Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech rounds
Spanish biotech firm Ona announced an $86.6 million Series B financing, ranking among the largest venture rounds in Spain’s life‑science sector this year. The round was led by Seventure Partners with participation from existing backers and new strategic investors. The funding will be used to scale Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical programs.
Radiopharma Firm Secures $85M to Expand Domestic Production of Radioisotopes
Indiana‑based SpectronRx announced an $85 million investment from OrbiMed to expand its U.S. radioisotope production capacity. The funding will support construction of a 150,000‑square‑foot facility on its Grissom Aeroplex campus, adding to existing 200,000‑square‑foot manufacturing space and bringing total global capacity above 400,000 sq ft. SpectronRx’s expanded platform will produce a broad portfolio of more than 20 therapeutic and diagnostic isotopes, including Actinium‑225 and Lutetium‑177, and currently delivers over 300,000 radioligand doses annually. Its Indiana location near major cargo hubs shortens delivery times for short‑half‑life isotopes, strengthening the domestic supply chain.
Nionyx Bio’s Kidney Gene Therapy Wins the 2026 BIO-Europe Spring Startup Spotlight
Nionyx Bio, led by CEO Magdalena Tyrpien, captured first place in the 2026 BIO‑Europe Spring Startup Spotlight in Lisbon. The company focuses on a proprietary adeno‑associated virus (AAV) capsid platform paired with a Kidney Atlas to deliver gene therapies for...
Annovis Publishes Historical Review of Buntanetap
Annovis released a historical review of its investigational drug Buntanetap in The Scientist, charting its evolution from a 19th‑century execution poison to a modern candidate for Alzheimer’s and Parkinson’s disease. The article details discovery, mechanism elucidation, chemical optimization, and progression...
New FDA‑approved Oral Weight‑loss Pill Expands Patient Options
So… hot off the press: a NEW weight loss PILL just got FDA approved. We’ve had oral (non-injectable) GLP-1s before — but this is one of the first specifically for weight management. When it reaches Malaysia, it could significantly increase demand...
I-Lumen Receives FDA IDE to Start US I-SIGHT2 Enrollment
I‑Lumen announced that the U.S. Food and Drug Administration has granted an Investigational Device Exemption (IDE) for its i‑SIGHT2 clinical study. The clearance allows the company to begin enrolling participants in the United States to evaluate its breath‑based metabolic monitoring...
Eli Lilly Reports US FDA Approval of Foundayo (Orforglipron) for Weight Loss
The U.S. FDA has approved Foundayo (orforglipron), Lilly’s first oral GLP‑1 pill, for obese or overweight adults with weight‑related health issues, to launch via LillyDirect on April 6, 2026. In the ATTAIN‑1 trial the highest dose produced an average 27.3‑lb (12.4%) weight...
French AI: 20 Million Funding for Generare to Find Better Data in Nature
Generare, a Paris‑based tech‑bio startup, raised €20 million in Series A funding to expand its proprietary library of evolution‑derived small molecules. The company tackles the data bottleneck in AI‑driven drug discovery by decoding microbial genomes to uncover cryptic chemistry, having identified over...
Generare Raises $23.2M to Discover Unknown Molecules and Advance New Drugs
Generare Bioscience, a Paris‑based biotech, announced a €20 million (≈$23.3 million) Series A round led by Alven and Daphni. The company is constructing the largest proprietary library of previously unknown small‑molecule structures extracted from microbial genomes. In 2025 it identified over 200 novel...
Inductive Bio on a Winning Streak With ADMET Predictions
Inductive Bio captured first place in the OpenADMET‑ExpansionRx blind challenge, beating over 370 competitors including Merck‑NVIDIA and EMD Serono. The AI‑driven platform accelerates ADMET prediction for diseases such as myotonic dystrophy, ALS and dementia, compressing traditional four‑year drug‑discovery cycles to nine‑12...
Biopharma Catalysts in Q2 2026 Signal High-Profile Approval Decisions and Rising Competition
The Q2 2026 catalyst slate highlights several high‑profile FDA decisions that could reshape the breast‑cancer and obesity markets. Replimune plans a BLA resubmission for vusolimogene oderparevec with a PDUFA date of April 10, 2026, while Arvinas expects a June 5, 2026 decision on vepdegestrant, which showed...
FLAV‑27 Reverses Cognitive Decline in Early Alzheimer’s Trials, Raising Biohacker Hopes
A research team announced that FLAV‑27, an experimental compound targeting the epigenome, restored memory function in mice and nematodes with early Alzheimer’s pathology. The finding shifts focus from amyloid‑beta plaques to gene‑regulation mechanisms, a development that resonates with longevity‑focused biohackers.
