GILEAD SCIENCES SL
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Established
- 1994-01-01
- Employees
- -
- Market Cap
- $95.8B
ROSALINE Trial: Neoadjuvant Letrozole/Entrectinib Shows Limited Efficacy in Invasive Lobular Breast Cancer
• The phase 2 ROSALINE trial found that combining entrectinib with letrozole failed to meet its primary endpoint, with no efficacy-evaluable patients achieving residual cancer burden (RCB) of 0 or 1 in invasive lobular breast cancer.
• Despite the primary endpoint failure, the treatment showed a 49% objective response rate by MRI assessment, with 10% complete responses and 39% partial responses among the 41 evaluable patients.
• ROSALINE represents the first neoadjuvant endocrine therapy trial dedicated exclusively to invasive lobular breast cancer, demonstrating the feasibility of subtype-specific trials while researchers continue biomarker analyses.
ADPHC Partners with AstraZeneca to Combat COPD in Abu Dhabi
• Abu Dhabi Public Health Centre and AstraZeneca have signed a two-year MoU to improve outcomes for COPD patients through enhanced disease awareness, prevention, and best practice sharing.
• The strategic partnership will establish a joint task force to implement initiatives focused on early screening and comprehensive care for chronic obstructive pulmonary disease in Abu Dhabi.
• This collaboration aligns with Abu Dhabi's public health strategy to address non-communicable diseases and builds on recommendations from the Public Health System Sustainability and Resilience report.
GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure
• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients.
• The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments.
• iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.
SystImmune to Present Promising Data on Iza-bren for HER2-Negative Breast Cancer at ESMO Breast 2025
• SystImmune will present updated safety and efficacy data for izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific antibody-drug conjugate, in locally advanced or metastatic breast cancer at ESMO Breast 2025 on May 16.
• Early clinical results show encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, suggesting potential therapeutic benefits for patients with limited treatment options.
• Iza-bren, being jointly developed by SystImmune and Bristol Myers Squibb, works by blocking EGFR and HER3 signals to cancer cells while delivering a therapeutic payload that induces cancer cell death.
Bulevirtide Shows Durable Response in Chronic Hepatitis Delta Virus After Treatment Cessation
• Final data from Gilead's Phase 3 MYR301 study reveals 36% of chronic HDV patients maintained virologic suppression for nearly two years after stopping bulevirtide treatment.
• Notably, 90% of patients who achieved undetectable HDV RNA for ≥96 weeks during treatment remained virus-free after discontinuation, with no relapses occurring in the second year of follow-up.
• The findings, presented at EASL Congress 2025, demonstrate bulevirtide's potential as the first effective monotherapy for chronic HDV that maintains benefits even after treatment ends.
Ipsen's Elafibranor Shows Promise in Phase II Trial for Primary Sclerosing Cholangitis
• Elafibranor demonstrated a favorable safety profile and significant dose-dependent efficacy in the Phase II ELMWOOD trial for primary sclerosing cholangitis (PSC), a rare liver disease with no currently approved treatments.
• Patients treated with elafibranor showed significant improvements in liver biochemical parameters, including alkaline phosphatase, with stabilization of non-invasive markers of liver fibrosis compared to placebo.
• The 120mg dose of elafibranor significantly improved pruritus symptoms, offering potential relief for a common and distressing symptom experienced by PSC patients.
Sylvester Comprehensive Cancer Center to Present Groundbreaking Research at ASCO 2025 Annual Meeting
• Researchers from Sylvester Comprehensive Cancer Center will deliver 9 oral presentations, 4 rapid oral presentations, and 51 poster presentations at the upcoming ASCO 2025 Annual Meeting, showcasing significant advances across multiple cancer types.
• Highlighted studies include the ADVANCE clinical trial examining novel multiple myeloma treatments, innovative virtual reality interventions for stem cell transplant patients, and groundbreaking research on alcohol-related cancer mortality in the US.
• The extensive research portfolio demonstrates Sylvester's leadership in developing cutting-edge cancer therapies, addressing health disparities, and improving supportive care for diverse patient populations.
Galapagos Reverses Course on Company Split, Appoints Henry Gosebruch as New CEO
• Belgian biotech Galapagos has abandoned its planned separation into two companies, citing unfavorable "regulatory and market conditions" that prompted a strategic reassessment.
• Henry Gosebruch, former CEO of Neumora Therapeutics, has been appointed as Galapagos' new chief executive, replacing Paul Stoffels who will transition to a non-executive chairman role earlier than planned.
• With approximately €3.3 billion ($3.4 billion) in cash reserves, Galapagos will now pursue "transformative" business development opportunities while exploring strategic options for its cell therapy portfolio.
AbTherx Partners with Rondo and Spice Biotechnologies to Accelerate Bispecific Antibody Development for Cancer Immunotherapy
• AbTherx has formed strategic partnerships with Rondo Therapeutics and Spice Biotechnologies to leverage its Atlas™ transgenic mouse platform for developing next-generation bispecific antibodies for cancer immunotherapy.
• The collaborations utilize AbTherx's innovative Binary Fixed Light Chain Mouse technology, which enables native-like IgG bispecific antibodies with improved manufacturability and developability for treating solid tumors.
