Nuclear Medicine Firm Shine Technologies Raises $240M
Shine Technologies announced a $240 million financing round led by Patrick Soon‑Shiong’s NantWorks, bringing its total capital raised to over $1 billion. The infusion will accelerate the company’s commercial fusion initiatives and expand its Lu‑177 isotope production, a cornerstone of targeted cancer therapies. The funding follows Shine’s recent acquisition of Lantheus’ SPECT business, bolstering its imaging portfolio. A strategic partnership with NantWorks grants the investor priority access to Lu‑177, positioning both firms to advance next‑generation oncology treatments.
Changes in the Gut Microbiome Drive Age-Related Intestinal Barrier Dysfunction
Researchers identified that the aging gut microbiome harbors increased Klebsiella aerogenes, which elevates histamine production and compromises intestinal barrier integrity. The excess histamine suppresses Nlrp6 expression, disrupting LC3‑mediated autophagy and intensifying inflammation in septic models. Experiments showed that lowering histamine...
Clinical Labs Gain Ground with Noninvasive Dd-cfDNA Transplant Surveillance
A new donor‑derived cell‑free DNA (dd‑cfDNA) blood test is transforming post‑transplant surveillance by providing real‑time, noninvasive insight into graft health. The assay quantifies donor DNA fragments released when a transplanted organ is injured, offering a high negative predictive value that...
Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia
The U.S. FDA granted accelerated approval to Ascendis’ Yuviwel (navepegritide) for increasing linear growth in children aged two years and older with achondroplasia and open epiphyses. Approval rests on three placebo‑controlled trials and up to three years of open‑label extension...
Why It’s Critical to Close Open Steps in Cell Therapy Manufacturing
Cell therapy manufacturing is vulnerable to contamination because living cells cannot be terminally sterilized. Regulatory bodies such as EU GMP Annex 1 and the FDA now require risk‑based contamination control strategies that prioritize closed, sterile, and automated processes. Closing open steps...
Sanofi Receives CHMP Recommendation for Dupixent Expansion in Europe
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Dupixent (dupilumab) for paediatric chronic spontaneous urticaria (CSU) in children aged 2‑11. The recommendation is based on robust Phase III data from the LIBERTY‑CUPID...
Opus Genetics Reports Phase I/II Trial Results of OPGx-BEST1 Gene Therapy
Opus Genetics presented early Phase I/II data for its OPGx‑BEST1 gene therapy targeting best vitelliform macular dystrophy and autosomal‑recessive bestrophinopathy. In a sentinel 63‑year‑old participant, the treatment was well tolerated and delivered a 12‑letter gain in best‑corrected visual acuity after...
BioMarin Receives FDA Approval for Palynziq Use in Adolescents
BioMarin’s enzyme substitution therapy Palynziq received FDA approval for use in adolescents aged 12 and older with phenylketonuria (PKU). The decision was based on Phase III PEGASUS trial results showing 44.4% of participants lowered blood phenylalanine below guideline levels, with a...
18 UK Biotech Companies You Should Know About
The article profiles 18 UK biotech firms spanning oncology, immunology, regenerative medicine and AI‑driven drug design, highlighting recent milestones such as Amphista’s $30 million upfront deal with BMS, Autolus’ FDA and EU approvals for obe‑cel, and Isomorphic Labs’ $600 million raise to...
Monolithic 3D Nanoelectrode Arrays on CMOS Circuitry for Scalable, High‐Resolution Neural Recording
Researchers have developed a monolithic 3D nanoelectrode array (HD‑NEA) that integrates 26,400 vertical nanowire electrodes directly onto commercial CMOS chips. The low‑temperature wafer‑scale post‑fabrication process maintains circuit functionality while delivering uniform, high‑yield electrode performance across 4‑inch wafers. In vitro recordings...
X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome
X4 Pharmaceuticals’ Xolremdi (mavorixafor) received a positive opinion from the European CHMP, recommending approval under exceptional circumstances with an EC decision expected in Q2 2026. The recommendation is based on the global Phase III 4WHIM trial involving 31 patients aged 12 and...
Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending conditional approval of Ipsen’s Ojemda (tovorafenib) as monotherapy for pediatric low‑grade glioma with BRAF fusions, rearrangements or V600 mutations. The recommendation is based on...
