and greater clinical benefits. The FDA’s orphan drug designation ...
- Source: drugdu
- 52
- January 7, 2026
FDA approves new motion sickness drug

Vanda Pharmaceuticals recently announced that its core pipeline product, traditional vomiting (brand name: NEREUS™), has been approved by the FDA for the prevention of exercise-induced vomiting. 40 years since the approval of scopolamine transdermal patches in 1979. This approval is a significant milestone. This approval is primarily based on three pivotal clinical trials: two Phase III real-world induced trials conducted at sea and a supportive study, with all participants having a clear history of motion sickness. In the Motion Syros trial (during November 2021 to April 2023, a total of 365 adult subjects participated in 34 sea trials in the waters near the United States, during which nausea and vomiting symptoms were assessed every 30 minutes using a standardized questionnaire, and the sailing time was approximately 4 hours), the incidence of vomiting in the drug group was significantly lower than that in the placebo group (170 mg group 18.3%, 85 ...
- Source: drugdu
- 45
- January 7, 2026
Hong Kong-listed “first AI pharmaceutical company” reaches new cooperation

On January 5, Insilicon announced a multi-year collaboration with Servier to develop anti-tumor drugs. Under the agreement, InSilicon Technologies combines its AI-driven drug discovery platform with Servier’s expertise in anti-tumor drug development, focusing on the research and development of such drugs. Servier will pay a $32 million upfront payment and recent research milestones, bringing the total agreement value to $888 million. Servier will share the research and development costs and, after nominating a drug candidate, will lead subsequent clinical development, regulatory communications, and commercialization. Founded in 2014, Insil Intelligence is an AI-driven biopharmaceutical company that has built a rich pipeline of innovative research and development over the past 11 years. Its first pipeline, a TNIK inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF), has been included in the Breakthrough Therapy Programme. Subsequent pipeline projects include a USP1 inhibitor, a KAT6 inhibitor, and a TEAD inhibitor. In conclusion , on ...
- Source: drugdu
- 43
- January 7, 2026
Jointown subsidiary’s Bupivacaine Hydrochloride Injection receives Drug Registration Certificate

CNSTOCK News (Shanghai Securities News) — On the evening of January 6, Jointown Pharmaceutical Group (600998.SH) announced that Huiyu Yuanhe (Hainan) Pharmaceutical Co., Ltd., a subsidiary of the company’s unit Beijing Jingfeng Pharmaceutical Group, has received the “Drug Registration Certificate” for Bupivacaine Hydrochloride Injection approved and issued by the National Medical Products Administration (NMPA). According to the announcement, Bupivacaine Hydrochloride Injection is a long-acting amide local anesthetic primarily used for local infiltration anesthesia, peripheral nerve blocks, and spinal blocks. The drug is listed in the National Medical Insurance Category A and the National Essential Medicine List. Data from Minenet shows that in 2024, the sales of Bupivacaine Hydrochloride Injection across China’s three major terminals and six major markets exceeded 200 million RMB. As of the date of the announcement, Huiyu Yuanhe has invested approximately 4.66 million RMB (unaudited) in research and development for this drug. The announcement stated that the ...
- Source: drugdu
- 40
- January 7, 2026
Novo Nordisk launches oral weight-loss pill

On the 5th local time, Novo Nordisk launched its oral weight-loss pill in the United States, with a price significantly lower than that of similar injectable treatments. The medication is now available at over 70,000 pharmacies across the U.S., as well as through select online telehealth platforms. For cash-paying customers, the monthly cost ranges from $149 to $199 (approximately 1,060 to 1,420 RMB). Patients with insurance coverage could pay as little as $25 per month (around 180 RMB). In contrast, current injectable weight-loss drugs from Novo Nordisk and the U.S.-based Eli Lilly both cost over $1,000 per month (approximately 7,100 RMB). While Eli Lilly’s own oral weight-loss drug is expected to receive approval later this year, Novo Nordisk’s early entry into the market is a strategic move aimed at regaining previously lost market share. https://finance.eastmoney.com/a/202601063610098754.html
- Source: drugdu
- 46
- January 7, 2026
【EXPERT Q&A】What are the requirements for quality management in medical device production?

Drugdu.com expert’s response: The requirements for the quality management of medical device production cover multiple aspects, aiming to ensure the safety and effectiveness of medical devices. The core is to establish and effectively operate a quality management system to systematically control the entire product lifecycle. The specific requirements are as follows: Establishment and Operation of the Quality Management System Establish a system based on product characteristics: Enterprises should, in accordance with regulatory requirements and in combination with the characteristics of the medical devices they produce, establish a sound quality management system that is compatible with the products and ensure its effective operation. This system covers multiple links such as commissioned research and development, commissioned production, outsourced processing, and commissioned inspection. Quality assurance system and documentation: Enterprises should establish a quality assurance system and possess a complete set of quality management system documents to ensure the effective operation of the quality ...
- Source: drugdu
- 56
- January 7, 2026
High-quality innovative drugs benefit melanoma patients

Melanoma is a highly malignant tumor that can occur in multiple parts of the body, such as the palms and soles, under the nails, or in the nasal cavity and digestive tract mucosa. In its early stages, it is often mistaken for a common mole or ulcer. If not detected in time, it can rapidly metastasize and threaten life. Recently, the anti-PD-1 monoclonal antibody drug toripalimab has been added to the list of first-line treatments for unresectable or metastatic melanoma and has been included in the National Basic Medical Insurance Program .This drug is listed in the National Medical Insurance Drug Catalog (2025), specifically the “Drug Catalog for Maternity and Work Injury Insurance ,” and is the only anti-PD-1 monoclonal antibody drug in the catalog used for melanoma. Professor Luo Zhiguo, Deputy Director of the Department of Medical Oncology at Fudan University Cancer Hospital, pointed out that understanding the characteristics ...
- Source: drugdu
- 65
- January 6, 2026
Yifan Pharmaceutical subsidiary introduces innovative cancer treatment drugs

On January 5th, Yifan Pharmaceutical…The company announced that its wholly-owned subsidiary, Yifan Pharmaceutical, has signed exclusive agreements with Shangde Pharmaceutical and Tianjin Shangde respectively. Under these agreements, Shangde Pharmaceutical grants Yifan Pharmaceutical an irrevocable and exclusive right to license its independently developed product, dimethylamino micaceous lactone fumarate monohydrate, within the designated cooperation area. Yifan Pharmaceutical is authorized to use the licensed intellectual property rights within the cooperation area.The company will develop, manufacture, and commercialize the target product, and simultaneously grant exclusive priority negotiation rights for the production and commercialization of the target product for other indications within the cooperation area. In addition, Yifan Pharmaceutical will pay Shangde Pharmaceutical a down payment of RMB 100 million, a cornerstone investment of RMB 100 million or a milestone payment of RMB 50 million (choose one), tiered net sales revenue sharing, and a share of sublicense revenue outside of China (if any). The announcement ...
- Source: drugdu
- 59
- January 6, 2026

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