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PMV Pharmaceuticals reported Phase I results of rezatapopt, a small‑molecule p53 reactivator, in 77 patients with advanced solid tumors carrying the TP53 Y220C mutation. The oral drug was generally well tolerated, with few dose‑limiting toxicities, allowing the selection of a recommended Phase II dose. Objective responses were seen across multiple tumor types, and all responders were KRAS wild‑type, confirming selective Y220C pocket binding. The data, published in the New England Journal of Medicine, set the stage for a Phase II trial in platinum‑resistant ovarian cancer and a planned NDA submission in 2027.
New: Generate caps a strong month for #biotech IPOs with $400M offering https://t.co/HzslZOPcwM by @gwendolynawu $GENB $AZN $AMGN #IPO
Fulgent Genetics reported Q4 2025 revenue of $84.1 million, a sequential increase and strong year‑over‑year growth across its Precision Diagnostics and Biopharma segments. Non‑GAAP gross margin improved to 44.3% while operating expenses fell, delivering a $0.7 million adjusted EBITDA and a $4.5 million...
An expression of concern has been issued for a 2003 Nature paper that reported the gene product Murr1 restricts HIV‑1 replication in resting CD4⁺ lymphocytes. The editors identified duplicated control panels in Figure 3b, which were meant to demonstrate siRNA activity,...
Senator Ron Johnson (R‑WI) is urging Congress to draft a “Right to Try 2.0” bill that would force the FDA to grant broader, faster access to experimental therapies for rare diseases. FDA Commissioner Martin Makary pushed back, defending the agency’s...
Catalyst OrthoScience announced FDA 510(k) clearance for its Archer® Patient‑Specific Instrumentation (PSI), a suite of humeral and glenoid guides designed to translate 3D pre‑operative plans into the operating room. The system pairs with Archer® 3D Planning Software, supporting both anatomic...
Researchers have adapted lymphovenous bypass, a microsurgical technique that reroutes lymphatic fluid into the venous system, as a potential treatment for Alzheimer’s disease. In a Phase I pilot study of 20 patients, the procedure reduced cerebral amyloid‑β levels by roughly 30%...
A 2026 Nature Communications study used single‑cell RNA sequencing to map the hair follicle microenvironment in men with androgenetic alopecia. The researchers discovered that fibroblasts in the connective tissue sheath (CTS) adopt an abnormal actomyosin‑driven contractile phenotype, compressing follicles and...
A new macrophage‑targeted PET/CT tracer (11C‑DPA‑713) can identify rheumatoid arthritis patients who will respond to anti‑TNF therapy within four weeks, far earlier than the traditional three‑to‑six‑month window. The study of 20 patients showed that standardized uptake values (SUVs) at baseline...
Researchers from Japan Tobacco and D‑Wave have unveiled a hybrid framework that merges deep generative models with quantum annealing to design drug‑like molecules. The system introduces a Neural Hash Function that enables binarisation for quantum processing while preserving gradient flow....
The FDA granted accelerated approval to zongertinib (Hernexeos) for adults with unresectable or metastatic non‑squamous NSCLC that carry activating HER2 TKD mutations, extending its use to treatment‑naive patients. The decision rests on the Beamion LUNG‑1 trial, which reported a 76%...
An international team led by Oxford, Nanjing Agricultural University and the Chinese Academy of Sciences identified the rice gene OsWRI1a as a key regulator of growth under varying nitrogen levels. Over‑expressing a strong OsWRI1a allele increased root‑to‑shoot ratios and grain...
RIKEN scientists have shown that an intrinsically disordered region (IDR) of the DEAD‑box helicase DDX3X confers selective binding to specific mRNA structures, a mechanism uncovered using solution NMR spectroscopy. The discovery clarifies how DDX3X distinguishes target transcripts, linking its specificity...
ARUP Laboratories has unveiled the Innovation Central Laboratory, a dedicated hub for co‑development with pharmaceutical and biotech partners. The facility is designed to validate technologies and move next‑generation diagnostics from concept through to commercial readiness. It will host projects ranging...
Boston’s life‑sciences sector is adding thousands of well‑paying technician positions that often don’t require a four‑year degree. To address the fragmented training ecosystem, the city funded the Life Sciences Career Alliance with $4.7 million, appointing Year Up United as the coordinating...