Defect Engineering of Bi2S3‐x@PDA/CuS Z‐Scheme Heterojunction for Enhanced Sonodynamic and Chemodynamic Cancer Therapy
Researchers have engineered a sulfur‑vacancy‑rich Bi2S3‑x@PDA/CuS (BPC) nanocomposite that forms a Z‑scheme heterojunction and is further functionalized with hyaluronic acid (BPC@HA). The defect‑rich structure enhances charge separation, enabling efficient singlet‑oxygen generation under ultrasound and Fenton‑like hydroxyl‑radical production for chemodynamic therapy....
FDA Action Alert: BMS, GSK, Aldeyra and More
The FDA will render decisions this March on five high‑profile drug applications, including two delayed from last year. Bristol Myers Squibb seeks a psoriatic arthritis label for Sotyktu, backed by Phase 3 data showing a 54.2% ACR20 response. Aldeyra, Rhythm, GSK...
Quanterix Corp (QTRX) Q4 2025 Earnings Call Transcript
Quanterix (QTRX) reported FY 2025 revenue of $16.1 million, down $11 million from the prior year, driven by steep declines in collaboration and contract‑manufacturing income. R&D spending fell modestly to $140.7 million, while SG&A rose to $65.5 million due to higher professional fees for...
Cerus Corp (CERS) Q4 2025 Earnings Call Transcript
Cerus Corp reported record total revenue of $233.8 million in 2025, a 16% increase year‑over‑year, driven by strong product sales and robust growth in EMEA. Product revenue rose 14% for both the quarter and full year, with IFC kit sales...
Combining Neurobiological Markers and a Sociodemographic Risk Score to Predict Adolescent Depression – An IDEA RiSCo Prospective Cohort Study
Researchers integrated inflammatory cytokines, kynurenine pathway balance, and amygdala reactivity with the IDEA‑RS sociodemographic risk score to predict adolescent depression over three years. The composite model (IDEA‑BIO‑RS) raised predictive accuracy from a 0.715 AUC to 0.889, correctly classifying 82.2% of...
Xeris Biopharma Holdings Inc (XERS) Q4 2025 Earnings Call Transcript
Xeris Biopharma reported record Q3 2025 product revenue of $74.1 million, a 40% year‑over‑year increase driven primarily by Recorlev’s 109% revenue jump. The company posted its first quarterly net income and an adjusted EBITDA of $17.4 million, reflecting strong operating leverage and...
Uniqure NV (QURE) Q4 2025 Earnings Call Transcript
UniQure reported a regulatory setback as the FDA now deems the Phase 1/2 external‑control data for AMT‑130 insufficient for a Biologics License Application, creating uncertainty around the U.S. filing timeline. Despite this, the high‑dose AMT‑130 achieved a statistically significant 75% slowdown...
Nuvation Bio Inc (NUVB) Q4 2025 Earnings Call Transcript
Nuvation Bio reported $7.7 million net product revenue for Iptrozi in Q3 2025, driven by 204 new patient starts and payer coverage expanding to over 80% of U.S. lives. Clinical data showed an 89% overall response rate and a median...
Rational Design of Rigid mRNA Folding Architecture to Enhance Intracellular Processing and Protein Production
A team of researchers from Singapore and China has engineered a rigid mRNA folding architecture that markedly improves intracellular processing and protein output. By integrating all‑atom and coarse‑grained molecular dynamics simulations with lipid‑nanoparticle (LNP) formulation, they created stiffened mRNA structures...
Mike White: Academia and Genomics in the 21st Century
In a recent Unsupervised Learning episode, Razib Khan interviews Washington University genetics professor Mike White about his lab’s work on the biophysical architecture of regulatory DNA. White’s interdisciplinary approach combines functional genomics, synthetic biology, computational biology and deep‑learning to predict...
NMN Restores NAD, Shields Heart via SIRT3
According to ITOA, NAD declines with age, causing epigenetic changes & disease susceptibility In 2010, we showed NAD-dependent enzyme, SIRT3, protects the heart 🐁 New study says NAD precursor NMN protects the heart via SIRT3 in mice fed a Western diet https://www.sciencedirect.com/science/article/pii/S0022316626000842
OpenADMET Releases Massive CYP Assay Datasets for Community AI
OK. Here it is. Over the last year, the @OctantBio and OpenADMET team have been hard at work developing scalable, quantitative, data-rich, and low-cost methods for assessing CYP reactivity and inhibition. The interplay between building a data engine and building...
