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Gilead Sciences Reports 7% YOY Increase in Q3 2024 Product Sales, Driven by HIV Therapies
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Gilead Sciences Inc., (NASDAQ: GILD), a major US-based pharmaceutical company, has released its financial results for the third quarter of 2024, showing a 7% year-on-year (YOY) increase in product sales to USD 7.515 billion. Excluding sales of the COVID-19 drug Veklury (remdesivir), the figure stands at a 7% YOY increase…
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Shanghai Pharmaceutical Co., Ltd Secures Multiple Partnerships at CIIE
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At the 7th China International Import Expo (CIIE), China-based Shanghai Pharmaceutical Co., Ltd (SPH, SHA: 601607, HKG: 2607) announced a series of partnerships with prominent pharmaceutical companies, spanning domestic and international entities. Expanding Collaborations in Pharmaceutical InnovationFrance’s Sanofi (NASDAQ: SNY) has agreed to deepen its existing partnership with SPH, initially…
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Gilead Sciences to Withdraw Accelerated Approval of Trodelvy in Urothelial Carcinoma
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Gilead Sciences Inc., (NASDAQ: GILD), a leading US-based biopharmaceutical company, has announced its intention to voluntarily withdraw the accelerated approval of its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have been previously treated with platinum-based chemotherapy…
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Hetero and Gilead Sciences Partner to Expand Access to HIV Treatment in Low-Income Countries
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Indian pharmaceutical company Hetero has announced a new partnership with US healthcare giant Gilead Sciences (NASDAQ: GILD), securing a non-exclusive, royalty-free voluntary licensing agreement to manufacture and distribute lenacapavir in 120 primarily low- and lower-middle income countries (LMICs). This marks a significant step in expanding access to this groundbreaking HIV-1…
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Gilead Sciences Partners with AI Firm Genesis Therapeutics to Develop Novel Small-Molecule Therapies
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Gilead Sciences Inc. (NASDAQ: GILD), a biopharmaceutical company based in the U.S., has entered into a strategic collaboration with Genesis Therapeutics Inc., an AI-driven drug development firm, to discover and develop innovative small-molecule therapies across a range of therapeutic targets. Under the terms of the agreement, Genesis will receive an…
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Gilead Secures FDA Accelerated Approval for Livdelzi in Liver Disease Treatment
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Gilead Sciences Inc. (NASDAQ: GILD) has received accelerated approval from the U.S. FDA for its liver disease treatment, Livdelzi (seladelpar), following its acquisition of CymaBay Therapeutics Inc. for $4.3 billion earlier this year. The FDA has authorized Livdelzi for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary…
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Gilead Buys Out Janssen’s Royalty Rights to Seladelpar for Primary Biliary Cholangitis Treatment
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Gilead (NASDAQ: GILD)’s financial report for the second quarter of 2024, followed by an earnings call, has disclosed a significant transaction: the company has paid Johnson & Johnson’s Janssen division USD 320 million to acquire full royalty rights to the PPAR-delta agonist, seladelpar, a drug for which Gilead obtained global…
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Gilead’s Lenacapavir Shows 100% Efficacy in Phase III HIV PrEP Study
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Gilead Sciences Inc. (NASDAQ: GILD), a U.S. biopharmaceutical company, has announced topline results from the Phase III PURPOSE 1 study. The study indicates that lenacapvir has successfully demonstrated its potential as a twice-yearly pre-exposure prophylaxis (PrEP) drug to prevent HIV infection. The trial involved 5,300 cisgender women and adolescent girls…
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Gilead and Arcus Biosciences Report Positive Combination Therapy Results in mCRC Trial
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Biopharmaceutical companies Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced safety and efficacy data from a Phase Ib/II clinical trial for a combination therapy in third-line metastatic colorectal cancer (mCRC). The trial evaluated the combination of adenosine receptor antagonist etrumadenant, anti-PD-1 drug zimberelimab, VEGF inhibitor bevacizumab, and chemotherapy…
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Gilead and Arcus Biosciences Report Positive Interim Phase II Data for Domvanalimab Combo in GI Cancers
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Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced interim Phase II data for their anti-TIGIT biologic domvanalimab in combination with the anti-PD-1 drug zimberelimab. The treatment is being investigated for locally advanced unresectable or metastatic upper gastrointestinal cancers. The study, which has a median time on treatment of…
