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EMA’s CHMP Recommends Approval for BMS’s Opdivo/Yervoy Combo in mCRC
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch…
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BMS’s Opdivo Secures NMPA Approval for Urothelial Carcinoma Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine. This approval is for a first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The Opdivo/chemo…
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Legend Biotech Corporation Appoints Alan Bash as President of Carvykti
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China-based chimeric antigen receptor (CAR) T cell therapy specialist, Legend Biotech Corporation (NASDAQ: LEGN), has announced the appointment of Alan Bash as the President of Carvykti, a BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy. In this role, Mr. Bash will oversee the continued growth of Carvykti, managing Legend Biotech’s…
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AbbVie Partners with EvolveImmune to Develop Immunotherapies for Cancer
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US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a collaboration and option-to-license agreement with EvolveImmune Therapeutics, Inc., an immunotherapy platform company backed by industry giants including Pfizer (NYSE: PFE) and BMS (NYSE: BMY). The partnership will focus on leveraging EvolveImmune’s T-cell engager platform to develop novel antibody-based therapies for…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
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BMS Launches Cardiac Myosin Inhibitor Camzyos in China for Obstructive Hypertrophic Cardiomyopathy
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the official market launch of its cardiac myosin inhibitor Camzyos (mavacamten) in China. The drug is indicated for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded II to III under the New York Heart Association (NYHA) functional classification, aiming to improve…
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BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
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On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient…
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BeiGene Prices TEVIMBRA 10% Below Competitors Following FDA Approval for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
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BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
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The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision…
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FDA Approves Cobenfy as Novel Schizophrenia Treatment with First-in-Decades Mechanism
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The U.S. Food and Drug Administration (FDA) has granted official approval to Cobenfy (KarXT, xanomeline and trospium chloride) as an oral treatment for schizophrenia, marking it as the first therapy with a novel mechanism of action in this indication in several decades within the U.S. KarXT, an oral M1/M4 type…
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FDA Panel Weighs in on Narrowing Use of PD-1 Inhibitors in Stomach and Esophageal Cancers
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The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) convened on September 26 to scrutinize the application of PD-1 inhibitors in oncology, particularly focusing on Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Merck, Sharp & Dohme’s (NYSE: MRK) Keytruda (pembrolizumab). The committee evaluated the risk-benefit profile of these drugs for…
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2seventy bio and BMS Discontinue Phase III Trial for Multiple Myeloma Therapy Abecma
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2seventy bio Inc. (NASDAQ: TSVT), a U.S.-based biotechnology company partnered with Bristol-Myers Squibb (BMS, NYSE: BMY) on the development of the chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel; ide-cel), has announced the discontinuation of enrollment in a Phase III clinical trial. The trial, known as KarMMa-9, was investigating…
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Sichuan Kelun-Biotech Reports 32.2% Revenue Growth in 2024 H1, Driven by MSD Partnership
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced its financial results for the first half of 2024, reporting a 32.2% year-on-year (YOY) increase in revenues to RMB 1.383 billion, which includes a USD 90 million cooperation payment from its U.S. partner Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK),.…
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Bristol-Myers Squibb Terminates Partnership with Agenus on TIGIT/CD96 Bispecific Antibody
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced its decision to end its collaboration with Agenus Inc. (NASDAQ: AGEN) regarding the development of the TIGIT/CD96-targeted bispecific antibody BMS-986442 (AGEN1777). This move follows an initial decision to advance the antibody to Phase II trials earlier this year, which resulted…
