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AstraZeneca’s Imfinzi-Imjudo Combo Sets New Longevity Benchmark in Liver Cancer Treatment
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has achieved a significant milestone with its drug combination of Imfinzi (durvalumab) and Imjudo (tremelimumab), used in the treatment of patients with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC). Data from the Phase III HIMALAYA trial, showcased at the 2024 European…
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Roche’s Tecentriq Hybreza Becomes First Subcutaneous Anti-PD-(L)1 Immunotherapy in the US
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Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
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BioNTech’s mRNA Cancer Immunotherapy BNT111 Achieves Primary Endpoint in Phase II Trial
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Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating…
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Roche’s Tiragolumab Misses Primary Endpoints in NSCLC Trial, Study Halted
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Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
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Tracon Pharmaceuticals Halts Development of Envafolimab After Clinical Trial Failure
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Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s…
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Bristol Myers Squibb Invests in UK Immuno-Oncology Firm NeoPhore’s Series B Extension Round
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Bristol Myers Squibb (BMS; NYSE: BMY) has participated in an oversubscribed Series B extension round for NeoPhore, a UK-based immuno-oncology company. The funds will be utilized by NeoPhore to advance its pre-clinical studies, with the goal of delivering a small-molecule candidate by 2025. The specific amount invested by BMS was…
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Merck KGaA Subsidiary Teams Up with Aulos Bioscience to Test PD-L1 and Anti-IL-2 Combination
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Germany’s Merck KGaA (ETR: MRK) has announced that its Switzerland-based subsidiary, Ares Trading, has entered into a partnership with US-based Aulos Bioscience. This collaboration aims to advance the clinical development of Merck’s anti-PD-L1 drug Bavencio (avelumab) in combination with Aulos’s anti-IL-2 antibody candidate, AU-007. The financial details of the agreement…
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Takeda Strikes Deal with AC Immune for Global Rights to Alzheimer’s Immunotherapies
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Takeda Pharmaceutical Company Limited (NYSE: TAK) has entered into an agreement with AC Immune SA (NASDAQ: ACIU), a Switzerland-based developer of advanced immunotherapies, to obtain an exclusive global license for the company’s active immunotherapies that target toxic forms of amyloid beta (Abeta). This strategic partnership positions Takeda at the forefront…
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Roche’s Q1 2024 Turnover Rises 2% YOY, Driven by New Medicines and Diagnostics
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has reported a 2% year-on-year (YOY) increase in turnover at constant exchange rates (CER) for the first quarter of 2024, reaching CHF 14.4 billion (USD 15.7 billion). The growth was modest but steady, driven by newer medicines and diagnostics, which compensated for…
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Shanghai Junshi Biosciences’ PD-1 Inhibitor Toripalimab Files for Two Indications in Hong Kong
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong Drug Office (DO) has accepted two indication approval filings for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The filings seek approval for the drug in combination with chemotherapy as a first-line treatment for metastatic or…
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BeiGene’s Tislelizumab Secures EC Approval for Three NSCLC Indications
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, for three distinct non-small cell lung cancer (NSCLC) indications. The approvals allow for the use of tislelizumab in the following scenarios: The approvals were supported by…
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Jiangsu Hengrui Medicine Secures IND Approvals for Two Drug Candidates from China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
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Gilead Strikes Deal with Xilio Therapeutics for Tumor-Activated IL-12 Candidate
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Gilead Sciences (NASDAQ: GILD) has announced an in-licensing agreement with fellow US biotechnology company Xilio Therapeutics (NASDAQ: XLO) to acquire an early-stage tumor-activated interleukin 12 (IL-12) for the treatment of solid tumors. Gilead will pay an initial sum of USD 43.5 million for the exclusive development and global commercialization rights…
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Sino Biological Partners with Rapid Novor to Market mAb Sequencing Services Across Asia
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Sino Biological Inc. (SHE: 301047), a leading supplier of reagents based in China, has announced a partnership with Canada-based Rapid Novor Inc. Under the terms of the agreement, Sino Biological will market select services from Rapid Novor across multiple Asian markets, including China, Singapore, Thailand, Malaysia, Indonesia, Vietnam, the Philippines,…
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Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II study. The study will assess the drug candidate HRS2398 in combination with HRS-1167 or adebrelimab…
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Boehringer Ingelheim, J&J, and Novo Holdings Invest in Asgard Therapeutics for Cancer Immunotherapy
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Germany’s Boehringer Ingelheim (BI), US-based Johnson & Johnson (J&J; NYSE: JNJ), and Denmark’s major Novo Nordisk’s controlling shareholder, Novo Holdings, have participated in a EUR 30 million (USD 32.6 million) Series A financing round for Sweden-based Asgard Therapeutics. Asgard Therapeutics specializes in in in vivo cell reprogramming for cancer immunotherapy,…
