Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech financings
Spanish biotech Ona announced a $86.6 million Series B round, ranking among the largest venture financings 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 funds will expand Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical pipeline.
Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN
Health Canada has granted approval for Empaveli (pegcetacoplan) to treat patients aged 12 and older with C3 glomerulopathy (C3G) or primary immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN). The decision follows the Phase III VALIANT trial, which demonstrated a 68% reduction in proteinuria, stabilization of kidney function, and clearance of C3 deposits. Empaveli, a C3 complement inhibitor co‑developed by Swedish Orphan Biovitrum (Sobi) and Apellis, becomes the first therapy sanctioned for these rare kidney disorders in Canada. The approval expands therapeutic options for a historically underserved patient population.
CNN Debuts Kara Swisher’s Six‑Part Docuseries on Extending Human Lifespan
CNN launched a six‑part documentary series titled “Kara Swisher Wants to Live Forever,” premiering Saturday, April 11, 2026. Hosted by veteran tech journalist Kara Swisher, the series probes the science, technology and commercial forces shaping human longevity. The debut places...
NPPA Gene Therapy to Encourage Greater Regeneration Following Heart Attack
Researchers at Columbia Engineering have engineered an RNA‑lipid nanoparticle that programs skeletal muscle to secrete a pro‑ANP precursor, which the heart‑specific enzyme Corin converts into active atrial natriuretic peptide. This two‑phase gene‑therapy bypasses the need for direct cardiac drug delivery,...
FDA Pulls GSK's Wellcovorin Autism Approval After Company Request
The U.S. Food and Drug Administration has withdrawn its approval of GlaxoSmithKline's Wellcovorin, a branded leucovorin marketed for autism, after GSK formally requested the action. The reversal, noted in the Federal Register, underscores the unusual nature of pulling a drug...
ArkBio Starts First‑Cohort Dosing of Long‑Acting Antiviral AK0406 in Australian Phase I Trial
Shanghai Ark Biopharmaceutical announced that the first cohort of healthy volunteers has been dosed in a Phase I trial of AK0406, its long‑acting antiviral drug‑Fc conjugate, in Australia. The trial will assess safety, tolerability and pharmacokinetics, and could pave the...
Decoding ORR: What RECIST v1.1 Means for Investors
Investors will often see ORR quoted or displayed for oncology clinical trial results for solid tumors Here's what the CRs/PRs/SDs mean at a high level These are assessed on scans I'm using RECIST v1.1 definitions #learnbiotechinvesting #biotech #investing #BiotechPrometheus https://t.co/eZb86TcoLL
Telix Pharma Shares Jump Up to 10% After FDA Accepts NDA for Brain Cancer Imaging Agent TLX101‑Px
Telix Pharmaceuticals saw its shares climb as much as 10% in U.S. trading after the FDA accepted its resubmitted New Drug Application for TLX101‑Px, an investigational PET imaging agent for glioma. The agency set a PDUFA goal date of Sept. 11,...
Surface‑Engineered Primer Immobilization Enables Simplified and Affordable Nucleic‑Acid Capture for Molecular Diagnostics in Sub‑Saharan Africa
A study introduces a silica‑free nucleic‑acid capture method using polycarbonate surfaces modified with acetone‑UV pretreatment and branched polyethyleneimine linkers. The treatment doubles surface carboxyl groups, and BPEI chemistry attaches about 2.6 times more primers than conventional ethylenediamine links. Fluorescence assays confirm...
AllRock Bio Begins Patient Dosing in Phase IIa ROCSTAR Trial
AllRock Bio has begun dosing the first patients in its Phase IIa ROCSTAR trial of ROC‑101, an oral pan‑ROCK inhibitor aimed at pulmonary hypertension. The multi‑center study will enroll up to 30 pulmonary arterial hypertension (PAH) patients and 10 interstitial lung...
Precision Medicine in Early Oncology Trials: Biomarkers as Strategic Drivers
Oncology drug development is shifting toward precision immunotherapies, with biomarkers driving patient selection and trial efficiency. Experts at a Caidya webinar highlighted two trends: novel combination regimens and early integration of biomarker strategies, including companion diagnostics. Early biomarker adoption can...
Daraxonrasib (RMC-6236): The 2025 Molecule of the Year
Revolution Medicines’ daraxonrasib (RMC‑6236) was crowned 2025 Molecule of the Year after winning 50% of community votes. The oral, tri‑complex molecular glue inhibitor uniquely targets the active GTP‑bound state of KRAS, NRAS and HRAS, covering both mutant and wild‑type isoforms....