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Bristol-Myers Squibb Q2 2024 Sales Boosted by Growth Portfolio, Offset by R&D Impairment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced its financial results for the second quarter of 2024, with global sales increasing by 11% year-on-year to $12.2 billion, based on constant exchange rates. The growth was driven in part by the company’s ‘growth portfolio,’ which includes a dozen newer drugs that saw…
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Bristol-Myers Squibb Ends Collaboration with Eisai on Farletuzumab Eteribulin
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Bristol-Myers Squibb (BMS; NYSE: BMY), a prominent US pharmaceutical company, has decided to terminate its collaboration with Japanese pharmaceutical firm Eisai Co., Ltd, which was focused on the co-development of Eisai’s antibody drug conjugate (ADC) farletuzumab ecteribulin (FZEC; MORAb-202). According to a press release from Eisai, BMS’s decision is part…
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AbbVie Warns Shareholders Against Tutanota’s Unsolicited Mini-Tender Offer
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Private investment firm Tutanota has launched an unsolicited mini-tender offer to acquire up to 250,000 shares of AbbVie Inc. (NYSE: ABBV) at a price below market value, according to an announcement from the pharmaceutical company last week. AbbVie has made it clear that it does not endorse Tutanota’s offer and…
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FDA Approves Broadened Use of BMS’ Next-Gen TKI Augtyro for Advanced Solid Tumors
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in…
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Bristol Myers Squibb’s Breyanzi Shows Promising Results in Three Lymphoma Trials
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced results from three distinct clinical trials assessing the efficacy of its CAR-T therapy Breyanzi (lisocabtagene maraleucel) in treating patients with relapsed or refractory large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and relapsed or refractory follicular lymphoma (FL). In a placebo-controlled, late-stage…
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Bristol Myers Squibb’s Krazati Meets Primary Endpoint in Late-Stage Lung Cancer Study
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage study for its KRAS inhibitor, Krazati (adagrasib), has successfully met its primary endpoint in patients with previously treated locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC). The study demonstrated that Krazati increased median progression-free survival (PFS) from…
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FDA Extends Indication for BMS’ CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two…
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BMS Strikes Deal with Prothena for Potential Disease-Modifying Neurology Drug PRX019
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Bristol Myers Squibb (BMS; NYSE: BMY) has executed an exclusive global licensing agreement with Prothena Corporation (NASDAQ: PRTA), a biopharmaceutical company specializing in protein dysregulation, to acquire PRX019, a promising candidate for neurodegenerative diseases. The agreement follows PRX019’s attainment of Investigational New Drug (IND) status in the previous year. Under…
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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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BMS’s Sotyktu Sustains Clinical Response in Long-Term Psoriasis Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the release of long-term clinical data for Sotyktu (deucravacitinib), the company’s tyrosine kinase 2 (TYK2) inhibitor, used in the treatment of moderate-to-severe plaque psoriasis. The data, which spans a four-year period, indicates that the first-in-class drug has maintained a clinical response rate…
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Nabla Bio Forges Partnerships with Top Pharma Companies to Tackle Challenging Drug Targets
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Protein design specialist Nabla Bio has announced strategic collaborations with pharmaceutical giants AstraZeneca (AZ; NASDAQ: AZN), Bristol Myers Squibb (BMS; NYSE: BMY), and Takeda (NYSE: TAK). These partnerships underscore the biotech company’s commitment to leveraging its integrated AI and wet-lab technologies for the design of conformation- and target-selective antibody candidates.…
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BMS’s Opdivo/Yervoy Combo Misses PFS Endpoint in Unresectable Stage III NSCLC Trial
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage trial for its checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with unresectable stage III non-small cell lung cancer (NSCLC) did not achieve its primary endpoint of progression-free survival (PFS). The study compared the efficacy and safety of Opdivo…
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FDA Reviews BMS’ Opdivo Subcutaneous Formulation for Broad Indications
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The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers Squibb (BMS; NYSE: BMY) for a subcutaneous formulation of its anti-PD-1 therapy Opdivo (nivolumab). The new formulation utilizes Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) and aims to cover all previously approved indications for the…