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Gilead’s Trodelvy Misses Overall Survival Endpoint in Late-Stage Urothelial Cancer Study
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Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in…
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Gilead Partners with Cartography Biosciences to Develop Therapies for Triple-Negative Breast Cancer
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Gilead Sciences (NASDAQ: GILD) has entered into a collaboration agreement with Cartography Biosciences, a US-based biotechnology company, to discover and develop novel therapies for triple-negative breast cancer (TNBC) and adenocarcinoma. Cartography will leverage its computational and genomics platform to identify and validate target antigens and pairs of antigens in cancer,…
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Gilead’s Seladelpar Shows Interim Benefits in PBC-Related Itch Clinical Trial
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Gilead Sciences (NASDAQ: GILD) has announced interim results from a long-term study assessing the safety and efficacy of seladelpar, a PPAR-delta agonist, in treating pruritus associated with primary biliary cholangitis (PBC). The trial involved patients who had an inadequate response or were intolerant to ursodeoxycholic acid (UDCA), with 70% of…
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Sanofi Extends Collaboration with Nurix Therapeutics, Targeting STAT6 in Type 2 Inflammation
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France’s Sanofi (NASDAQ: SNY) has announced an extension of its 2019 collaboration with Nurix Therapeutics (NASDAQ: NRIX), a leader in targeted protein degradation, focusing on the drug target STAT6 for type 2 inflammation. The partners anticipate identifying a clinical candidate within the next year. As part of the collaboration, Nurix…
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Gilead Extends Collaboration with Nurix Therapeutics for Targeted Protein Degradation by Two Years
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Gilead Sciences (NASDAQ: GILD) has announced a two-year extension of its 2019 collaboration with Nurix Therapeutics (NASDAQ: NRIX) focused on the discovery, development, and commercialization of targeted protein degradation therapies. As part of the agreement, Nurix will receive a USD 15 million extension fee for identifying novel agents that induce…
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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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Gilead Nears Completion of CymaBay Acquisition After Waiting Period Expires
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Gilead Sciences (NASDAQ: GILD) has moved one step closer to finalizing its cash tender offer for the acquisition of fellow US company CymaBay Therapeutics (NASDAQ: CBAY), following the expiration of a mandatory waiting period under local laws last week. The two companies had previously submitted regulatory filings for approval of…
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Gilead and MSD Report Positive Interim Data for Once-Weekly HIV Treatment in Phase II Trial
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Gilead Sciences Inc. (NASDAQ: GILD) and Merck & Co., Inc., known as MSD (NYSE: MRK), have this week unveiled preliminary findings from a Phase II clinical trial of their investigational antiretroviral combination therapy, islatravir plus lenacapavir, as a potential once-weekly oral treatment for HIV/AIDS. Despite the primary endpoint being influenced…
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Gilead and Merus Form Strategic Oncology Alliance to Develop Trispecific T-Cell Engagers
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Gilead Sciences Inc., (NASDAQ: GILD), has entered into a strategic partnership with Netherlands-based Merus N.V. (NASDAQ: MRUS) to discover two to three trispecific T-cell engagers in the field of oncology. Merus is set to receive an upfront payment of $56 million, an equity investment worth $25 million, and is eligible…
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Gilead’s Biktarvy Receives FDA Approval for Expanded HIV Treatment Indication
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Gilead (NASDAQ: GILD), a leading US pharmaceutical company, has been granted an indication extension approval for its antiretroviral combination Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide) by the Food and Drug Administration (FDA). The approval expands Biktarvy’s use as an HIV treatment for individuals who have suppressed viral loads and…
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Gilead’s 2023 Flat Sales Reflect Stagnation and COVID-19 Demand Decline
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Gilead Sciences Inc. (NASDAQ: GILD) has reported a stagnant performance for the year 2023, with total product sales remaining unchanged at USD 26.9 billion. Amid a broad decline in demand for COVID-19 treatments, the company’s antiviral Veklury (remdesivir) sales could not offset the downturn, although HIV sales increased by 6%…
