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.
Zymeworks to Present Clinical and Preclinical Data on ADC Programs Including Novel RAS ADC Platform at AACR Annual Meeting
Zymeworks will present Phase 1 data on its folate‑receptor‑alpha ADC ZW191 and preclinical results for a novel pan‑RAS inhibitor ADC platform at the AACR Annual Meeting. The oral presentation will detail dose‑escalation safety and efficacy in advanced solid tumours, while poster sessions will showcase ADCs targeting PTK7, Ly6E, CLDN18.2 and other antigens with potent pan‑RAS payloads. Preclinical combination studies show ZW191 synergising with carboplatin, paclitaxel, bevacizumab and PARP inhibitors. The data underline Zymeworks’ diversified ADC pipeline aimed at RAS‑mutated cancers.
ORIC® Pharmaceuticals Announces Preclinical Rinzimetostat (ORIC-944) Presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting
ORIC Pharmaceuticals announced that two preclinical abstracts on its PRC2‑targeting agent rinzimetostat (ORIC‑944) have been accepted for poster presentation at the 2026 AACR Annual Meeting. The data show rinzimetostat, an allosteric EED inhibitor, maintains potency against EZH1‑overexpressing complexes and key...
ArriVent to Present Two Preclinical Posters on the EGFR Inhibitor Firmonertinib and on the Novel Dual-Target MUC16/NaPi2b Tetravalent ADC ARR-002...
ArriVent BioPharma will showcase two preclinical posters at the 2026 AACR Annual Meeting, highlighting its EGFR inhibitor firmonertinib and the dual‑target tetravalent ADC ARR-002. Firmonertinib demonstrates high‑potency inhibition of both classical EGFR mutations and exon‑20 insertion variants, with strong brain...
Study Finds GLP-1 Drugs Can Help Curb SUDs
A BMJ study of more than 600,000 Veterans Affairs patients with type‑2 diabetes found that glucagon‑like peptide‑1 (GLP‑1) drugs significantly lowered the risk of developing substance‑use disorders, including alcohol, cannabis, nicotine, cocaine and opioids. The analysis compared GLP‑1 therapy with...
AI's Real Bottleneck: Accelerating Human Processes, Not Tech
Our bottleneck for some of the biggest change ahead may be humans. I shared the story of Paul Conyngham and his dog Rosie on my Instagram when it broke. When I read the coverage, my shock was less that ChatGPT...
Clinical Trial Results Support Use of Weekly Extended-Release Buprenorphine for Treatment of Opioid Use Disorder During Pregnancy
A NIH‑backed multicenter trial of 140 pregnant adults found that weekly injectable extended‑release buprenorphine achieved significantly higher rates of illicit opioid abstinence than daily sublingual buprenorphine, while also reducing serious maternal adverse events. The study, published in JAMA Internal Medicine,...
ABIONYX Pharma: Availability of the Universal Registration Document for the Year 2025
ABIONYX Pharma filed its Universal Registration Document (URD) for the fiscal year 2025 with the French regulator AMF on March 17, 2026 (filing D. 26‑0099). The URD is now publicly available on both the company’s website and the AMF portal. The...
Transient but Transformative: Sanofi’s mRNA CAR-T Enters in Vivo Race
Sanofi unveiled pre‑clinical data for an in‑vivo CAR‑T platform that delivers mRNA via lipid nanoparticles (LNPs) and a CD8‑targeting VHH nanobody, eliminating the weeks‑long ex‑vivo manufacturing step. The approach achieved tumor suppression in mice with less than 5% liver uptake...
What Does a Sustainable Affordability Model Look Like in the Current Landscape?
Shivani Patel of ConnectiveRx explains how the Inflation Reduction Act forces pharmaceutical manufacturers to redesign patient‑assistance programs with a focus on gross‑to‑net protection rather than static access solutions. She emphasizes continuous program evaluation, cap adjustments, and alignment with channel‑distribution strategies...
Bicycle to Lay Off 30% of Staff, Pivot Away From Padcev Challenger
Biotech firm Bicycle Therapeutics announced it will lay off roughly 30% of its workforce, about 86 employees, as it deprioritizes its experimental ADC zelenectide‑pevedotin. Regulators expressed doubts that the Phase 2 Duravelo‑2 trial data will support accelerated approval for metastatic bladder...