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Bristol-Myers Squibb’s Camzyos Approved by China’s NMPA for Hypertrophic Cardiomyopathy Treatment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative drug Camzyos (mavacamten) for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded as II to III under the New York Heart Association (NYHA) functional classification. The drug is indicated…
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U.S. Judge Dismisses Johnson & Johnson and Bristol-Myers Squibb Lawsuits Against Drug-Pricing Provisions in Inflation Reduction Act
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In a recent legal development, a U.S. federal court judge has rejected the legal challenges brought by pharmaceutical giants Johnson & Johnson (J&J; NYSE: JNJ) and Bristol-Myers Squibb (BMS; NYSE: BMY) against the drug-price negotiations outlined in President Joe Biden’s Inflation Reduction Act (IRA). The companies had filed separate lawsuits…
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Bristol-Myers Squibb Prepares Contingency Plans in Response to the Biosecure Act
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Bristol-Myers Squibb (BMS; NYSE: BMY), a leading U.S. pharmaceutical company, is reportedly drafting ‘contingency plans’ to address the potential implications of the Biosecure Act, which is currently under legislative review in the United States. As detailed by the Financial Times, BMS’s CFO, David Elkins, disclosed on a media call that…
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Bristol Myers Squibb Reports 6% YOY Revenue Growth in Q1 2024, Driven by Eliquis and Reblozyl
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Pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY) has reported a 6% year-on-year (YOY) increase in revenues for the first quarter of 2024, excluding the impact of foreign exchange, reaching USD 11.9 billion, according to the company’s latest financial report. The U.S. market contributed USD 8.5 billion, marking a 7%…
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Bristol Myers Squibb Enhances CAR-T Manufacturing with Cellares Platform, Securing Exclusive Access
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Pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY) has secured a deal with Cellares, a U.S.-based cell therapy production platform, to bolster its manufacturing capacity for CAR-T therapies. In return for granting exclusive access to several of its fully automated systems, Cellares is set to receive up to USD 380…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Designation for Nasopharyngeal Carcinoma Treatment
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for its antibody-drug conjugate (ADC), BL-B01D1. This designation is for the treatment of patients with late-stage locally advanced or metastatic nasopharyngeal…
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Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had…
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Bristol Myers Squibb Reports Positive Long-Term Data for KarXT in Schizophrenia Trial
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Pharmaceutical giant Bristol Myers Squibb (BMS, NYSE: BMY) has announced preliminary long-term data from a late-stage extension trial of its muscarinic antipsychotic drug KarXT (xanomeline + trospium) in adult patients with schizophrenia. The 52-week study demonstrated significant improvements, with participants showing an average reduction of 34% in the positive and…
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European Commission Approves Reblozyl for First-Line Treatment of MDS-Related Anemia
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The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension for its erythropoietic agent Reblozyl (luspatercept) as a first-line treatment for transfusion-dependent anemia associated with lower-risk myelodysplastic syndromes (MDS) in adult patients. Originally indicated for anemia related to beta-thalassemia, Reblozyl is now positioned to address…
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Bristol Myers Squibb’s Krazati Trial Yields Positive Phase III Results in NSCLC
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Last week, Bristol Myers Squibb (BMS; NYSE: BMY) unveiled preliminary results from a Phase III confirmatory trial for its KRAS inhibitor Krazati (adagrasib) in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying a KRASG12C mutation. This encouraging data reinforces BMS’s strategic 2023 acquisition of original…
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Bristol Myers Squibb’s Zeposia Fails to Meet Primary Endpoint in Crohn’s Disease Trial
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a Phase III study for its S1P receptor modulator Zeposia (ozanimod) in patients with moderate-to-severe active Crohn’s disease (CD) did not meet its primary endpoint of clinical remission at week 12. The trial’s outcome means that Zeposia joins a number of…
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BMS Reports Positive Phase III Results for Opdivo and Yervoy in Advanced HCC