STAT+: Trump Administration Prepares 100% Tariffs on some Imported Drugs
The Trump administration is poised to issue an order that would levy a 100% tariff on imports of patented medicines and their active pharmaceutical ingredients. A draft of the order suggests the tariffs could be announced as early as Thursday,...
Fluvoxamine Cuts Long COVID Fatigue Risk by 99% in International Trial
Researchers from Canada, Brazil and the United States reported that fluvoxamine dramatically reduced fatigue in long COVID patients, achieving a 99% probability of benefit in the 399‑person REVIVE‑TOGETHER trial. The low‑cost antidepressant could become a first‑line option for a condition...
Pharvaris NV (PHVS) Q4 2025 Earnings Call Transcript
Pharvaris NV reported a breakout quarter, with U.S. net product revenue for its epinephrine spray Neffy soaring to $31.3 million – a 2.5‑fold increase quarter‑over‑quarter and beating consensus. Adoption accelerated among new prescribers, reaching a 10.3% market share, while provider...
Mix-and-Match Synthesis of 3D Small Molecules
A new chemistry reported in Nature enables modular, iterative construction of C_sp³–C_sp³ bonds while precisely controlling the three‑dimensional arrangement of attached atoms. The approach leverages interchangeable building blocks to assemble 3D small‑molecule scaffolds, a bond type that is pervasive in...
New Approach Methodologies for Drug Discovery
Traditional animal‑based drug discovery suffers a 90 % failure rate, prompting regulators and scientists to adopt human‑centric new approach methodologies (NAMs). Recent policy shifts—including the FDA Modernization Act 2.0 that removes mandatory animal testing and the NIH’s 2025 Organoid Development Center—create...
‘Treasure Trove’ of Antiviral Proteins Could Inspire Powerful Molecular Tools
Two independent studies published in Science used deep‑learning models to scan thousands of bacterial genomes, uncovering a massive pool of previously unknown antiviral proteins. The analyses estimate that about 1.5% of bacterial genes encode immunity functions—three times higher than earlier...
Excelsior Sciences: Automating Small Molecule Chemistry
Excelsior Sciences, backed by Deerfield, unveiled an automated platform for small‑molecule discovery that leverages modular "smart blocs" and generative AI. The system integrates iterative carbon‑carbon bond formation, robotic synthesis, and in‑vitro assays into a continuous make‑test‑learn loop. By translating chemical...
Lilly Weight-Loss Pill First Novel Drug Approved Under CNPRV
Eli Lilly’s anti‑obesity pill Foundayo (orforglipron) became the first new molecular entity approved under the FDA Commissioner’s National Priority Voucher (CNPRV) pilot. The FDA granted approval just 50 days after Lilly filed the NDA, well ahead of its 294‑day target deadline. Foundayo’s...
AI-Driven Biology Could Slash Drug Trial Failures Dramatically
AI for biology will have bigger near term wins. The ability for AI to learn from experiments and predict human biology will have very broad impacts in predicting targets, clinical trials, and precision medicine. Tackling the biggest challenge in Pharma (80%...
What Didn’t Exist Three Years Ago
The American Association for Cancer Research (AACR) annual meeting highlighted the latest direction of early‑stage drug development. This year’s sessions featured two prostate‑cancer candidates using mechanisms that were not in the clinic just eighteen months ago. The preview spotlights a...
Frequently Requested or Proactively Posted Drug-Specific and Other Records
The FDA has published a curated list of frequently requested and proactively released drug‑specific records, spanning from 2016 to 2026. The collection includes letters on hemp‑derived cannabidiol research, a tirzepatide injection shortage resolution, the JAYPIRCA approval package, and numerous REMS...
FDA Warns Patients and Health Care Professionals Not to Use Sterile Products From North American Custom Laboratories LLC, Dba FarmaKeio...
The FDA has issued a nationwide warning against using any drug products intended to be sterile that were compounded by North American Custom Laboratories LLC, operating as FarmaKeio Superior Custom Compounding. After an inspection uncovered conditions that could lead to...
North Carolina Foster Care Health Plan Blocks CAR T Therapy for 8‑Year‑Old Cancer Patient
Ollie Super, an 8‑year‑old foster‑care child with recurrent neuroblastoma, was denied enrollment in a CAR T‑cell clinical trial because North Carolina’s new specialized Medicaid plan for foster children will not cover the treatment. The decision highlights systemic gaps in the...
