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.
Press Release: Sanofi’s Lunsekimig Met Primary and Key Secondary Endpoints in Phase 2 Respiratory Studies in Asthma and CRSwNP
Sanofi announced that its bispecific Nanobody lunsekimig achieved both primary and key secondary endpoints in the phase 2b AIRCULES asthma trial and the phase 2a DUET study for chronic rhinosinusitis with nasal polyps (CRSwNP). The asthma study showed a statistically significant reduction in exacerbations and improved pre‑bronchodilator FEV1, while the CRSwNP trial demonstrated reductions in nasal polyp scores and better congestion outcomes. Both respiratory studies reported safety comparable to placebo. An exploratory atopic dermatitis trial missed its primary endpoint but showed secondary skin‑clearance benefits, and lunsekimig now moves into further phase 2 and phase 3 programs.
Neuronal NOS Inhibition Blocks mTOR, Halts Neuroblastoma Growth
Neuroblastoma cells rely on neuronal nitric oxide synthase to sustain mTOR signaling and proliferation; inhibiting this enzyme disrupts tumor growth in both cell culture and animal models, highlighting a promising upstream therapeutic target. cancerbiology
Stop, Reduce or Stay on Antipsychotics After First-Episode Psychosis?
A recent pragmatic RCT followed 347 first‑episode psychosis patients to compare continued antipsychotic maintenance with gradual dose reduction or discontinuation. In the first year, the reduction group faced a higher relapse rate, lower quality of life, and increased mortality. By...
EU‑Funded PsyPal Project Starts Psychedelic Trials for Palliative Care Distress
The European Union‑funded PsyPal project kicked off its first psychedelic‑assisted therapy trials for psychological distress in palliative care on 13 April 2026 in Brussels. The launch, hosted by the Directorate‑General for Health and Food Safety, signals a coordinated effort to...
Interventional Radiologist 1st in World to Deliver Newly Approved Cancer Treatment
Interventional radiologists at Mount Sinai performed the world’s first TheraSphere Y‑90 Any Day Dosing procedure for hepatocellular carcinoma, following the FDA’s March 2026 clearance. The treatment uses microspheres to deliver targeted radiation directly to liver tumors while sparing healthy tissue. The...
Self‑Administered Peptide Clinics Surge After Huberman Podcast, Raising Safety Concerns
After a 2024 appearance on Andrew Huberman’s podcast, Dr. Koniver’s peptide‑focused clinic added 800 new patients in a month, now serving about 1,000 and maintaining a 6,000‑person waitlist. Memberships cost $15,000 a year, generating tens of millions in revenue, while...
AI Meets Drug Discovery at NYC Meetup Tuesday
AI x Drug Discovery meetup next Tues (14) in NYC ! @ginkgo excited to host with @AAlphaBio — sign up here : https://t.co/GG5c7F4ogO
Study Shows 88% Accuracy for OTC Medication Abortion Kit Self‑Assessment
A new JAMA Internal Medicine study reports that 88% of participants accurately judged their eligibility for an over‑the‑counter medication abortion kit, suggesting self‑assessment could be safe. The findings arrive amid state bans and a lack of FDA applications, intensifying calls...
209. Will Trump's Pharmaceutical Tariffs Lower Prices and Secure Supply Chains?
In this episode, host Chad Bowne and guest Tom Boyke dissect the Trump administration’s new pharmaceutical tariffs and the U.S.-U.K. pricing arrangement, explaining how they aim to address two distinct challenges: low‑margin generic drug shortages tied to China and India,...
An Opinionated Take on NEJM Highlights for Q1 of 2026
The first quarter of 2026 NEJM featured several disruptive studies, including a Canadian‑Australian dialysis trial where fish‑oil supplementation halved myocardial infarctions and cut strokes by two‑thirds. Merck’s oral PCSK9 inhibitor enlicitide achieved a 57% LDL reduction, positioning it for a...
Why ImmunityBio Stock Slumped on Monday
ImmunityBio (NASDAQ: IBRX) saw its stock dip after the FDA sent a warning letter accusing the company of false or misleading promotion of its bladder‑cancer drug Anktiva. The regulator flagged a TV advertisement and a provocative podcast episode, prompting ImmunityBio...
