The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors
The U.S. Food and Drug Administration has granted IND clearance for Harbour BioMed’s bispecific antibody HBM7004, allowing a Phase I trial in patients with advanced solid tumors. HBM7004 links the tumor‑associated antigen B7H4 to CD3, redirecting T‑cells to the tumor microenvironment. Preclinical data demonstrated robust T‑cell activation, strong anti‑tumor efficacy, in‑vivo stability and reduced systemic toxicity, with synergistic effects when combined with a B7H4×4‑1BB bispecific. The drug is built on Harbour’s HBICE plug‑and‑play platform, highlighting rapid bispecific development capabilities.
Friday Hope: Eriodictyol: Found in Citrus Fruits, This Flavonoid Downregulates ACE2, TMPRSS2 and TGF-Β
The post highlights eriodictyol, a citrus‑derived flavanone, as a multi‑target therapeutic candidate. Recent studies show it can down‑regulate ACE2 and TMPRSS2, the key entry proteins for SARS‑CoV‑2, and suppress TGF‑β‑driven fibrosis in animal models. Additional research links eriodictyol to neuroprotective...
Eisai, Biogen Face Delay to Subcutaneous Leqembi
The FDA has extended its review of Eisai and Biogen’s subcutaneous Leqembi Iqlik, moving the decision on its use as a starting dose to August 24. The agency requested a major amendment to the marketing application but has not raised safety...
Gilead Sets Blockbuster Bar for Yeztugo’s First Full Year on the Market
Gilead announced a $1 billion sales target for its twice‑yearly PrEP injection Yeztugo in 2026, up from a prior $800 million outlook. The drug generated $166 million in Q1, a 72% increase from the previous quarter, and 95% of U.S. patients enjoy $0...
FDA Approves the First PROTAC in History, a $1B siRNA Wave Hits Cardiometabolic Disease, and Cytokinetics Cracks Non-Obstructive HCM –...
The FDA granted its first-ever approval for a PROTAC drug, Arvinas’ Veppanu, targeting ESR1‑mutated metastatic breast cancer, marking a regulatory milestone for targeted protein degradation. In parallel, precision‑medicine siRNA deals surged: Madrigal paid $25 million upfront (up to $975 million in milestones)...
Ascendis Retreats to Rare Endocrinology Wheelhouse as Cancer Plans Falter
Ascendis Pharma announced it will halt development of onvapegleukin alfa, its IL‑2 β/γ oncology candidate, after a Phase 1/2 trial showed modest survival benefit in platinum‑resistant ovarian cancer. The company cited a strategic mismatch and will instead concentrate on its rare‑endocrinology franchise,...
FDA Clears Flow Neuroscience’s At‑Home Brain‑Stimulation Headset for Depression
The U.S. Food and Drug Administration approved Flow Neuroscience’s FL-100 at‑home transcranial direct current stimulation headset for adults with major depressive disorder, marking the first regulatory clearance for a consumer‑grade neurostimulation device. The decision opens a non‑drug, clinic‑free treatment pathway...
Moderna Launches mRNA Hantavirus Vaccine Development in 2024
Did ya know… Moderna began working on an mRNA vaccine for hantavirus in 2024. $MRNA
Natalie Holles' Next Move After Third Harmonic Shutdown; Mark Alles Passes the Torch at ADC Biotech
Natalie Holles rebounded quickly after the shutdown of Third Harmonic, securing the chief executive role at Aura Biosciences. The transition was disclosed in a GlobeNewswire release on May 4, 2026, as the company moves toward enrollment completion for its Phase‑3 COMPASS trial....
Capricor Sues Nippon Shinyaku over Duchenne Drug 'Pricing Flaw' And Launch Prep
Capricorn Therapeutics has filed a lawsuit against Japan’s Nippon Shinyaku, alleging a breach of their licensing agreement for the Duchenne muscular dystrophy cell‑therapy candidate deramio‑cel. The complaint centers on a pricing flaw that Capricorn says Nippon Shinyaku misrepresented during launch...
Endometriosis Imaging Study Highlights 99mTc-Maraciclatide as Diagnostic and Monitoring Tool
Serac Healthcare and Oxford’s Nuffield Department have published Phase 2 results of the DETECT study, showing that the gamma‑emitting radiotracer 99mTc‑maraciclatide can non‑invasively locate endometriotic lesions, including superficial peritoneal disease. Imaging findings matched laparoscopy in 16 of 19 participants and identified disease...
