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.
Bavarian Nordic and SII Sign Agreement for Chikungunya Vaccine Production
Bavarian Nordic has signed a manufacturing agreement with the Serum Institute of India to transfer full technology for its chikungunya vaccine, CHIKV VLP (branded Vimkunya). The deal replaces an earlier partnership with Biological E and builds on the companies' existing mpox‑vaccine collaboration. Approved in the UK, EU and the US, the single‑dose, adjuvanted VLP vaccine targets individuals aged 12 and older. The agreement aims to boost production capacity and secure supply for low‑ and middle‑income countries facing rising chikungunya incidence.
Generic GLP-1s Are Coming, but Americans Don’t Want to Wait
GLP‑1 drugs such as semaglutide have surged from diabetes treatment to a mass‑market weight‑loss solution, with roughly 12.4% of Americans now using them. Global sales are projected to climb from $50‑60 billion today to over $135 billion within a decade, driven largely...
Pharma Pulse: FDA Launches AEMS and the Rise of Direct-to-Employer Drug Purchasing
The FDA unveiled the Adverse Event Monitoring System (AEMS), a unified platform that shifts drug safety surveillance from quarterly updates to real‑time reporting and is expected to save roughly $120 million over five years. Simultaneously, a direct‑to‑employer drug‑purchasing model is gaining...
Lilly Warns of Impurity Risk in Certain Compounded Forms of Mounjaro and Zepbound
Eli Lilly warned that compounded versions of its GLP‑1 drugs Mounjaro and Zepbound, when mixed with vitamin B12, may contain unsafe impurities. The alert follows growing off‑label compounding as demand outpaces supply. Lilly’s notice urges clinicians and patients to verify product sources...
From Two Trials to One, Sponsors Face a Higher Standard
The FDA announced that a single pivotal trial can now satisfy efficacy requirements for new drug applications, replacing the previous two‑study mandate. This change raises expectations for data depth, quality, and risk‑based management throughout the trial lifecycle. Guests Oxana Iliach...
Rethinking Endocrine Therapy in ER-Positive Breast Cancer
Dr. Steven Quay, CEO of Atossa Therapeutics, highlighted a new focus on tolerability and prevention in estrogen‑receptor‑positive breast cancer, where five‑year survival now exceeds 90%. Atossa is developing a next‑generation SERM that aims to reduce side‑effects while maintaining efficacy and...
Injectable Mini-Livers as an Alternative to Liver Regeneration
Researchers have introduced INSITE, an injectable platform that combines primary human hepatocytes with hydrogel microspheres to form self‑assembling, vascularizable tissue ensembles in situ. Using ultrasound guidance, the scaffold is delivered to an ectopic site where it integrates with host vasculature...
Gesynta Pharma Doses First Patient in Phase II NOVA Trial
Gesynta Pharma has begun dosing the first patient in its Phase II NOVA trial, evaluating oral vipoglanstat for endometriosis. The double‑blind, placebo‑controlled study will enroll about 190 women across Europe and compare two dose levels against placebo over four menstrual cycles....
GSK Backs £11m Centre to Build Digital Twins of Organs for Faster Drug Discovery
GSK has pledged £11 million to launch the Modelling‑Informed Medicine Centre (MiMeC), a joint venture with Imperial College London and the University of Oxford. The centre will develop digital twins—computer‑based replicas of lungs, liver and kidneys—to run in‑silico experiments and speed...
Moving CAR-T Beyond Oncology
Researchers are expanding CAR‑T cell therapy beyond cancer to treat autoimmune diseases such as lupus and rheumatoid arthritis. Sail Biomedicine’s chief products and operations officer highlighted on the Pharmaceutical Executive podcast that the company has pivoted to RNA‑based CAR‑T platforms,...
Lilly Issues Public Warning About Tirzepatide Compounded with B12
Eli Lilly has issued a public warning after testing revealed a significant impurity formed when tirzepatide is compounded with vitamin B12. The impurity’s health effects are unknown, and the company has alerted the FDA and urged patients to consult physicians....
George Medicines Partners with Ahngook Pharmaceutical to Commercialize GMRx2 in Korea
George Medicines has signed an exclusive licensing and supply agreement with South Korea’s Ahngook Pharmaceutical to bring its triple‑combination antihypertensive pill, GMRx2, to the Korean market. The single‑pill formulation blends telmisartan, amlodipine and indapamide in three dose strengths, aiming for...