The FDA approved KOMZIFTI (ziftomenib) on November 13 2025 as an oral 600 mg capsule for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring an NPM1 mutation. Approval rests on the single‑arm KO‑MEN‑001 trial, which enrolled 112 participants across seven...
Researchers at the Institute for Bioengineering of Catalonia have created a nickel‑linked chitosan material that becomes stronger when wet, achieving nearly a 50 % increase in tensile strength. By incorporating small amounts of nickel ions, the polymer forms water‑bridged networks that...
The January 2026 Patent Highlights roundup spotlights a wave of new intellectual‑property activity across several cutting‑edge drug discovery areas. Notable filings include lysine‑directed covalent inhibitor chemotypes, strategies to balance potency with drug‑like properties, refined target‑selection frameworks, dozens of Polθ synthetic‑lethal patents...
The University of Toronto has partnered with Cambridge‑based BioLabs to operate its 40,000‑square‑foot life‑sciences incubator after Johnson & Johnson announced it will withdraw support by the end of 2025. BioLabs, entering Canada for the first time, will manage the space...
The Centers for Medicare & Medicaid Services entered the third year of its Medicare drug price negotiation program, selecting 15 drugs—including, for the first time, therapies covered under Medicare Part B. Patient advocacy groups have until March 1 to submit written comments...
Researchers at UNIST, KAIST and Yonsei have developed a reusable molybdenum disulfide (MoS₂) radio‑frequency biosensor for liquid‑biopsy cancer detection. The sensor detects single‑stranded DNA fragments as low as 154.67 nM by monitoring shifts in resonant frequency, and can be washed and...
(Hopefully) Final word today on the Makary $QURE (or was it $RGNX) thing: Bottom line: Makary shouldn't be talking publicly about unresolved drug applications. Uniqure doesn't even have an application submitted; and RegenxBio's CRL letter isn't posted to the FDA's...
Bristol Myers Squibb reported that its antibody‑drug conjugate iza‑bren, licensed from Chinese partner SystImmune, achieved statistically significant improvements in progression‑free and overall survival versus chemotherapy in a Phase III trial for advanced triple‑negative breast cancer. The study, conducted in mainland China...
You've got to watch this Makary interview on CNBC. He attacks a drug, hits the Old FDA and circles all the wagons around Vinay Prasad, who "loves President Trump" and faces a fatwa (WSJ). Makary is getting major props for...
FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad "Vinay Prasad is a genius,” Makary said. “He’s on loan from UCSF. He’s published over 500 scientific peer-reviewed articles, and some of the drugs they are criticizing him for...
An international team led by the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust and Bristol Myers Squibb has produced the most detailed spatial atlas of pancreatic ductal adenocarcinoma (PDAC) to date. Using spatial transcriptomics and spatial molecular imaging...
Elevidys, Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, posted $110 million in fourth‑quarter sales, bringing full‑year revenue to $898.7 million—well below the $1 billion benchmark. Safety incidents in 2025 and a severe flu season have eroded confidence, prompting analysts to project 2026...
![[Comment] Impact of Adding Hormone Therapy to Postoperative Radiotherapy in Prostate Cancer](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/f1452ec53e5201a4460c9aaf141538d3.webp)
Adding androgen deprivation therapy (ADT) to definitive radiotherapy improves overall survival for men with high‑risk prostate cancer, but its benefit when combined with postoperative radiotherapy (PORT) after prostatectomy is less clear. Randomised trials such as GETUG‑AFU 16, SPPORT, and the RADICALS‑HD...
Researchers at the University of Macau have demonstrated the first in‑situ synthesis of covalent organic frameworks (COFs) inside lysosomes of cancer cells, using acidic pH‑driven imine condensation of TAPB and DMTP. The crystalline UMCOF1 particles rupture lysosomal membranes, liberating ferrous...
The FDA announced it will default to a single pivotal trial for new drug applications, extending a practice long used in oncology and rare‑disease approvals. In 2024, 66% of new molecular entities were cleared based on one trial, signaling a...
The latest episode of BioSpace’s Denatured podcast spotlights a growing partnership between ALS patients and pharmaceutical developers, featuring insights from EverythingALS founder Indu Navar and VectorY Therapeutics CMO Dr. Olga Uspenskaya. The discussion highlights how patient‑driven collaborations are accelerating trial timelines...
