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AI Becomes Essential in Biopharma for Accelerating Drug Development and R Pipelines

AI Becomes Essential in Biopharma for Accelerating Drug Development and R Pipelines

AI Becomes Essential in Biopharma for Accelerating Drug Development and R Pipelines
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Cellular Intelligence Appoints Moderna Co-founder and AI Pioneer to Scientific Advisory Board to Advance AI in Medicine

Cellular Intelligence Appoints Moderna Co-founder and AI Pioneer to Scientific Advisory Board to Advance AI in Medicine

Cellular Intelligence Appoints Moderna Co-founder and AI Pioneer to Scientific Advisory Board to Advance AI in Medicine
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MaaT Pharma Schedules Pre-IND Meeting with FDA for MaaT034 in Solid Tumors

MaaT Pharma Schedules Pre-IND Meeting with FDA for MaaT034 in Solid Tumors

MaaT Pharma, a clinical-stage biotechnology company, has scheduled a Pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for October 2026. This meeting will focus on Chemistry, Manufacturing, and Controls (CMC) for MaaT034, a novel Microbiome Ecosystem Therapy (MET-C) candidate. MaaT034 is designed to be evaluated in combination with PD-(L)1 inhibitors for advanced solid tumors, including second-line advanced non-small cell lung cancer (NSCLC) and refractory advanced melanoma. The company aims to initiate a First-in-Human study in late 2027, pending regulatory clearance and funding. MaaT034 is the first candidate from MaaT Pharma's MET-C platform, which utilizes artificial intelligence and co-culture technology to produce functionally selected microbial ecosystems.
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Viking Therapeutics' VK2735 Shows Promising Weight Loss Maintenance in Clinical Trials

Viking Therapeutics' VK2735 Shows Promising Weight Loss Maintenance in Clinical Trials

Viking Therapeutics announced positive topline results for its injectable GLP-1/GIP dual agonist, VK2735, demonstrating significant weight loss and impressive maintenance of that weight loss in a Phase 1 clinical trial. After 21 weeks, participants receiving 17.5 mg of VK2735 experienced an average body weight reduction of 17.7%. Crucially, the study also evaluated various maintenance dosing options. Following a transition to every-other-week dosing for three months, up to 97% of the weight loss was maintained, compared to 61% for the placebo group. Monthly dosing maintained up to 90% of the weight loss. An exploratory control arm that continued weekly dosing showed a 21.7% weight loss, with Viking suggesting further weight loss could occur with longer-term weekly administration. The safety profile was favorable, with gastrointestinal-related adverse events during the 12-week maintenance period being comparable to placebo, and no moderate or severe nausea reported in the step-down regimens.
Asheville Citizen-TimesAsheville Citizen-Times
Is kratom legal in North Carolina? What to know after Ole Miss deaths

Is kratom legal in North Carolina? What to know after Ole Miss deaths

Though the FDA and DEA both warn against it, kratom remains federally legal in the U.S. Here's the legality of it in North Carolina.
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Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics has announced positive preliminary efficacy results from its Phase II clinical study of lavengratinib (ABSK061), a selective orally available small-molecule FGFR2/3 inhibitor, for children with achondroplasia (ACH). In the initial and lowest dose cohort (0.064mg/kg QD), children aged 6 years and older with ACH who received lavengratinib for 27 weeks showed a mean increase of +2.4 cm/year in annualized height velocity (AHV) from baseline, achieving a 100% responder rate. The drug was well-tolerated, with no observed FGFR1 or FGFR2-associated adverse events. The ABSK061-202 study is a Phase II, multicenter, open-label, dose-escalation study evaluating the safety and efficacy of lavengratinib in children aged 3 to 12 years with ACH, with a planned treatment duration of 78 weeks. Preliminary safety evaluations for the first three dose cohorts have been successfully completed without identifying any safety concerns.
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Goldman Sachs Initiates Neutral Coverage on Tempus AI Amidst Diagnostic Growth and Data Monetization Challenges

Goldman Sachs Initiates Neutral Coverage on Tempus AI Amidst Diagnostic Growth and Data Monetization Challenges

Goldman Sachs Initiates Neutral Coverage on Tempus AI Amidst Diagnostic Growth and Data Monetization Challenges
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FDA Moves to Reduce Animal Testing Requirements for Drug Approval

FDA Moves to Reduce Animal Testing Requirements for Drug Approval

The U.S. Food and Drug Administration (FDA) has issued a direct final rule aimed at removing outdated references to animal testing in its drug and biologics regulations. This action is a significant step towards encouraging drug companies to utilize cutting-edge non-animal testing methods. Despite the FDA's public commitment to advancing non-animal test methods, existing regulations have often led companies to believe that animal testing is a mandatory requirement for drug approval. The new rule, which could become effective as early as February 4, 2027, directly responds to a 2024 legal petition filed by Humane World for Animals and Humane World Action Fund. These organizations advocated for the FDA to clarify that animal testing is not legally required. This initiative aligns with the FDA's stated goal of making animal tests "the exception rather than the norm" for preclinical safety and toxicity testing within the next three to five years.
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Bio-Techne Opens New Customer Experience Center in Düsseldorf to Advance Scientific Discovery

Bio-Techne Opens New Customer Experience Center in Düsseldorf to Advance Scientific Discovery

Bio-Techne Opens New Customer Experience Center in Düsseldorf to Advance Scientific Discovery
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Cellares and Seoul National University Hospital Partner for Automated Gene-Modified HSPC Therapy Manufacturing

Cellares and Seoul National University Hospital Partner for Automated Gene-Modified HSPC Therapy Manufacturing

Cellares, an Integrated Development and Manufacturing Organization (IDMO), and Seoul National University Hospital (SNUH) have announced a partnership to evaluate the automated manufacturing of a gene-modified hematopoietic stem and progenitor cell (HSPC) therapy. This collaboration aims to target paroxysmal nocturnal hemoglobinuria (PNH) using Cellares’ Cell Shuttle platform. The proof-of-concept study will focus on translating SNUH’s existing gene-modified HSPC manufacturing process onto the Cell Shuttle, specifically incorporating a two-step transfection workflow through Cellares’ fully integrated and single-use electroporation module. This marks Cellares’ second collaboration in Asia and is intended to support SNUH’s program towards future clinical development in the United States. The partnership seeks to address the challenges of gene-modified HSC manufacturing, which is currently labor-intensive, variable, and difficult to scale, thereby limiting clinical development, increasing costs, and restrictin...
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Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment
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Cellular Intelligence Appoints Moderna Co-founder Robert Langer and AI Pioneer Yann LeCun to Board, Advancing AI in Medicine

Cellular Intelligence Appoints Moderna Co-founder Robert Langer and AI Pioneer Yann LeCun to Board, Advancing AI in Medicine

Cellular Intelligence Appoints Moderna Co-founder Robert Langer and AI Pioneer Yann LeCun to Board, Advancing AI in Medicine