FDA Says It Explained Issues Early on for Corcept's Rejected Cushing's Syndrome Drug
The U.S. Food and Drug Administration issued a formal rejection of Corcept Therapeutics' experimental treatment for Cushing's syndrome, stating that it had raised serious scientific concerns early in the review process. FDA officials say they communicated these issues to Corcept well before the company filed its final application, giving the firm an opportunity to address them. Despite the feedback, the agency concluded the data package remained insufficient for approval. The decision postpones any potential market launch and adds uncertainty to Corcept's pipeline timeline.
Model‑Robotics Loop Accelerates Experimental Discovery Rates
Agree completely with @kevinweil this loop between models and robotic labs works today and it’s going to be exciting the directions that scientists take autonomous labs. Feels inevitable that it will yield a great speed up in our...
Kinetochores Regulate Anaphase Spindle Length via Depolymerization
Researchers have uncovered that kinetochores actively regulate anaphase spindle length by promoting microtubule depolymerization. Live‑cell imaging and laser ablation experiments showed that loss of kinetochore‑mediated depolymerization reduces spindle length by roughly 15‑20 percent. The study identifies the kinesin‑13 family protein...
Despite Wide Support for Rare Disease, Voucher Program Caught Up in Senate's ICE Fight
The Senate’s failure to pass the omnibus spending bill left the rare‑pediatric priority review voucher (PRV) program without reauthorization, prompting biotech CEOs to intensify lobbying. Without a renewal, about 200 rare‑disease therapies could lose eligibility, threatening up to $4 billion in...
Vetter Announces Plan to Build Manufacturing Site in Germany with €1.5 Billion CDMO Investment
Vetter Pharma announced a €1.5 billion expansion to build a new commercial sterile‑injectable manufacturing plant in Saarlouis, Germany, slated to create up to 2,000 jobs and begin phased construction in Q2 2026. The investment also includes a clinical production facility in Des Plaines,...
The Pros and Cons of Pesticides and Fertilizers in Real-World Mandarin Orange Farms
Researchers at Japan's RIKEN Center applied inverse probability weighting to data from mandarin orange orchards in 12 prefectures, revealing that cutting chemical pesticides boosts soil microbial diversity but also increases leaf‑pathogen fruit diseases. The analysis showed soil carbon improves when...
Decoding Ashwagandha’s Withanolide Genes via Yeast
Researchers have mapped the complete set of genes responsible for withanolide biosynthesis in Ashwagandha and successfully transferred them into engineered Saccharomyces cerevisiae. The yeast platform produced withanolide A and related compounds at concentrations exceeding 150 mg per liter, a five‑fold improvement over prior...
Nipah Risk Moderate Locally, Low Globally, Not Like Covid
For those worried about #Nipah virus: Yes, it's a dangerous disease. Yes, India has recently reported 2 cases. But Nipah doesn't spread as easily as Covid. "WHO assesses the risk posed by Nipah to be moderate at the sub-national level, and...
Regeneron Unveils Next‑Gen Dupixent Amid Rising Competition
There's a fascinating fight brewing between Regeneron and, well, everybody else. But what do we call it? Dupixent, the treatment for atopic dermatitis and other autoimmine issues that $REGN sells with Sanofi, is one of the biggest selling drugs in the...
Bitterroot Reverts to Preclinical Biotech in CD47 as CEO Leaves
Bitterroot Bio, a specialist in CD47 immunotherapy, announced that its program has reverted to the pre‑clinical discovery stage after a brief push toward clinical development. The move coincides with the unexpected resignation of its chief executive officer, raising questions about...
Moderna Swaps Vaccine Chief as Development Hurdles Rise
Another possible data point on the challenges for new vaccine development: Moderna's chief medical officer, Jacqueline Miller, a longtime vaccine developer who rose through the ranks at GSK and Merck, is departing. David Berman, a veteran of immuno-oncology efforts at AstraZeneca...
CHMP Opposes Lilly’s Mounjaro in Heart Failure, Backs Novo’s Kayshild
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) voted against extending Eli Lilly’s weight‑loss drug tirzepatide (Mounjaro) to treat heart failure, citing insufficient efficacy data. In the same meeting, the CHMP gave a positive opinion to...
Amgen Gives up on Its Once-Prized Eczema Drug
Amgen has terminated its collaboration with Kyowa Kirin on the OX40‑targeting eczema drug rocatinlimab, returning all rights to the Japanese partner. The decision follows Phase 3 trials that met primary endpoints but failed to demonstrate superiority over established therapy Dupixent and showed...
