En Carta Diagnostics Receives FDA Breakthrough Device Designation for EC Pocket Lyme Test
En Carta Diagnostics announced that its EC Pocket Lyme test has received FDA Breakthrough Device Designation, accelerating its path to U.S. market entry. The point‑of‑need molecular assay detects Borrelia DNA directly from skin interstitial fluid using a microneedle sampler, delivering a visual result in a single‑use cassette. Early detection addresses the current diagnostic gap where antibody tests only become positive weeks after a tick bite. The designation validates the platform’s clinical relevance and promises faster commercialization for a disease affecting an estimated 476,000 new U.S. cases annually.
Serina Therapeutics Enrols First Patient for SER-252 Trial
Serina Therapeutics has enrolled the first patient in its Phase Ib registrational trial of SER‑252 for advanced Parkinson’s disease. The study, conducted with Parkinson’s Australia and Neuroscience Trials Australia, will assess safety, pharmacokinetics, tolerability and early efficacy, with dosing slated to...
Syngene and VivaMed Collaborate on Therapeutic Programmes
Syngene International has entered a strategic collaboration with VivaMed BioPharma to advance AI‑derived drug repurposing programmes. The partnership combines Syngene’s pre‑clinical development capabilities with VivaMed’s AI‑generated therapeutic hypotheses, creating a pathway from computational hits to translational validation. Together they will...
Researchers Uncover Signalling Pathway Behind Nitrate-Stimulated Root Growth
Researchers identified a MAPKKK called MEKK14 that activates a nitrate‑driven signalling cascade in Arabidopsis thaliana. The cascade triggers the circadian transcription factor CCA1, which in turn up‑regulates MEKK14, forming a positive feedback loop. This loop amplifies auxin signaling, leading to...
Accelerating Rare Disease Cures with ASOs, Gene Editing, and AI
Professor Matthew Wood, Oxford’s leading neuroscientist, heads the Oxford‑Harrington Rare Disease Centre, a partnership designed to fast‑track therapies for rare neuromuscular and genetic disorders. He outlines a vision to make antisense oligonucleotides (ASOs) and gene‑editing tools more modular, scalable, and...
Boehringer Ingelheim Secures US FDA’s EUA for NexGard and NexGard COMBO to Treat NWS
Boehringer Ingelheim received an Emergency Use Authorization (EUA) from the U.S. FDA for its NexGard chewable tablets to treat New World screwworm (NWS) infestations in dogs and puppies, and for NexGard COMBO topical solution to treat NWS in cats and...
Grail's Cancer Test Misses Primary Study Goal in UK Study
Grail announced that its Galleri multi‑cancer blood test failed to achieve the primary endpoint in a large United Kingdom clinical trial. The study, which evaluated the test’s ability to detect early‑stage cancers across dozens of tumor types, showed promising signals...
This Biotech ETF Is a Catalyst-Rich Story
Biotech stocks and ETFs rebounded strongly last year, and the ALPS Medical Breakthroughs ETF (SBIO) is positioned to benefit from that momentum. SBIO tracks nearly 90 companies with drugs in Phase II or III trials, but it carries a modest YTD...
Electronic Mesh Spurs Islet Cell Maturation, Could Aid Diabetes Care
Researchers at the University of Pennsylvania and Harvard have created an ultrathin, flexible electronic mesh that can be implanted into developing pancreatic tissue. The mesh delivers a 24‑hour rhythmic electrical pulse, coaxing stem‑cell‑derived islet cells toward functional maturity and synchronized...
Vaccine Protects Against Multiple Respiratory Viruses, Bacteria, and Allergens in Mice
Stanford researchers have created an intranasal vaccine that elicits a combined innate‑adaptive response, providing broad lung protection in mice. The formulation, containing TLR agonists and a harmless antigen, shielded animals for at least three months against SARS‑CoV‑2, other coronaviruses, two...
Gel Helps Mini Spinal Cords to Heal From Injury
Researchers have engineered miniature, three‑dimensional spinal‑cord organoids that can be deliberately injured and subsequently repaired with a biocompatible gel. The gel promotes cell survival and rapid axonal regrowth, effectively modeling the healing cascade observed in vivo. This human‑derived platform provides...