Gan & Lee and JW Pharmaceutical Agree on Bofanglutide Commercialisation
Gan & Lee Pharmaceuticals has signed an exclusive licence with JW Pharmaceutical to develop and commercialise the GLP‑1RA bofonaglutide in South Korea. JW will receive a $5 million upfront payment and up to $76.1 million in milestones, bringing total potential value to...
FDA Approves Higher Dose Nusinersen for Spinal Muscular Atrophy
The FDA has approved a higher‑dose regimen of nusinersen (Spinraza) for spinal muscular atrophy, updating both the loading and maintenance phases. The new schedule delivers two larger injections two weeks apart, followed by maintenance doses every four months. Approval follows...
Addressing Pain Points in Organoid Sorting: The Orgadroid
Visienco, a Swiss life‑sciences startup, unveiled the Orgadroid—an automated platform that combines precision robotics with AI‑driven microscopy to sort and classify organoids. The organoid market is forecast to reach $15.01 billion by 2031, growing at a 22.43% CAGR, but manual handling...
Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging
Telix Pharma announced that the U.S. FDA has accepted the resubmitted New Drug Application for TLX101‑Px, marketed as Pixclara, an investigational 18F‑FET PET imaging agent for glioma detection in adults and children. The agency set a PDUFA action date of...
Amgen’s Lung Cancer Drug Tarlatamab Wins China Approval
Amgen’s bispecific antibody tarlatamab, marketed in the U.S. as Imdelltra, has received approval from China’s National Medical Products Administration. The drug is designed for adults with extensive‑stage small cell lung cancer that has progressed despite chemotherapy. Amgen will commercialize the...
UK Cancer Trial Targets Difficult-to-Treat Tumours in Children
A new CAR T‑cell immunotherapy trial, called Mighty, will enroll up to 60 children and young adults with hard‑to‑treat solid tumours in the UK and US. The study targets rhabdomyosarcoma, Ewing sarcoma and soft‑tissue sarcoma, cancers that behave differently from...
Multi-Agent AI Delivers Reliable and Scalable Insights for Single-Cell Omics
Nygen Analytics, a Lund‑based startup founded by computational genomics expert Parashar Dhapola, is deploying multi‑agent AI to streamline single‑cell omics analysis. The platform automates cell‑type annotation, handling millions of cells while reducing error rates that can misguide drug discovery. By...
Kymera Therapeutics Reports Gilead’s Option Exercise to License KT-200, a CDK2 Molecular Glue Degrader
Gilead Sciences exercised its option to exclusively license KT‑200, a first‑in‑class oral CDK2 molecular‑glue degrader, from Kymera Therapeutics. The transaction triggers a $45 million milestone payment, with Kymera eligible for up to $750 million in additional milestones and tiered royalties. Gilead will...
Iron‐Based Metal‐Organic Framework MIL‐100(Fe) Regulates Keloid Scarring in a Humanized Keloid Model
The study shows iron‑based metal‑organic framework MIL‑100(Fe) nanoparticles are highly biocompatible, rapidly taken up by keloid fibroblasts, and selectively inhibit the TGF‑β/SMAD pathway, reducing collagen I, collagen III, and P4HA1 expression. In vitro experiments maintained >90% cell viability and curtailed...
Imagene AI Partners with Daiichi Sankyo to Advance Multimodal Biomarker Discovery in Oncology
Imagene AI has teamed up with Daiichi Sankyo to use its OI Suite, powered by the CanvOI foundation model, for multimodal biomarker discovery in oncology. The collaboration will integrate H&E and IHC whole‑slide images with molecular and clinical data to...
RxERP Hub Targets Pharma’s Serialization Blind Spots
RxERP unveiled the RxERP Hub, upgrading its serialized platform into a full‑scale infrastructure for the pharmaceutical supply chain. The Hub adds unit‑level audit logging that records every transaction—from receiving to dispensing—creating a real‑time, immutable trail. This turns serialization from a...
Advanced Biotech Delivers Precise Disease Detection
Accurate Disease Detection with Advanced Biotech Diagnostics by @antgrasso #MedTech #Healthcare #HealthTech #Tech #TechForGood https://t.co/71nTNGOdDQ
Scala Biodesign Raises $16 Million Series A to Speed Protein Bio‑hacking
Scala Biodesign announced a $16 million Series A round led by Grove Ventures to expand its ScalaOS platform, which uses AI and physics‑based modeling to streamline protein engineering. The funding aims to cut years of trial‑and‑error for drugmakers developing longevity‑focused biologics.
