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Takeda Reports Flat 9-Month Revenue Growth Amid Pipeline Optimization Efforts
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Takeda (TYO: 4502), a leading Japanese pharmaceutical company, has released its financial results for the 9-month period ended December 31, 2023, reporting a revenue of JPY 3.2 trillion (USD 21.9 billion) with a 0.0% growth at constant exchange rates (CER). The company’s performance was impacted by declines in oncology, neuroscience,…
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Novartis Sees Robust Growth in Innovative Medicines with 2023 Financials Reflecting a Shift Toward R&D Focus
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, reported a substantial leap in its global sales for the last financial year, amassing USD 45.4 billion—a 10% year-on-year (YOY) increase in constant currency terms, as per the 2023 financials released this week. This achievement marks Novartis’s inaugural annual report following the strategic…
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Manhattan BioSolutions Strikes Agreement with Biocytogen for Access to Novel Tumor Antigens
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Manhattan BioSolutions Inc., a U.S.-based biotechnology company, has entered into an assessment and potential licensing agreement with Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a Chinese biopharmaceutical firm. Through this agreement, Manhattan BioSolutions is poised to gain access to a range of antibodies targeting a novel tumor antigen that is…
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Pfizer Reports USD 58.5 Billion in Revenues Amid Post-Pandemic Sales Shifts and Oncology Pipeline Expansion
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Pfizer Inc. (NYSE: PFE) has reported a significant downturn in global revenues for the week, amounting to USD 58.5 billion, following a 41% year-on-year (YOY) decrease in operational terms. This substantial drop reflects the diminishing sales of the SARS-CoV-2 vaccine Comirnaty and the antiviral treatment Paxlovid. The reported figures align…
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Astellas Forges Partnership with Mass General Brigham to Boost Oncology and Rare Disease Research
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced a strategic partnership with Mass General Brigham, a prominent academic institution in the United States. This collaboration aims to drive scientific and clinical advancements in critical areas, including oncology, rare diseases, and cell and gene therapy. Astellas will…
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Mabwell Bioscience Extends Research Partnership with Fudan University Cancer Center
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Mabwell (Shanghai) Bioscience Co., Ltd., (SHA: 688062) has announced the renewal of its strategic research partnership with Fudan University Shanghai Cancer Center. The collaboration, initiated in July 2021, focuses on advancing research cooperation, nurturing talent, enhancing hospital management, and constructing robust platforms for scientific exchange. The partnership has seen significant…
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Hengrui Pharmaceuticals Scores First-Mover Status with FDA Approval for Generic Astagraf XL
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this…
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Gilead Increases Stake in Arcus Biosciences and Invests in Anti-TIGIT Program
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Gilead (NASDAQ: GILD) has strengthened its 2020 collaboration agreement with US-based Arcus Biosciences (NYSE: RCUS) by amending it to accelerate their joint program on the anti-TIGIT monoclonal antibody (mAb) domvanalimab. The amendment includes an additional investment of USD 320 million, which increases Gilead’s ownership stake in Arcus to 33% and…
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AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic…
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Bristol Myers Squibb’s Subcutaneous Opdivo Shows Noninferiority in Phase III ccRCC Trial
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Bristol Myers Squibb (BMS; NYSE: BMY) this week announced preliminary Phase III data demonstrating that its subcutaneous formulation of Opdivo (nivolumab), developed in partnership with Halozyme Therapeutics (NASDAQ: HALO), is noninferior to the intravenous version for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The equivalence trial…
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Johnson & Johnson’s Rybrevant and Lazertinib Filings Accepted for Review by CDE
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The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ) market filings for Rybrevant (amivantamab) and lazertinib, designated as JXSS2400004 and JXHS2400009 respectively, have been accepted for review. Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET, received its initial approval in May 2021 for the…
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Laekna Therapeutics Reports Phase II Data for Afuresertib in Platinum-Resistant Ovarian Cancer
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Laekna Therapeutics Shanghai Co., Ltd, a China-based pharmaceutical company, has announced topline data from the global multi-center Phase II PROFECTA-II study for its afuresertib combined with paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC). The Sino-US study aimed to assess the efficacy and safety of the combination therapy in…
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Yantai Dongcheng’s Radiopharmaceutical 68GaLNC1007 Gets FDA Nod for Diagnostic Use in Solid Tumors
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) for its radiopharmaceutical 68GaLNC1007. This diagnostic agent targets fibroblast activating protein (FAP) and integrin αvβ3 and is under development to support the treatment…
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Roche Commences Phase II Trial of Repare Therapeutics’ ATR Inhibitor, Camonsertib, in Solid Tumors
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Swiss pharmaceutical giant Roche (SWX: ROG) has reached a significant milestone this week with the dosing of the first patient in an open-label Phase II trial using its Canadian partner Repare Therapeutics’ (NASDAQ: RPTX) ATR inhibitor, camonsertib. The trial aims to evaluate the safety and efficacy of various targeted therapies…
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Roche’s Tecentriq in Combination with Exelixis’s Cabometyx Meets Primary Endpoint in mCRPC Phase III Study
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced positive results from a Phase III study showcasing the efficacy of its anti-PD-L1 drug Tecentriq (atezolizumab) in combination with Exelixis’s (NASDAQ: EXEL) tyrosine kinase inhibitor (TKI) Cabometyx (cabozantinib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The study focused on…
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Biosion’s SIRPα-Targeting Monoclonal Antibody BSI-082 Clears US FDA Clinical Trial Hurdle
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Biosion, a global clinical-stage biotechnology company dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its pipeline candidate BSI-082. This monoclonal antibody (mAb) targets SIRPα and is under development for the…
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MSD’s Keytruda Combines with PharmAbcine’s PMC-309 in Phase Ia/b Solid Tumor Trial
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its blockbuster anti-PD-1 drug Keytruda (pembrolizumab) has entered a Phase Ia/b trial in combination with South Korea-based PharmAbcine’s (KOSDAQ: 208340) VISTA-inhibiting biologic PMC-309 for the treatment of advanced or metastatic solid tumors. The study aims to determine the recommended dose,…
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China Grand Pharmaceutical Gets NMPA Green Light for mRNA Cancer Vaccine ARC01 Phase I Study
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, dosage escalation Phase I study for its therapeutic cancer vaccine ARC01 (A002). The study will assess the safety, tolerability, immunogenicity, pharmacokinetics, and…
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China Anti-Cancer Association Forms Consortium for Standardizing Cancer Research Ethics Reviews
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The medical ethics professional committee of the China Anti-Cancer Association (CACA) has announced the formation of the China Cancer Clinical Research Medical Ethics Review Mutual Recognition Consortium. This consortium aims to streamline and standardize the ethical review process for clinical research in cancer treatment across China. The founding members of…
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Boan Biotech Secures FDA Orphan Drug Designations for Two Claudin18.2 Targeting Candidates
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Boan Biotech (HKG: 6955), a Chinese biotechnology company, has announced that it has received orphan drug designation (ODD) awards from the US Food and Drug Administration (FDA) for two of its pipeline candidates. The ODDs were granted to the antibody BA1105 and the antibody-drug conjugate (ADC) BA1301, both of which…
