Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at Merck’s new production plant in North Carolina for Gardasil, Elance’s efforts to develop the next generation of obesity drugs, J&J’s suspension of its phase 3 depression program, and other top news! Stay informed and inspired by the innovations driving life sciences forward!
Merck Expands U.S. Manufacturing with New $1 Billion Facility in Durham
Merck has launched a new $1 billion, 225,000-square-foot bulk manufacturing facility at its Durham, North Carolina, complex. The facility, part of Merck’s 262-acre campus, will produce ingredients for Gardasil, the company’s HPV vaccine, as well as other vaccines for diseases like chickenpox and measles. The site, which employed over 1,000 workers last year, produced 70 million doses and plans to expand production. Equipped with advanced technology, including AI and digital twin modeling, the facility also manufactures TICE BCG for bladder cancer. The expansion aligns with Merck’s broader $12 billion U.S. investment in research and manufacturing infrastructure.
Harbour BioMed Launches Élancé Therapeutics for Innovation in Obesity Treatment
China-based Harbour BioMed has introduced Élancé Therapeutics, a biotechnology company focused on developing bispecific antibodies aimed at promoting weight loss while preserving muscle mass. The company will leverage Harbour BioMed’s HCAb-based bispecific antibody technology alongside the Hu-mAtrIx AI platform from its subsidiary, Nona Biosciences. Currently, Élancé Therapeutics has multiple preclinical candidates that could complement existing GLP-1, GIP, and GCG receptor-targeting treatments. While Harbour BioMed has not disclosed financial details, the initiative aligns with broader industry efforts, including those by Roche and Altimmune, to develop obesity treatments that maintain muscle integrity.
Johnson & Johnson Halts Development of Aticaprant for Major Depressive Disorder
Johnson & Johnson has discontinued its phase 3 development of Aticaprant, an oral kappa opioid receptor antagonist, as an adjunctive treatment for major depressive disorder (MDD) due to insufficient efficacy. This follows the recent failure of Neumora’s Navacaprant in a similar phase 3 trial. Despite the setback, J&J has indicated it may explore alternative applications for Aticaprant. The company has shifted focus toward its $15 billion acquisition of Intra-Cellular Therapies, securing access to Caplyta, a phase 3-approved MDD treatment. The move aligns with J&J’s broader strategy to become a leader in neuroscience by 2030.
FDA Halts BioNTech’s Malaria Vaccine Trial
The U.S. Food and Drug Administration (FDA) has placed a hold on BioNTech’s phase 1/2a clinical trial for BNT165e, an RNA-based malaria vaccine candidate. The regulatory action, disclosed in a March 4 SEC filing, affects BioNTech’s investigational new drug (IND) application and its associated study. Prior to the FDA’s intervention, the company had voluntarily paused the trial. The study aimed to evaluate BNT165e’s efficacy in preventing Plasmodium falciparum malaria in healthy adults. BioNTech is working with the FDA to determine the next steps, as the future of its malaria vaccine program remains uncertain.
Pfizer and Arvinas’ Breast Cancer Drug Falls Short in Phase 3 Trial
Pfizer and Arvinas announced that their estrogen receptor degrader, vepdegestrant, did not meet the primary endpoint in its first phase 3 trial. The study compared vepdegestrant to AstraZeneca’s Faslodex in 624 patients with ER+/HER2- metastatic breast cancer. While the drug showed progression-free survival (PFS) benefits in patients with estrogen receptor 1 mutations, overall results were insufficient to reassure investors, causing Arvinas’ stock to drop 50%. The companies plan further analyses and a combination trial with Pfizer’s CDK4 inhibitor atirmociclib. Despite mixed outcomes, vepdegestrant remains a potential treatment option for a subset of breast cancer patients.
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