STAT+: FDA Slams Soon-Shiong and ImmunityBio for Making ‘False and Misleading’ Claims About a Drug
The FDA sent a March 13 warning letter to ImmunityBio, a company controlled by biotech magnate Patrick Soon‑Shiong, after finding multiple false and misleading statements about its bladder‑cancer drug Anktiva. The agency highlighted that television ads and a podcast claimed the therapy could treat all cancers and render patients cancer‑free, while omitting that Anktiva must be used with a BCG vaccine and downplaying serious risks. Clinical data do not support these sweeping efficacy claims, prompting regulatory action. The letter underscores the FDA’s focus on truthful drug promotion.
Antibiotics Selectively Supercharged Against MRSA
Yale and Cornell chemists have devised a metal‑free aminoxyl catalyst that oxidizes a single secondary alcohol in the macrolide antibiotic erythromycin A. The catalyst, paired with mCPBA, proved highly selective, but analogous macrolides clarithromycin and azithromycin required different reagents to achieve...
Ocugen Heads to Phase 3 with Gene Therapy for Geographic Atrophy
Ocugen announced that its investigational gene therapy for geographic atrophy, a leading cause of vision loss in age‑related macular degeneration, will move into a Phase 3 clinical trial. The company reported mixed Phase 2 results, showing a favorable safety profile but inconsistent...
NanoZymeX Secures €160K to Advance Lipid Nanoparticle Enzyme Therapies for Rare Diseases
Swiss biotech NanoZymeX has secured €160,000 (about $174,000) from Venture Kick to accelerate its lipid‑nanoparticle platform for enzyme replacement therapies. The technology, spun out of the University of Basel, seeks to improve delivery of therapeutic enzymes into muscle cells and lysosomes,...
Fusion Enzyme Boosts Polyester Textile Recycling – Study
Researchers at the University of Portsmouth and the University of Manchester have engineered a “plastic‑eating” enzyme that dramatically speeds the depolymerisation of PET, the polymer used in polyester clothing. The enzyme remains highly active even at the high substrate concentrations...
FDA Warns ImmunityBio over Misleading Podcast with Patrick Soon-Shiong
The U.S. Food and Drug Administration issued a warning to ImmunityBio after a television ad and a podcast featuring billionaire biotech entrepreneur Patrick Soon‑Shiong suggested that the company’s bladder‑cancer drug Anktiva could cure or prevent all cancers. The FDA said...
Optibrium Introduces Graphical Interface for QuanSA to Enhance Ligand-Based Affinity Predictions
Optibrium has released a new PyMOL plugin that adds a graphical user interface to its QuanSA ligand‑based affinity prediction tool. QuanSA uses physically‑motivated machine learning to deliver free‑energy perturbation‑level accuracy without needing a protein structure, dramatically lowering computational cost. The...
Alnylam Advances Future of ATTR-CM Care Through Strategic Collaboration with Viz.ai and Support for the American Heart Association
Alnylam Pharmaceuticals announced a strategic partnership with Viz.ai to develop an AI‑enabled care pathway for earlier detection of transthyretin amyloid cardiomyopathy (ATTR‑CM), launching the AWARE study in five health systems. The company also pledged support for the American Heart Association’s...
Karyopharm’s Mixed Myelofibrosis Data; Rezolute to Seek FDA Approval Despite Trial Failure
Karyopharm reported mixed results from its Phase 3 SENTRY trial of selinexor in myelofibrosis, achieving a statistically significant reduction in spleen volume but raising safety concerns. The data fell short of expectations for overall survival benefit. Meanwhile, Rezolute announced it will...
Q&A: Controversial Embryo Editing Entrepreneur Cathy Tie on Her New Startup
Cathy Tie, the founder of Origin Genomics, announced the shutdown of her previous embryo‑editing venture and the launch of a new startup focused on pre‑implantation genetic modification. The new company, dubbed EmbryoX, has secured $55 million in Series A funding led by...
Seven T Cell Engager Companies You Should Know About
T‑cell engagers are bispecific antibodies that redirect T cells to destroy cancer cells and are being explored for autoimmune disorders. Seven companies are leading the field: Adaptin Bio secured FDA IND clearance for APTN‑101 in glioblastoma; Candid Therapeutics merged with...
