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The FDA issued a warning letter to Henan Lvyuan Pharmaceutical after a September 2025 inspection uncovered multiple Current Good Manufacturing Practice (CGMP) violations. Inspectors cited severe facility maintenance issues, including corrosion and water leaks that could compromise API potency and foster microbial growth. The agency also found incomplete master batch records and inadequate segregation between drug streams, raising cross‑contamination concerns. FDA has demanded a detailed risk assessment, corrective‑preventive action plan, and a pledge not to ship certain APIs to the United States until compliance is verified.
The FDA issued Warning Letter 320‑26‑53 to Microbiological Testing & Consulting, LLC after a September 2025 inspection uncovered multiple Current Good Manufacturing Practice (CGMP) violations. The firm failed to maintain adequate laboratory controls, documentation, media qualification, and a functional quality‑control unit,...
Researchers used transcranial ultrasound to stimulate the amygdala during a fear‑conditioning experiment, finding that participants learned fear more slowly and extinguished it faster. The breakthrough suggests a drug‑free tool for anxiety, PTSD and self‑mastery.
The FDA’s recent “green list” designation has cleared more than 50% of Chinese manufacturers of GLP‑1 obesity drugs, effectively handing China a dominant role in the U.S. supply chain. Critics warn the move could expose American patients to substandard products...
Natera’s Signatera circulating‑tumor DNA test was shown in a prospective Clinical Cancer Research study to identify older women (≥70) with early‑stage ER⁺/HER2‑ breast cancer who can safely forgo surgery and remain progression‑free on primary endocrine therapy. Baseline MRD‑negative patients (68%...
The FDA issued a drug safety communication warning that Tavneos (avacopan) is linked to 76 post‑marketing cases of drug‑induced liver injury, including eight fatalities. Seven patients developed biopsy‑confirmed vanishing bile duct syndrome, a severe cholestatic condition, with three deaths. Median...
The FDA has released two public lists identifying registrants that failed to submit required drug amount reports for calendar year 2024. One list covers entities with active drug listings, the other captures those with inactive listings. Registrants must certify or...
The FDA’s Adverse Event Monitoring System (AEMS) released a slate of new safety signals for a range of products covering October‑December 2025. Alerts include heightened hypersensitivity reactions for certain lots of Alyglo, hypogammaglobulinemia linked to multiple bispecific T‑cell engager therapies,...
Eisai/Biogen’s Leqembi and Eli Lilly’s Kisunla are the only FDA‑approved disease‑modifying Alzheimer’s therapies, but they follow opposite treatment models—continuous dosing versus a finite course after amyloid clearance. Four‑year data presented at AD/PD 2026 showed Leqembi delayed disease progression by roughly 9.8 months, with...
Telomir filed IND for oral Telomir‑1 in TNBC. Data: clean GLP safety; Phase1/2 planned. Risk: pre‑revenue, weak balance sheet, stock -65%. Trade: speculative long on IND clearance. — Viktor Kopylov, PhD, CFA. More insights: t.me/si14Kopylov
NVIDIA has assembled a comprehensive AI infrastructure stack for healthcare, encompassing BioNeMo, MONAI, Isaac for Healthcare, Holoscan, Parabricks, Clara and NIM. Its 2026 State of AI in Healthcare survey shows 70% of organizations actively using AI, with generative models now...
As a medical school professor, I've long suspected that Alzheimer's disease is metabolic at its core. Now we have clinical proof. A Wake Forest trial tested empagliflozin -- a common diabetes drug -- in NON-DIABETIC Alzheimer's patients for the first time. The...
Pharma executives face mounting pressure to deliver faster, more successful product launches amid volatile markets and tighter timelines. Inizio Ignite’s Global President Remco op den Kelder argues that traditional static launch plans must give way to agile, data‑driven execution models....
The article charts the transition of pharmaceutical 3D printing from research pilots to routine pharmacy practice, focusing on pediatric compounding. Companies such as FabRx and CurifyLabs have built platforms that let pharmacists print chewable tablets, gels, and mini‑tablets tailored to...
Novo Nordisk introduced a subscription service for its obesity treatment Wegovy, allowing cash‑pay patients to lock in three‑month, six‑month or twelve‑month supplies. The model promises lower out‑of‑pocket costs compared with traditional pay‑per‑dose purchases. By bundling shots and oral pills, Novo...
UCB’s Kygevi, a combination of doxecitine and doxribtimine, received its first EU approval for treating thymidine kinase 2 deficiency (TK2d) under exceptional circumstances. The drug, aimed at patients whose disease began before age 12, cut mortality risk by 95% compared with...
