GILEAD SCIENCES SL

Gilead Sciences announces FDA Breakthrough Therapy Designation for Trodelvy in extensive-stage small cell lung cancer, based on Phase 2 TROPiCS-03 study results. Trodelvy is already approved for multiple breast cancers and urothelial cancer in over 40 countries.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed due to insufficient enrollment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Median recurrence-free intervals were 11.4 months with niraparib vs. 5.4 months with placebo, though conclusions on efficacy are limited.

Wesley Sundquist, Ph.D., developed a long-lasting HIV prophylactic, lenacapavir, recognized as Breakthrough of the Year by Science. His research on HIV's molecular structure led to the discovery that altering the virus's protein shell can inhibit replication.

Grace Liu from Sino Biological discusses Antibody-Drug Conjugates (ADCs), a cancer therapy combining precision targeting with potent cytotoxic drugs. ADCs consist of a monoclonal antibody, cytotoxic payload, and linker, balancing efficacy and safety. Sino Biological offers comprehensive ADC development solutions, aiding in the complex process from discovery to clinical studies.

Key opinion leaders discuss RFID in food sector translating to pharma. Semaglutide shows potential for knee osteoarthritis pain relief. Hackers target health records for personal info. Gilead Sciences appoints Dietmar Berger as Chief Medical Officer. Elevar Therapeutics wins 2024 APEX Awards for oncology campaign.

2024 saw significant clinical successes and failures in biopharma, with Vertex, BMS, and Alnylam achieving notable wins, while AbbVie, Sage Therapeutics, Pfizer, and Gilead faced setbacks in neurological and other indications. Despite high failure rates in drug trials, particularly in CNS diseases, some companies advanced new treatments, while others faced challenges in their pipelines.

University of Utah Health announced the development of lenacapavir, a promising HIV drug named 2024 breakthrough by Science. Developed by Gilead Sciences, it offers six-month protection, 96% effective in trials. Wesley Sundquist's research on HIV's molecular structure led to its discovery, targeting the viral protein shell to prevent reproduction. Clinical trials in South Africa and Uganda showed no HIV transmission among women, with follow-up trials confirming efficacy in men and nonbinary individuals.

The University of Utah's Wesley Sundquist lab laid the groundwork for lenacapavir, a long-lasting HIV prophylactic named Breakthrough of the Year by Science. Lenacapavir, developed by Gilead Sciences, provides six months of protection and has shown exceptional efficacy in clinical trials, potentially diminishing HIV/AIDS as a global health crisis.

The CHMP of the EMA recommended seladelpar for treating primary biliary cholangitis (PBC) in adults, based on the RESPONSE study showing ALP normalization in 25% of participants and significant pruritus reduction. If approved by the European Commission, seladelpar would offer a new treatment option for PBC in the EU.