Autologous versus Allogeneic: How Cell Therapy Development Is Changing in Oncology
Autologous CAR‑T therapies dominate the current market but face logistical and clinical challenges. Patients must undergo leukapheresis, endure long vein‑to‑vein times, and often need bridging therapy, which can cause adverse events. To address these issues, companies are shifting toward off‑the‑shelf...
FDA Warns Telehealth Companies Over Marketing of Compounded GLP-1 Weight-Loss Drugs
On February 20, 2026, the FDA issued warning letters to 30 telehealth companies for misleading claims about compounded GLP‑1 weight‑loss drugs such as semaglutide and tirzepatide. The agency highlighted that compounded products are not FDA‑reviewed for safety, efficacy, or quality,...
Zalsupindole
Delix Therapeutics announced the results of a Phase 1b study of zalsupindole, a selective 5‑HT2A receptor partial agonist, in patients with major depressive disorder. The trial, published in the January 2026 issue of ACS Chemical Neuroscience, demonstrated favorable safety, tolerability, and early...
GLP‑1 Weight Loss Shows No Extra Muscle Loss
A study asserts lack of disproportionate loss of muscle mass or strength cf weight loss from GLP-1 drug treatment, in mice and a small short term (12 weeks) trial in men The issue remains unsettled and counters the efforts by companies...
NQO1‐Responsive Prodrug for in Cellulo Release of Cytochalasin B as Cancer Cell‐Targeted Migrastatic (Small 16/2026)
Researchers introduced BQTML‑CB, an NQO1‑responsive prodrug that releases cytochalasin B inside tumor cells, disrupting actin filaments and halting migration and proliferation. The design exploits the enzyme NQO1, overexpressed in many aggressive cancers, to achieve tumor‑selective activation while sparing NQO1‑deficient cells and...
Bioengineered Bacterial Vesicles and Biomimetic Hybrids Eliminate Biofilms and Balance the Gut Microbiome
Researchers have engineered biomimetic nanocarriers that combine liposomal structures with Myxobacteria outer‑membrane vesicles (OMVs) to deliver antibiotics. The hybrid carriers achieve higher drug loading and can penetrate intracellular Gram‑negative pathogens, while native OMVs avoid immune clearance and sustain extracellular exposure....
From Membrane Composition to Antimicrobial Strategies: Experimental and Computational Approaches to AMP Design and Selectivity
The review highlights how bacterial membrane composition critically shapes the activity of antimicrobial peptides (AMPs) and outlines experimental and computational strategies for their rational design. By examining case studies, it maps structure‑activity relationships that govern membrane disruption versus intracellular targeting....
Third FDA Rejection for Aldeyra’s Dry Eye Disease Drug Sends Shares Plummeting
The FDA issued a third complete response letter rejecting Aldeyra Therapeutics' lead dry‑eye candidate, reproxalap, citing a lack of substantial evidence and inconsistent efficacy data. The agency noted the drug failed to demonstrate clear benefit in well‑controlled studies, though no...
Gifthealth Launches Off-the-Shelf Solution for Most Favored Nation Pricing
Gifthealth unveiled an off‑the‑shelf platform that enables manufacturers to offer Most Favored Nation (MFN) pricing through direct‑to‑patient (DTP) programs. The solution leverages Gifthealth’s position as the nation’s largest DTP partner, handling over 90% of U.S. DTP volume and supporting more...
Can Bristol Myers Squibb’s Pipeline Strategy Offset a Major Patent Cliff?
Bristol Myers Squibb faces a major patent cliff as flagship drugs like Revlimid, Pomalyst, Opdivo and Eliquis lose exclusivity, threatening its revenue base. To counteract the decline, the company is reshaping its pipeline through internal R&D and high‑profile acquisitions, emphasizing...
NVIDIA and Persistent Systems Partner to Bring ‘Agentic AI’ to Drug Discovery
Persistent Systems has partnered with NVIDIA to bring Agentic AI to the healthcare and life‑sciences sector, focusing on computational drug discovery. Leveraging NVIDIA’s full AI stack—including AI Enterprise, BioNeMo, the NeMo Agent Toolkit, and NIM microservices—Persistent built GenMolVS, a generative...
EMA Marketing Authorization of New Drugs in February 2026
In February 2026 the European Commission and the CHMP granted marketing authorisations and positive opinions for a slate of innovative therapies spanning COVID‑19, oncology, cardiology, immunology and rare diseases. Notable approvals include Moderna’s mNEXSPIKE COVID‑19 vaccine, Hansoh’s Aumseqa for EGFR‑mutated...
