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Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response…
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Gilead Sciences’ Lenacapavir NDA for HIV Prevention Accepted by FDA for Priority Review
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that the New Drug Application (NDA) for its lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), has been accepted by the US Food and Drug Administration (FDA) for priority review. The Prescription Drug User Fee Act (PDUFA) target action date…
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Gilead Sciences’ Q4 2024 Financials Show 6% Revenue Growth, Driven by HIV and Oncology
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Gilead Sciences Inc. (NASDAQ: GILD) reported a 6% year-on-year (YOY) increase in global revenues for Q4 2024, reaching USD 7.6 billion, driven by strong performance in HIV, oncology, and liver disease segments. Full-year revenues also rose 6% to USD 28.8 billion. Product Performance Geographical Breakdown Outlook for 2025Gilead plans to…
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Gilead Sciences and LEO Pharma Alliance Targets Inflammatory Diseases
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US-based major Gilead Sciences Inc. (NASDAQ: GILD) has formed a strategic alliance with Denmark-based dermatology specialist LEO Pharma A/S. The partnership aims to bolster the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs, targeting the potential treatment of patients with…
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Gilead Sciences’ Sunlenca Receives NMPA Approval for Multidrug-Resistant HIV-1 Infection
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US-based pharmaceutical company Gilead Sciences Inc., (NASDAQ: GILD), has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Sunlenca (lenacapavir). The drug is approved for use in combination with antiretroviral drugs for adult patients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1)…
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Analytical BioSciences Sells Global Rights to Pre-Clinical Anti-Tumor Drugs to Gilead
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Sino-US firm Analytical BioSciences Limited has entered into an asset purchase agreement with Gilead (NASDAQ: GILD), granting the US firm global rights to Analytical’s multiple pre-clinical anti-tumor candidate drug assets. The financial details of the upfront and milestone payments remain undisclosed, and Gilead will also grant Analytical priority purchase rights…
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Gilead Sciences Secures Exclusive Option for Tubulis’ Tubutecan and Alco5 Platforms to Develop ADC
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US-based Gilead Sciences Inc., (NASDAQ: GILD) has announced an exclusive option and license agreement with Tubulis GmbH, a German firm. This agreement grants Gilead access to Tubulis’ proprietary Tubutecan and Alco5 platforms for the joint development of an antibody-drug conjugate (ADC) targeting solid tumors. Financial Terms and Milestones of the…
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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,…
