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Amgen and Horizon Therapeutics Reach Agreement with FTC to Proceed with Acquisition
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Amgen (NASDAQ: AMGN) and Horizon Therapeutics (NASDAQ: HZNP) have announced a consent order agreement with the US Federal Trade Commission (FTC), which they anticipate will resolve the antitrust agency’s legal challenges to Amgen’s acquisition of Horizon. The conflict arose from a preliminary injunction motion and temporary restraining order (TRO) filed…
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Japan’s MHLW Reviews GSK’s Nucala for Chronic Rhinosinusitis with Nasal Polyps Indication
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has begun the review process for an indication extension filing submitted by the UK pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK). The filing seeks to expand the use of GSK’s anti-IL-5 biologic Nucala (mepolizumab) as a treatment for adults with chronic…
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Eli Lilly’s Verzenios Receives NMPA Approval for Extended Indication in Early-Stage Breast Cancer
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical Products Administration (NMPA) has approved an indication extension for its Verzenios (abemaciclib). The drug is now indicated as adjuvant therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and lymph…
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Shanghai Biotech Cataya Secures $35 Million in Series B Financing for Synthetic Biology
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Shanghai-based biotech company Cataya, which specializes in synthetic biology, has reportedly raised RMB 250 million (USD 35 million) in a Series B financing round. The round was co-led by Hengxu Capital and Eight Roads Ventures, with additional investments from Hui Rong Technology Service and Bits x Bites. Cataya’s DBTL Platform…
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Shanghai Junshi Biosciences’ JS207 Bispecific Antibody Receives NMPA Clinical Trial Approval
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) in China has approved a clinical trial filing for its bispecific antibody (BsAb) JS207. The drug is under development to target PD-1 and VEGF for the treatment of advanced malignant tumors. Pre-Clinical…
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XtalPi Partners with Parthenon Therapeutics to Harness AI for Solid Tumor Antibody Development
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has entered into a strategic partnership with US cancer therapy developer Parthenon Therapeutics Inc. to develop antibodies targeting solid tumors. This collaboration aims to leverage the power of AI to advance oncology treatments. Access to XtalPi’s XupremAb Platform and “Experiment+AI” SolutionsUnder the terms…
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United Laboratories’ UBT251 Receives Tacit Approval for Obesity Clinical Study in China
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate, UBT251, has been tacitly approved in China for a clinical study to assess its effectiveness against overweight and obesity conditions. UBT251: A Triple Agonist for Metabolic ConditionsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP…
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Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
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The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB, HKG: 9688) Margenza (margetuximab), an Fc-engineered monoclonal antibody (mAb) targeting HER2 and developed by MacroGenics Inc., has been approved for the China market. The drug is indicated for the treatment of metastatic HER2-positive breast cancer…
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