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BMS’s Opdivo/Yervoy Combo Approved by NMPA for First-Line HCC Treatment
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced that it has received approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC). This approval makes the Opdivo/Yervoy combination the first and currently…
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BMS’s Breyanzi Approved by EC for Relapsed or Refractory Follicular Lymphoma
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US giant Bristol-Myers Squibb (BMS; NYSE: BMY) announced receiving another indication approval from the European Commission (EC) for its Breyanzi (lisocabtagene maraleucel; liso-cel). The approval allows the drug to be used in adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Clinical…
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Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved by EU for Hepatocellular Carcinoma
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US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission (EC) for its Opdivo (nivolumab) combined with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval marks a significant advancement in treatment options for this aggressive…
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Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult…
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Bristol-Myers Squibb’s Opdivo-Yervoy Combo Nears FDA Approval for MSI-H Colorectal Cancer
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the U.S. FDA has accepted its filing for Opdivo (nivolumab) combined with Yervoy (ipilimumab) as a first-line treatment for adult and pediatric patients (aged 12+) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA set…
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Bristol-Myers Squibb’s Opdivo Shows Survival Benefit in CheckMate-816 Study
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced the final analysis of overall survival (OS) data from the Phase III CheckMate-816 study for its Opdivo (nivolumab) in patients with resectable non-small cell lung cancer (NSCLC). Study HighlightsThe CheckMate-816 study evaluated Opdivo in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult…
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TAHO Pharma’s TAH3311 Oral Film Shows Bioequivalence to Eliquis in Study
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Taiwan-based TAHO Pharmaceuticals announced positive preliminary results from a pivotal study for its TAH3311 oral dissolving films, a generic version of Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban). The study demonstrated that TAH3311 was bioequivalent to the reference drug under fasting conditions. Study ResultsThe trial involved 60 healthy subjects, with 48 completing the…
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Bristol-Myers Squibb Releases Five-Year Data on Sotyktu’s Long-Term Efficacy and Safety
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In a recent announcement, US pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) unveiled the latest five-year results from its POETYK PSO long-term extension study. The study evaluates the sustained efficacy and safety of Sotyktu (deucravacitinib), a groundbreaking treatment for adults with moderate-to-severe plaque psoriasis. Sotyktu, recognized as the world’s first…
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Bristol Myers Squibb’s Opdualag Fails to Meet Primary Endpoint in Melanoma Study
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US pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) provided an update on the RELATIVITY-098 study for its Opdualag (nivolumab and relatlimab-rmbw). The Phase III study, which evaluated the drug as an adjuvant treatment for patients with completely resected stage III-IV melanoma, failed to meet its primary endpoint of recurrence-free survival…
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Bristol-Myers Squibb’s Breyanzi Hits Primary Endpoint in Lymphoma Study
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Bristol-Myers Squibb (BMS, NYSE: BMY) reported positive results from the Phase II TRANSCEND FL study of Breyanzi (lisocabtagene maraleucel), its CD19-directed CAR T cell therapy, in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL). The trial met its primary endpoint in the marginal zone lymphoma (MZL) cohort, demonstrating…
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Sichuan Kelun-Biotech’s Datailai Gains NMPA Approval for Colorectal Cancer Treatment
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab (trade name: Erbitux). The drug, to be traded under the name Datailai, is approved…
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Bristol-Myers Squibb Posts 8% Q4 Revenue Growth, Driven by Opdivo and New Products
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Bristol-Myers Squibb (BMS, NYSE: BMY) reported an 8% year-on-year (YOY) increase in revenues to USD 12.3 billion during Q4 2024, excluding foreign exchange impact. For the full year, revenues rose 7% YOY to USD 48.3 billion, according to the company’s financial report released this week. The US market expanded 9%…
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Sichuan Biokin Re-submits IPO Application to Hong Kong Stock Exchange
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that it has resubmitted its application for an initial public offering (IPO) to the Hong Kong Stock Exchange. The company also published the application documents on the exchange’s website on the same day. This move follows the expiration of its previous…
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Bristol-Myers Squibb’s Opdivo Qvantig Receives FDA Approval for Expanded Indications
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). This combination product pairs nivolumab with recombinant human hyaluronidase (rHuPH20) and is set to be used in most previously approved adult solid…
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Bristol-Myers Squibb’s Sotyktu Meets Primary Endpoints in POETYK PsA Studies
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from the pivotal Phase III POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) studies for its drug Sotyktu (deucravacitinib). These studies assessed the efficacy and safety of Sotyktu in adults with active psoriatic arthritis (PsA). Achievement of Primary and…
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Bristol-Myers Squibb’s Opdivo-Yervoy Combo Approved by EC for MSI-H/mCRC
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that it has received marketing approval from the European Commission (EC) for its combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab). This treatment is indicated for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient…
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BioArctic AB Secures Global Rights to PyroGlu-Aβ Antibody Program in BMS Deal
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Sweden-based BioArctic AB (OTCMKTS: BRCTF) has announced a significant licensing agreement with US pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY). The deal grants BMS global exclusive development and commercialization rights to BioArctic’s PyroGlutamate-amyloid (PyroGlu-Aβ) antibody program, which includes BAN1503 and BAN2803. Under the agreement, BioArctic retains the option to co-commercialize…
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BMS Regains Exclusive Rights to ABZ-706 in Greater China
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Bristol-Myers Squibb (BMS; NYSE: BMY) has reached an agreement with China-based Ablaze Pharmaceuticals to regain exclusive development and commercialization rights for ABZ-706 in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan. ABZ-706 is a targeted therapy for liver cancer that focuses on the GPC3 biomarker. Background on…
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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…
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Sichuan Biokin Pharmaceutical’s BL-M08D1 ADC Receives NMPA Approval for Clinical Trials
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), BL-M08D1, to enter clinical trials. The drug is intended for the treatment of recurrent or refractory hematological malignancies and…
