Know What's Happening in BioTech
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Every morning
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A new study published in Nature Medicine shows that a single course of antibiotics can alter the gut microbiome for up to eight years. Researchers linked Sweden’s national drug‑dispensing register with microbiome data from 14,979 adults, revealing lasting changes in bacterial diversity. The strongest long‑term effects were observed for clindamycin, fluoroquinolones and flucloxacillin, while penicillin V caused only brief shifts. Follow‑up sampling is underway to map recovery trajectories.
ICON Biotech’s 2025 survey of 163 global biotech leaders, plus 100 Chinese executives, reveals shifting dynamics as China overtakes the United States in innovative trial volume and is projected to contribute 35% of FDA approvals by 2040. Funding remains scarce,...
Canada‑based Kainova Therapeutics announced positive top‑line results from its Phase I EPRAD study of DT‑9081, an oral EP4 receptor antagonist, in patients with advanced, recurrent and metastatic solid tumours. The trial, conducted at four sites in Belgium and France, met all...
The 3rd International Conference on the Ethics of Engineering Life (ICEEL 2026) will be held online March 23‑24, 2026, and is free to attend. Organized by the University of Basel, ETH Zurich, the Pontifical Academy for Life and Bambino Gesù Hospital,...
Osteoarthritis incidence is climbing as populations age and obesity spreads, intensifying health and economic pressures. Conventional treatments merely decelerate disease progression and often entail systemic side effects or surgical risks. Emerging hydrogel microsphere platforms create a biomimetic joint microenvironment, offering...
GELITA and Black Drop have signed an R&D agreement to develop methacrylated gelatin (GelMA) bioinks for 3D bioprinting applications. The partnership will leverage GELITA’s ultra‑low endotoxin gelatin (MEDELLAPRO) and Black Drop’s custom bioprinting platforms to create clinically usable, scalable bioinks....
Grand Avenue Software has published its 2026 Life Sciences Quality, Compliance & Operations Benchmark Report, drawing on hundreds of responses from QA, regulatory affairs and manufacturing professionals. The study reveals wide variation in FDA QMSR readiness, persistent quality improvement hurdles,...
Out‑Of‑Pocket’s 2025 outlook forecasts a turning point for several health‑care segments. Obesity drugs such as GLP‑1s are expected to become cost‑effective as pricing pressure and outcomes‑based contracts expand access. AI models will split, with healthcare‑specific versions emphasizing explainability, security and...
Swedish precision‑fermentation startup Melt&Marble has obtained regulatory clearance to commercialise its animal‑free “designer fats.” The MeltyMarble fat received US Generally Recognized as Safe status, while its Marble7 lipid earned an INCI name for worldwide personal‑care use. Backed by an $8.5 million...
In this episode, Daniel Levine interviews Richard Freed, CEO of Rheumagen, about the pivotal role of HLA genes in autoimmune diseases and the company’s innovative gene‑editing approach to cure them. Freed explains how a single amino‑acid change at a conserved...
Russia is expanding its national genetics database by adding data from 80,000 additional individuals, focusing on patients with socially significant diseases. The first phase (2020‑2024) already catalogued over 200,000 genomes from healthy volunteers, creating one of the world’s largest variant...
Big pharma is intensifying its M&A hunt as the pool of late‑stage biopharma assets shrinks, turning deal processes into competitive auctions. Sellers are leveraging multiple inquiries to secure higher upfront cash and better terms, while unsolicited public bids—exemplified by the...
The Role of Cellular Senescence and SASP in the Pathogenesis of Atherosclerosis and the Therapeutic Potential of Senolytic Strategies in Cardiovascular Diseases "Cellular senescence and SASP drive chronic inflammation and vascular dysfunction central to atherosclerosis pathogenesis, with senescent endothelial cells, VSMCs,...
Correct. There will likely be no RCTs on BPC. Unless a new variant can perform better and be patented and Rx’d… and THATs happening.
Veru Inc. reported a $23.4 million public offering that lifted cash and working capital to $33 million and $29.7 million respectively, while narrowing its quarterly net loss to $5.3 million ($0.26 per share). The company received FDA feedback confirming two regulatory pathways for its...
Lab-grown teeth might become an alternative to dental fillings by @Khulood_Almani #HealthTech #Healthcare #Technology #Innovation #TechForGood https://t.co/S4x8tYCjaq
Researchers solved cryo‑EM structures of Marburgvirus (RAVV) glycoprotein (GP) in three states—unbound, bound to human NPC1‑C, and bound to a neutralizing nanobody. The structures reveal a flexible glycan‑cap loop that partially blocks the receptor‑binding site and a distinct NPC1 binding...