Study Links Consistent Daily Rest Patterns to Slower Biological Aging
Johns Hopkins scientists reported that adults with stable daily rest‑activity rhythms show slower biological aging, based on epigenetic clock data from 207 participants. The finding positions consistent sleep and activity as a measurable lever for longevity‑focused biohackers.
FDA Reconsiders Ebvallo Cell Therapy After Surprise Rejection
Pierre Fabre Pharmaceuticals and Atara Biotherapeutics secured a meeting with the FDA that reversed the agency’s Jan. 2026 rejection of their EBV‑associated T‑cell therapy, Ebvallo. The regulator now deems the completed single‑arm trial sufficient for a resubmission, opening a path...
Court Rulings Threaten Nationwide Access to Abortion Pill Mifepristone
A 5th U.S. Circuit Court of Appeals decision that blocks the FDA’s 2023 rule allowing mail delivery of mifepristone was temporarily halted by the Supreme Court, leaving the future of the abortion pill’s nationwide availability unclear. Advocates warn the split...
A Light at the End of the Tunnel for Huntington’s Disease Treatment
Researchers at Florida Atlantic University have uncovered a cellular pathway that enables mutant huntingtin protein (mHTT) to travel between neurons via tunneling nanotubes (TNTs). Using LC‑MS/MS, they identified the intracellular pH sensor Slc4a7 as a critical membrane partner of the...
Odyssey Therapeutics Upsizes IPO to 15.5 Million Shares at $18, Raising $304 Million
Odyssey Therapeutics announced an upsized initial public offering of 15.5 million shares at $18 per share, granting underwriters a 30‑day option for an additional 2.33 million shares and completing a concurrent private placement of 1.39 million shares to a TPG Life Sciences affiliate....
Webinar Q&A Follow Up: Immunoassay Signal Amplification: Bold New Solutions for Existing ELISAs
Cavidi’s principal scientist Peter Stenlund explained how the BOLD signal‑amplification platform boosts ELISA sensitivity by lowering the lower limit of quantification while modestly reducing the upper limit. The technology relies on click‑chemistry conjugation of stable DBCO‑modified oligos, offering precise stoichiometry...
Streamline Data Capture and Automate EHR-to-EDC Data Transfer
Paradigm Health introduced eSource Casebook, an EHR‑integrated platform that extracts both structured and unstructured clinical data, auto‑populates electronic case report forms, and streams the information directly to sponsor EDC systems. The tool tackles the industry‑wide surge in manual data entry,...
Aplantex Closes $5 Million Bridge Round to Accelerate Shift to Production-Scale Green Biotechnology
Aplantex announced the close of a $5 million bridge financing round in 2025, exceeding its original target. The round was led by board member François Ravenelle with Investissement Québec’s Impulsion Fund as a principal backer. The capital will fund the company’s transition from...
Best Practices for Handling Research Reconstitution Solutions Safely
Reconstitution solutions are essential for dissolving lyophilized compounds, but mishandling can ruin weeks of research. The guide stresses a clean workspace, sterile single‑use equipment, and gentle injection to preserve sample integrity. After reconstitution, temperature control, avoiding freeze‑thaw cycles, and precise...
MEDSIR Reports PHERGain and PHERGain-2 Trial Results for Breast Cancer
MEDSIR presented Phase II data from the PHERGain and PHERGain‑2 trials, exploring chemotherapy‑free strategies for early HER2‑positive breast cancer. PHERGain showed that PET‑guided use of trastuzumab and pertuzumab allowed roughly 30% of patients to omit chemotherapy while achieving nearly 90% five‑year...
Venom and Hot Peppers Offer a Key to Killing Resistant Bacteria
Researchers at Mexico’s UNAM have created three new antibiotics from scorpion venom and habanero pepper compounds. Two benzoquinone molecules from Diplocentrus melici venom show activity against tuberculosis, Staphylococcus aureus and Acinetobacter baumannii, while a defensin peptide from Capsicum chinense targets...
ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26
ALX Oncology reported exploratory Phase Ib/II data on evorpacept combined with Ziihera in 24 heavily pre‑treated HER2‑positive metastatic breast cancer patients, all of whom had previously received Enhertu. Overall, the regimen achieved a 33% confirmed overall response rate (cORR) with...
Cera and uMed Announce New Partnership
Cera, Europe’s largest HealthTech provider, has partnered with uMed’s automated living registry platform to bring clinical trial recruitment into patients’ homes. The collaboration leverages Cera’s network of over 2.5 million monthly home‑care visits and uMed’s regulated digital consent platform to reach...