Amylyx Pharmaceuticals Announces Completion of Enrollment in Pivotal Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia
Amylyx Pharmaceuticals announced that the pivotal Phase 3 LUCIDITY trial of avexitide has completed enrollment, randomizing and dosing the final participant to bring the total to 78 patients across 21 U.S. sites. The double‑blind, placebo‑controlled study evaluates avexitide, a first‑in‑class GLP‑1...
Novartis Pledges $480M to Expand China Presence, Following Eli Lilly and AstraZeneca
Swiss drugmaker Novartis announced a $480 million investment to expand its manufacturing and R&D footprint in China. The plan allocates about $218 million to upgrade its Beijing Changping facility, which can produce up to 3 billion tablets annually, and $262 million to expand its...
Aardvark Pauses 2 Obesity Trials, Reveals New Details on Cardiac Concerns
Aardvark Therapeutics has paused two Phase 2 obesity trials, POWER and STRENGTH, after cardiac safety signals emerged in its lead compounds ARD‑101 and ARD‑201. The anomalies were observed in healthy volunteers receiving double the target dose, prompting a halt to the...
ImmuneBridge Secures $7.7M to Open Cell Therapy Manufacturing Platform to Biotech Partners
ImmuneBridge announced a $7.7 million second seed round, bringing its total seed capital to roughly $20 million, to commercialize its proprietary cell‑therapy screening and manufacturing platform for external partners. The platform combines machine‑learning‑driven donor selection with a unique small‑molecule that preserves stem‑cell...
Dual-Action Antiviral Treatments Offer A New Path Forward
Scientists at the U.S. Army Medical Research Institute of Infectious Diseases have engineered a dual‑action antibody that simultaneously targets two stages of Venezuelan equine encephalitis virus (VEEV) entry. The single‑molecule treatment protected animals even when given after exposure and neutralized...
Celosia Therapeutics Starts First‑Human Dosing of CTx1000 Gene Therapy for ALS
Celosia Therapeutics has dosed the first participant in its Phase 1b KOANEWA trial of CTx1000, a gene‑editing medicine that clears pathological TDP‑43 protein in ALS patients. The open‑label study, run at Macquarie University Hospital, marks the first human test of...
Leica Biosystems Launches Aperio GT Elite Scanner, Aperio iQC Software
Leica Biosystems, a Danaher company, launched the Aperio GT Elite digital pathology scanner in the U.S., paired with Aperio iQC software featuring AI‑driven rescan capabilities. The scanner can process up to 103 slides per hour, scanning a slide in as...
Imaging Agent Granted FDA Fast Track Designation
FluoGuide A/S announced that the U.S. FDA has granted Fast Track designation to its intraoperative imaging agent FG001, targeting high‑grade glioma surgery. The designation recognizes the serious nature of glioblastoma and the agent's promise to improve tumor visualization during resection....
New AD Combos Outpace Dupilumab, Injection Frequency Drops
Atopic dermatitis landscape from Wedbush. Looks like there are two parallel vectors: lower injection frequency ( $APGE ) and combining new mechanisms with IL13/IL4R. So far $JNJ's IL13+IL31 failed (the only one to be directly compared to dupi) while $PFE's...
Quotient Therapeutics & Merck Enter ~$2.2B Partnership to Discover Novel Drug Targets in IBD
Quotient Therapeutics and Merck have signed a multi‑year collaboration to use Quotient’s somatic genomics platform for discovering new drug targets in inflammatory bowel disease. The agreement provides Quotient with $20 million upfront and includes milestone payments that could lift the total...
The Journal at a Glance: Q1 2026 Highlights From Our Editor in Chief
BioTechniques’ Q1 2026 editorial roundup spotlights three impactful studies. An optimized Southern blot protocol from Merck enhances resolution of transgene insertions in high‑copy CHO cell lines, simplifying bioprocess validation. Researchers in Germany refined a DNA microarray to type 96 vancomycin‑resistant...
Radiopharmaceutical Clinical Trials in 2026: How to De-Risk Isotope Supply, Imaging Variability, and Regulatory Pathways
Radiopharmaceutical clinical trials are becoming a high‑velocity segment in 2026, but they remain vulnerable to three predictable bottlenecks: isotope supply chain fragility, imaging variability, and regulatory pathway selection. Axcellant, a boutique CRO with an integrated imaging core lab, demonstrates that...
Synthetic DNA Manufacturing Hub Set Up in Boston by Artis BioSolutions
Artis BioSolutions, a San Diego‑based advanced therapies firm, has launched a synthetic DNA manufacturing hub in Boston using Syngoi Technologies' proprietary enzymatic platform. The new site complements its GMP manufacturing facility in Watertown, creating a bi‑continental network with an existing...