India’s ministerial panel will examine field trials of a genetically modified rapeseed (mustard) variety, a step that could reshape the country’s cautious stance on GM food crops. The review comes as the Supreme Court prepares to revisit a pending case...
The U.S. Food and Drug Administration rejected a rare‑disease cell therapy that had already secured approval in Europe, despite earlier internal support from the agency. The decision comes under the FDA’s new leadership and has sparked debate over whether the...
$QURE down this morning on comments made by FDA Commissioner Marty Makary to CNBC's Becky Quick. In a discussion about rare-disease drug approvals and Vinay Prasad, Makary said this: "I think there has been a bit of an effort to...
Simple Blood Test For Small RNA Molecules Could Predict Who Is Likely To Live Longer https://t.co/lr59o4Yegp https://t.co/MccF3k72pT
In Episode 9 of Drug Dealin, hosts Kenny and Shibu demonstrate how patients can use publicly available tools like ClinicalTrials.gov and AI language models to uncover novel treatment options, focusing on a hypothetical Parkinson’s disease case inspired by a TV...
🆕 @ScienceMagazine How gut bacteria interactions [cooperation vs competition, positive vs negative] shape risk for health and disease https://t.co/q8TvbaHDQI https://t.co/kS0S3uUIli
What accounts for the progression from healthy aging to Alzheimer's disease over an extended period of time? The critical role of the immune system, particularly T cells and microglia. A new, excellent review @ImmunityCP https://t.co/XqEBcptTuG https://t.co/Xt24BvkDWe
Researchers at the Broad Institute and University of Helsinki analyzed over 81,000 individuals with autoimmune hypothyroidism (AIHT) and identified more than 400 genetic markers, including nearly 50 protein‑coding variants. The study distinguished genetic signals specific to thyroid autoimmunity from those...
We'll be gearing up today's webinar on biotech venture capital at the top of the hour. Great guests, great topics. If this is a central issue in your life, tune in. Thousands have signed up already. https://t.co/c16y04mFsD
Direct-to-consumer gut microbiome assessments are unreliable, problematic: a review of 7 companies with significant methodologic issues https://t.co/atwmZUNjVE https://t.co/SqlMljuW0y
Candida species normally coexist harmlessly on mucosal surfaces, but immune disruption can trigger a shift to opportunistic infection ranging from mild thrush to invasive candidemia with mortality over 30%. Genetic variants in innate and adaptive pathways—such as CARD9, Dectin‑1, and...
m6A is the most common internal mRNA modification, but we still don't know what most m6A sites actually DO. Zhang et al. built FOCAS -- a CRISPR-based platform using dCas13b-FTO to precisely remove m6A at specific sites without touching the DNA. https://t.co/G6kSgpSSbV...
Anyone who uses CRISPR systems outside of non-profit and research purposes is subject to the patents that claim those processes as theirs. A lot of startups forget to do due diligence on that and think its fair game. Have you...
Atara Biotherapeutics’ stock jumped 20% after STAT reported that internal FDA inconsistencies may have driven the rejection of its EBV‑positive PTLD cell therapy, Ebvallo. The FDA denied the U.S. application citing insufficient evidence of effectiveness, yet former reviewers said data...
Master these 6 types of plots to reproduce any genomics paper figures. I will prove it at the end of the video. https://t.co/gjRs0gY6Mx
Head-to-head trial of the oral GLP-1 drugs in people with T2D. Orforglipron was superior https://t.co/9B7RXIgdJY
Boehringer Ingelheim announced a potential $500 million investment in UK biotech Sitryx to obtain global rights to an undisclosed small‑molecule immunology programme. The partnership covers upfront fees, milestones and royalties, giving Boehringer full responsibility for research, clinical development and commercialization. Sitryx’s...
We're making headway for off the shelf preventive cancer vaccines in people with hereditary forms of cancer, e.g. Lynch syndrome https://t.co/F3LqKS46BQ
Researchers have captured the fleeting i‑DNA structure inside living cells, showing it acts as a molecular switch for genes that drive cancer. The study demonstrates that i‑DNA formation and resolution are tightly timed during DNA replication, influencing gene expression and...