Ultragenyx Resubmits Gene Therapy for Rare Neuro Disease to FDA
Ultragenyx has re‑submitted its FDA approval request for UX111, an adeno‑associated virus (AAV) gene‑therapy targeting a rare neurodegenerative disease. The company previously faced a complete response letter last summer, prompting additional pre‑clinical work and safety analyses. UX111 aims to replace...
Ex-CEO Behind Bars, 10x’s Clinical Ambitions, Pharma’s AI Gambit
The former CytoDyn chief executive was sentenced to 30 months in prison after convictions for securities fraud, wire fraud and insider trading. Meanwhile, major pharmaceutical companies are accelerating AI adoption, signing multi‑billion‑dollar deals with platform providers such as Nvidia and...
Quince's Steroid Therapy for Rare Disease Fails, Shares Tank
Quince Therapeutics announced that its once‑monthly steroid‑based therapy for ataxia‑telangiectasia failed to meet the primary endpoint in a pivotal Phase 3 trial. The rare genetic disorder affects roughly 1 in 100,000 children and currently lacks disease‑modifying treatments. Following the data...
Moderna Licenses Phase 3 Asset to Recordati; ProMIS' Private Placement
Moderna has signed a licensing agreement with Italy’s Recordati to transfer a Phase 3 rare‑disease mRNA therapeutic to the European drugmaker. The deal provides Recordati with worldwide commercialization rights, an upfront cash payment estimated at $150 million, and a series of development...
Amgen Ends Partnership with Kyowa Kirin on Immunology Drug, Despite Phase 3 Wins
Amgen abruptly terminated its collaboration with Japan’s Kyowa Kirin on a late‑stage immunology candidate, returning all rights to the partner despite the drug’s recent Phase 3 success. The move aligns with Amgen’s broader strategic shift toward internal R&D priorities and upcoming biosimilar...
Lilly Unveils $3.5B Factory that Will Make Retatrutide and Other Obesity Drugs
Eli Lilly has allocated $3.5 billion to build a new manufacturing complex in Pennsylvania’s Lehigh Valley that will produce its next‑generation obesity injectable retatrutide and related compounds. The plant is designed for flexible, single‑use bioreactor technology and aims to output over a...
Lanifibranor (IVA-337)
Lanifibranor (IVA-337) is an oral pan‑PPAR agonist entering Phase 3 trials for metabolic dysfunction‑associated steatohepatitis (MASH/MASLD). The molecule was optimized from high‑throughput screening and its preclinical data were published in the Journal of Hepatology in June 2025. Inventiva Pharma is leading development,...
FDA’s Multiple Myeloma Guidance Highlights Decade of Success
The FDA released draft guidance urging sponsors of multiple myeloma drugs to use minimal residual disease (MRD) negativity as the primary endpoint for accelerated approval, moving beyond traditional overall response rates. The agency defines MRD‑negative as one cancer cell per...
Polish Nurses’ Evidence-Based Practice: Knowledge and Leadership Insights
Evidence‑based practice (EBP) is essential for modern nursing, linking care decisions to the best research. A cross‑sectional study by Miszewska and Zarzeczna‑Baran surveyed Polish nurses across specialties, revealing a stark split in EBP competence. While a minority demonstrated solid knowledge,...
Long COVID Impact: Ethnic Variations in Symptoms
A recent multinational cohort study reveals pronounced ethnic disparities in long COVID symptom profiles. Black and Hispanic patients report fatigue and neurological complaints at rates significantly higher than White counterparts, even after adjusting for age and comorbidities. Socioeconomic deprivation and...
Resurrecting Ancient Enzymes in NASA’s Search for Life Beyond Earth
NASA‑backed researchers have resurrected a 3.2‑billion‑year‑old nitrogenase enzyme, demonstrating that its nitrogen‑isotope signature remains unchanged despite billions of years of molecular evolution. By reverse‑engineering modern nitrogenase, the team recreated ancestral versions and expressed them in microbes, confirming that the isotopic...
3D Patellar Shape Linked to Dislocation Risk
A new study by Yan, Yao, and Liu demonstrates a direct link between three‑dimensional patellar shape and the likelihood of patellar dislocation. Using automated coordinate algorithms and statistical shape modeling on a diverse cohort, the researchers identified distinct geometric features...