C2N Diagnostics Partners with BeauBrain Healthcare to Offer PrecivityAD2 Blood Test for Alzheimer’s Disease in South Korea
C2N Diagnostics has signed a partnership with BeauBrain Healthcare to introduce its PrecivityAD2 blood test for Alzheimer’s disease in South Korea, targeting patients aged 50 and older with mild cognitive impairment or dementia. Clinical studies published in JAMA and npj...
Tigecycline-Induced Hypoglycemia in Critically Ill Patients with Severe Infections: A Retrospective Cohort Study
A retrospective cohort of 169 critically ill patients receiving tigecycline showed significant reductions in blood glucose at three daily time points. Hypoglycemia occurred in 11.2% of patients and was linked to a nearly four‑fold increase in 28‑day mortality (OR 3.83). Larger...
Join Final FDA Advisory Committee on Flu Shot Access
If you are curious about seeing what may be the last competent FDA advisory committee left standing in action as they contribute to determining access to flu shots next fall, join me, @jessicamalaty, & @SaveAmericaMvm at 12:30 pm ET on...
The Trump Drug Deal Threatens the Very Purpose of the NHS
The UK government has negotiated a UK‑US pharmaceutical trade deal that raises NICE’s cost‑effectiveness threshold from £20‑30k to £25‑35k per QALY. The higher threshold will deem more expensive drugs cost‑effective, increasing NHS drug spend while reducing rebate rates from 22.9%...
Ancient Mushroom, Modern Medicine: Paul Stamets Says Agarikon Mycelium May Be Key to Fighting Viral Pandemics
Mushroom mycologist Paul Stamets presented data indicating that Agarikon (Fomitopsis officinalis) mycelium possesses broad antiviral properties. In two placebo‑controlled trials, a combined Agarikon‑turkey‑tail extract reduced COVID‑19 vaccine side effects, sustained antibody titers, and accelerated recovery in hospitalized patients. The research,...
FDA Signals Potential Updates to SUPAC Guidances—Comments Due June 1, 2026
The FDA has opened a public docket to solicit comments on its long‑standing Scale‑Up and Post‑Approval Changes (SUPAC) guidances for immediate‑release solid oral, non‑sterile semisolid, modified‑release solid oral dosage forms and the manufacturing equipment addendum. The agency seeks feedback on...
New Tissue Models Accelerate Liver Disease Drug Development
New tissue models could help researchers develop drugs for liver disease by Anne Trafton @MIT Learn more: https://t.co/hkeRZ0W47B #HealthTech #EmergingTech #TechForGood #Innovation https://t.co/LNvft8iX9M
Capricor Therapeutics Inc (CAPR) Q4 2025 Earnings Call Transcript
Capricor Therapeutics reported fourth‑quarter 2025 revenue of $16 million, a modest 4% year‑over‑year increase, while gross margin rose to 86% driven by higher selling prices and manufacturing efficiencies. Net loss widened to $11.9 million as operating expenses outpaced revenue growth, but the...
Vaxart Inc (VXRT) Q4 2025 Earnings Call Transcript
Vertex Pharmaceuticals reported Q4 2025 revenue of $3.2 billion, a 10% quarterly increase, and $12 billion for the full year, up 9% year‑over‑year. Gross margin reached 85.7% and non‑GAAP net income rose 24% to $1.3 billion, underscoring strong profitability. New product...
Nektar Therapeutics (NKTR) Q4 2025 Earnings Call Transcript
Nektar Therapeutics reported strong Q4 2020 results, highlighting robust progress on its cytokine platform. The IL‑2 agonist BEMPEG demonstrated a median progression‑free survival of 30.9 months in melanoma and is now enrolled in six registrational trials across melanoma, renal, bladder,...
DNA Origami Vaccine Rivals mRNA Shots While Being Easier to Store and Manufacture
Researchers at Harvard’s Wyss Institute and Dana‑Farber unveiled DoriVac, a DNA origami‑based vaccine platform that delivers antigens and adjuvants on a self‑folding nanostructure. In pre‑clinical mouse studies and a human lymph‑node‑on‑a‑chip model, DoriVac generated antibody and T‑cell responses comparable to...
Startup Vima Adds Parkinson’s to Movement Disorder Scope, Expanding Series A Round to $100M
Vima Therapeutics announced an additional $40 million raise, taking its Series A funding to $100 million. The capital will support parallel Phase 2 trials of its lead candidate VIM0423 in isolated dystonia and Parkinson’s disease, expanding the startup’s focus beyond the rare movement disorder....
Can FDA Tolerate Cancer Risk for Rare Pediatric Disease Gene Therapies?
