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.
AL-S Pharma Tests How Far SOD1 Biology Extends Into Sporadic ALS
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Penn Engineers Unveil aroLNPs Cutting Liver Delivery Tenfold While Boosting Lymph‑Node Targeting
University of Pennsylvania bioengineers have created a redesigned lipid nanoparticle, aroLNP, that delivers at least ten‑fold less mRNA to the liver while preserving lymph‑node uptake. The breakthrough could lower the dose needed for effective vaccination and expand mRNA therapeutics.
Towards Intelligent and Miniaturized Drug Delivery Devices
Intelligent and miniaturized drug delivery devices (IMDDDs) combine biotechnology, AI, electronics, and novel materials to provide precise, programmable drug release inside the body. These platforms integrate real-time sensing with adaptive control, enabling dose adjustments based on biomarkers such as glucose...
U.S. FDA Approves Label Update to Accelerate Thaw Time for ADSTILADRIN® (Nadofaragene Firadenovec-Vncg)
The U.S. FDA has approved a label update for Ferring Pharmaceuticals' ADSTILADRIN® (nadofaragene firadenovec‑vncg) that permits an accelerated water‑bath thawing process completed in roughly 25 minutes. The therapy, the only FDA‑approved non‑replicating intravesical gene‑therapy for high‑risk BCG‑unresponsive non‑muscle invasive bladder...
Proposed FTC, CVS Agreement Underway To Settle Inflated Insulin Costs Allegations
The Federal Trade Commission and CVS Caremark have reached a settlement that resolves all claims alleging the pharmacy‑benefit manager inflated insulin prices through anticompetitive rebate practices. Court filings on March 23 indicate the agreement ends the FTC’s lawsuit in its...
Hawley Seeks Internal Data From Danco As Telehealth Abortions Rise
Sen. Josh Hawley (R-MO) has demanded that Danco Labs, the maker of mifepristone and misoprostol, turn over any internal communications it has had with the FDA, telehealth providers, pharmacists, patients, state medical boards, and attorneys general concerning the safety of...
Doctors for America Raises PDUFA, CNPV, Bayesian, Supply Chain Concerns With Lawmakers
Doctors for America met with bipartisan lawmakers to flag several regulatory concerns at the FDA. The group warned that “America First” provisions in the upcoming PDUFA negotiations could increase user fees and hinder drug access, while the agency’s reliance on...
Absci Reports Business Updates and Fourth Quarter and Full Year 2025 Financial and Operating Results
Absci Corporation announced that its AI‑designed antibody ABS‑201 has been dosed in the first three single‑ascending‑dose cohorts of the Phase 1/2a HEADLINE trial, showing favorable safety and early hair‑growth signals in human ex vivo studies. The company also unveiled Origin‑1, a generative‑AI...
Biomea Fusion Reports Full Year 2025 Financial Results and Corporate Highlights
Biomea Fusion announced its FY 2025 results, reporting $56.2 million in cash and a net loss of $61.8 million, roughly half the loss recorded a year earlier. The company highlighted durable 52‑week HbA1c reductions of 1.2 % from icovamenib in type 2 diabetes and launched...
BMS’ Sotyktu Receives FDA Expansion in Psoriatic Arthritis
Bristol Myers Squibb received FDA approval expanding Sotyktu (deucravacitinib) to treat adults with active psoriatic arthritis, making it the first oral selective TYK2 inhibitor for this indication. The label extension is backed by the POETYK PsA-1 and PsA-2 trials, where...
Karyopharm Therapeutics Inc. (KPTI) Discusses Top Line Results From Phase III SENTRY Trial in Myelofibrosis Transcript
Karyopharm Therapeutics announced top‑line data from its Phase III SENTRY trial, which evaluated selinexor combined with ruxolitinib in patients with myelofibrosis. The company reported that the regimen met its primary efficacy endpoints and demonstrated a manageable safety profile. Alongside the clinical...
STAT+: Drug Company Penalties for Paying Kickbacks to Doctors Failed to Dent Bottom Lines, Analysis Finds
A JAMA Network Open study examined 64 pharmaceutical kickback settlements from 2000 to 2025, uncovering $10.25 billion in penalties. The drugs at the center of those cases generated $458.6 billion in U.S. sales, meaning fines represented just 2.2 percent of related revenue. The...
BioAge Labs Provides Business Updates
BioAge Labs reported full‑year 2025 results, highlighting positive Phase 1 data for its oral NLRP3 inhibitor BGE‑102, which achieved up to 86% reduction in hsCRP and strong suppression of IL‑1β, IL‑6, and fibrinogen. The company announced a Phase 2a cardiovascular risk trial...