Fagron Posts 10% Q1 Revenue Rise and Sets Mid‑Single‑Digit FY26 Growth Target
Fagron N.V. announced first‑quarter 2026 revenue of €263.4 million, up 10.3% year‑on‑year, and forecast FY26 organic sales growth of mid‑to‑high single digits with a 20% REBITDA margin. The growth was powered by a 39% surge in Latin America and the recent...
Evotec Posts 7% Revenue Drop but Secures $650M Sandoz Deal and Phase II Pipeline Gains
Evotec SE posted third‑quarter 2025 revenue of €535.1 million, a 7% decline, while unveiling a strategic sale of its Just‑Evotec Biologics site to Sandoz valued at over $650 million. The company also highlighted cost‑out progress and the advancement of two drug candidates...
Louisiana Judge Upholds Lawsuit, Orders FDA to Complete Mifepristone Safety Review
U.S. District Judge David C. Joseph in Lafayette upheld Louisiana’s lawsuit against the FDA, ordering the agency to finish its safety review of the abortion pill mifepristone within six months. The decision leaves the drug’s mail‑order availability intact for now...
Joint‑On‑Chip Platforms Add Real‑Time Multi‑Sensor Capabilities for Disease Monitoring
A team led by Paola Occhetta has integrated multi‑modal sensors into joint‑on‑chip (JoC) platforms, moving the technology from endpoint assays to continuous, nondestructive monitoring of joint disease. The breakthrough promises faster drug testing and more precise, personalized treatments for osteoarthritis...
CDC Delays Publishing Report Showing Covid Vaccine Benefits
The acting director of the CDC has postponed a report that found COVID‑19 vaccines cut emergency‑department visits and hospitalizations for healthy adults by roughly 50% last winter. Officials say the delay stems from concerns about the study’s methodology, a design...
Egypt Launches Largest Whole‑Genome Sequencing Project to Power Precision Medicine
Egypt announced the launch of its biggest whole‑genome sequencing effort, analyzing 1,024 volunteers from 21 governorates and identifying roughly 17 million previously unknown variants. The initiative creates the country’s first comprehensive genomic reference, a cornerstone for precision medicine and genetics‑based biohacking.
University of Michigan Nanoparticle Blocks Tick‑Borne Red‑Meat Allergy in Mice
University of Michigan scientists have demonstrated that an intravenously delivered nanoparticle can prevent the allergic response to red meat caused by lone‑star tick bites in mice, with 10 of 12 test subjects showing a muted immune reaction. The finding could...
Vedanta Biosciences Showcases Innovative Work on Its Microbiome-Based Therapeutics at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID)...
Vedanta Biosciences presented a poster on its eight‑strain consortium VE303 and an oral talk on VE707 at the ESCMID 2026 Congress in Munich. VE303 showed more than an 80% reduction in recurrent Clostridioides difficile infection odds in a Phase 2 trial...
TriSalus Life Sciences to Present New Data at the 2026 Society of Interventional Radiology Annual Scientific Meeting
TriSalus Life Sciences will present new pre‑clinical and clinical data on its Pressure Enabled Drug Delivery™ (PEDD) platform at the Society of Interventional Radiology 2026 Annual Scientific Meeting in Toronto. The company’s posters and sessions will cover hepatic tumor penetration...
In a First, a Drugmaker’s Lawsuit Challenges HRSA’s 340B Patient Definition
AbbVie Inc. has filed a lawsuit in Washington, D.C. challenging the Health Resources and Services Administration’s (HRSA) 30‑year‑old guidance on who qualifies as a “patient” under the 340B drug pricing program. The drugmaker argues the guidance is overly broad, allowing...
New TB Vaccines Safe, Effective for Children, Not All Forms
Two new tuberculosis vaccines demonstrated safety and immune response in a large Indian trial, but did not provide broad protection against all TB forms; notable efficacy was observed against extrapulmonary TB and in children. tuberculosis
Safety and Efficacy Assessments Created to Prevent Thalidomide Disaster
The current system of assessing safety and efficacy was literally invented to avoid the best thalidomide 😃
Thursday Discussion Post
Johns Hopkins Clinical and Translational Research Institute announced a clinical trial for a combined Shigella and ETEC vaccine aimed at preventing traveler’s diarrhea. The study will enroll volunteers for outpatient and inpatient arms, offering compensation of up to $5,100. The...
