Know What's Happening in BioTech
Know What's Happening in BioTech
BioTech Pulse
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Daily
Every morning
Weekly
Tuesday recap
The Division of Applied Regulatory Science (DARS) operates within the FDA’s Office of Clinical Pharmacology and the Office of Translational Sciences. Its mandate is to translate emerging scientific advances into the agency’s regulatory framework, tackling complex questions that hinder drug development. DARS creates and validates novel tools, standards, and methodologies to streamline the review of safe and effective products. Recent outputs include a peer‑reviewed publication and a 2025 annual report outlining its research portfolio.
Valo Health is reshaping drug development by applying AI to human causal biology, aiming to raise clinical success rates from roughly 10% to 20%. The company leverages over 17 million de‑identified patient records and Mendelian randomization to pinpoint genetically validated targets....
Panome Bio has launched MassID™, a cloud‑based platform that streamlines the processing and interpretation of untargeted LC/MS metabolomics data. The system delivers an end‑to‑end pipeline that cleans, normalizes, and annotates raw spectra while assigning probability‑based confidence scores and global false...
Novo Nordisk has struck a deal with Boston biotech Vivtex worth up to $2.1 billion to develop next‑generation oral GLP‑1 obesity and diabetes pills. The partnership leverages Vivtex’s AI‑driven gastrointestinal‑on‑a‑chip platform that can boost drug absorption by orders of magnitude. Novo...
Chinese biotech firms are moving beyond licensing deals as capital markets open, highlighted by a 64% rise in the Hang Seng Biotech Index in 2025. Reforms to listing rules since 2018 have unlocked public financing, enabling a record $138 billion in...
Generate Biomedicines (GENB) filed its IPO prospectus, unveiling a programmable biology platform that engineers therapeutic proteins previously considered undruggable. The company highlighted a pipeline featuring oncology and immunology candidates that have progressed to Phase 2 trials, supported by early efficacy signals....
A patient in MacroGenics' Phase 2 LINNET trial of the bispecific antibody lorigerlimab suffered grade 4 neutropenia and septic shock, leading to a fatality and prompting the FDA to place a partial clinical hold on the study. The company also reported three...
IDEAYA Biosciences announced the enrollment of the first patient in a Phase‑I dose‑escalation and expansion study of IDE034, a bispecific B7H3/PTK7 TOP1 antibody‑drug conjugate for solid tumours. The trial will assess safety, tolerability and pharmacokinetics of IDE034 as a monotherapy...
Researchers are exploring single‑cell omics as a next‑generation tool for preventive health screening. By profiling thousands of individual cells, the technology can detect subtle genetic mutations and immune‑cell shifts years before clinical symptoms appear. Early studies have identified driver mutations...
IQVIA Holdings announced an agreement to acquire five drug discovery service sites from Charles River Laboratories, adding in‑vitro capabilities, New Approach Methodologies and a small‑molecule AI platform. The assets, built on more than 20 years of data, have helped launch...
Zifo and Maze Therapeutics have teamed up to launch an AI‑powered platform that manages, stores, and scales massive biobank datasets. The solution tackles the fragmentation of genetic, proteomic, and phenotypic data by providing a unified workflow that delivers summary statistics...
Eli Lilly’s obesity drug Zepbound achieved a 25.5% weight loss in a head‑to‑head Phase 3 trial, outpacing Novo Nordisk’s CagriSema and sending Novo’s shares down 20%. The FDA launched Rare Disease Week, issuing draft guidance for a new Plausible Mechanism Pathway that...
The article argues that the brain is the rate‑limiting organ for longevity, asserting that neural network degradation drives functional decline across the body. While peripheral organ rejuvenation has advanced, preserving and repairing brain tissue remains the critical bottleneck. It proposes...
SteinCares has signed a strategic licensing agreement with Shilpa Biologicals to commercialize a biosimilar across Latin America. Under the deal, SteinCares receives exclusive rights to register, market and distribute the product throughout the region, while Shilpa Biologicals will complete development...
Vico Therapeutics has initiated patient dosing in an expanded European cohort for its Phase I/IIa VO659 trial, targeting Huntington's disease, spinocerebellar ataxia type 3 and type 1. The study employs a twice‑annual intrathecal regimen and will monitor safety, tolerability, pharmacodynamics and pharmacokinetics...
NorthX Biologics and Demeetra have formed a strategic alliance to provide an end‑to‑end solution that couples Demeetra’s CleanCut CHO cell line development platform with NorthX’s GMP manufacturing capabilities. The partnership leverages a high‑titre GS‑knockout CHO cell line that carries no...
