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Novo Holdings’ Acquisition of Catalent Gets EU Nod, Paving Way for Novo Nordisk Expansion
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The acquisition of contract development and manufacturing organization (CDMO) Catalent (NYSE: CTLT) by Novo Holdings A/S, the controlling shareholder of Denmark’s major pharmaceutical company Novo Nordisk (NYSE: NVO), has been cleared by the European Commission (EC). This endorsement smooths the path for Novo Nordisk’s subsequent acquisition of three manufacturing sites…
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Johnson & Johnson’s Darzalex Faspro Showcases Clinical Efficacy in Multiple Myeloma at ASH 2024
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US healthcare conglomerate Johnson & Johnson (J&J, NYSE: JNJ) has presented results from several clinical studies for its Darzalex Faspro (daratumumab and hyaluronidase-fihj) at the 2024 American Society of Hematology (ASH) annual meeting. Darzalex Faspro, a CD38-directed antibody co-formulated with Halozyme’s ENHANZE drug delivery technology, has shown promising results in…
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AstraZeneca’s Imfinzi Demonstrates Positive Outcomes in PACIFIC-5 III Study for NSCLC
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UK-based pharmaceutical company AstraZeneca (AZ, NASDAQ: AZN) has announced positive results from the PACIFIC-5 III study for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The study focused on patients with unresectable stage III non-small cell lung cancer (NSCLC) who did not experience disease progression after receiving synchronous or sequential…
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Duality Biologics’ BNT324/DB-1311 Shows Positive Results in Global Phase I/IIa Study at ESMO Asia
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Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China, has unveiled the first batch of results from the global Phase I/IIa clinical study for its investigational next-generation antibody-drug conjugate (ADC), BNT324/DB-1311, targeting the transmembrane glycoprotein B7-H3. The data, presented during an oral…
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Innovent Biologics’ IBI343 Shows Promising Results in Phase I Study for Pancreatic Cancer at ESMO Asia
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China-based biopharmaceutical company Innovent Biologics, Inc. (HKG: 1801) presented updated data from the Phase I study of its IBI343, an innovative anti-CLDN18.2 antibody drug conjugate (ADC), for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) during an oral presentation at the ESMO Asia Congress 2024. Updated Data Highlights Efficacy and…
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Hainan Haiyao Secures Exclusive Rights for AFT Pharmaceuticals’ Nutritional Products in China
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China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced a significant licensing agreement with Australia-based AFT Pharmaceuticals Ltd (NZE: AFT, ASX: AFP). Through this agreement, Hainan Haiyao has obtained exclusive distribution rights to AFT Pharmaceuticals’ range of products in China, including Lipo-Sachets liposomal Vitamin C, Lipo-Sachets liposomal Vitamin D3, Ferro…
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Novartis’ Scemblix Demonstrates Superior MMR Rates in Phase III ASC4FIRST Study
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Swiss pharmaceutical giant Novartis (NYSE: NVS) unveiled longer-term results from the pivotal Phase III ASC4FIRST study for its Scemblix (asciminib) at the 66th American Society of Hematology (ASH) annual meeting. The study demonstrated superior major molecular response (MMR) rates for Scemblix at week 96 compared to standard-of-care (SoC) tyrosine kinase…
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Tecvayli (Teclistamab) Demonstrates Positive Results in MajesTEC-5 and MajesTEC-4 Trials
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Janssen-Cilag International NV, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), announced the presentation of results from the MajesTEC-5 and MajesTEC-4 studies for its bispecific antibody (BsAb) Tecvayli (teclistamab) at the 66th American Society of Hematology (ASH) annual meeting. The studies focused on patients with newly…
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SinoPep-Allsino Biopharmaceutical Partners with Spraying Systems Co. for Peptide API Manufacturing
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Jiangsu-based Contract Development and Manufacturing Organization (CDMO) Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has announced a strategic partnership with US-based Spraying Systems Co. to collaborate on the application of electrostatic spray drying technology in the commercial manufacturing of peptide active pharmaceutical ingredients (APIs). Enhancing Market Advantages in Peptide ManufacturingThe collaboration,…
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Merck’s Zilovertamab Vedotin Shows 100% CR Rate in Phase II Study for DLBCL: ASH Presentation
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US pharmaceutical giant Merck (NYSE: MRK) has revealed promising data from the Phase II waveLINE-007 study for its antibody drug conjugate (ADC) zilovertamab vedotin at the 66th American Society of Hematology (ASH) annual meeting. Zilovertamab Vedotin’s Potential in Treating DLBCLZilovertamab vedotin, an ADC that targets receptor tyrosine kinase-like orphan receptor…