PSMA PET Imaging’s Proliferation Produces Uptick in Aggressive Treatment for Prostate Cancer
Prostate-specific membrane antigen (PSMA) PET imaging, FDA‑approved in 2021, has rapidly displaced conventional bone scans among U.S. insurers, becoming the dominant diagnostic tool for advanced prostate cancer by 2023. A national Blue Cross Blue Shield claims analysis of nearly 6,000...
Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-Zova in X-Linked Retinitis Pigmentosa (XLRP)
Beacon Therapeutics presented 12‑month data from its Phase‑2 DAWN trial of laruparetigene zovaparvovec (laru‑zova) in patients with X‑linked retinitis pigmentosa (XLRP) who previously received an AAV‑RPGR gene therapy. The study showed sustained gains in low‑luminance visual acuity (LLVA) and microperimetry mean...
Semaglutide Race: Torrent Grabs 38% Market Share
Torrent Pharma has seized a 38% share of India’s generic semaglutide market within a month of launch, generating about ₹17 crore ($2 million) in April sales. Generic semaglutide revenue reached ₹44 crore ($5.3 million), while total market sales—including Novo Nordisk’s innovator—hit roughly ₹89 crore ($10.7 million)....
FDA’s Expedited Drug Reviews Are Hailed in some Quarters but Other Approval Practices Are Problematic
In July 2025 the FDA launched the Commissioner’s National Priority Voucher (CNPV) pilot to slash drug review times from six‑to‑eight months down to one‑or‑two months, issuing 17 vouchers for therapies ranging from cancer to cholesterol drugs. Commissioner Marty Makary later...
Follistatin-344: Myostatin Signaling, Tissue Plasticity, and Molecular Modulation Research
Follistatin-344, a 344‑amino‑acid precursor of the follistatin family, binds and neutralizes key TGF‑β ligands such as myostatin and activins. Structural studies show it wraps these ligands, preventing receptor engagement and downstream SMAD signaling. In pre‑clinical models, overexpressing Follistatin‑344 or its...
Odyssey Raises More than $300M as Biotech Goes Public
Odyssey Therapeutics completed a Nasdaq debut, raising $279 million by selling 15.5 million shares in its initial public offering. The biotech, focused on autoimmune‑disease therapeutics, priced the offering at $18 per share, above the $16.50 low end of its range. Proceeds will...
Blood Test May Improve Early Tuberculosis Detection Among Household Contacts
A prospective study of more than 2,000 household contacts in Tanzania, Zimbabwe and Mozambique evaluated the Cepheid Xpert MTB‑HR blood test, a three‑gene host‑response assay, for early tuberculosis detection. The assay demonstrated good accuracy in identifying active TB and showed...
Study Finds Rapamycin May Undermine Exercise Gains in Older Adults
Researchers led by Dr. Brad Stanfield reported that older adults taking a low weekly dose of rapamycin gained less muscle strength and physical function from a structured exercise program than those on placebo. The findings suggest the popular anti‑aging drug...
Revolution Medicines' Daraxonrasib Doubles Survival in Advanced Pancreatic Cancer
Revolution Medicines announced that its experimental KRAS inhibitor daraxonrasib doubled overall survival for patients with metastatic pancreatic cancer in a Phase 3 trial. The FDA has granted expanded‑access permission, allowing the drug to be used outside trials while regulators review the...
Roche to Acquire PathAI for Up to $1.05 B, Accelerating AI‑Driven Diagnostics
Roche announced a definitive agreement to buy U.S. digital‑pathology specialist PathAI for up to $1.05 billion, with $750 million paid upfront and up to $300 million in milestone payments. The deal, expected to close in the second half of 2026, aims to fuse...
Why Not Do Random Testing in Randomized Trials Designed to Measure Risk of Infection?
The post argues that randomized trials measuring infection risk, such as the recent Moderna flu study, rely on symptom‑driven testing rather than random testing of all participants. This selective approach inflates reported efficacy by omitting mild or asymptomatic cases and...
Armata Pharmaceuticals Wins FDA Fast Track for AP‑SA02 Bacteriophage Therapy
Armata Pharmaceuticals announced that the FDA granted Fast Track designation to its AP‑SA02 bacteriophage candidate for complicated Staphylococcus aureus bacteremia. The status promises more frequent agency interaction and a rolling Biologics License Application review, positioning the drug for accelerated approval...
Esperion Therapeutics Inc (ESPR) Q1 2026 Earnings Call Transcript
Esperion Therapeutics reported a strong Q1 2022 performance, with total revenue jumping 135% year‑over‑year to $18.8 million, driven by product sales up 109% to $13.4 million and partner revenue soaring 244%. The company achieved 32% cost‑savings in operating expenses and reduced R&D...