DDW Highlights: 17 March 2026
In this DDW Highlights episode, Bruno Quinney reviews four major stories: a Mayo Clinic study linking the Parkinson's protein alpha‑synuclein to dramatically faster Alzheimer’s progression in women; a Texas A&M‑funded project testing extracellular vesicle (EV) therapy to modulate microglia and...
Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer
Pfizer disclosed topline Phase II (FOURLIGHT‑1) data showing that atirmociclib combined with fulvestrant outperformed fulvestrant alone or everolimus + exemestane in 264 HR+, HER2‑negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors. The trial met its primary endpoint, delivering a statistically significant...
Cancer Vaccines Could Transform Treatment and Prevention – but Misinformation About mRNA Vaccines Threatens Their Potential
Scientists are accelerating development of mRNA cancer vaccines, with more than 120 clinical trials targeting melanoma, brain, breast, lung and prostate tumors. Early studies, such as personalized vaccines for glioblastoma, demonstrate rapid immune activation and improved survival. Simultaneously, a false...
Peptide Drugs Require Robust Safety and Efficacy Evidence
In response to suggesting peptide drugs should have good evidence on safety and efficacy in order to weigh the risks and benefit…
Unregulated Online Market Sells Ketamine for Depression Relief
Ketamine, an operating-room anesthetic also prized as the street drug “K” is now at the heart of a largely unregulated online industry offering depression relief. https://t.co/pGd0TO5uFy via @WSJ
China’s Control Over US Drug Supply Alarms Lawmakers
U.S. lawmakers warned that China dominates the supply chain for essential hospital and outpatient medicines, especially generic drugs that fill 90% of prescriptions. Witnesses at a Senate Aging Committee hearing highlighted that China controls roughly 90% of key starting materials...
World's Largest In‑Vivo CRISPR Data Engine Unveiled
From Prof Jin and my colleagues @scrippsresearch the largest in vivo CRISPR data engine, nearly 8 million cells, in collaboration with @nvidia and featured at GTC
Pfizer's Ibrance Successor Advances with Fresh Study Data
Pfizer’s Ibrance successor moves forward with new study data https://t.co/ozXAZYmc3M by Kristin Jensen $PFE $LLY $NVS $RHHBY $ONC
Designing Clinical Trials to Address Asthma and COPD Flare-Ups
Acute asthma and COPD exacerbations remain a costly, life‑threatening gap despite advances in chronic therapies. Connect Biopharma, led by Barry Quart, is the first biotech targeting these flare‑ups with a biologic that blocks IL‑4Rα, aiming to curb upstream inflammation. The...
Trump Pushes Drug Pricing Overhaul Despite Congressional Resistance
The Trump administration is "gearing up for war" to push Congress to codify its drug pricing policy — despite little appetite for it on the Hill. Still, the pharma industry sees risk in the back-and-forth. https://t.co/DR2LotvXFq
Scientists Finally Reveal How This Alzheimer’s Drug Really Works
Scientists from VIB and KU Leuven have identified the mechanism by which lecanemab (Leqembi) clears amyloid plaques in Alzheimer’s disease. Their study shows that the antibody’s Fc fragment engages microglia, reprogramming them to phagocytose and degrade plaques. Removing the Fc...
R1 Secures $78M to Advance Kidney Drug Development
R1 starts up with $78M, aiming for a better kidney drug https://t.co/PQQjX47ODM by @gwendolynawu #biotecjh #startups
New Drug Could Eradicate Sleeping Sickness, Says NPR
Sleeping sickness could be wiped out with this new drug: my comments @NPR @NPRGlobalHealth https://t.co/T0mAeX8P0A
R1: China-to-U.S. NewCo Planning Global Testing of New CKD Mechanism
The article outlines BioCentury’s cookie policy, detailing categories of cookies used on its website. Strictly necessary cookies are always active and enable authentication, registration, and core navigation. Functional, marketing, advertising, and analytics cookies provide personalization, targeted promotions, ad tracking, and...
Huntington’s Disease Gene Therapy: FDA Reversal Delays AMT-130
A Phase I/II trial of AMT‑130, an AAV‑delivered microRNA gene therapy, showed a 75% reduction in Huntington's disease progression over three years in 12 patients. The FDA initially supported using external control data from the Enroll‑HD database for the Biologics...