How Pharma Supply Chains Can Brace for FDA’s 12-Digit NDC Standard
The FDA issued a final rule on March 5, 2026 establishing a uniform 12‑digit National Drug Code (NDC) that will replace the current variable 10‑digit format, with an effective date of March 7, 2033 and a seven‑year preparation window followed by a three‑year transition...
CVS Reaches Insulin Pricing Settlement with FTC
CVS Health announced a proposed settlement with the Federal Trade Commission concerning its insulin pricing practices. The agreement, negotiated by CVS’s pharmacy benefit manager Caremark, is modeled after the FTC’s recent deal with Express Scripts, a Cigna subsidiary. While the...
Safety Similar Across Advanced Crohn’s Disease Therapies
Researchers analyzed real‑world claims data from 12,245 Crohn’s disease patients treated between 2016 and 2022 to compare safety outcomes across five advanced therapies, including TNF antagonists, vedolizumab, ustekinumab, risankizumab, and upadacitinib. Incidence rates for serious infections, major adverse cardiovascular events,...
Aurinia Shares Jump 6% as Kevin Tang Becomes CEO
Aurinia Pharmaceuticals' shares climbed about 6% to $14.88 after board chair Kevin Tang was appointed chief executive officer, accompanied by a slate of new senior executives. The leadership overhaul is expected to reshape the company's financial strategy and investor outlook.
Kintor’s KX-826 Meets Phase III Endpoints in Alopecia
Kintor Therapeutics announced that its oral JAK inhibitor KX-826 successfully met both primary and key secondary endpoints in a pivotal Phase III trial for alopecia areata. The double‑blind study enrolled 620 patients and showed statistically significant hair regrowth compared with...
STAT+: FDA Slams Soon-Shiong and ImmunityBio for Making ‘False and Misleading’ Claims About a Drug
The FDA sent a March 13 warning letter to ImmunityBio, a company controlled by biotech magnate Patrick Soon‑Shiong, after finding multiple false and misleading statements about its bladder‑cancer drug Anktiva. The agency highlighted that television ads and a podcast claimed the...
Antibiotics Selectively Supercharged Against MRSA
Yale and Cornell chemists have devised a metal‑free aminoxyl catalyst that oxidizes a single secondary alcohol in the macrolide antibiotic erythromycin A. The catalyst, paired with mCPBA, proved highly selective, but analogous macrolides clarithromycin and azithromycin required different reagents to achieve...
Ocugen Heads to Phase 3 with Gene Therapy for Geographic Atrophy
Ocugen announced that its investigational gene therapy for geographic atrophy, a leading cause of vision loss in age‑related macular degeneration, will move into a Phase 3 clinical trial. The company reported mixed Phase 2 results, showing a favorable safety profile but inconsistent...
NanoZymeX Secures €160K to Advance Lipid Nanoparticle Enzyme Therapies for Rare Diseases
Swiss biotech NanoZymeX has secured €160,000 (about $174,000) from Venture Kick to accelerate its lipid‑nanoparticle platform for enzyme replacement therapies. The technology, spun out of the University of Basel, seeks to improve delivery of therapeutic enzymes into muscle cells and lysosomes,...
FDA Warns ImmunityBio over Misleading Podcast with Patrick Soon-Shiong
The U.S. Food and Drug Administration issued a warning to ImmunityBio after a television ad and a podcast featuring billionaire biotech entrepreneur Patrick Soon‑Shiong suggested that the company’s bladder‑cancer drug Anktiva could cure or prevent all cancers. The FDA said...
Optibrium Introduces Graphical Interface for QuanSA to Enhance Ligand-Based Affinity Predictions
Optibrium has released a new PyMOL plugin that adds a graphical user interface to its QuanSA ligand‑based affinity prediction tool. QuanSA uses physically‑motivated machine learning to deliver free‑energy perturbation‑level accuracy without needing a protein structure, dramatically lowering computational cost. The...
Karyopharm’s Mixed Myelofibrosis Data; Rezolute to Seek FDA Approval Despite Trial Failure
Karyopharm reported mixed results from its Phase 3 SENTRY trial of selinexor in myelofibrosis, achieving a statistically significant reduction in spleen volume but raising safety concerns. The data fell short of expectations for overall survival benefit. Meanwhile, Rezolute announced it will...