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BMS’s Yervoy-Opdivo Combo on Track for Breakthrough Therapy Designation in China for CRC
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The China Center for Drug Evaluation (CDE) website has indicated that the market approval filing for Bristol-Myers Squibb’s (BMS, NYSE: BMY) combination regimen of Yervoy (ipilimumab) and Opdivo (nivolumab) for first-line unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) is on track to receive…
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Chia Tai Tianqing’s Anlotinib-Benmelstobart Combo Therapy Receives CDE Review for Endometrial Cancer
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Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted for review a new indication filing for its anlotinib (trade name: FOCUS V) in combination with the anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The proposed indication…
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AbbVie Partners with OSE Immunotherapeutics to Develop First-in-Class Immunotherapy OSE-230
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AbbVie (NYSE: ABBV) has entered into a strategic partnership with France-based OSE Immunotherapeutics (EPA: OSE) to develop the potential first-in-class immunotherapy OSE-230, which is currently in the pre-clinical stage for the treatment of chronic and severe inflammation. Under the terms of the agreement, AbbVie will acquire exclusive global rights to…
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BeiGene’s Tislelizumab Receives CHMP Recommendation for Three NSCLC Indications in Europe
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BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended its programmed death-1 (PD-1) inhibitor tislelizumab for a marketing license for three non-small cell lung cancer (NSCLC) indications. The CHMP’s positive opinion is for: Patients with EGFR or ALK mutation-positive…
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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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Henlius Biotech Ships First International Batch of HanSiZhuang for Cancer Treatment to Indonesia
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biotech company from China, has announced the first international shipment of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab), from Shanghai Pudong Airport to Indonesia. HanSiZhuang, the inaugural innovative monoclonal antibody (mAb) developed by Henlius, has gained approval from the National Medical Products…
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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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Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
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Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
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Gilead Acquires Pre-Clinical IL-18BP Targeting Antibody Candidate from Compugen in $848 Million Deal
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Gilead (NASDAQ: GILD) has licensed a potential first-in-class IL-18 binding protein (IL-18BP) targeting antibody candidate from cancer immunotherapy developer Compugen (NASDAQ: CGEN), which is currently in the pre-clinical stage. Gilead will assume development responsibilities from Phase II onwards and will pay USD 60 million upfront, with up to USD 788…
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MSD Partners with Phanes Therapeutics for Innovative Cancer Combo Therapy
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Global pharmaceutical leader Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic partnership with US-based biotechnology firm Phanes Therapeutics to develop a novel combination therapy. The collaboration will see MSD’s anti-PD-1 blockbuster Keytruda (pembrolizumab) paired with Phanes’s first-in-class CD47×claudin 18.2 drug PT886, targeting claudin 18.2-positive gastric or gastroesophageal…
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PharmaEssentia Announces Licensing Agreement with WuXi Biologics for Antibody Development
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Taiwan-based PharmaEssentia Corporation (TPE: 6446, FRA: 8Z1) has entered into a licensing agreement with China’s WuXi Biologics (HKG: 2269), a leading Contract Research, Development, and Manufacturing Organization (CRDMO). This agreement grants PharmaEssentia exclusive rights for research and development, manufacturing, and marketing of specific antibody sequences targeting the myeloid immune checkpoint,…
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AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra…
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Sandoz Inks Deal with Samsung Bioepis for Ustekinumab Biosimilar SB17
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The Sandoz (SWX: SDZ) unit of Switzerland-based Novartis (NYSE: NVS) has announced the in-licensing of ustekinumab biosimilar SB17 from South Korea’s Samsung Bioepis. The agreement covers the markets of Canada, the European Economic Area (EEA), Switzerland, UK, and the US. The biosimilar references Johnson & Johnson (J&J; NYSE: JNJ) subsidiary…
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ImmuneOnco’s IMM2510 and IMM27M Achieve Milestones in Phase I Clinical Trials
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the completion of patient enrollment for Phase I dosage escalation studies for both IMM2510 and IMM27M, with the recommended Phase II dosage (RP2D) determined for each. IMM2510: A PD-L1/VEGF Bispecific Antibody for Solid TumorsIMM2510, a PD-L1/VEGF bispecific antibody (BsAb) based on…
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Eurofarma Invests in Abcuro as Part of $100 Million Disruptive Startups and Biotech Initiative
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Brazil-based multinational company (MNC) Eurofarma has announced an investment in US immunotherapy developer Abcuro as part of a broader program to invest up to USD 100 million in potentially disruptive startups and biotechnology companies in the discovery and development phase. This 5-year project aims to support up to 25 companies…