PepGen reported that its Phase 2 trial of an oligonucleotide therapy for a rare genetic nerve‑muscle disorder failed to meet its primary efficacy endpoints. The data showed no statistically significant improvement in muscle strength across the cohort, and one participant experienced...
1/Another mega M&A deal in the BioTech and Pharma sector with the acquisition of Apellis Pharmaceuticals - $APLS by Biogen $BIIB for $41 per share in cash at closing in a $5.6B deal. In addition, Apellis stockholders will also receive...
Researchers led by Wu, Lei and Wang have shown that O‑GlcNAcylation of the metabolic enzyme UGDH reshapes its activity, steering UDP‑glucuronic acid production and downstream glycan synthesis. This post‑translational modification links nutrient‑sensing pathways to immune cell adhesion, migration, and signaling,...
Eli Lilly announced a $6.3 billion acquisition of Centessa Pharmaceuticals, marking its largest deal in years. The purchase secures Centessa’s orexin‑based insomnia candidate and a pipeline of early‑stage neurological programs. Lilly is channeling cash generated by its GLP‑1 blockbuster drugs into the...
Alltrna, a biotech startup focused on transfer RNA (tRNA) therapeutics, has secured regulatory clearance to launch its first human clinical trial. The trial will evaluate a novel tRNA‑based drug designed to correct protein synthesis errors that underlie a range of...
Enveda Biosciences released its first clinical readout for an investigational atopic dermatitis therapy, showing efficacy comparable to AbbVie's Dupixent. The Phase 1 trial met its primary endpoints, demonstrating significant skin clearance and a safety profile similar to existing biologics. The...
Semarion, a Cambridge spin‑out, secured $3.8 million (≈£2.9 million) in a Series A round led by Parkwalk to scale its SemaCyte cell‑based screening platform. The funding follows a $2.89 million seed round in 2022 and will be used to expand manufacturing, field support,...
Two peer‑reviewed studies released this week reshape how depression is treated. Psychologists found that describing depression as a functional signal, not a brain defect, improves patients' expectations and reduces perceived chronicity. Meanwhile, Japanese neuroscientists identified the enzyme NOX‑1 as an...
A randomized trial of 958 adults aged around 70 found that two years of daily multivitamin–multimineral supplementation reduced the yearly rise of two epigenetic clocks by 2.6 and 1.4 months respectively. The modest effect, published in Nature Medicine, fuels debate...
Researchers have shown that low‑protein diets (LPDs) stimulate the conversion of white adipose tissue into thermogenic beige fat, mirroring effects seen with cold exposure or β‑adrenergic activation. The browning response depends on specific gut microbes; germ‑free mice fail to brown,...
RenovoRx announced a widened FY25 net loss of $11.2 million, despite its first full year of revenue from the FDA‑cleared RenovoCath device. The company also outlined a timeline to complete enrollment for its Phase III TIGeR‑PaC oncology trial by mid‑2026, a move...
Scientists at the University of Michigan have demonstrated that protein‑coated nanoparticles can efficiently deliver DNA and mRNA to liver cancer, kidney and immune cells in vitro, marking a potential shift away from viral vectors in gene therapy. The platform uses...
Galapagos NV and Gilead Sciences have signed a binding framework agreement that gives Galapagos a 50% share of the $1.675 billion upfront consideration for Gilead’s acquisition of Ouro Medicines. The deal also locks in a $500 million cash pool for Galapagos, including...
Eric Kelsic said: "To address the root cause of a genetic disease, you need to take action at the genetic level." But this isn’t possible today. If you have sickle cell, Huntington's or cystic fibrosis, there's no cure for you just yet. Here's...
Soley Therapeutics’ co‑founder and CEO Dr. Yerem Yeghiazarians explained the company’s novel strategy of using small‑molecule drugs to reverse cellular stress rather than targeting a specific virus or gene. The platform aims to restore function in stressed cells implicated in non‑oncology...
AstraZeneca’s Alexion unit intends to file a new long‑acting enzyme replacement therapy, efzimfotase alfa, as a successor to its Strensiq (asfotase alfa) for hypophosphatasia (HPP). Phase 3 data showed the drug met primary endpoints in pediatric patients but failed to achieve...
Researchers reported that homoharringtonine (HHT), a plant‑derived alkaloid already approved for certain blood cancers, acts as a potent senolytic in mice. The compound selectively eliminated senescent cells across adipose, liver and muscle, leading to lower inflammation, improved glucose tolerance and...
Researchers solved the atomic structures of two neutralizing monoclonal antibodies against the pandemic GII.4 norovirus, targeting the principal antigenic sites A and G. The spatial positioning of site G was shown to shape neutralizing responses, while coordinated substitutions within these...