Seven T Cell Engager Companies You Should Know About
T‑cell engagers are bispecific antibodies that redirect T cells to destroy cancer cells and are being explored for autoimmune disorders. Seven companies are leading the field: Adaptin Bio secured FDA IND clearance for APTN‑101 in glioblastoma; Candid Therapeutics merged with...
Amylyx Pharmaceuticals Announces Completion of Enrollment in Pivotal Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia
Amylyx Pharmaceuticals announced that the pivotal Phase 3 LUCIDITY trial of avexitide has completed enrollment, randomizing and dosing the final participant to bring the total to 78 patients across 21 U.S. sites. The double‑blind, placebo‑controlled study evaluates avexitide, a first‑in‑class GLP‑1...
Novartis Pledges $480M to Expand China Presence, Following Eli Lilly and AstraZeneca
Swiss drugmaker Novartis announced a $480 million investment to expand its manufacturing and R&D footprint in China. The plan allocates about $218 million to upgrade its Beijing Changping facility, which can produce up to 3 billion tablets annually, and $262 million to expand its...
Experts Urge Balanced Diets to Boost GLP‑1 Anti‑Obesity Drug Benefits
Nutritionists and obesity physicians say GLP‑1 drugs such as Wegovy and Zepbound only deliver lasting weight loss when paired with a high‑protein, high‑fiber, well‑hydrated diet. With roughly one in eight U.S. adults on these medicines and more than 600,000 Wegovy‑pill...
STAT+: Pharmalittle: We’re Reading About a Trump Drug Pricing Flaw, a Gilead Deal, and More
A senior Trump administration health official warned that the president’s most‑favored‑nation (MFN) drug‑pricing strategy may unintentionally raise prices abroad rather than lower them in the United States. The flaw arises because manufacturers could postpone launching new drugs in foreign markets,...
Digital Tech Redefines Pharma Manufacturing and Distribution
This book explains how disruptive technologies and emerging trends such as robotics, artificial intelligence, 3D printing, precision medicine or patient design will impact the manufacturing and distribution of pharmaceuticals in order to prepare successfully for a better future of healthcare. Everything...
Regulators Inspect 49 Companies Over Unauthorized Weight‑Loss Drug Sales
Regulatory agencies have launched inspections of 49 firms suspected of distributing unauthorized weight‑loss drugs. The sweep underscores heightened scrutiny of the booming weight‑loss market and raises questions about compliance across the industry.
Aardvark Pauses 2 Obesity Trials, Reveals New Details on Cardiac Concerns
Aardvark Therapeutics has paused two Phase 2 obesity trials, POWER and STRENGTH, after cardiac safety signals emerged in its lead compounds ARD‑101 and ARD‑201. The anomalies were observed in healthy volunteers receiving double the target dose, prompting a halt to the...
ImmuneBridge Secures $7.7M to Open Cell Therapy Manufacturing Platform to Biotech Partners
ImmuneBridge announced a $7.7 million second seed round, bringing its total seed capital to roughly $20 million, to commercialize its proprietary cell‑therapy screening and manufacturing platform for external partners. The platform combines machine‑learning‑driven donor selection with a unique small‑molecule that preserves stem‑cell...
Dual-Action Antiviral Treatments Offer A New Path Forward
Scientists at the U.S. Army Medical Research Institute of Infectious Diseases have engineered a dual‑action antibody that simultaneously targets two stages of Venezuelan equine encephalitis virus (VEEV) entry. The single‑molecule treatment protected animals even when given after exposure and neutralized...
Celosia Therapeutics Starts First‑Human Dosing of CTx1000 Gene Therapy for ALS
Celosia Therapeutics has dosed the first participant in its Phase 1b KOANEWA trial of CTx1000, a gene‑editing medicine that clears pathological TDP‑43 protein in ALS patients. The open‑label study, run at Macquarie University Hospital, marks the first human test of...
Viz.ai and Alnylam Pharmaceuticals Partner to Launch AI Care Pathway for Cardiac Amyloidosis
Viz.ai and Alnylam Pharmaceuticals have teamed up to launch an AI‑driven care pathway targeting cardiac amyloidosis, a frequently underdiagnosed heart disease. The solution embeds the FDA‑cleared Us2.ai echocardiography algorithm and generative AI into hospital IT systems to automatically detect subtle...
Imaging Agent Granted FDA Fast Track Designation
FluoGuide A/S announced that the U.S. FDA has granted Fast Track designation to its intraoperative imaging agent FG001, targeting high‑grade glioma surgery. The designation recognizes the serious nature of glioblastoma and the agent's promise to improve tumor visualization during resection....