Are Obesity Drugs Causing a Severe Complication? What the Science Says
The United Kingdom and Brazil have issued safety warnings linking GLP‑1 weight‑loss drugs to acute pancreatitis after recording 19 and 6 deaths respectively. Reports include roughly 1,300 UK and 145 Brazilian pancreatitis cases among millions of users, though the overall...
'Digital Blood Testing' Now at Hand
A collaborative team led by UNSW and Nutromics has demonstrated a wearable patch that continuously measures vancomycin levels using DNA‑based aptamer sensors. Published in Nature Biotechnology, the pilot trial showed the patch can track drug concentration in interstitial fluid, offering...
STAT+: Key Study of Grail’s Cancer Detection Test Fails in Setback for Company
Grail’s multi‑cancer blood test Galleri failed to meet its primary endpoint in a large NHS‑partnered study, casting doubt on its early‑detection claims. The test, priced at $1,000, generated $136.8 million from 185,000 units sold in 2025 but remains unapproved by the...
Galleri Test Misses Primary Goal, Shows Secondary Promise
A key study of $GRAL's Galleri test in the UK failed to reach its primary endpoint, but showed benefits on a secondary endpoint. Tell me what you all think. https://t.co/CDrvokqPop
STAT+: In First Speech to Her FDA Staff, Høeg Says She’ll Scrutinize RSV Shots and SSRIs in Pregnancy
FDA Commissioner Tracy Beth Høeg, in her inaugural staff address, announced a renewed focus on evaluating the safety of antidepressants prescribed during pregnancy and monoclonal antibody RSV prophylaxis for infants. She highlighted gaps in existing safety monitoring and pledged more...
Pharmaceutical Executive Daily: FDA Plans to Remove Two Study Requirement for New Drug Approvals
The FDA announced it will drop the historic requirement for two adequate and well‑controlled studies in certain new‑drug approval pathways, a move that could accelerate timelines and lower development costs. The change is especially relevant for therapies targeting unmet medical...
Overlooked and Undervalued: Why Novo Nordisk Stock Deserves Attention
Novo Nordisk’s shares have slumped 66% from their 2024 peak, reflecting weak 2026 guidance and fierce competition from Eli Lilly in the GLP‑1 arena. The Danish firm recently introduced the first oral GLP‑1 pill, positioning it ahead of Lilly’s upcoming tablet and...
Lower Glucose by Living High
Researchers at Gladstone Institutes discovered that red blood cells (RBCs) act as a primary glucose sink during hypoxia, explaining why people living at high altitude have lower blood sugar. PET/CT scans showed 70% of the extra glucose clearance in hypoxic...
Examining Vaccine Development Amid America's Science‑Anti‑Science Divide
Many thanks to Freedom Together Foundation medical research consortium for hosting my remarks this week @RockefellerUniv discussing our vaccine development program and my work on the history of medical science vs anti-science in America https://t.co/etbLqiezEA
Eli Lilly Announces Positive Results for Treating Crohn’s Disease with Omvoh
Eli Lilly reported that its biologic Omvoh (mirikizumab) sustained steroid‑free remission for three years in Crohn’s disease patients in the Phase 3 VIVID‑2 open‑label extension study. More than 90% of participants remained in remission, with 80% experiencing relief from bowel urgency. The...
IL-6 as a Measure of Peripheral Inflammation Is More Often Elevated in Cognitively Impaired Individuals
A recent open‑access study of 514 Canadian seniors examined peripheral inflammation using IL‑6 and C‑reactive protein. The analysis revealed that elevated IL‑6 levels were present in 12% of cognitively normal participants but rose sharply to 36‑55% among Alzheimer’s, mixed dementia,...
Lonza Boosts Advanced Synthesis Capabilities for Bioconjugates
Lonza has expanded its advanced synthesis portfolio to provide end‑to‑end support for antibody‑drug conjugates (ADCs) and other bioconjugates. The company fully integrated the Synaffix‑derived ADC platform—including GlycoConnect® conjugation, HydraSpace® spacers and toxSYN® linker payloads—into its services. A new dual‑payload ADC...
Machine Learning Streamlines the Complexities of Making Better Proteins
Researchers at UC Berkeley and the Arc Institute unveiled MULTI‑evolve, a machine‑learning framework that predicts how multiple amino‑acid mutations affect protein function in a single experimental round. The workflow first estimates single‑mutation effects, then measures pairwise interactions, and finally trains...