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Bristol Myers Squibb (BMS; NYSE: BMY) announced this week that its Phase III study evaluating the combination of anti-PD-1 drug Opdivo (nivolumab) and anti-CTLA-4 biologic Yervoy (ipilimumab) as a first-line treatment for advanced hepatocellular carcinoma (HCC) has yielded promising top-line results. According to data from a pre-specified interim analysis, the…
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AstraZeneca to Acquire Fusion Pharmaceuticals in a Deal Valued at USD 2.4 Billion
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based pharmaceutical giant, has announced its intention to acquire Fusion Pharmaceuticals (NASDAQ: FUSN), a Canada-based developer of radioconjugate (RC) therapies, in a deal valued at up to USD 2.4 billion, including upfront and potential contingent value payments. The acquisition is expected to be finalized in…
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Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL/SLL Treatment
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The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines…
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FDA Advisory Committee Backs Wider Use of Abecma in Relapsed or Refractory Multiple Myeloma
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An advisory committee to the US Food and Drug Administration (FDA) has recommended the use of Abecma (idecabtagene vicleucel), a CAR-T therapy developed by Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy bio (NASDAQ: TSVT), for the treatment of triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/rMM). This recommendation…
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Sichuan Biokin Gains NMPA Approval for Phase I Study of BL-M05D1 in Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its antibody drug conjugate (ADC) BL-M05D1, targeting locally advanced solid tumors. BL-M05D1 utilizes the same “linker+toxin” platform as BL-B01D1, an EGFR/HER3-targeted ADC that was the…
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Sichuan Biokin and Bristol-Myers Squibb Activate $800 Million ADC Licensing Deal
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has officially activated its licensing and cooperation agreement with U.S. pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) for the development of Biokin’s BL-B01D1 antibody-drug conjugate (ADC) candidate, effective February 8, 2024. As of March 7, the company confirmed receipt of the USD 800…
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BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The…
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BMS Reports Positive Long-Term Data for Zeposia in Multiple Sclerosis Trials
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Bristol Myers Squibb (BMS; NYSE: BMY) has unveiled results from several Phase III trials for its S1P receptor modulator Zeposia (ozanimod) in the treatment of relapsing forms of multiple sclerosis (MS). In a long-term study, the oral medication demonstrated a low annualized relapse rate, with disability progression observed in only…
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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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BMS Taps into Circular RNA Potential with Shanghai Circode Bio Agreement
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Shanghai Circode Bio has entered into a feasibility study cooperation agreement with US pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) to investigate the application feasibility of circular RNA technology within a specific therapeutic area. This collaboration aims to capitalize on Circode Bio’s proprietary circular RNA technology platform and BMS’s extensive…
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BMS’s Azacitidine, First Oral AML Therapy, Reaches GBA Patients via Special Policy
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Bristol-Myers Squibb (BMS, NYSE: BMY), a leading US pharmaceutical company, has announced the clinical application of its drug azacitidine in Shenzhen, within the Guangdong Hong Kong Macao Greater Bay Area (GBA). This marks the use of the world’s first and only oral maintenance therapy for acute myeloid leukemia (AML) in…
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BMS and Sichuan Biokin Commence Joint Development of EGFR/HER3-Targeted ADC
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced that a licensing and cooperation agreement with US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) has officially come into effect as of February 8, 2024, following the expiration of the waiting period for the deal. The agreement…
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BMS Sees Mixed Results in 2023: Growth in New Products Offset by Loss of Exclusivity
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Bristol Myers Squibb (BMS; NYSE: BMY) reported a 2% year-on-year contraction in 2023 revenues, excluding foreign exchange effects, totaling $45.0 billion, according to its recently released financial report. The company’s global sales were bolstered by a 4% increase in in-line products, generating $34.3 billion, and a remarkable 76% surge in…