The FDA placed a clinical hold on Regenxbio’s RGX‑111 and RGX‑121 gene‑therapy trials after a pediatric MPS I patient developed a tumor four years post‑treatment. The case marks the first documented long‑latency cancer linked to an adeno‑associated virus (AAV) vector in...
Phase 2 Trial Compares Dara‑Bor
EAA241 - Ph 2 RCT Dara-Bor-Dex vs Cy-Bor-Dex in the treatment of Newly Diagnosed Multiple Myeloma with Light Chain Cast Nephropathy (LCCN) [Study activated 8/11/25] @keruakous https://t.co/1NgvVZ3fTA #NCT07085728 #mmsm @eaonc https://t.co/IvK3UNeem9
Phase 3
#EAOnc EQUATE EAA181 Effective Quadruplet Utilization After Tx Evaluation: Ph3 RCT NDMM Not Intended for Early ASCT [Activated: 10/27/20] PI= @myelomaMD https://t.co/qD26HMx3J8 #NCT04566328 #mmMRD #mmsm @eaonc @mweissmdphd @VincentRK @LynneWagnerPhD Wei Snyder Kostakoglu @mtmdphd https://t.co/FLK0sJ0N1w
Science Spotlight: New Ways to Attack Β-Amyloid Plaques in Alzheimer’s
Two pre‑clinical studies propose active clearance of β‑amyloid as a new Alzheimer’s strategy. Researchers at Washington University engineered astrocytes with chimeric antigen receptors (CARs) that engulf plaques, while another team designed bispecific peptides that ferry amyloid into cells for lysosomal...
Daratumumab Boosts Revlimid Efficacy in Smoldering Myeloma
#EAonc EAA173 - Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM) - PI: @nsc_natalie https://t.co/VtBMJUjI5X Activated: Apr 30, 2019 #mmsm @eaonc #NCT03937635 @VincentRK @mweissmdphd https://t.co/ikQKjHjscU
Phase 3 Trial Tests
.@SWOG S2213 Ph3 RCT Dara-VC Induction Followed by ASCT or Dara-VCD Consolidation & Daratumumab Maintenance in Pts w/ Newly Diagnosed AL Amyloidosis [Activated: 12/1/23] https://t.co/OizUfJCc2c #mmsm #bmtsm https://t.co/FoT3i0xGcL
Hawley Unveils Bill to Ban Abortion Pill, Strip FDA Approval
Senator Josh Hawley introduced a bill to immediately withdraw the FDA's safety approval for mifepristone, the primary abortion medication. The legislation follows recent Supreme Court and Trump‑era reviews of the drug and cites a controversial conservative study alleging serious adverse...
Mapping Genomic Alterations in Multiple Myeloma Precursors
Genomic landscape of multiple myeloma and its precursor conditions [May 21, 2025] Jean-Baptiste Alberge et al. @IrenemGhobrial @NatureGenet https://t.co/DDWGRrpI4Y #mmsm #PrecisionMedicine #cagenome https://t.co/LY1MzFXSBN
Multiple Myeloma Evades GPRC5D T‑Cell Engagers via Multim
Multimodal antigenic escape to GPRC5D-targeted T cell engagers in multiple myeloma [Jan 15, 2026] @hollyleeYJ et al. @NBahlis @NatureMedicine https://t.co/mz393mPMAq #mmsm #PrecisionMedicine #tcellrx THREAD: https://t.co/lNX9b7LsnR HT @AuclairDan https://t.co/2qih7LwP1c
AGENT IDE Midterm Results Still Give DCB an Edge for In-Stent Restenosis
Three‑year follow‑up of the AGENT IDE trial shows the Agent paclitaxel‑coated balloon (DCB) outperforms uncoated balloon angioplasty in treating in‑stent restenosis (ISR), with target‑lesion failure (TLF) rates of 32.7% versus 40.9% (hazard ratio 0.72). The advantage is driven mainly by...
Foghorn Therapeutics Provides Financial Update for 2025 and 2026 Strategic Outlook
Foghorn Therapeutics announced a financial update highlighting progress on its lead oncology candidate FHD-909, which remains on schedule in Phase 1 dose‑escalation for SMARCA4‑mutant NSCLC. The company also confirmed that its selective CBP and EP300 degrader programs are slated for...
Elutia Reports Fourth Quarter and Full Year 2025 Financial Results; Initiates NXT-41 Regulatory Process
Elutia Inc. reported its Q4 and full‑year 2025 results, highlighting the $88 million sale of its BioEnvelope business to Boston Scientific and a cash position of $36.4 million plus $8 million in escrow. The company submitted a 510(k) for the base biologic matrix...