Stronger Scents and Healthier Crops: Unlocking Plants' Hidden Potential Through Precision Gene Editing
Researchers at Hebrew University used a virus‑based CRISPR/Cas9 system to edit the regulatory domain of the HMGR enzyme, removing its metabolic brake and dramatically increasing terpenoid production. The edit boosted scent intensity and flower size in petunias and enhanced flavor‑related...
EBV DNA Linked to Multiple Autoimmune Diseases in 800k Genomes
🆕@Nature Genome sequencing of >800,000 people finds Epstein-Barr virus reads and their association with other autoimmune diseases besides multiple sclerosis, including type 1 diabetes, inflammatory bowel disease, and hypothyroidism https://t.co/FKCV4OInT5
A New Method to Decode How DNA 'Switches' Control Gene Activity
Researchers unveiled e2MPRA, a massively parallel reporter assay that simultaneously measures regulatory activity, chromatin accessibility, and H3K27ac modifications across thousands of cis‑regulatory elements. Validated on ~10,000 synthetic and native sequences, the method links single‑base mutations to multi‑layered gene‑regulatory outcomes. The...
From Skin Biopsy to iPS Cell Proposals: Emails Involving George Church’s Personal Genome Project and Jeffrey Epstein
Recent court‑released Epstein files contain emails that link Harvard professor George Church’s Personal Genome Project to Jeffrey Epstein. The correspondence documents a skin‑biopsy taken from Epstein, proposals to generate induced pluripotent stem (iPS) cells, and even CRISPR editing ideas, with...
Altesa Secures $75M for Lung Drug, Led by Ex‑Trump Official
Altesa, run by former Trump official, raises $75M for well-traveled lung drug https://t.co/bUx5dcvNJy by @gwendolynawu #biotech #startups
A Circulating Inflammation Suppressor Decreases Mortality
Researchers used Mendelian randomization to demonstrate that the inflammatory cytokine IL6 directly increases all‑cause mortality, while its soluble receptor IL6R has the opposite effect. Elevated circulating IL6R was linked to lower risk of lung cancer, diabetes, stroke and coronary artery...
New Drug Development Reforms Aim to Match China
These proposed reforms to pre-clinical drug development and to smoothing the transition to first-in-human studies could be the most consequential steps toward leveling the playing field with China. https://t.co/oVY6N3xo9Y
Adding Fragmentomics Boosts GRAIL’s Multicancer Detection Accuracy
The most used multicancer early detection (MCED) blood test (liquid biopsy) uses methylation (GRAIL). But combining that with DNA fragmentomics, as reported today @NatureCancer, improves early detection https://t.co/VkNDR4XuW3
Obesity Biotech Verdiva Plans Big Year of Data, Explores Deals
Verdiva Bio, an obesity‑focused biotech, is gearing up for a data‑heavy 2026, with Phase 2 results for its lead long‑acting peptide slated for the third quarter. The company is also courting strategic partnerships, eyeing potential deals with major pharma players after...
FDA Proposes Single Pivotal Trial as Approval Standard
FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals https://t.co/ADRb1miphf by Kristin Jensen #biotech
Tradipitant
Vanda Pharmaceuticals received FDA approval for tradipitant (Nereus®), an oral selective NK1 receptor antagonist, to treat motion‑induced nausea and vomiting. The approval marks the first new drug for motion sickness in more than four decades, highlighting a significant regulatory milestone....
Redefining Obesity Treatment Beyond GLP-1 Limits
BioSpace’s Denatured podcast featured Verdiva Bio’s R&D head Jane Hughes and MitoRx CEO Jon Rees discussing next‑generation obesity therapies that move beyond the limitations of GLP‑1 agonists. They highlighted how GLP‑1 treatments can cause muscle loss and suffer from poor...
Biogen Stops Part of an MS Trial; Merck Reports More Enflonsia Data
Biogen announced it is halting the combination‑therapy arm of its multiple sclerosis (MS) trial after interim data showed insufficient efficacy and safety concerns. The decision pauses enrollment in the experimental regimen while the company continues evaluating its monotherapy components. Meanwhile,...