New AD Combos Outpace Dupilumab, Injection Frequency Drops
Atopic dermatitis landscape from Wedbush. Looks like there are two parallel vectors: lower injection frequency ( $APGE ) and combining new mechanisms with IL13/IL4R. So far $JNJ's IL13+IL31 failed (the only one to be directly compared to dupi) while $PFE's...
Free Market Could Make Ozempic Affordable for Millions
The free market (no government-granted patent monopolies) will make Ozempic affordable for tens of millions of people https://t.co/SYl5M82mux
Quotient Therapeutics & Merck Enter ~$2.2B Partnership to Discover Novel Drug Targets in IBD
Quotient Therapeutics and Merck have signed a multi‑year collaboration to use Quotient’s somatic genomics platform for discovering new drug targets in inflammatory bowel disease. The agreement provides Quotient with $20 million upfront and includes milestone payments that could lift the total...
SWIFT-Seq Maps Single-Cell Transcriptomes of Myeloma CTCs
SWIFT-seq enables comprehensive single-cell transcriptomic profiling of CTCs in multiple myeloma & precursors [Aug 8, 2025] Lightbody, @RomanosSP et al. @IrenemGhobrial - @LabGhobrial @NatureCancer https://t.co/LhqmRShFo9 #mmsm #LiquidBiopsy #cactc THREAD: https://t.co/87VZtDNy80 https://t.co/41MRROCXwI
Measurable Residual Disease: Crucial Metric in Multiple Myeloma
#mmMRD healthcare social media hashtag [Nov 21, 2020] Minimal/measurable residual disease (MRD) in multiple myeloma. Submitted by @bdermanmd to @symplur @healthhashtags https://t.co/grkkiox2yh #mmsm No longer available at Symplur https://t.co/WmKH0fcB4p
THE IMPACT OF ARTIFICIAL INTELLIGENCE ON PHARMACEUTICAL AND LIFESCIENCES INDUSTRY
Artificial intelligence is reshaping the pharmaceutical and life‑sciences value chain, from molecule discovery with generative and structure‑prediction models to clinical trial design, manufacturing, regulatory submissions, intellectual property and supply‑chain orchestration. Tools such as AlphaFold and de‑novo design engines accelerate lead...
Radiopharmaceutical Clinical Trials in 2026: How to De-Risk Isotope Supply, Imaging Variability, and Regulatory Pathways
Radiopharmaceutical clinical trials are becoming a high‑velocity segment in 2026, but they remain vulnerable to three predictable bottlenecks: isotope supply chain fragility, imaging variability, and regulatory pathway selection. Axcellant, a boutique CRO with an integrated imaging core lab, demonstrates that...
Synthetic DNA Manufacturing Hub Set Up in Boston by Artis BioSolutions
Artis BioSolutions, a San Diego‑based advanced therapies firm, has launched a synthetic DNA manufacturing hub in Boston using Syngoi Technologies' proprietary enzymatic platform. The new site complements its GMP manufacturing facility in Watertown, creating a bi‑continental network with an existing...
Biotech Investors Set to Meet with Key Congressional Panel
A bipartisan congressional commission focused on maintaining U.S. leadership in biotechnology will host a meeting with leading biotech investors next week. The investors, representing venture capital firms and industry funds, aim to discuss policy gaps, funding mechanisms, and regulatory hurdles....
Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)
Prestige Biopharma announced topline results from its phase‑III SAMSON‑II trial comparing HD204, a biosimilar to Avastin (bevacizumab), with the reference product in 625 patients with advanced non‑squamous non‑small cell lung cancer. The study demonstrated an objective response rate (ORR) of...
Mosaic Therapeutics to Present Poster Highlighting Preclinical Data for Lead Program MOS101 at the American Association for Cancer Research (AACR)...
Mosaic Therapeutics will present preclinical data on its lead program MOS101—a combination of the next‑generation MDM2 antagonist ASTX295 and the FDA‑approved PARP inhibitor olaparib—at the AACR 2026 Annual Meeting. The poster focuses on BRCA2‑mutant, TP53‑wild‑type solid tumours and highlights the...
Apnimed Set to Exit Sleep Disorder Joint Venture with Shionogi for $100M Upfront
Japanese pharmaceutical company Shionogi is buying out Apnimed’s 50% stake in their sleep‑disorder joint venture for an upfront payment of $100 million. The acquisition gives Shionogi full control over the partnership’s pipeline, which focuses on treatments for conditions such as obstructive...