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Gilead’s 2023 Stagnation Foresees Flat 2024 Sales as Veklury Revenues Dwindle
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Gilead Sciences (NASDAQ: GILD) has reported a stagnant performance for 2023, with product sales remaining flat at USD 26.9 billion. The company’s financials were affected by a widespread downturn in demand for COVID-19 treatments, as its antiviral Veklury (remdesivir) sales offset growth in other areas. HIV sales reached USD 18.2…
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Gilead’s Kite Subsidiary Reduces CAR T-Cell Therapy Turnaround Time with FDA Approval
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Kite, a subsidiary of Gilead (NASDAQ: GILD), has announced a significant enhancement in the treatment process for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). The median turnaround time (TAT) for this life-saving therapy is set to decrease from 16 days to 14 within the United States, following an approval by…
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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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Merck’s Bavencio Shows Promising Survival Data in Real-World Urothelial Carcinoma Studies
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German pharmaceutical company Merck (NYSE: MRK) has released data from real-world studies for its anti-PD-L1 biologic Bavencio (avelumab), used as a maintenance therapy in eligible patients with locally advanced or metastatic urothelial carcinoma (UC). Preliminary results indicate that the median overall survival (OS) in patients without progression after first-line chemotherapy…
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Gilead’s Trodelvy Misses Primary Endpoint in Late-Stage NSCLC Trial
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Gilead Sciences (NASDAQ: GILD) has announced that a late-stage trial for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in metastatic or advanced non-small cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS) in patients who had previously received treatment for metastatic NSCLC. Despite this setback,…
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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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Gilead’s Descovy Receives Additional Indication Approval from China’s NMPA for HIV-1 PrEP
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Gilead Sciences, Inc. (NASDAQ: GILD), a major player in the pharmaceutical industry in the U.S., has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its anti-viral drug Descovy (emtricitabine, tenofovir alafenamide fumarate). The NMPA has granted approval for the use of…
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Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
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Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and Drug Administration (FDA) to update the label of Yescarta (axicabtagene ciloleucel) to include overall survival (OS) data for its use as a second-line treatment for relapsed or refractory large B-cell lymphoma (r/r LBCL). This new…
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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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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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Gilead Announces Low-Carbon Bronchodilator Study for H1 2024
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Gilead Sciences Inc. (NASDAQ: GILD) has announced plans for a Phase III study in the first half of 2024 for a new iteration of its bronchodilator Ventolin (salbutamol). This version utilizes a low-carbon propellant, which could potentially reduce the greenhouse gas emissions from the associated metered dose inhaler (MDI) by…
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Gilead’s Kite Expands Partnership with Arcellx for Innovative Cell Therapies
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Gilead (NASDAQ: GILD), a leading biopharmaceutical company, has announced an expansion of its 2022 partnership with Arcellx (NASDAQ: ACLX), a US-based biotechnology firm. The collaboration includes the in-licensing of ACLX-001, a multiple myeloma (MM) engineered cell therapy, and the extension of their CART-ddBCMA program to include lymphomas . Financial Terms…
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EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead’s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized…
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Gilead’s Kite CAR-T Therapy Yescarta Achieves 71% CMR in Phase II Trial for R/R LBCL Patients
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Gilead’s (NASDAQ: GILD) subsidiary Kite has announced early results from a Phase II trial of its CAR-T therapy, Yescarta (axicabtagene ciloleucel), for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The study achieved a primary endpoint…
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Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