Balancing the Risks and Rewards of Drug Development in China: A Small Biotech CEO Perspective
The blog by HotSpot Therapeutics CEO Jonathan Montagu argues that China is no longer just a manufacturing hub but a burgeoning source of innovative drug candidates, evidenced by its 17% lead over the U.S. in Nature’s Index and nearly half...
AstraZeneca Secures the EC Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers
The European Commission has granted approval for AstraZeneca’s Imfinzi (durvalumab) combined with FLOT chemotherapy as a perioperative treatment for resectable, early‑stage and locally advanced gastric and gastro‑esophageal junction (G/GEJ) cancers. The decision is based on the Phase III MATTERHORN trial, which...
GEN Secures BEBO Foundation Approval for Phase II PD Trial
GEN Pharmaceuticals received BEBO Foundation ethical approval to launch a Phase II proof‑of‑concept trial of its mitochondrial‑targeting drug SUL‑238 in Parkinson’s disease. The single‑centre, randomised, double‑blind, placebo‑controlled study, named SHEPHERD, will begin patient enrolment in Groningen in April 2026. Over a 28‑day...
Opinion: Semaglutide Is Going Off-Patent in India. But Will People Who Need It Be Able to Get It?
Semaglutide’s patent will lapse in India on March 24, 2026, unlocking generic competition that could slash prices by up to 90%. The GLP‑1 drug, sold as Ozempic and Wegovy, has been shown to cut major cardiovascular events by 20%. Indian regulators, however,...
STAT+: White House Digs in on ‘Most-Favored Nation’ Drug Pricing Despite Congress’ Cool Reception
The White House is intensifying pressure on Congress to pass a “most‑favored nation” drug‑pricing bill that would cap U.S. medication prices at levels paid by peer nations. Administration officials say the proposal would overhaul pricing for providers, insurers, federal programs...
Revolutionizing Data Capture Through Integrated Patient Experience Platforms
Clinical trials are adopting integrated eCOA platforms that connect medical devices directly to digital systems, eliminating manual data entry and improving data quality. Interoperability enables real‑time monitoring and AI‑driven insights, reducing patient burden especially in long‑duration obesity studies. The obesity...
NeuroScientific Readies Stem Cell Supply Boost for Bowel Disease Trials
NeuroScientific Biopharmaceuticals has begun its first manufacturing run of the StemSmart mesenchymal stem cell therapy at Q‑Gen Cell Therapeutics in Brisbane, initiating a critical technology transfer. The engineering run will validate quality, potency and regulatory compliance ahead of a Phase 2...
Abeona Therapeutics Inc (ABEO) Q4 2025 Earnings Call Transcript
Abeona Therapeutics reported its Q4 2018 results, highlighting progress on its lead cell therapy EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The Phase 1/2 trial demonstrated continuous type VII collagen expression for over two years, a favorable safety profile, and durable wound...
ION717 Trial Re-Opens with 3rd Dosing Regimen
Ionis Pharmaceuticals announced that its Phase 1/2a PrProfile trial of ION717, the first PrP‑lowering antisense oligonucleotide for symptomatic prion disease, has reopened with a third dosing regimen. The study, which enrolled 56 patients in 2024, will now recruit at three...
No Evidence to Suggest Medicinal Cannabis Is Effective for Depression, Anxiety or PTSD, Says Systematic Review
A systematic review published in Lancet Psychiatry, analysing 54 randomized controlled trials from 1980‑2025, found no evidence that medicinal cannabis treats depression, anxiety or PTSD. The paper highlights modest benefits for conditions such as epilepsy, multiple sclerosis spasticity, pain and...
Roche Bought Thousands Of Nvidia AI Chips To Speed Up Drug Development
Roche announced a new AI factory, adding 2,176 Nvidia Blackwell GPUs to its existing pool and bringing total GPU count above 3,500 – the highest in the pharmaceutical sector. The purchase, likely costing $65 million or more, aims to accelerate drug...
TrumpRx List Grows To 54 Drugs, Many Nearing End Of Exclusivity
The TrumpRx website now lists 54 prescription drugs after adding seven products from GlaxoSmithKline and Amgen. The expansion pushes the total from 47 to 54, but health‑policy analysts note that the majority are older medicines nearing the end of their...
New Recommendations for Naloxone
On July 23, 2020 the FDA issued new recommendations urging health‑care professionals to discuss and consider prescribing naloxone for any patient at heightened risk of opioid overdose. The guidance covers three groups: patients on opioid pain relievers, patients receiving medications...