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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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EMA’s CHMP Endorses Bristol Myers Squibb’s CAR-T Therapy Abecma for Multiple Myeloma
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of relapsed and refractory multiple myeloma (r/r MM) in adults who have undergone at least two prior therapies.…
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BMS’s Opdivo-Yervoy Combo Cuts Cancer Progression Risk by 79% in Phase III Study
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Bristol Myers Squibb (BMS; NYSE: BMY) has published late-stage and long-term data for its anti-PD-1 drug Opdivo (nivolumab) across various cancer indications. Early results from a Phase III trial in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) indicate that the combination of Opdivo with anti-CTLA-4…
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BMS’s Mavacamten Used to Treat First Patient with Hypertrophic Cardiomyopathy in Hainan
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that the first patient with obstructive hypertrophic cardiomyopathy (oHCM) has been treated using its drug mavacamten at Ruijin Hospital’s Hainan branch. Mavacamten, the world’s first cardiac myosin inhibitor, received approval from the Hainan Medical Products Administration for special entry into the Hainan Bo’ao…
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International Society for Cell & Gene Therapy Comments on FDA’s CAR-T Investigation
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The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration’s (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. The FDA launched the inquiry in November following 20 reported cases of patients developing these malignancies after…
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BMS’s Abraxane Approved in China for First-Line Metastatic Pancreatic Cancer Treatment
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Bristol Myers Squibb (BMS, NYSE: BMY), a leading U.S. pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Abraxane (paclitaxel, albumin). This approval is for the first-line treatment of metastatic pancreatic cancer in combination with gemcitabine. Since June 2008,…
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BMS’s Sotyktu, First TYK2 Inhibitor, Hits Chinese Market
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US pharmaceutical giant Bristol Myers Squibb (BMS, NYSE: BMY) has announced the market launch of Sotyktu (deucravacitinib) in China, marking a significant milestone for the treatment of moderate to severe plaque psoriasis. Sotyktu is recognized as the world’s first and only TYK2 allosteric inhibitor, suitable for patients eligible for systemic…
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BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
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The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers Squibb (BMS; NYSE: BMY) for its orphan drug, Augtyro (repotrectinib), which targets ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and NTRK-positive locally advanced or metastatic solid tumors. The next-generation tyrosine kinase inhibitor…
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BMS Expands Oncology Portfolio with $4.1 Billion RayzeBio Acquisition
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the acquisition of RayzeBio (NASDAQ: RYZB), a clinical-stage developer of actinium-based radiopharmaceutical therapeutics (RPT), bolstering its oncology portfolio. BMS will purchase all outstanding shares of RayzeBio for an estimated $4.1 billion, with the transaction anticipated to close in the first half of…
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BMS to Acquire Karuna Therapeutics for $14 Billion, Expanding Psychosis Treatment Portfolio
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Bristol Myers Squibb (BMS; NYSE: BMY), a leading US pharmaceutical company, has announced its intention to acquire Karuna Therapeutics, Inc. (NASDAQ: KRTX) for a total consideration of USD 14 billion. This acquisition will bolster BMS’s product pipeline with the inclusion of the antipsychotic drug KarXT (xanomeline-trospium), which is currently awaiting…
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Sanofi Expands Oncology Portfolio with NK Cell Engager In-License from Innate Pharma
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Sanofi (NASDAQ: SNY) has in-licensed a natural killer (NK) cell engager candidate for solid tumors from France-based Innate Pharma (NASDAQ: IPHA), as per an agreement reached in 2022. Sanofi will pay an initial fee of EUR 15 million (USD 16.4 million) and is committed to potential milestone payments of up…
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BMS Partners with Terray Therapeutics for AI-Driven Drug Discovery
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Bristol Myers Squibb (BMS; NYSE: BMY) has entered into an agreement with U.S.-based Terray Therapeutics to discover and develop multiple small-molecule drugs in undisclosed therapeutic areas. Under the terms of the agreement, BMS will receive development and commercialization rights, and in return, will provide Terray with upfront payments and potential…