Harvard researchers uncovered that post‑natal skin scarring is driven by fibroblast‑produced Cxcl12, which triggers excessive nerve growth that blocks full tissue regeneration. By deleting Cxcl12 or applying Botox to suppress local nerve signaling, mice healed wounds without scars, restoring all...
Blackstone announced that its sixth life sciences fund, BXLS VI, closed at $6.3 billion, making it the largest private fund ever raised for the sector. The fund was oversubscribed and is about 40% larger than the $4.6 billion fifth fund closed in 2020,...
Merck presented Phase III CORALreef AddOn trial results for enlicitide decanoate, an oral PCSK9 inhibitor, in hypercholesterolemic adults on statins. At eight weeks, the drug lowered LDL‑C by 64.6%, outperforming bempedoic acid, ezetimibe and their combination. It also achieved 54.6%...
Psychedelic biotech firms Helus Pharma and AtaiBeckley have hired marketing agencies to produce YouTube videos that tout exaggerated efficacy claims and alleged FDA fast‑track status for their investigational drugs. The ads, labeled only as “informational,” suggest near‑perfect Phase 2 results and...
Standing Ovation, a French precision‑fermentation startup, closed a €30 million Series B round (≈$32.5 million) led by the France 2030‑backed Ecotechnologies 2 fund and Crédit Mutuel Innovation, with participation from Danone Ventures, Bel Group and other investors. The financing includes €25 million in equity (≈$27 million) and...
Teva Pharmaceutical received U.S. FDA approval for Ponlimsi, a biosimilar to Amgen’s Prolia (denosumab), covering all approved indications. The approval was granted after extensive analytical and clinical studies demonstrated comparable efficacy, safety, and immunogenicity to the reference product. In parallel,...
Researchers have unveiled a vertically stacked paper‑based microarray device (µAPAD) that integrates the full immunoassay workflow for high‑throughput SERS detection of cancer biomarkers. The 16‑layer wax‑patterned platform ensures uniform nanotag distribution, cutting signal variation from 36.6% to 6.69% and enabling...
Researchers have unveiled a fully water‑based lipid nanoparticle (LNP) platform that eliminates cholesterol and PEG, using poly(2‑methyl‑2‑oxazoline) as a stealth polymer. The solvent‑free formulation enables efficient delivery of CRISPR‑Cas9 components, achieving robust gene editing in primary human immune cells and...
Researchers have engineered a bioinspired nanoparticle that co‑assembles an anti‑VEGF peptide with copper ions, adds a ROS‑scavenging moiety and a cell‑penetrating peptide, and achieves deep corneal delivery. The formulation extends ocular residence to roughly 70 minutes and reaches 300 µm in a...
A mouse model of parenteral nutrition‑associated liver disease (PNALD) was analyzed using combined RNA‑sequencing and untargeted metabolomics. Integrated machine‑learning pipelines (LASSO and SVM‑RFE) pinpointed five gene biomarkers (Itgam, Clec4d, Orm2, Lcn2, Cd14) and three metabolites (6‑n‑octylaminouracil, 6β‑hydroxy‑hydromorphone, α‑teresantalic acid). These...
A post‑hoc analysis of the SURPASS‑CVOT trial finds the dual GLP‑1/GIP agonist tirzepatide lowers a broad six‑component cardiorenal endpoint by 14% compared with the GLP‑1‑only drug dulaglutide. The result, presented at ACC 2026, could reshape how biohackers approach metabolic health...
Aurinia Pharmaceuticals announced a definitive agreement to acquire Kezar Life Sciences for $6.955 in cash per share plus a contingent value right (CVR). The deal, slated to close in Q2 2026, gives Aurinia access to Kezar’s lead immunoproteasome inhibitor, zetomipzomib, and...
Researchers from OIST, ISTA, Vienna and CAB published a computational study in PNAS showing that common ancestry, rather than selection or epistasis, is the primary constraint on protein sequence diversification. By estimating the effective dimensionality of protein families and simulating...
Hopefully blood testing companies can measure GDF15 sooner than later... A deep-learning based biomarker of systemic cellular senescence burden to predict mortality and health outcomes https://t.co/lqM7w3aPfJ
Immune Modulation, Inc. announced it is finalizing pre‑IND toxicology and pharmacokinetic studies to file an FDA submission for hypoestoxide, a plant‑derived anti‑inflammatory candidate for Parkinson's disease. The move caps a 30‑year scientific trek that began with a rainforest compound identified...
United Therapeutics reported that its TETON-1 Phase III trial met the primary endpoint, delivering a 130.1 mL improvement in forced vital capacity for idiopathic pulmonary fibrosis patients. The news lifted the stock more than 12% and set the company on a path...