Screening for Photoreceptor Survival
Researchers used human retinal organoids to screen compounds that affect cone survival under glucose starvation. They identified two kinase inhibitors, CS‑KI‑1 and CS‑KI‑2, targeting CK1 and MAPK11, that protected cones and rods in vitro and in a mouse model of...
AI Unifies Fragmented Spatial Multi‑omics Into Comprehensive Tissue Atlases
A new AI-powered method integrates fragmented spatial multi-omics data, enabling unified tissue atlases and accurate prediction of unmeasured molecular layers across diverse tissues and species. bioinformatics
AI Tool Unifies Fragmented Cell Maps Into Spatial Atlases Across Tissues
A new AI-driven framework called SpaMosaic unifies fragmented spatial multi‑omics datasets by aligning RNA, protein, chromatin accessibility and histone‑modification layers across batches and technologies. The tool combines contrastive learning with graph neural networks, outperforming existing integration methods on mouse brain...
Amplia Therapeutics Launches New Narmafotinib Ovarian Cancer Study with ANZGOG
Amplia Therapeutics announced the launch of the PRROSE investigator‑initiated trial, testing its FGFR inhibitor narfotininb together with carboplatin and paclitaxel in high‑grade serous ovarian cancer patients who responded poorly to initial platinum therapy. The study will enroll 15‑20 participants, prioritize...
Finger‑prick Blood Test Accurately Detects Active TB, Predicts Risk
A finger-prick blood test measuring immune response can accurately detect active tuberculosis and moderately predict future disease in household contacts, offering potential for more targeted TB screening and prevention. tuberculosis
ART Reverses HIV‑Induced Aging, Cutting Years Off Biological Clock
Great news for HIV positive patients. A study presented at ESCMID Global 2026 found that untreated HIV can accelerate biological aging by up to a decade, but antiretroviral therapy can reverse this effect by nearly four years within about 18...
Macrophages Use Cell Volume Changes to Sense Danger and Amplify Inflammation
Researchers at the University of Manchester found that loss of the volume‑regulated anion channel (VRAC) prevents macrophages from correcting swelling under hypo‑osmotic stress, triggering type I interferon signaling and amplifying inflammation. The swelling reprograms gene expression toward antiviral and pro‑inflammatory pathways....
Spermidine Halts Liver Fibrosis by Cell Signal Remodeling
Researchers have demonstrated that spermidine, a naturally occurring polyamine, can halt the progression of liver fibrosis by reprogramming cellular signaling pathways. In mouse models, spermidine treatment reduced collagen deposition and restored normal liver architecture within eight weeks. The study identified...
Two Mechanisms Vie to Deliver First Hypoxic Ischemic Encephalopathy Drug
The article is BioCentury’s cookie policy, outlining five cookie categories—strictly necessary, functional, marketing, advertising, and analytics—and describing their purposes for site operation, personalization, outreach, and data collection. It explains how each type works, the data it handles, and the impact...
Astellas Touts Data From Early Test of Stem Cell-Derived Eye Therapy
Astellas Pharma announced early-stage data from its stem cell‑derived retinal therapy, aimed at treating age‑related macular degeneration (AMD). In a small cohort receiving the highest dose, patients showed statistically significant gains in best‑corrected visual acuity and no serious safety signals....
Novel Nanoparticle Therapy Using Manganese Could Improve Cancer Treatment
Researchers at the University of Michigan and MD Anderson have engineered a manganese‑based nanoparticle named CRYSTAL that activates the cGAS‑STING immune pathway without provoking systemic inflammation. Preclinical studies across several tumor models, including advanced triple‑negative breast cancer, demonstrated robust, sustained...
Mozza Foods Targets Late 2028 Launch for Soybean-Grown Casein
Mozza Foods, a California molecular‑farming startup, plans to commercialize casein proteins harvested from genetically engineered soybeans by late 2028, pending USDA field‑crop approval and an FDA GRAS filing. The company has raised roughly $24 million and is targeting a technical milestone...
Ultrasound Waves Rupture COVID-19 and Flu Viruses without Damaging Cells
Researchers at the University of São Paulo have shown that high‑frequency ultrasound waves (3–20 MHz) can rupture the envelopes of SARS‑CoV‑2 and H1N1 viruses while leaving human cells unharmed. The effect, termed acoustic resonance, exploits the spherical geometry of enveloped viruses,...