Group 3 Medulloblastoma Shows Diverse Lipid Dependencies
Multiomic integration reveals tumoral heterogeneity of lipid dependence within lethal group 3 medulloblastoma https://t.co/tpjJiRa08t https://t.co/z7aIYerTqO
Valneva’s Lyme Disease Vaccine Offers Beacon of Hope Amid 2025 Sales Dip
Valneva reported a 3.3% decline in product sales to €157.9 million in 2025, driven primarily by regulatory suspensions of its chikungunya vaccine Ixchiq in the US and UK. Despite the sales dip, total revenue rose to €174.7 million, buoyed by a licensing...
Pembrolizumab-Induced Adrenal Insufficiency: Recognizing and Managing a Diagnostic Challenge in Adjuvant NSCLC Therapy
Pembrolizumab used as adjuvant therapy for NSCLC can cause central adrenal insufficiency, presenting with nonspecific fatigue, nausea, and hyponatremia. In a 67‑year‑old patient, a markedly low morning cortisol and suppressed ACTH confirmed the diagnosis within ten weeks of treatment. Prompt...
2024-2025 COVID-19 Vaccines Provided Moderate Protection Against JN.1 Variants
A recent JAMA Network Open case‑control study of 8,493 hospitalized adults shows that 2024‑2025 COVID‑19 vaccines provided moderate protection against the JN.1 lineage, with overall effectiveness of 40% against hospitalization and up to 52% after 90‑179 days. Updated Moderna and...
Intronic Reads in Bulk RNA‑seq: Common and Multi‑Faceted
Why are there intronic reads in your bulk RNA-seq data? You're not alone—it's common, and the reasons are more layered than you think. Let’s break it down. 🧵 https://t.co/SNJnohqHUM
Former Psilocybin Trial Participant Shocked by New Findings
"I took part in a 2012 psilocybin trial. What I’m seeing now horrifies me" https://t.co/T1BLv6n59X via @statnews
Treg Pioneer Bluestone Joins Vie Ventures as It Builds Autoimmune Portfolio
Vie Ventures has hired immunology veteran Jeff Bluestone to strengthen its autoimmune‑focused venture portfolio. Bluestone, founder of the Immune Tolerance Network and former CEO of the Parker Institute for Cancer Immunotherapy, previously co‑founded Sonoma Biotherapeutics and created Tzield teplizumab, the...
Blood P‑tau217 Test Predicts Alzheimer’s Symptoms 20 Years Ahead
Predicting when symptoms of Alzheimer's disease will occur with elevated p-tau217 blood test and a person's age, even 20+ years in advance @NatureMedicine https://t.co/EYaGglBh1H
Gossamer Lung Trial and ProMis Alzheimer Therapy Spotlight
This week's Biotech Scorecard newsletter: -- What to expect from $GOSS Gossamer Bio’s late-stage lung disease study -- A better, safer Alzheimer’s treatment? ProMis $PMN takes its shot https://t.co/YaA8kvUR4Z
LPM-5140276 Shows Enhanced Antitumor Efficacy in Combination with RMC-4550
Researchers reported that the novel KRAS G12D inhibitor LPM-5140276 markedly improves antitumor activity when paired with the SHP2 inhibitor RMC-4550. The combination demonstrated synergistic tumor regression in preclinical models of pancreatic and colorectal cancers harboring KRAS G12D mutations. Data suggest enhanced pathway...
Profusa Enables Real‑Time Tissue Biochemistry Monitoring
👍Profusa is my pick for 2026. Fascinating technology to measure real time tissue biochemistry. This is a fundamental shift from blood to tissue to shine a new light on cellular status and metabolism. https://t.co/gfduGvgJTX @ProfusaInc #medicine $PFSA #diabetes
FNIH Biomarkers Consortium Study Shows “Clock Model” Blood Test Can Predict Onset of Alzheimer’s Symptoms Years in Advance
The FNIH Biomarkers Consortium unveiled a “clock model” that uses a single blood test to forecast Alzheimer’s disease symptom onset 3‑4 years before clinical presentation. The model aggregates plasma biomarkers into a temporal trajectory, and a new web‑based visualization tool...
ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients
ViiV Healthcare presented results from the Phase III LATITUDE trial evaluating Cabenuva, a long‑acting injectable of cabotegravir and rilpivirine, in 453 adults with adherence challenges. Among 306 virally suppressed participants, the quarterly injection reduced cumulative regimen failure to 22.8% versus...