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BMS Presents Promising Golcadomide Trial Results for Non-Hodgkin Lymphomas
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Bristol Myers Squibb (BMS; NYSE: BMY) has presented results from Phase I and Phase I/II trials for combination therapies with golcadomide, a potential first-in-class drug from the company’s CELMoD line of protein degraders, in the treatment of non-Hodgkin lymphomas. The Phase I study indicated that previously untreated patients with aggressive…
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BMS Advances TIGITxCD96 Bispecific Antibody into Phase II Dose Expansion
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Bristol Myers Squibb (BMS; NYSE: BMY) has advanced its development program for the TIGITxCD96 bispecific antibody (BsAb) BMS-986442 into a Phase II dose expansion trial. The candidate was licensed from Agenus (NASDAQ: AGEN) in 2021, and as part of the agreement, Agenus will receive a USD 25 million cash payment,…
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Sichuan Biokin and Bristol Myers Squibb Ink USD 8.4 Billion Licensing Deal for ADC Candidate
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced a landmark licensing and cooperation agreement with US pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY). The agreement focuses on Biokin’s antibody-drug conjugate (ADC) candidate, BL-B01D1, which targets EGFR and HER3. The deal was conducted specifically between…
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BMS Broadens Scope of IMID Collaboration, Aiming for Deeper Insights into Sjögren’s and Atopic Dermatitis
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Bristol Myers Squibb (BMS; NYSE: BMY) has expanded its 2016 partnership with IMIDomics, broadening the collaboration’s focus to include the collection of clinical and epidemiological data from patients with Sjögren’s disease and atopic dermatitis. This initiative aims to enhance the understanding of the underlying mechanisms of these immune-mediated inflammatory diseases…
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CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
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Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance…
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BMS and Avidity Biosciences Join Forces on $2.2 Billion Cardiology Antibody Oligonucleotide Conjugate Deal
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Bristol Myers Squibb (BMS, NYSE: BMY) has announced a strategic partnership with Avidity Biosciences (NASDAQ: RNA) focused on the discovery, development, and commercialization of cardiology-oriented antibody oligonucleotide conjugates (AOCs). This innovative class of RNA therapeutics merges the specificity of monoclonal antibodies with the precision of oligonucleotide therapies, building on insights…
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BMS and 2seventy Bio’s Abecma Faces FDA Review Extension
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The US Food and Drug Administration (FDA) has postponed the target action date for Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy Bio (NASDAQ: TSVT)’s CAR-T cell therapy Abecma (idecabtagene vicleucel) from December 16. The decision affects the therapy’s filing for earlier lines of triple-class exposed relapsed or refractory multiple…
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BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
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EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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BMS Secures ORM-6151 for Acute Myeloid Leukemia Treatment with Orum Therapeutics Deal
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Bristol Myers Squibb (BMS; NYSE: BMY) has made a significant move in the field of oncology by purchasing ORM-6151, a potential first-in-class antibody-drug conjugate (ADC) from US-based Orum Therapeutics. The acquisition includes approval from the local regulator for ORM-6151 to enter a Phase I study for acute myeloid leukemia (AML)…
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Boan Biotech Enrolls First Patient in Phase III Study for Opdivo Biosimilar BA1104 in China
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate BA1104. This marks a significant milestone as BA1104 becomes the first biosimilar to Opdivo (nivolumab) to reach the Phase III stage in…
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BMS and Karyopharm Partner to Evaluate Mezigdomide and Xpovio in Relapsed/Refractory Multiple Myeloma
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Bristol Myers Squibb (BMS; NYSE: BMY) has entered into a collaboration and supply agreement with Karyopharm Therapeutics (NASDAQ: KPTI) to evaluate the combination of BMS’s cereblon E3 ligase modulator (CELMoD) candidate, mezigdomide, with Karyopharm’s first-in-class Exportin 1 (XPO1) inhibitor, Xpovio (selinexor), plus dexamethasone. This combination is targeted at relapsed/refractory multiple…
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BMS Revenue Slips Due to Revlimid Erosion: Q3 2023 Insights