Drug Discovery Bottleneck? Cell-Free Platform Screens Peptides Faster, Even in Harsh Conditions
Researchers at the Innovation Center of NanoMedicine unveiled PL‑display, a cell‑free platform that immobilizes individual peptides on magnetic beads for rapid screening. The method delivers over ten‑fold efficiency gains versus traditional cell‑based displays and can operate under high‑temperature, high‑salt, or...
Ginkgo's 2025 Revenue Far Misses $7.6B Promise
Ginkgo reported full year 2025 revenue of $170M at the end of last week. When it went public at a $15B valuation in 2021, they guided to investors that they’d be adding $7.6B in new business PER YEAR in 2025...
Vaccine Policy Shifts Spark Resurgence of Deadly Diseases
But also it’s not only measles, pertussis (whooping cough) is also returning, and based on latest ACIP (or what used to be ACIP) stunts, we’ll see rotavirus, meningococcal meningitis, HBV liver cancer, return after that. A public health disaster built...
Why Crowning the Protein that Makes Jellyfish Glow Green as a Model Can Help Scientists Streamline Biology
The article proposes designating green fluorescent protein (GFP) as a model protein to standardize protein research, much like fruit flies or mice serve as model organisms. It argues that GFP’s visual read‑out makes it ideal for benchmarking AI‑generated protein designs...
Large cfDNA Methylome Atlas Powers Multi‑Cancer Detection
A pan-cancer compendium of 1,294 plasma cell-free DNA methylomes and fragmentomes enabling multicancer detection https://t.co/A6gHwcEzqq https://t.co/mSMcR0a833
Weekly Reads: Longevity Hype Vs. Cool Research, Losing Your Y, FDA Maelstrom
This week’s coverage juxtaposes longevity hype with emerging science, highlighting David Sinclair’s bold claim that aging could be reversed within 10‑20 years, a new Nature paper confirming adult hippocampal neurogenesis, and research showing men lose the Y chromosome as they...
Hidden Ingredient in Ozempic and Wegovy Tablets Raises New Gut Health Questions
Researchers at Adelaide University conducted the first in‑vivo study of salcaprozate sodium (SNAC), the absorption enhancer used in oral semaglutide tablets such as Ozempic and Wegovy. Over a 21‑day period in rats, repeated SNAC exposure reduced fibre‑degrading gut bacteria, lowered...
DNA as the Super Data Storage Medium of the Future
Penn State researchers have built a bio‑hybrid memristor that couples synthetically produced DNA with a perovskite semiconductor. The device stores data in the molecular lattice of DNA while processing signals through the perovskite layer, effectively merging memory and compute. Laboratory...
Welireg Poised to Broaden Reach per GU26 Data
$MRK Welireg could be about to expand its reach at last. #GU26 data via @ApexOnco with relevance to $RCUS -> https://t.co/k59284INdK
Miami Preps for Biotech Week; BiotechTV Covers Barclays Conference
Looks like Miami is getting ready for biotech week (the week after next). Note: BiotechTV will be broadcasting from the Barclays conference March 10 & 11. https://t.co/ToZH0EgOVz
In China, Phase 2 Study of Relma-Cel in R/R MCL Finds Durable Responses
A phase‑2 trial of relmacabtagene autoleucel (relma‑cel), a CD19‑directed CAR‑T therapy, enrolled 59 Chinese patients with relapsed/refractory mantle‑cell lymphoma after BTK‑inhibitor failure. The study reported a 71.2% overall response rate and a 59.3% complete response rate, with median time to...
IL11 Deficiency Causes Female Infertility, Low Weight, Osteoporosis
But note IL11 knockout mice are infertile (females) and have low body weight and some osteoporosis. Still interesting angle though.
Recent Advances Raise Hopes of Better Addressing Richter Transformation
A new review synthesizes recent advances that clarify the biology of Richter transformation (RT), the aggressive lymphoma that develops in 2%‑10% of chronic lymphocytic leukemia (CLL) patients. The analysis confirms that 70%‑80% of RT cases are clonally related to the...