Opentrons Global Robotics Chief, James Atwood, Named Chief Executive Officer
Opentrons Labworks has promoted James Atwood, who has led its Robotics Business Unit since April 2023, to chief executive officer. Under his guidance the company expanded its installed base to more than 10,000 robotic systems deployed worldwide across academia, biotech...
Stable Coacervate Microdroplets as Robust Microreactors for Enhanced Enzymatic Catalysis
Researchers have engineered highly stable coacervate microdroplets using polyethyleneimine (PEI) and sodium thioctate (ST) that resist coalescence for over 35 days without any additives. The droplets exploit electrostatic and hydrophobic interactions, creating a charge‑repelled surface that preserves structural integrity. They...
Multifunctional Biomimetic Hematoma Microspheres for Sustained Local Hydrogen Sulfide (H2S) Delivery to Enhance Vascularized Bone Regeneration
Researchers have engineered biomimetic hematoma microspheres that combine a pH‑responsive GelMA outer layer with a NaHS‑loaded liposomal core to deliver hydrogen sulfide (H₂S) directly to bone defect sites. The microspheres release H₂S in acidic environments, simultaneously reducing chronic inflammation, stimulating...
Bioinformatics Needs Nuance, Not Hard Cutoffs
You can not do Bioinformatics with hard cutoffs and thresholds Let me tell you something real: Biology is more about p-values. It’s messier than that. 🧵 https://t.co/iewqWMvU6D
Funding Uncertainty Threatens Future US Science Talent
With continued uncertainty over federal government support for biomedical research, PhD students are struggling to find labs willing to take on new students, @JonathanWosen reports. New students are the future of US science. https://t.co/1eeq2PAbCm
Alginate/PCL Dressing for Silver Nanoparticle and PDGF-B Delivery
Researchers have engineered an alginate/polycaprolactone (PCL) composite dressing that co‑delivers silver nanoparticles and platelet‑derived growth factor‑B (PDGF‑B). The hybrid matrix provides sustained antimicrobial release while preserving the bioactivity of PDGF‑B to stimulate tissue regeneration. In vivo tests on rodent wound...
Johnson & Johnson’s Pipeline Strategy: What Does 2026 Have in Store for the Big Pharma?
Johnson & Johnson entered 2026 aiming for $100‑$101 billion in sales after a 9.1 % Q4 revenue rise to $24.6 billion. The company is banking on its oncology portfolio—particularly Darzalex, Tecvayli, Carvykti and emerging lung‑cancer combos—to offset the imminent loss of exclusivity for...
TrumpRx Delayed Amid Potential Anti-Kickback Concerns
The White House postponed the rollout of TrumpRx, the federal direct‑to‑consumer drug marketplace. Officials cite potential violations of the federal anti‑kickback statute as a key factor, prompting HHS to issue a guidance bulletin outlining required safeguards. Major manufacturers including Pfizer,...
EMA Looks Into 'Data Integrity' Issue with Amgen's Tavneos
The European Medicines Agency has opened a review into the data integrity of the pivotal ADVOCATE trial that underpinned the EU approval of Amgen’s oral complement C5 inhibitor Tavneos. The regulator’s concerns focus on how the study data were handled...
How Brick-Building Bacteria React to Toxic Chemical in Martian Soil
Researchers at the Indian Institute of Science examined how perchlorate, a toxic chemical in Martian regolith, influences biocementation by a robust native strain of Sporosarcina pasteurii. While perchlorate slows bacterial growth, it triggers extracellular matrix formation that creates microbridges, resulting...
Sorghum Genotypes Show Anthracnose Resistance in Ethiopia
Researchers in Ethiopia identified several sorghum genotypes that exhibit strong resistance to anthracnose, a fungal disease that can devastate yields. Field trials across major growing regions showed up to 20% higher grain production compared with susceptible varieties under disease pressure....
Pinus Nigra’s Defense Mechanisms Against Diplodia Sapinea
Researchers have detailed how Pinus nigra (black pine) resists infection by the fungal pathogen Diplodia sapinea, which causes tip blight and significant timber loss. The study highlights rapid resin exudation, elevated phenolic production, and a coordinated transcriptional shift toward defense...
Sanofi Moves Away From mRNA Flu Vaccine as CEO Projects Confidence
Sanofi announced it has deprioritized its SP0237 mRNA‑based seasonal flu vaccine, removing the candidate from near‑term launch plans. The hexavalent shot was in a Phase I/II safety and immunogenicity trial for adults over 50, which remains active but is not recruiting...