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Bristol Myers Squibb (BMS; NYSE: BMY) reported a 3% year-on-year (YOY) revenue decline, excluding foreign exchange impact, to USD 11.0 billion for Q3 2023, as detailed in the company’s recently released financial report. The downturn was primarily attributed to a significant 41% YOY drop in sales of the multiple myeloma…
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BMS’s BMS-986278 Receives FDA Breakthrough Therapy Designation for Pulmonary Fibrosis
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Bristol-Myers Squibb (BMS; NYSE: BMY) announced this week that it has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for BMS-986278, its potential first-in-class lysophosphatidic acid receptor 1 (LPA1) antagonist. This oral treatment for progressive pulmonary fibrosis (PPF) is now set for expedited development and review,…
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BMS Regains Full Rights to Mavacamten in China and Asia from LianBio
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Bristol-Myers Squibb (BMS; NYSE: BMY) is set to regain full control of mavacamten, a treatment for hypertrophic cardiomyopathy (HCM), from China’s LianBio (NASDAQ: LIAN) in China and other Asian markets. This strategic move follows LianBio’s previous acquisition of development rights for mavacamten in Greater China, Singapore, and Thailand from MyoKardia…
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BMS’s Sotyktu Receives NMPA Approval for Psoriasis Treatment
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The National Medical Products Administration (NMPA) has granted regulatory approval to US-based pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) for its first-in-class selective tyrosine kinase 2 (TYK2) inhibitor, Sotyktu (deucravacitinib). The drug is indicated for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Mechanism of…
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BMS’s Subcutaneous Opdivo Meets Phase III Study Endpoints in ccRCC
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from a Phase III comparative study of its anti-PD-1 drug Opdivo (nivolumab) formulated as a subcutaneous injection. The study, conducted in pre-treated advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients, utilized Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) for…
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BMS Expands CAR-T Collaboration with Cellares on Automation Tech
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Bristol-Myers Squibb (BMS; NYSE: BMY) has entered into a technology transfer agreement with US-based Cellares, a company specializing in automated manufacturing platforms for cell therapies. This marks the second collaboration between the two entities, focusing on the production of an unnamed CAR-T cell therapy. The agreement highlights BMS’s commitment to…
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BMS to Acquire Mirati Therapeutics in a $4.8 Billion Deal
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Bristol-Myers Squibb (BMS; NYSE: BMY) has entered into a definitive merger agreement with US-based oncology specialist Mirati Therapeutics (NASDAQ: MRTX) in a transaction valued at USD 4.8 billion, with an additional potential contingent value right (CVR) payment of up to USD 1.0 billion to Mirati stockholders. The companies anticipate completing…
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BMS Expands Partnership with Samsung Biologics for Oncology Drug Manufacturing
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Global pharmaceutical company Bristol-Myers Squibb (BMS; NYSE: BMY) has announced an expansion of its existing partnership with Samsung Biologics (KRX: 207940) for the production of an unnamed oncology antibody drug. This new agreement signifies a further step in the collaboration between the two companies, focusing on enhancing the manufacturing capabilities…
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Sichuan Kelun Pharmaceutical Submits Biosimilar Cetuximab for NMPA Approval
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced a market approval filing for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (NYSE: MRK/BMS, NYSE: BMY) cetuximab, known under the trade name Erbitux. The…
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BMS Announces Positive Outcomes for BMS-986278 in Progressive Pulmonary Fibrosis Study
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Bristol-Myers Squibb (BMS; NYSE: BMY) has released the final results from a Phase II trial evaluating the potential first-in-class LPA1 antagonist BMS-986278 in the treatment of progressive pulmonary fibrosis (PPF). The trial’s findings indicate that the twice-daily pill significantly reduced the rate of decline in percent predicted forced vital capacity…
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Bristol-Myers Squibb Acquires Rights to Zenas BioPharma’s Obexelimab for Autoimmune Diseases
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has entered into a licensing and cooperation agreement with Zenas BioPharma, investing USD 50 million for development and commercial rights to Zenas’s obexelimab for autoimmune diseases in Japan, South Korea, Taiwan, Singapore, Hong Kong, and Australia. Under the terms of the agreement,…