Olezarsen Doesn’t Lower Plaque Volume: Essence-TIMI 73b
Olezarsen, an antisense drug targeting APOC3, dramatically lowered triglycerides (‑64 %) and remnant cholesterol (‑72 %) in the Phase III Essence‑TIMI 73b trial, yet a 12‑month coronary CTA subanalysis showed no significant reduction in non‑calcified plaque volume versus placebo. The study involved 468 patients...
University of Michigan Shows Protein Nanoparticles Can Deliver Gene Therapy Without Viruses
Scientists at the University of Michigan engineered protein‑based nanoparticles that delivered DNA and mRNA into human liver, kidney and immune cells without using viral vectors. The proof‑of‑concept experiment showed successful gene activation and could lower the risk of immune reactions...
Novel Therapeutic and Trial Approaches for Lysosomal Storage Disorders with Polaryx’s Alex Yang — Episode 249
In episode 249 of the Xtalks Life Science Podcast, Alex Yang, JD, LLM, CEO of Polaryx, discusses the company’s mission to develop disease‑modifying small‑molecule therapies for rare pediatric lysosomal storage disorders. Yang leverages more than 25 years of experience across...
STAT+: Government Watchdog Urges FDA to Finalize Guidance for Advisory Committee Conflicts of Interest
The Government Accountability Office (GAO) reports that the FDA has still not finalized the financial conflicts‑of‑interest (COI) guidance for its advisory committees, despite a law mandating it 13 years ago. The agency also fails to publicly disclose how it evaluates...
FDA Warns Consumers Not to Purchase or Use Artri and Ortiga Products, Which May Contain Hidden Drug Ingredients
The FDA has issued a renewed public warning that over‑the‑counter products bearing the names “Artri” or “Ortiga” may contain undeclared prescription drugs such as dexamethasone, diclofenac sodium, and methocarbamol. Since April 2022, more than 30 consumers have reported severe health effects,...
The Man Who Let Deadly Snakes Bite Him for 20 Years—And the Universal Antivenom Hiding in His Blood
A Wisconsin man, Tim Friede, let venomous snakes bite him for two decades, building a unique repertoire of antitoxin antibodies. Researchers at biotech firm Centivax isolated two of these antibodies and combined them with the toxin‑blocking drug varespladib, creating a...
To Counter China, FDA Chief Wants to Speed New Drug Trial Process
FDA Commissioner Marty Makary said the agency will slash the amount of non‑safety data required to launch new drug trials in the United States. The streamlined approach aims to eliminate redundant paperwork, focusing only on safety‑related information. Makary framed the...
Tobacco Plant Altered to Produce Five Psychedelic Drugs
Scientists at Israel's Weizmann Institute have engineered tobacco (Nicotiana benthamiana) to produce five psychedelic compounds—including psilocin, psilocybin, DMT, bufotenin and 5‑methoxy‑DMT—using agroinfiltration, a transient gene‑delivery method that does not integrate DNA into the plant genome. The approach leverages nine introduced...
Pfizer, BioNTech to Pause COVID Vaccine Study Due to Low Enrollment
Pfizer and BioNTech announced the suspension of a FDA‑mandated post‑marketing study of their COVID‑19 vaccine due to insufficient participant enrollment. The trial, aimed at 25,500 adults aged 50‑64, was designed to assess safety, immune response, and efficacy against infection. Companies...
They Thought Their Hearing Was Gone Forever—Until Doctors Tried Something Radical
A 2025 Nature Medicine study showed that delivering a functional OTOF gene via an adeno‑associated virus dramatically improves hearing in patients with genetic deafness. Ten participants aged 1 to 24 across five Chinese hospitals experienced a reduction in hearing threshold...
Kailera Plots IPO to Fuel Obesity Pipeline
Kailera Therapeutics, after raising $1 billion across a $400 million Series A and $600 million Series B, is preparing an IPO to fund its obesity drug pipeline. Its lead candidate, ribupatide, has delivered up to 23.6% weight loss in Phase 3 injectable trials and 12.1% loss...
Eli Lilly Opposes Push to Pass Trump's Drug Pricing Deals Into Law, CEO Says
Eli Lilly is publicly opposing the White House’s effort to turn its voluntary “most‑favored‑nation” (MFN) drug‑pricing agreements into law. The company, along with more than a dozen peers, signed MFN deals in 2025 to align U.S. prices with those in other...
Enlivex Clears Pivotal FDA Hurdle in Knee Osteoarthritis
Enlivex has secured FDA Investigational New Drug (IND) clearance to launch a global Phase 2b trial of its immunotherapy Allocetra for moderate‑to‑severe age‑related knee osteoarthritis. The study will be randomized, double‑blind, and placebo‑controlled, building on promising Phase 1/2a data from 134 patients....