• Spice Bio's founder, Alan J. Korman, previously collaborated with AbTherx cofounders to develop groundbreaking immune checkpoint inhibitors YERVOY® and OPDIVO®, highlighting the potential significance of these new partnerships.
Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate
• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests.
• The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods.
• The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
Sanofi Advances Respiratory Pipeline with Promising Amlitelimab Data in Heterogeneous Inflammatory Asthma
• Sanofi's amlitelimab demonstrated clinically meaningful efficacy in heterogeneous inflammatory asthma, showing over 70% reduction in exacerbations in patients with specific biomarkers at week 60 of the TIDE-Asthma phase 2 study.
• The company is expanding its respiratory portfolio with lunsekimig now targeting chronic rhinosinusitis and COPD alongside asthma, with phase 2 readouts anticipated in 2026.
• Itepekimab, developed in partnership with Regeneron, is broadening its clinical program beyond COPD into chronic rhinosinusitis, with phase 3 readouts in COPD expected in H2 2025.
Novartis Announces $23 Billion Investment to Expand US Manufacturing and R&D Footprint
• Novartis plans to invest $23 billion over five years to establish seven new facilities and expand three existing ones across the United States, enabling 100% end-to-end US production of key medicines.
• The expansion includes a $1.1 billion research hub in San Diego and new radioligand therapy manufacturing facilities in Florida and Texas, creating approximately 5,000 jobs directly and indirectly.
• This strategic investment reverses Novartis' recent US pullback and comes amid trade policy uncertainties, positioning the company to maintain its projected sales growth of +5% CAGR through 2029.
2025 Pharmaceutical Pipeline: Major Patent Expirations Set to Transform Drug Market with Generics and Biosimilars
• The US pharmaceutical market is poised for significant change in 2025 as several blockbuster drugs including Xarelto, Entresto, and Stelara face patent expirations, opening the door to generic and biosimilar competition.
• Multiple biosimilars for ustekinumab (Stelara) are entering the market in 2025, with Wezlana already launched in January as the first interchangeable biosimilar, while other major drugs like ticagrelor and denosumab will also face competition.
• The pharmaceutical pipeline continues to expand with innovative therapies for cancer and neurological disorders, alongside the Medicare Drug Price Negotiation program which will further impact pricing dynamics for high-cost medications.
AstraZeneca Acquires EsoBiotec for Up to $1 Billion to Transform Cancer Cell Therapy
• AstraZeneca has agreed to acquire Belgium-based EsoBiotec for up to $1 billion, with an initial payment of $425 million and additional milestone-based payments of up to $575 million.
• EsoBiotec's Engineered NanoBody Lentiviral (ENaBL) platform enables in vivo modification of immune cells, potentially reducing cell therapy delivery time from weeks to minutes through a simple injection.
• The acquisition, expected to close in Q2 2025, aims to revolutionize cancer treatment by making cell therapies more accessible and efficient for patients while expanding AstraZeneca's oncology portfolio.
Over 120 Pipeline Therapies Target Acute Myeloid Leukemia as Research Intensifies
• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer.
• Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy.
• Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.
AstraZeneca Acquires FibroGen China for $160 Million, Strengthening Roxadustat Position
• FibroGen has agreed to sell its China subsidiary to AstraZeneca for approximately $160 million, comprising $85 million in enterprise value plus an estimated $75 million in net cash holdings.
• The strategic sale will extend FibroGen's cash runway into 2027 and enable continued development of its oncology pipeline, including the Phase 2 trial of FG-3246 for metastatic prostate cancer.
• Upon closing in mid-2025, AstraZeneca will acquire all rights to roxadustat in China, where it leads the market for chronic kidney disease anemia treatment.
Nurix Therapeutics' BTK Degrader NX-5948 Shows Promise in B-Cell Malignancies and Autoimmune Diseases
• Nurix Therapeutics' NX-5948 demonstrates a 75.5% objective response rate in relapsed/refractory CLL/SLL patients in Phase 1 study.
• NX-5948 receives PRIME designation from EMA for CLL and Fast Track designation from FDA for Waldenstrom's Macroglobulinemia.
• Nurix plans to initiate pivotal trials for NX-5948 in CLL and expand development into autoimmune diseases in 2025.
• The company's strong financial position, with $609.6 million in cash, supports aggressive development of its pipeline.
Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer
• The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression.
• DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy.
• Patients on Enhertu had a median progression-free survival of 13.2 months versus 8.1 months on chemotherapy.
• This approval expands Enhertu's use to an earlier treatment setting and a broader patient population.
DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer
• DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy.
• The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months.
• This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.
Lenacapavir: Twice-Yearly Injection Shows High Efficacy in HIV Prevention
• Lenacapavir, administered as a twice-yearly injection, demonstrates a 96% reduction in HIV infection risk compared to background incidence.
• Clinical trials reveal lenacapavir's superior efficacy over daily oral PrEP medications like Truvada, particularly addressing adherence challenges.
• The FDA is reviewing lenacapavir for potential approval in 2025, offering a promising long-acting option for HIV prevention.
• Global health experts emphasize the importance of equitable access and affordability to ensure widespread adoption of lenacapavir.
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