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CDE Releases 74th Batch of Generic Reference Preparations with 58 New Specifications
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The Center for Drug Evaluation (CDE) has released the 74th batch of chemical generic reference preparations, marking a significant update to the list with the addition of 24 new specifications and an increment of 34 specifications in total. Review Outcomes and Specification DetailsEleven specifications did not meet the review criteria…
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Roche’s Genentech Partners with Peptidream for First-in-Class PDCs in Radioisotope Therapy
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Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has announced a partnership with Japan’s peptide-based therapeutics and diagnostics specialist, Peptidream (TYO: 4587). The collaboration aims to discover and develop potential first-in-class peptide-drug conjugates (PDCs) for the targeted delivery of radioisotopes against specific disease targets. Details of the PartnershipUnder the terms…
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Lynk Pharmaceuticals Secures Series C2 Financing to Advance pipeline
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Lynk Pharmaceuticals Co., Ltd, a China-based pharmaceutical company, has announced the successful completion of its Series C2 financing round. The round saw participation from the Shaoxing Binhai New Area Biomedical Industry Equity Investment Fund, managed by China Grand Prosperity Investment, Haibang Venture, and Howbuy Primary Fund, with existing shareholders New…
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Hainan Poly Pharm Submits DMF for Tecovirimat API to US FDA
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced the filing of a Drug Master File (DMF) with the US Food and Drug Administration (FDA) for its tecovirimat active pharmaceutical ingredients (APIs). This move signifies the company’s initiative to bring a potential treatment for poxvirus infections, including smallpox and…
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South Africa’s Competition Commission Investigates J&J for MDR-TB Drug Pricing and Evergreening
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The Competition Commission of South Africa has announced an investigation into Johnson & Johnson (J&J; NYSE: JNJ) concerning allegations of profiteering on the multidrug-resistant tuberculosis (MDR-TB) drug Sirturo (bedaquiline) and employing evergreening practices to extend its patent until 2027. Investigation Details and Pricing ConcernsThe government currently pays ZAR 5,400 (USD…
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Tonghua Golden-Horse’s Octohydroaminoacridine Succinate Meets Phase III Endpoints in Alzheimer’s Disease
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China-based Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) has announced positive results from its Phase III clinical study for the in-house developed octohydroaminoacridine succinate, an oral acetylcholinesterase inhibitor designed for the treatment of mild to moderate Alzheimer’s disease (AD). Study Design and OutcomesThe Phase III study was a double-blind,…
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China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
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The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…
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AIM Vaccine’s Serum-Free Rabies Vaccine Completes Phase III Safety Observation
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the successful completion of the 7-day safety observation period in a Phase III clinical study for its investigational freeze-dried human rabies vaccine, developed using serum-free Vero cells. The study, which was conducted in a randomized, blinded, and similar vaccine parallel controlled…