Loargys (Pegzilarginase) Wins FDA Nod for Ultrarare Metabolic Disorder After Earlier Setbacks
The U.S. FDA granted accelerated approval to Loargys (pegzilarginase‑nbln) for treating arginase‑1 deficiency (ARG1‑D), an ultrarare metabolic disorder affecting roughly 250 Americans. Loargys, a recombinant human arginase‑1 enzyme, is the first therapy shown to lower plasma arginine levels, achieving about...
FDA Open To More Data On Rare Disease Drug Ersodetug Despite Missed Phase 3 Endpoint
Rezolute announced that the FDA remains open to reviewing additional data from its Phase 3 trial of the rare‑disease hypoglycemia drug ersodetug, despite the study missing its primary efficacy endpoint. The agency’s willingness suggests the experimental therapy could still move toward...
Scientists Create Plant That Produces Ayahuasca, Shrooms, and Toad Psychedelics All At Once
Scientists have genetically modified tobacco plants to biosynthesize five distinct psychedelic compounds typically sourced from psilocybin mushrooms, ayahuasca vines, and the Sonoran Desert toad. The engineered pathway, detailed in a Science Advances paper, yields measurable amounts of psilocybin, DMT, 5‑MeO‑DMT...
New GLP‑1 Pill Approved: Orfoglipron Offers Easier Dosing
New GLP-1 pill approved Foundayo (orfoglipron). Not as much weight loss as oral wegovy but no issues with food or more liquid around taking it. Same price. Not April fools joke.
NEJM Review Overlooks Inflammation in GLP‑1 Drugs
A new review of the GLP-1 receptor drugs @NEJM https://t.co/PK03jApZWB surprisingly, the word inflammation only appears once, in this diagram https://t.co/1PeBakBAQb
Key Considerations for Drug Development Pipelines in Early Phase Clinical Trials
Early‑phase clinical trials are shifting from traditional maximum‑tolerated dose (MTD) hunting to identifying an optimal biological dose (OBD) that balances safety, efficacy, and exposure. The FDA’s Project Optimus and related guidance now require dose‑optimization using all clinical data, prompting broader...
CBP and FDA Seize 5,000 Peptide Packages, Including GLP‑1 Drugs
5000 packages of peptides seized by CBP and FDA “The seized materials included several GLP-one medications such as retatrutide, semaglutide, and tirzepatide. Officers also found various other peptides prohibited by the U.S. Food and Drug Administration, including MOTS-C, TB10, semax, and...
Genome Editing Shows Promise for Sickle Cell, Β‑Thalassemia
3 new trial results for genome editing of sickle cell disease and β-thalassemia @NEJM https://t.co/qGGdjgKqP5 (with summary Table below) https://t.co/RdiM3urCKJ https://t.co/W15cPAfMoS https://t.co/F3PHKuktPx https://t.co/t6Z35S8L7h
Researchers Unlock the Key to Axon Regeneration
Researchers at Icahn School of Medicine discovered that the aryl hydrocarbon receptor (AHR) acts as a molecular brake preventing axon regeneration after nerve injury. Genetic deletion or pharmacological inhibition of AHR in mouse models redirected neurons from a stress‑survival mode...
New Early-Stage Cancer Drugs Emerge at AACR26
A look at some promising early stage drug developments coming down the pike at #AACR26. A few of these concepts were not on the radar a couple of years ago: https://t.co/w6oD4CEckq https://t.co/kfR1AXG41K
LSD and DOI Reduce Opioid Intake and Withdrawal in Mice
Effects of Psychedelics Lysergic Acid Diethylamide and R(–)-2,5-Dimethoxy-4-Iodoamphetamine on Oral Opioid Consumption and Naloxone-Precipitated Withdrawal in Male C57Bl/6J Mice https://t.co/78DNsREzoR
FDA Revises Recommendation on First Full Epcoritamab Dose in R/R DLBCL to Allow Outpatient Monitoring
The FDA has revised the label for epcoritamab (Epkinly) to permit outpatient monitoring of the first full 48‑mg dose in relapsed/refractory diffuse large B‑cell lymphoma (R/R DLBCL). The change follows interim EPCORE‑NHL‑6 data showing the dose can be safely administered...
Doctors Will Swap Pills for Gene Therapies and Epigenetics
Longevity 2.0: Your next doctor won't prescribe pills—they'll prescribe gene therapies, epigenetic reprogramming, and personalized longevity protocols. Medicine is shifting from "treat symptoms" to "reverse aging at the cellular level."