Mosaic’s Nanoneedle Granted Advanced Manufacturing Technology Designation for Gene Therapy Products
The FDA’s Center for Biologics Evaluation and Research granted NanoMosaic an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle platform, which multiplexes vector genome and capsid titer testing in AAV gene‑therapy production. The designation confirms the technology’s ability to streamline...
IDDI Unveils New Brand, Marks 35 Years of Clinical Data Science Excellence
IDDI, a global clinical data science partner, launched a refreshed brand to mark its 35‑year anniversary, debuting publicly at the SCOPE Summit on February 2, 2026. The new identity underscores a patient‑centric approach, biostatistical rigor, and regulatory insight while highlighting...
Summit’s Potential Keytruda Rival Gets November FDA Decision Date
The U.S. Food and Drug Administration has set a November 14 deadline to rule on Summit Therapeutics’ bispecific antibody ivonescimab, which targets PD‑1 and VEGF in EGFR‑mutant non‑small cell lung cancer. Summit’s Phase III HARMONi trial demonstrated a roughly 50% improvement in...
Three More Biotechs Price Their Nasdaq IPOs
AgomAb Therapeutics, SpyGlass Pharma, and Veradermics have filed Nasdaq IPO pricing, each seeking $150‑200 million. AgomAb plans to sell 2.5 million shares at $15‑$17, targeting a post‑money valuation near $875 million. SpyGlass will issue 9.4 million shares at the same price range, aiming for...
Janux Hires CMO After T Cell Engager Deal with Bristol Myers; A Batch of Appointments at Lexeo
Janux Therapeutics announced the appointment of William Go, M.D., Ph.D., as its new chief medical officer, replacing Zachariah McIver. The hire follows a recently disclosed partnership with Bristol Myers Squibb that provides a $50 million upfront payment for Janux’s T‑cell engager...
Politicization Runs Deeper than Ever at FDA, Risking Long-Term Impacts
The FDA has undergone an unprecedented wave of politicization in the past year, marked by mass staff departures, early retirements, and a surge of political appointees across senior roles. This shift has altered advisory committees, review processes, and introduced the...
Facial Skin Regenerates with Less Scarring, and the Underlying Mechanism Could Be Applied Elsewhere in the Body
Researchers have uncovered why facial skin heals with less scarring than other body sites. They identified a signaling pathway centered on the protein ROBO2 that keeps facial fibroblasts in a low‑fibrotic state by inhibiting EP300. In mouse models, pharmacologic EP300...
Reed Jobs' Cancer Biotech Investment Firm Yosemite Eyes $350M Fund
Yosemite, the cancer‑research investment firm led by Reed Jobs, is seeking to raise a fund of up to $350 million. The capital target positions the firm among the largest early‑stage biotech funds currently forming. Jobs leverages his Silicon Valley connections and...
AI Battle: GPT-5, DeepSeek, Claude Tackle Dental MCQs
A recent study evaluated three leading AI models—GPT‑5, DeepSeek, and Claude—on multiple‑choice questions that simulate dental treatment scenarios for medically compromised patients. GPT‑5 delivered the most accurate and comprehensive answers, while DeepSeek excelled in localized problem solving but faltered on...
Metformin Shown to Prevent Long COVID Across Risk Groups in Multiple Randomized Trials
Multiple randomized trials and electronic‑health‑record analyses show that a 14‑day course of metformin, started during or shortly after acute SARS‑CoV‑2 infection, significantly lowers the risk of developing Long COVID. Across four studies, one Long COVID case is prevented for every...
Building a Smart Oncology Pipeline with Cumulus Oncology
Dr. Clare Wareing, founder and CEO of Cumulus Oncology, discussed the company’s risk‑adjusted preclinical pipeline aimed at high‑unmet‑need cancers. Cumulus employs a platform‑agnostic, precision‑medicine strategy that prioritizes patient subgroups to improve development success. The interview highlighted the supportive Scottish biotech...
Timing of Cord Blood Transplant Affects Graft Disease
Researchers have linked the circadian rhythm of soluble CD26 (sCD26) to acute graft‑versus‑host disease (aGVHD) risk in cord blood transplantation (CBT). Peak sCD26 levels suppress pathogenic T‑cell activity, creating a temporal window that lowers aGVHD incidence and severity. The team...