Kamada reported Q3 2025 revenue of $47 million, a 13% year‑over‑year increase, and adjusted EBITDA of $11.7 million, up 34% from the prior year. The company reaffirmed its full‑year revenue target of $178‑$182 million and adjusted EBITDA guidance of $40‑$44 million, citing strong performance...
A multinational team integrated single‑cell and single‑nucleus RNA sequencing, 10x Xenium spatial transcriptomics, and live‑cell imaging to map heterogeneity in supratentorial ependymomas (ST‑EPN). The study profiled 42 tumors across all molecular subgroups, uncovering eight recurrent transcriptional metaprograms that align with distinct...
A high‑resolution clinical surveillance program in Bangladesh identified a novel phage‑inducible chromosomal island‑like element, PLE11, that rapidly spread through Vibrio cholerae populations, reaching 91% prevalence within nine months. PLE11 conferred resistance to the dominant lytic phage ICP1 despite the phage’s...
Vanda Pharmaceuticals reported 2025 revenue of $216.1 million, up 9% year‑over‑year, driven primarily by Fanapt’s 24% sales increase and a successful bipolar launch. The company secured FDA approval for tradipitant (Nirius) to prevent motion‑sickness vomiting, with a commercial rollout slated for...
Scientists have engineered Aedes aegypti mosquitoes to carry oral vaccines for rabies and Nipah virus, allowing the insects to inoculate bats through feeding or saline drinking stations. Laboratory trials showed that vaccinated bats and mice generated neutralising antibodies and survived...
CareDx reported fourth‑quarter 2025 revenue of $108.4 million, a 25% year‑over‑year increase, driven by strong testing services and rapid growth in patient‑digital solutions. Adjusted EBITDA fell 34% to $6.5 million, reflecting a one‑time $6.7 million non‑executive cash bonus, while cash balances topped $200 million...
Elutia Inc. reported a 49% sequential revenue surge for its LU Pro bio‑envelope, driven by new hospital contracts and seven national GPO agreements, pushing the product toward a $20 million run‑rate by year‑end. The company settled the bulk of legacy litigation, resolving...
Researchers have described a new African psychedelic mushroom, Psilocybe ochraceocentrata, that closely resembles the well‑known Psilocybe cubensis. Genetic analysis shows the two share a common ancestor about 1.5 million years ago, overturning the long‑held belief that cattle introduced P. cubensis to the...
The FDA granted approval for leucovorin calcium tablets to treat a rare genetic disorder that impairs folate transport to the brain. Unlike typical approvals, the agency relied primarily on a handful of patient case reports rather than a sponsor‑run clinical...
![Understanding the Science Behind Embryo Grading Improves IVF Decision Making [PODCAST]](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://kevinmd.com/wp-content/uploads/Design-1-scaled.jpg)
In a KevinMD podcast, reproductive endocrinologist Dr. Erica Bove breaks down embryo grading, contrasting day‑three cell counts with day‑five blastocyst morphology. She explains how labs assess cell number, fragmentation, trophectoderm and inner cell mass to assign grades such as 8A...
The FDA approved 18 biosimilars in 2025, spanning six therapeutic areas and marking a surge in interchangeable designations to over 20. A wave of denosumab biosimilars and first‑in‑kind interchangeable products such as Poherdy® and Omlyclo® highlighted market diversification. BPCIA litigation...
Researchers at the University of Toronto have engineered synthetic long non‑coding RNA (lncRNA) molecules that can dampen inflammatory responses. The study, led by PhD student Janice Pang and biologist Omar Khan, demonstrates that these engineered lncRNAs reduce cytokine release in...
Ochsner Health and the MD Anderson Cancer Center have launched a joint precision radiation oncology program in New Orleans, marking the first Southern U.S. facility to offer MR‑guided adaptive radiotherapy. The center leverages AI‑driven treatment planning and real‑time imaging to...
Protara Therapeutics reported a Q4 2025 loss of $0.37 per share, an improvement from the $0.48 loss a year earlier. The narrowing loss reflects higher clinical development spending as the company advances its lead cell‑therapy candidate, TARA-002, into Phase II...
Neuland Laboratories announced that the first module of its new commercial peptide manufacturing facility will be operational by summer on its 17‑acre Bonthapally campus in India. The module adds 6,370 L of solid‑phase and liquid‑phase peptide synthesis capacity, ranging from 250 L...
Researchers published a comparative study in Pediatric Research showing that procalcitonin (PCT) rises within 6‑12 hours of infection in very low birth weight infants, while C‑reactive protein (CRP) peaks later at 24‑48 hours. The data reveal that PCT offers higher...