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Medtide Inc. Submits Second IPO Application to Hong Kong Stock Exchange
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Medtide Inc., a Contract Research, Development, and Manufacturing Organization (CRDMO) specializing in polypeptides and based in Hangzhou, has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange for the second time. This move comes after the company’s initial attempt in May of this year, with the…
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AstraZeneca’s Calquence Combo Shows 35% Reduced Risk in CLL: AMPLIFY Phase III Results
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At the 66th American Society of Hematology (ASH) annual meeting, UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) revealed the latest results from the Phase III AMPLIFY study for its drug Calquence (acalabrutinib) in combination with venetoclax for adult patients with chronic lymphocytic leukaemia (CLL). AMPLIFY Study Design and FindingsThe AMPLIFY…
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Abbisko Therapeutics Presents Positive Phase II Results for Pimicotinib in cGvHD at ASH
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the presentation of preliminary Phase II study results for pimicotinib (ABSK021) in patients with chronic Graft-versus-Host Disease (cGvHD) at the 66th American Society of Hematology (ASH) annual meeting. The study focused on patientszhe who have either progressed or not responded to…
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Jacobio Pharma’s BET Inhibitor JAB-8263 Shows Promising Results in Myelofibrosis Phase I Study
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Jacobio Pharma (HKG: 1167) has announced the presentation of preliminary results from the Phase I study of its bromodomain and extra-terminal domain (BET) inhibitor, JAB-8263, in the treatment of myelofibrosis (MF), at the 66th American Society of Hematology (ASH) annual meeting. JAB-8263 Demonstrates Good Tolerability and Efficacy in Phase IThe…
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Youcare Pharmaceutical Gets FDA Clearance for Herpes Zoster mRNA Vaccine YKYY026
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China-based Youcare Pharmaceutical Group (SHA: 688658) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate, YKYY026, aimed at preventing herpes zoster. YKYY026: An Innovative mRNA Vaccine with Proprietary Delivery SystemYKYY026 is a novel mRNA vaccine that utilizes Youcare…
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Duality Biologics’ DB-1311 ADC Shows Promising Results in Global Phase 1/2a Trial
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Duality Biologics, in partnership with BioNTech (NASDAQ: BNTX), has announced the initial data from the global 1/2a phase clinical trial of its B7H3-targeting antibody-drug conjugate (ADC), DB-1311 (BNT324). The trial marks a significant advancement in the treatment of patients with locally advanced or metastatic solid tumors who have previously received…
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Chipscreen Biosciences’ Chiauranib Phase III Trial Results for SCLC Announced
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China-based innovative drug company Chipscreen Biosciences (SHA: 688321) has announced the completion of the analysis of results from the Phase III clinical trial for its drug candidate chiauranib, used as a monotherapy for third-line and above small cell lung cancer (SCLC). The independent review committee (IRC) has assessed the trial’s…
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Immunofoco’s IMC002 CAR-T Therapy Receives FDA Fast Track Designation for Gastric Cancer
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Immunofoco, a biotechnology company specializing in immunotherapy, has announced that its self-developed autologous CAR-T product, IMC002, targeting CLDN 18.2, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). This designation is for the treatment of patients with unresectable locally advanced, recurrent, or metastatic CLDN…
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Shanghai Juncell Therapeutics’ GC101 TIL Therapy Receives CDE Approval for Pivotal Phase II Trial
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Shanghai Juncell Therapeutics has announced that the National Medical Products Administration’s Center for Drug Evaluation (CDE) has approved the first pivotal Phase II registration clinical trial for its GC101 TIL injection. The trial, designated as NCT06703398, is for the treatment of advanced melanoma patients who have progressed or are intolerant…
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AI Proteins Partners with Bristol-Myers Squibb to Develop Miniprotein-Based Therapeutics
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US-based biotech AI Proteins, Inc. has entered into a research collaboration and option agreement with New York-headquartered Bristol-Myers Squibb (BMS; NYSE: BMY). This partnership allows BMS to explore and develop novel miniprotein-based therapeutics using AI Proteins’ advanced discovery platform. Agreement Terms and FinancialsUnder the terms of the agreement, AI Proteins…