Codexis Reports Fourth Quarter and Fiscal Year 2025 Financial Results
Codexis reported FY 2025 revenue of $70.4 million, a 19% increase year‑over‑year, driven largely by a $37.8 million technology‑transfer agreement with Merck. Q4 revenue jumped 81% to $38.9 million, and product gross margin improved to 64% for the year. The company ended 2025 with...
FDA Merges Adverse Event Trackers Into One Database
The FDA announced a unified adverse‑event database that will eventually incorporate all of its existing reporting systems, including the vaccine‑side‑effect tracker jointly operated with the CDC. The new platform, called the Adverse Event Monitoring System, centralizes data from drugs, biologics,...
Pharmaceutical Executive Daily: FDA's New Guidance for Biosimilar Development
The FDA issued its fourth revision of draft biosimilar development guidance, allowing scientifically justified streamlining of pharmacokinetic (PK) studies and estimating up to a 50% cost reduction—about $20 million per program. The new guidance also expands the use of clinical data...
New Chromatography Resin Developed for Secretory Antibodies
Researchers at BOKU University in Vienna have engineered a novel chromatography resin designed to capture secretory immunoglobulin A (IgA) at titers suitable for commercial manufacturing. The resin employs a reengineered bacterial surface ligand, analogous to Protein A, within a macropore...
Sen. Markey Admits He Doesn
Sen. Markey (D-Mass.) tells me outside the Capitol he doesn’t know who Vinay Prasad is and would need to be briefed by staff to respond to questions on the FDA
A Better View of How Cells Take Up Mitochondria to Restore Function
Researchers have demonstrated that mesenchymal stromal cells (MSCs) can actively internalize isolated, functional mitochondria through endocytic pathways. The study shows that the internalized organelles retain structural integrity and boost cellular proliferation, stress tolerance, and oxygen consumption. Chemical inhibition of endocytosis...
Regulation Will Push Peptide Market to Clean Providers
Consider this arc: peptides were around in niche communities, GLPs from Pharma then exploded, people realized they could take less or source them elsewhere, regulation enters & now gray & black market are going bye-bye & companies like HIMs &...
Safer Large DNA Insertion Moves Genetic Medicine Toward Scalability
Researchers at Massachusetts General Hospital, in partnership with Full Circles Therapeutics, have introduced a circular single‑stranded DNA donor platform called INSTALL that enables kilobase‑scale gene insertion without triggering the cGAS immune sensor. The method combines a short double‑stranded DNA segment...
Simple 'Cocktail' Of Amino Acids Dramatically Boosts Power of mRNA Therapies and CRISPR Gene Editing
Researchers at Biohub identified a three‑amino‑acid cocktail—methionine, arginine and serine—that dramatically improves lipid nanoparticle (LNP) delivery of therapeutic mRNA and CRISPR components. Co‑administering the supplement boosted protein expression up to 20‑fold and raised gene‑editing rates from roughly 25% to nearly...
Biodegradable Nanoparticles Can Seek and Destroy Diseased Immune Cells
Johns Hopkins researchers have engineered a streamlined biodegradable polymeric nanoparticle that delivers mRNA to T cells, prompting them to generate CD19‑CAR receptors that target disease‑causing B cells. In mice, a single intravenous dose eliminated 95% of circulating B cells within...
Net Pricing Could Cut Patients' Drug Costs by 40%
If big pharma sold to big 3 distributors at net prices rather than list prices, patients would save on average 40pct on their specialty and brand medications. This isn't hard. @BernieSanders @HawleyMO @SenTedCruz @SenateGOP @SenWarren @AOC https://t.co/COdRaMJPgq
VIDO – Six Years Later: How VIDO Helped Respond to the COVID-19 Pandemic
VIDO swiftly responded to COVID‑19 by designing a subunit vaccine candidate within days of the SARS‑CoV‑2 genome release, isolating the virus, and establishing animal models that enabled a Phase 1 human trial by early 2021, making it the first Canadian university...
Costco Is Slashing Fertility Drug Prices By Up To 80%
Costco announced a partnership with digital health platform Sesame and fertility network IVI RMA North America to offer members dramatically reduced prices on fertility medications, with discounts of up to 80 percent. The program guides members through a digital intake,...
FDA Drug Official Moves To Hire A Friend Who Touts Unproven Claims About Antidepressants
The FDA’s acting CDER director, Dr. Tracy Beth Hoeg, is reportedly moving to hire Dr. Adam Urato, a maternal‑fetal specialist who is petitioning the agency to add boxed warnings about alleged pregnancy risks of antidepressants. Urato’s claims rely on limited...