NorthX Biologics and Demeatriz have formed a strategic alliance to deliver an end‑to‑end platform that couples Demeatriz’s CleanCut CHO cell line development with NorthX’s GMP manufacturing capabilities. The partnership leverages a high‑titre GS‑knockout CHO cell line that carries no royalty...
The Evolution Summit, organized by Marcus Evans, will take place May 7‑8, 2026 at the Ritz‑Carlton in Fort Lauderdale. The invitation‑only event convenes senior clinical‑trial executives with innovative suppliers to discuss pressing challenges in clinical operations and drug development. Featured speakers include...
GlaxoSmithKline announced a $950 million cash acquisition of 35Pharma, a privately held biotech focused on lung diseases. The deal brings the experimental compound HS235, slated to enter pulmonary arterial hypertension (PAH) trials, into GSK’s pipeline. PAH has become a lucrative target,...
In this episode, Dr. Aaron Vinnie shares his journey from a leukemia survivor to a Columbia University hematology‑oncology researcher, advocating a shift from traditional cytotoxic chemotherapy to precision strategies that rewire malignant blood cells. He explains how hematologic cancers stem...
Long‑term data from the Phase 3 ULTIMATE I and II trials show that continuous treatment with Briumvi (ublituximab) provides sustained clinical benefits for relapsing multiple sclerosis over five years. More than 80 % of patients who started Briumvi remained free of relapses and...
Johnson & Johnson has filed a supplemental Biologics License Application (sBLA) with the U.S. FDA for Imaavy (nipocalimab‑aahu), a monoclonal antibody intended to treat warm autoimmune hemolytic anemia (wAIHA). The filing is supported by the Phase II/III ENERGY trial, which demonstrated...
President Donald Trump used a brief four‑minute segment of his State of the Union address to push Congress to codify his Most‑Favoured Nations (MFN) drug‑pricing program. He claimed the voluntary agreements would give Americans the lowest prescription prices worldwide, though...
In July 2025 the FDA ordered a complete halt of Sarepta’s gene‑therapy Elevidys after two non‑ambulatory Duchenne muscular dystrophy (DMD) patients died, sparking a market plunge and patient access concerns. Sarepta argues that ambulatory patients, who had been receiving Elevidys...
LB Pharma went public in September 2024, pricing its shares at $15 and raising $285 million despite a severely constrained capital market. The IPO followed a Phase 2 trial that showed LB‑102 markedly reduced schizophrenia symptoms, sparking investor demand even as venture...
The FDA reauthorized its rare pediatric disease priority review voucher program, bolstering a wave of regulatory incentives that include new guidance on plausible mechanisms and a Rare Disease Evidence Principles framework. Yet ultra‑rare indications still struggle to attract traditional venture...
Can anything really be “GMO-free” these days? The answer is definitely no. A significant % of all atmospheric CO2 was made by GMO crops in the last 30 yrs, and these molecules cycles back into all plants and into your...
With Vivtex deal, Novo gains a chance at better oral obesity drugs https://t.co/DhIelbC9jI by @gwendolynawu $NVO #obesity
Veracyte reported fourth‑quarter 2025 revenue of $140.6 million, a 19% year‑over‑year increase driven by strong testing volume and higher average selling prices. Non‑GAAP gross margin rose to 75.1%, with testing margin reaching 76.1% after the transition to the v2 transcriptome platform....
Stand Up! with Pete Dominick: 1538 Dr Peter Hotez on the state of Vaccination in America. My latest with @PeteDominick https://t.co/LsuvmglNBx
Assets from China are ubiquitous but China is no longer the 'bargain basement' in terms of deals. Will be interesting to see how rising prices impact deal interest https://t.co/yM3P28QCDc $XBI $IBB $BBC https://t.co/W61XACPX7O
Recent research highlights myelin dysfunction as a central factor in autism spectrum disorder, linking abnormal white‑matter development to core social and communication deficits. Genetic and epigenetic studies reveal that disruptions in oligodendrocyte maturation, driven by mTOR and ERK signaling, occur...
United Therapeutics reported record Q4 2025 revenue of $800 million, a 7% year‑over‑year increase driven by double‑digit growth of its Tyvaso DPI inhaler and Orenitram. The company unveiled new 80‑112 µg Tyvaso DPI cartridges, expanding dosing flexibility, and highlighted unprecedented results from...