Biotech Investors Set to Meet with Key Congressional Panel
A bipartisan congressional commission focused on maintaining U.S. leadership in biotechnology will host a meeting with leading biotech investors next week. The investors, representing venture capital firms and industry funds, aim to discuss policy gaps, funding mechanisms, and regulatory hurdles....
Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)
Prestige Biopharma announced topline results from its phase‑III SAMSON‑II trial comparing HD204, a biosimilar to Avastin (bevacizumab), with the reference product in 625 patients with advanced non‑squamous non‑small cell lung cancer. The study demonstrated an objective response rate (ORR) of...
Mosaic Therapeutics to Present Poster Highlighting Preclinical Data for Lead Program MOS101 at the American Association for Cancer Research (AACR)...
Mosaic Therapeutics will present preclinical data on its lead program MOS101—a combination of the next‑generation MDM2 antagonist ASTX295 and the FDA‑approved PARP inhibitor olaparib—at the AACR 2026 Annual Meeting. The poster focuses on BRCA2‑mutant, TP53‑wild‑type solid tumours and highlights the...
Apnimed Set to Exit Sleep Disorder Joint Venture with Shionogi for $100M Upfront
Japanese pharmaceutical company Shionogi is buying out Apnimed’s 50% stake in their sleep‑disorder joint venture for an upfront payment of $100 million. The acquisition gives Shionogi full control over the partnership’s pipeline, which focuses on treatments for conditions such as obstructive...
FDA Clears 7.2 Mg Wegovy HD, Boosting Weight‑Loss Potential by 19%
The U.S. Food and Drug Administration approved a 7.2‑milligram version of Novo Nordisk’s semaglutide weight‑loss drug Wegovy, dubbed Wegovy HD. Clinical data showed participants lost roughly 19% of body weight, about 47 pounds on average, compared with 16% on the...
Gubra‑AbbVie’s ABBV-295 Achieves Up to 9.8% Weight Loss in Early Trial
Gubra and AbbVie announced that participants in a Phase 1 multiple‑ascending‑dose study of ABBV-295 lost between 7.8% and 9.8% of their body weight after roughly three months. The amylin analog was well tolerated, positioning it as a potential new class of...
Gilead to Pay $1.68 B Upfront for Ouro Medicines, Adding T‑cell Engager to Autoimmune Portfolio
Gilead Sciences signed a definitive agreement to acquire privately held Ouro Medicines for $1.675 billion in cash up front and up to $500 million in milestone payments, targeting the experimental T‑cell‑engaging antibody OM336. The deal, valued at up to $2.18 billion, gives Gilead...
Pharma Pulse: A Rare Disease Drug Approval and the Evolving Scope of Pharmacy Practice
The FDA has broadened approval for Imcivree (setmelanotide), creating the first targeted therapy for acquired hypothalamic obesity and reporting an 18.4% placebo‑adjusted BMI reduction in Phase III trials. Parallel research shows that deploying pharmacy technicians as vaccine injectors dramatically improves uptake...
E Fund HK Launches “Global First” Biotech ETF Bridging Hong Kong and US Markets
E Fund Management Hong Kong launched the E Fund (HK) Solactive Biopharma Select Index ETF (code 3186) on March 23, 2026, the first ETF to blend Hong Kong and US biotech stocks. The index tracks up to 100 biotechnology and pharmaceutical firms, weighting...
Patented Chemo Reform Boosted Profits, Not Patient Benefits
Please. This is nonsense. You figured out a way to swap castor oil for albumin making it easier to administer paclitaxel, a standard chemotherapy. Same side effects. Look at the label. The best thing you did, for you, was secure...
Aging May Be Reversible by Restoring Cellular Information
It’s not often that a theory about aging feels this transformative. I recently came across research suggesting that aging may not be permanent damage — but a loss of biological information inside our cells. Think of it like a scratched CD. The data...
Clemastine Fumarate Activates Lipophagy to Promote Oligodendrocyte Progenitor Cells Differentiation and Remyelination in a Cuprizone-Induced Demyelination Model
Researchers discovered that clemastine fumarate activates lipophagy in oligodendrocyte progenitor cells (OPCs), clearing lipid droplets that impede differentiation. In vitro, the drug enhanced OPC maturation and removed myelin debris, while in a cuprizone‑induced mouse model it restored myelin integrity and...