Accelerating CAR Engineering Shows Promising Cancer Immunotherapy
Some very good news about engineering our cells vs cancer (accelerating the CAR). A short thread 1. For background, a new 5★ review on cancer immunotherapy @Cancer_Cell https://t.co/1Qz2rCs8I5 https://t.co/sJ6BwaXyjk
Single-Cell Atlas Links Marrow Immune Dysregulation to Myeloma Outcomes
A single-cell atlas characterizes dysregulation of the bone marrow immune microenvironment associated with outcomes in multiple myeloma https://t.co/5t0M2eX0fB https://t.co/p3kv8LEzrC
Analysis Finds Efficiencies, Savings of Using a Single Bispecific for DLBCL and FL
A new analysis quantifies the operational and financial benefits of using Genmab’s epcoritamab, a dual‑indication bispecific antibody, for both relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) and follicular lymphoma (FL). In a community‑practice model of 100 patients, the study projects 3,110...
Stale Bread and Bacteria Could Power a New Era in Green Chemicals
Scientists at the University of Edinburgh's Wallace Lab engineered E. coli to generate hydrogen from simple sugars, including stale bread, and paired it with a palladium surface catalyst to hydrogenate organic molecules. The biocatalytic system achieved up to 99% conversion efficiency,...
Mixed Immune Signature Identified in Chronic Hand Eczema
A phase‑2b trial enrolling 94 adults with chronic hand eczema (CHE) without etiologic pre‑selection uncovered a mixed immune signature spanning type 2, type 3 and type 1 pathways. Dupilumab, an IL‑4Rα antagonist, delivered a 59.8% mean improvement in modified Total Lesion Symptom Score...
Inside Lemnisca’s Big Leap For Digital Twins To Make Biotech More Scalable
Lemnisca, a Bengaluru startup, is launching a digital‑twin platform that models fermentation at industrial scale, merging microbial biology with physical process conditions. The hybrid model, paired with an in‑house wet lab, creates a feedback loop that refines simulations and cuts...
GLP-1 News Galore; Top 100 Venture Investors; Doug Ingram to Step Down; and More
This week’s Endpoints Weekly highlighted a surge of GLP‑1 developments, including new trial data and expanded indications that reinforce the class’s dominance in obesity and diabetes treatment. The newsletter also released its annual Top 100 venture investors list, showing a notable...
EMA’s CHMP Recommends Three New Orphan Drugs, Rebuffs Two FDA-Approved Programs
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, including three orphan drugs already approved by the FDA—Ojemda for pediatric low‑grade glioma, Palsonify for acromegaly, and Xolremdi for WHIM syndrome. The agency also gave a...
Tylenol Not Linked to Autism Genes, Study Shows
There are a few known chemical exposures in early pregnancy that interact with autism genes. But not Tylenol. I’ve spoken to RFK Jr about them but he had no interest, and he can’t process scientific information. Here’s my article https://t.co/pxLaDLInlf
Emerging Models Point to a New Operating System for Rare Disease Innovation
BioCentury’s cookie policy details five categories of cookies—strictly necessary, functional, marketing, advertising, and analytics—each serving distinct purposes on its website. Strictly necessary cookies support authentication, registration, and navigation, while functional cookies enable personalization of services. Marketing and advertising cookies help...
![[Review] Autosomal Dominant Polycystic Kidney Disease](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/e5c772f073be33a83118f46a1ac91f13.webp)
[Review] Autosomal Dominant Polycystic Kidney Disease
Autosomal dominant polycystic kidney disease (ADPKD) remains the most common hereditary cause of chronic kidney disease, imposing substantial morbidity, mortality, and healthcare costs worldwide. Recent advances in molecular genetics and high‑resolution imaging have sharpened diagnostic criteria and enabled more accurate...
![[Comment] Safeguarding Genomic Integrity in Pluripotent Stem-Cell Therapies](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/fba52b2aab9c591bf0e059f57acce9ea.webp)
[Comment] Safeguarding Genomic Integrity in Pluripotent Stem-Cell Therapies
Human pluripotent stem cells (hPSCs) are emerging as a transformative platform for Parkinson’s disease, with recent phase I/II trials showing successful engraftment of hESC‑ and iPSC‑derived dopaminergic neurons. Yet extensive data reveal that cultured hPSCs frequently acquire recurrent genetic lesions—most...
FDA Approves Next-Generation CardioMEMS Reader for Heart Failure Monitoring
Abbott received FDA approval for its next‑generation CardioMEMS HERO reader, a pulmonary artery pressure device for heart‑failure patients. The HERO unit is 60% lighter than earlier readers and incorporates built‑in Wi‑Fi and cellular connectivity, allowing measurements anywhere. The upgrade builds on...