A recent study reveals that carnitine palmitoyltransferase 1C (CPT1C) exerts dual regulatory functions in chronic stress‑induced depression‑related phenotypes. CPT1C enhances surface expression of GluA1‑containing AMPA receptors via SAC1‑mediated lipid signaling while simultaneously dampening mTORC1 activity through AMPK pathways. Genetic deletion...
Amarin reported Q4 2024 revenue of $62.3 million, down from a year earlier as U.S. VASCEPA sales fell under generic pressure. Internationally, the company added pricing and reimbursement wins in Europe and grew partnership revenue, boosting total 2024 revenue to $228.6 million....
Geron Corp reported full‑year 2025 Rytelo net revenue of $184 million, with Q4 sales of $48 million, and projected 2026 revenue between $220 million and $240 million. Operating expenses are expected to dip to $230‑$240 million, a $20 million reduction year‑over‑year, while cash balances sit at...
Sarepta Therapeutics reported a blockbuster fourth quarter, with ELEVIDYS gene‑therapy sales of $384 million, surpassing guidance by $60 million, and total net product revenue of $1.79 billion for 2024, up 56% year‑over‑year. The company achieved GAAP profitability and cash‑flow positivity, confirming the financial...
Schrödinger reported Q2 FY2025 revenue of $54.8 million, up 16% year‑over‑year, driven by 15% software growth to $40.5 million and 19% drug‑discovery growth to $14.2 million. Gross margin slipped to 68% as the mix shifted toward lower‑margin services and new predictive‑toxicology investments. Net...
Researchers identified that neuronal nitric oxide (NO) S‑nitrosylates the TSC2 protein at cysteine 203, triggering its ubiquitination and degradation. The loss of TSC2 removes inhibition of the mTOR pathway, causing hyperactivation in both excitatory and inhibitory neurons of Shank3Δ4–22 and Cntnap2‑/‑...
Revolution Medicines reported that its lead KRAS inhibitor doraxonrasib secured breakthrough therapy, orphan drug, and a FDA National Priority Voucher, underscoring its potential in pancreatic cancer. Phase I data revealed median overall survival of 13.1‑15.6 months and a 47% objective...
Procept Biorobotics reported a 48% year‑over‑year revenue increase to $79.2 million in Q2 2025, driven by strong U.S. growth and a 58% surge in handpiece and consumable sales. Gross margin expanded to 65.4%, up 640 basis points, while adjusted EBITDA loss narrowed...
Soleno Therapeutics reported $190.4 million in net revenue for fiscal 2025, representing less than nine months of commercial sales of its VICAT XR therapy. The company turned profitable, posting $20.9 million net income and generating $48.7 million of operating cash in Q4, ending the...
A multi‑omics investigation identified molecular signatures that link alcohol craving to acamprosate treatment response in patients with alcohol use disorder (AUD). The study highlighted IL17RB genetic variants and elevated plasma TNFSF10 as robust predictors of therapeutic success, while proteomic and...
Lot's of requests to discuss the Wedbush report on $ABVX today. It's a doozy. Obviously I'm a biased bull so sure, take my thoughts with a grain of salt, but this is truly, awful work from my perspective....
University of Toronto researchers unveiled LUMI‑lab, an AI‑driven self‑driving lab that combined a 28‑million‑molecule foundation model with active‑learning robotics to synthesize and test over 1,700 lipid nanoparticles. The system independently identified brominated lipid tails as a potent new class for...
Researchers at Northwestern University have created HYDRACs, hybrid degrading copolymers that bind and eliminate traditionally "undruggable" oncogenic proteins such as MYC and KRAS. The polymers display target‑recognizing peptides on one side and degron motifs on the other, directing the proteins...
Th FDA is absolutely correct, and confirms what I’ve said all along. This $IBRX @DrPatrick “lymphopenia” push means nothing until or unless they come up with real data showing patient benefit. The “number” doesn’t matter.
UCLA researchers engineered T cells with two fungal proteins that let them import and metabolize cellobiose, a sugar tumors cannot use. This protected fuel restores T‑cell viability, cytokine production, and tumor‑killing capacity in glucose‑deprived environments. In mouse models of lung,...
The FDA has granted approval for Dupixent (dupilumab) to treat allergic fungal rhinosinusitis (AFRS) in adults and children six years and older, marking the first indication for this rare sinus disease. The approval follows a 52‑week trial that demonstrated significant...
I love that biotech has returned to the "data in the morning, raise in the afternoon" way of living its best life. $VIR $PVLA