Dietary Fructo-Oligosaccharides Dose-Dependently Modulate the Microbiome and Suppress Type 2 Lung Inflammation in a Murine Model of House Dust Mite-Induced...
Researchers fed BALB/c mice diets containing 1 %, 2.5 %, 5 %, or 10 % fructo‑oligosaccharides (FOS) before and during house‑dust‑mite sensitisation. While overall eosinophil recruitment to the lungs was unchanged, FOS dose‑dependently lowered lung Th2 cell frequencies and reduced key type 2 cytokines such...
AI-Driven Partnership Targets Unmet Gynecological Diseases
We are very happy to join forces together with the wonderful ASKA to go after Novel Targets for Women's Health. Gynecological diseases have long posed challenges, including difficult diagnosis, limited treatment options, and a substantial disease burden, affecting millions of...
Ecnoglutide Approval Intensifies Competition in China GLP-1 Obesity Market
China's National Medical Products Administration approved Sciwind Biosciences' Ecnoglutide injection, marking the country's fifth GLP‑1 obesity therapy. The drug demonstrated a 15.4% average weight loss in the Phase III SLIMMER trial, with over 90% of participants achieving at least 5%...
P‑tau217 Predicts Dementia Risk with Combined Hormone Therapy
Blood levels of the Alzheimer's biomarker p-tau217 may help identify which women are more vulnerable to dementia when using combined hormone therapy after menopause, while estrogen-only therapy does not show the same association. menopause
SWIFT-Seq Maps Single-Cell Transcriptomes of Myeloma CTCs
SWIFT-seq enables comprehensive single-cell transcriptomic profiling of CTCs in multiple myeloma & precursors [Aug 8, 2025] Lightbody, @RomanosSP et al. @IrenemGhobrial - @LabGhobrial @NatureCancer https://t.co/LhqmRShFo9 #mmsm #LiquidBiopsy #cactc THREAD: https://t.co/87VZtDNy80 https://t.co/41MRROCXwI
Accumulus Technologies Launches the Accumulus Connector, Delivering Live Integration Across Regulatory Systems
Accumulus Technologies launched the Accumulus Connector, extending its platform into customers’ existing pharma and biotech systems for live, bi‑directional regulatory communication. The Connector provides real‑time, one‑click global submissions to more than 70 national regulators, eliminating manual data reconciliation. By integrating...
Sex‑specific Epigenetic Network Drives Cholesterol and Atherosclerosis
Sex-specific KDM6A-HNF4A-CREBH network controls lipoprotein cholesterol metabolism and atherosclerosis via epigenetic reprograming of hepatocytes https://t.co/2XpUt6ndcs https://t.co/r5DvCeGMeS
Focus on Fundamentals, Not Every New Sequencing Method
1/ I used to panic every time a new *Seq method dropped. ATAC-seq, CUT&Tag, scNOMe-seq, SHARE-seq... the list never ends. I tried to learn them all. I burned out. Here's what I wish someone told me earlier. https://t.co/xUlsvXmaQh
Latest TechBio News
Evotec SE announced that its Seattle CDMO, Just‑Evotec Biologics, has been selected by BARDA’s BioMaP‑Consortium for a multi‑year, up‑to‑$10 million program to optimize manufacturing of a monoclonal‑antibody cocktail against Ebola and Sudan viruses. The same day, Evotec disclosed that partner Bristol...
Direct Immune Cell Injection Eradicates Multiple Mouse Cancers
A potentially game-changing discovery by @UCSF's Justin Eyquem @j_eyquem & colleagues – injecting cancer-fighting immune cells directly into the body kills several types of cancers in mice. Paper in @Nature: https://t.co/EXbsfx7whl Summary/video by UCSF: https://t.co/qLYXXvEDTV
Oral PCSK9 Pill Slashes LDL Cholesterol by Up to 60% in Phase 3 Trial
Enlicitide, a once‑daily oral PCSK9 inhibitor, lowered LDL cholesterol by as much as 60% in a phase 3 trial of 2,909 high‑risk adults. The results, published in The New England Journal of Medicine, could shift cholesterol management from injections to...
Insmed’s ARIKAYCE Shows Positive Phase 3b ENCORE Results, Stock Rises 10%
Insmed Inc. announced that its Phase 3b ENCORE trial of ARIKAYCE in patients with new Mycobacterium avium complex lung infection met its primary and all secondary endpoints, showing significant improvements in culture conversion and symptom scores. The data sparked a...