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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 modified drug, HY-2003. This drug is designed to improve moderate to severe contour protrusion caused by subcutaneous fat accumulation…
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Johnson & Johnson (J&J, NYSE: JNJ)’s auto-immune disease drug Stelara (ustekinumab) is set to encounter another potential competitor in the Chinese market. CSPC Pharmaceutical Group Ltd (HKG: 1093), a local firm, has recently announced that the National Medical Products Administration (NMPA) has accepted its market filing for review, marking a…
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The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s (AZ, NASDAQ: AZN) ALXN1850, known as efzimfotase alfa, in the patient-centered rare disease drug development pilot program, referred to as the Care Plan. This move signifies a significant step forward in the global efforts to…
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US biotechnology company Amgen (NASDAQ: AMGN) has announced positive outcomes from the double-blind, dose-ranging Phase II study of MariTide (maridebart cafraglutide), formerly known as AMG 133, at 52 weeks. This investigational antibody peptide conjugate, administered subcutaneously on a monthly or less frequent basis, has demonstrated significant potential in obesity treatment.…
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China-based gene delivery technology developer VectorBuilder has entered into a partnership with Zhejiang Dapu Biotechnology Co., Ltd, a specialist in droplet microfluidics and molecular diagnostics. The collaboration aims to integrate the respective technology advantages and platform resources of both companies to overcome technological bottlenecks in life sciences and innovative biopharmaceutical…
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Swiss pharmaceutical giant Roche (SWX: ROG) has reported an update on the phase III SKYSCRAPER-01 study, which evaluated the combination of tiragolumab with Tecentriq (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 Study Details and ResultsThe global, randomized, double-blind…
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US-based clinical-stage biopharmaceutical company, Poseida Therapeutics (NASDAQ: PSTX), which specializes in donor-derived CAR-T cell therapies, has announced a definitive merger agreement with Roche (SWX: ROG). The deal, valued at a total equity value of USD 1.5 billion, is anticipated to close in the first quarter of 2025. Expanding Allogeneic Cell…
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Partners Zymeworks Inc. (NASDAQ: ZYME) and Jazz Pharmaceuticals, Inc. have received accelerated approval from the US Food and Drug Administration (FDA) for Ziihera (zanidatamab), a treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). This marks a significant advancement in the treatment options for…
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US-based supply chain solution provider Lakeside Holding Limited (NASDAQ: LSH), which specializes in the Asian market, has announced a strategic partnership agreement between its recently acquired Hupan Pharmaceutical (Hubei) Co., Ltd. and Sinopharm Group Hubei Co., Ltd., a subsidiary of China’s Sinopharm Group Co., Ltd (HKG: 1099). The financial details…
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The National Healthcare Security Administration (NHSA) will unveil the results of the negotiation and price bidding for the National Reimbursement Drug List (NRDL) adjustment at a press conference scheduled for 10:00 am on November 28th. This event marks a significant moment in the healthcare sector as it will disclose the…
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The National Medical Products Administration (NMPA) has released a notification regarding the pilot work for optimizing the review and approval procedures of supplementary drug applications, a program introduced in February this year. The initiative aims to enhance the efficiency of drug application reviews and has designated Beijing, Tianjin, Hebei province,…
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Danish antibody drug conjugate (ADC) specialist, Adcendo ApS, has announced the completion of an oversubscribed Series B financing round, raising USD135 million. The proceeds from this round will be utilized to accelerate the development of its first-in-class ADC pipeline, which includes the ADCE-T02 (Tissue Factor ADC), ADCE-D01 (uPARAP ADC), ADCE-B05,…
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US-based Abbott Laboratories (NYSE: ABT) has announced the successful application of its transcatheter aortic valve implantation (TAVI) balloon-expandable system in treating the first patient with symptomatic severe aortic stenosis. This milestone marks a significant step forward in the company’s efforts to provide advanced heart valve therapies. Pioneering Software-Guided TAVI SystemThe…
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US-based pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced positive interim analysis results from the pivotal Phase III ZENITH study for its activin signaling inhibitor, Winrevair (sotatercept-csrk). The study focused on the efficacy and safety of sotatercept in treating adults with pulmonary arterial hypertension (PAH) who are in…
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US-based medical device giant Boston Scientific Corporation (NYSE: BSX) has announced a definitive acquisition agreement with fellow US firm Intera Oncology Inc., a company specializing in devices for the treatment of colorectal cancer and cholangiocarcinoma. The transaction is anticipated to be completed in the first half of 2025, marking a…
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China-based Nasal-Phyto Pharmaceutical Technology Group Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its NPRD003, the world’s first precision olfactory area constant flow drip drug-device combination product. The product is indicated for the treatment of cerebral vasospasm secondary to subarachnoid hemorrhage (SAH).…
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin). GSK is seeking approval for the drug in combination with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex…
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China’s generative artificial intelligence (AI)-driven biotech company, Insilico Medicine, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its potential best-in-class ENPP1 inhibitor, ISM5939, in solid tumors. ISM5939: A Promising ENPP1 InhibitorISM5939 targets ENPP1, an external nucleotide pyrophosphatase…
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the enrollment of the first patient in the Phase I study for its 20-valent pneumococcal polysaccharide conjugate vaccine. This vaccine is designed to prevent infectious diseases caused by 20 pneumococcal serotypes, targeting infants and children aged between 2 months…