A new tool called AI‑enabled Quantum Refinement (AQuaRef) merges quantum‑mechanical calculations with machine‑learning to refine protein structures. Developed by Lawrence Berkeley National Lab and Carnegie Mellon, it is integrated into the Phenix software suite used worldwide. In tests on 71...
Lundbeck chief executive Charl van Zyl warned that Europe’s fragmented drug‑pricing regime threatens biotech sustainability and patient access. He cited recent remarks by HHS Secretary Robert F. Kennedy Jr. suggesting Europeans already pay higher prices than Americans. Van Zyl called...
The FDA has cleared Pylarify TruVu, a reformulated version of Lantheus’ PSMA‑targeting radiopharmaceutical piflufolastat F‑18. The new formulation improves stability at higher radioactive concentrations, enabling larger batch production and broader distribution. Lantheus plans a Q4 2026 commercial launch with a rolling geographic...
Johnson & Johnson has filed a Type II variation with the European Medicines Agency to add teclistamab, a bispecific T‑cell‑redirecting antibody, as a second‑line monotherapy for relapsed/refractory multiple myeloma. The Phase III MajesTEC‑9 trial, enrolling 614 patients, demonstrated a 71 % reduction in...
The FDA has expanded approval of leucovorin calcium tablets as the first therapy for cerebral folate transport deficiency linked to FOLR1 gene variants. The decision relied on published case literature, showing 87‑89% of patients achieved clinical improvement. In oncology, AstraZeneca...
Tenax Therapeutics Inc. posted a Q4 2025 net loss of $0.38 per share, reflecting continued investment in its clinical-stage pipeline. The company’s cardiopulmonary portfolio includes TNX-101, TNX-102 and TNX-103, which have all cleared Phase II trials for pulmonary hypertension in...
Australian startup Samsara Eco, which uses AI‑designed enzymes to break down plastics into reusable monomers, is raising more than $70 million to apply the technology to extract critical minerals from electronic waste. The company, backed by Temasek, Hitachi’s VC arm and...
Several U.S. universities have launched two‑year medication safety fellowships that rotate participants through academic training, a major pharmaceutical company, and the FDA. Butler University offers two tracks with Regeneron and Eli Lilly, Purdue partners with AbbVie, and Rutgers collaborates with Pfizer....
Peptide therapeutics are booming, with more than 2,000 candidates in discovery and pre‑clinical stages and projected global sales of $91.4 bn by 2025. Companies like Orocidin faced severe synthesis and purification hurdles for their QR‑01 peptide, but Syngene’s custom low‑loading resin...
Johns Hopkins Medicine is heading a five‑year, $24 million NIH‑funded Hepatitis B and HIV Cure Consortium that brings together research teams from the United States, Brazil, India, Senegal and Uganda. The first year will enroll 450 participants co‑infected with HIV and chronic...
Is biology finally becoming too complex for static models? For decades, biological modeling has relied on fixed equations, narrow simulations, and local approximations. That works until it doesn’t. Once you move into real systems, gene regulation, signaling cascades, protein networks, the...
"AI will not replace biological reasoning, but it may become indispensable for navigating biological systems whose complexity exceeds human intuition." A perspective on future applications for cancer neuroscience https://t.co/TnDFZ7NRFN @scisignal https://t.co/ijbhfbjXcs
A multicenter retrospective study of 17 Chinese patients with juvenile myasthenia gravis found that weekly efgartigimod 10 mg/kg for four weeks produced rapid and substantial clinical improvement. Clinically meaningful improvement was observed in 70.6% of patients by week 1 and 91.7% by...
Crazy cool > Embedded soft, stretchable electronics into tiny clusters create cyborg islet organoids. Miniature pancreas-like tissue can eavesdrop on the electrical charging of individual lab-grown cells, learning to sense glucose and release hormones. https://t.co/0ntJ3cJ16n
Last fall the administration was talking about leucovorin as a potential treatment for large numbers of people with #autism. Today's approval suggests the evidence supports its use in a much smaller group of people, @rosebroderick_ reports. https://t.co/NlJR8KlaqP
BioNTech announced it will create an independent biotech company dedicated to next‑generation mRNA technologies. The spin‑out will be led by co‑founders Ugur Sahin and Özlem Türeci, who will assume management by the end of 2026. BioNTech will contribute core mRNA assets in...
CSL‑Behring broke ground on a $1.5 billion expansion of its Kankakee, Illinois manufacturing complex, slated to be operational by 2031. The project will add at least 300 pharmaceutical positions and roughly 800 construction jobs, with the state offering more than $200 million...