Bispecific ADCs and the Conditions Nobody Is Talking About
Sidewinder Therapeutics announced a $137 million Series B round to push precision bispecific antibody‑drug conjugates (BspADCs) into clinical trials. The funding follows a prior preview of the emerging bispecific ADC niche at AACR, highlighting a surge of early‑stage programs. While the concept...
LP(a)-Lowering Drugs Poised as Pharma’s Next Breakthrough
The next big thing in pharma over the next few years - drugs to reduce LP(a). https://t.co/2rmLcAFGp1
AI Diffusion Models Tailor Drug Molecules to Custom-Fit Protein Targets, Speeding Drug Development and Evaluation
University of Virginia researchers unveiled YuelDesign, an AI diffusion‑model platform that simultaneously generates drug‑like molecules and their flexible protein binding pockets. Complementary tools YuelPocket and YuelBond locate precise binding sites and ensure chemically realistic bonds, respectively. Early validation on the...
CDC Vaccine Panel Rules Target Lawsuit, Boost Kennedy Allies
New rules for CDC vaccine panel aim to address lawsuit, empower Kennedy’s allies https://t.co/miSg4oOYSu via @statnews
AI Can Now Run Biology Labs, but Regulations Are Falling Behind
AI systems are now capable of autonomously designing and executing thousands of biological experiments, illustrated by OpenAI’s GPT‑5 and Ginkgo Bioworks completing 36,000 runs and cutting protein‑production costs by roughly 40%. This programmable biology accelerates protein engineering, drug discovery and...
Baebies’ Finder Platform Secures Dual FDA Clearance and CLIA Waiver
Baebies announced that its Finder platform has received FDA 510(k) clearance for a Flu A&B/SARS‑CoV‑2 test and a CLIA waiver, making it the first molecular point‑of‑care system with multifunctional capabilities. The cartridge‑based device delivers PCR‑quality results in 15‑20 minutes, enabling...
ZEO ScientifiX Joins XPRIZE Healthspan Semi-Finals with Regenerative Biologics Platform
ZEO ScientifiX, a clinical‑stage biotech, was named a Qualified Team for the XPRIZE Healthspan semi‑finals, moving its extracellular‑vesicle therapeutics into the competition’s Finals Application phase. The $101 million global contest seeks therapies that can restore muscle, cognition and immune function by...
Gilead and Roche Bet on Protein Degraders for Their Cancer Drug Pipelines
Gilead exercised its option to license Kymera Therapeutics' CDK2 molecular‑glue degrader KT‑200, triggering a $45 million payment and opening a potential $665 million milestone path, with an IND target of 2027. Roche paid $20 million upfront to C4 Therapeutics to co‑develop degrader‑antibody drug...
Graphene Drum Sensor Detects Superbugs in Real Time
Researchers at TU Delft and its spin‑off SoundCell have demonstrated a graphene nanodrum that identifies antibiotic‑resistant bacteria by their acoustic signatures. The label‑free method can sense the motion of a single cell, offering a rapid alternative to conventional culture tests.
Drugs From a Text Prompt, Wegovy Pill Competition Dampens Lilly’s Surge
In this episode of Touching Base, the GEN editors discuss how AI agents are accelerating scientific discovery, highlighting startups like Latent Labs that can design therapeutic antibodies from a simple text prompt and LabOS, an extended‑reality platform that integrates AI,...
Recalls of Angiotensin II Receptor Blockers (ARBs) Including Valsartan, Losartan and Irbesartan
The FDA has issued recalls for certain generic angiotensin II receptor blockers—including valsartan, losartan and irbesartan—after detecting nitrosamine impurities such as NDMA, NDEA and NMBA. These contaminants are probable carcinogens and were traced to manufacturing processes of the active pharmaceutical ingredient....
Mississippi 340B Law Upheld by Appeals Court in Two Cases
On April 9, 2026, the U.S. Court of Appeals for the Fifth Circuit upheld Mississippi’s law that protects 340B drug pricing for contract‑pharmacy arrangements. The court affirmed district‑court rulings rejecting injunction requests from Novartis, the Pharmaceutical Research and Manufacturers of America...
BBB Access Route via Proteomic Vascular Mapping
Researchers led by Jiefu Li at the Howard Hughes Medical Institute have unveiled an in‑vivo proteomic method that tags and isolates proteins on the luminal surface of blood vessels. By perfusing a lectin‑conjugated peroxidase, they biotinylate adjacent proteins, enabling mass‑spectrometry...