3D‑Printed Spanlastics Directly Target Tumors, Cut Side Effects
3D-printed spanlastics, microscopic carriers for cancer drugs, show potential to target tumors directly and reduce side effects by concentrating therapy at the tumor site rather than throughout the body. nanotechnology
3D-Printed 'Spanlastics' Could Change How Cancer Drugs Reach Tumors
University of Mississippi researchers unveiled a FRESH 3D‑printing technique that fabricates hydrogel‑based spanlastic nanocarriers, 200–300 nm in size, loaded with anticancer drugs such as doxorubicin. The printed implants can be placed directly onto tumor sites, delivering high‑dose therapy locally while shielding...
2Q Markets Preview, Tariffs and Biotech Takeouts — a BioCentury Podcast
Biotech remains resilient as markets wobble, with M&A activity persisting. The BioCentury podcast highlighted two major pending deals: Eli Lilly’s $6.3 billion acquisition of Centessa Pharmaceuticals and Biogen’s proposed $5.6 billion purchase of Apellis. Analysts also examined the lingering effects of Trump-era tariffs...
A Nanoparticle Therapy to Treat Lung Cancer and Associated Muscle Wasting at the Same Time
Researchers at Oregon State University have engineered lipid nanoparticles that carry follistatin messenger RNA to lung tumors, simultaneously attacking the cancer and the muscle‑wasting cachexia that often accompanies it. In mouse models the nanocarriers bind circulating vitronectin, home to integrin‑rich...
Pharmacist-Led Discharge Programs Show No Overall Benefit: 4 Study Notes
A randomized trial at Cedars‑Sinai evaluated pharmacist‑led transition‑of‑care programs for adults 55 and older on multiple or high‑risk medications. Across 6,478 hospitalizations, the intervention did not significantly lower 30‑day overall or same‑hospital utilization compared with usual care. However, among patients...
Treating Previously Untreatable Cancers: How CAR-T Cell Therapy Could Be Made Accessible to More Patients
CAR‑T cell therapy, a personalized immunotherapy that re‑programs a patient’s T cells, has transformed treatment for certain leukemias and lymphomas but remains prohibitively expensive in Canada, with commercial products costing roughly $325‑$466 k USD per patient and requiring 4‑6 weeks for manufacturing....
Trump Imposes 100% Tariff on Select Pharma Imports; Jefferies Says Indian Generics Likely Spared
U.S. President Donald Trump announced a sweeping 100% tariff on select pharmaceutical imports, prompting alarm across the global supply chain. Jefferies analysts argue that Indian generic exporters will largely escape the levy, though some specialty products may face limited duties....
STAT+: Pharma Companies and Patient Groups Seek to Exempt Orphan Drugs From Colorado Pricing Limits
Colorado lawmakers are advancing a second bill in two years that would carve out orphan drugs—medicines for rare diseases—from any price caps imposed by the state Prescription Drug Affordability Board. The board, created to curb soaring prescription costs, could otherwise...
Massachusetts Health Chief Predicts GLP‑1 Price Crash Could Restore Coverage Within Three Years
Massachusetts Health and Human Services Secretary Kiame Mahaniah warned that insurers are dropping GLP‑1 weight‑loss drugs to save $46 million annually, but he expects a major price crash within two to three years that will bring back full coverage for all...
DIG-RHD: Digoxin Effective in Rheumatic Heart Disease
The DIG‑RHD trial, presented at ACC 2026, randomized 1,759 patients with symptomatic rheumatic heart disease in India to digoxin or placebo. Over a median 2.1‑year follow‑up, digoxin achieved a 4.1‑percentage‑point absolute reduction in the composite of all‑cause death or new‑onset/worsening...
Mayo Clinic's Dual-Drug Nanotherapy Doubles Survival in Glioblastoma Models
Mayo Clinic scientists have created a lipid‑based nanocarrier that transports everolimus and vinorelbine across the blood‑brain barrier, extending survival more than twofold in patient‑derived glioblastoma models. The preclinical breakthrough could reshape treatment strategies for the deadliest brain cancer.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
The FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) now requires manufacturers to supply prepaid mail‑back envelopes (MBEs) for safe opioid disposal, with pharmacies able to order them starting March 31 2025. The REMS education program, funded by unrestricted grants, offers...
Court Strikes HRSA 340B Policy Restricting Initial Hospital Drug Purchases Through GPOs
On March 31, a U.S. District Court in Washington, D.C. vacated the Health Resources and Services Administration’s 2013 rule that barred disproportionate‑share hospitals from making initial outpatient drug purchases through both the 340B Drug Pricing Program and a group purchasing...
New Federal Market Access Restrictions: Optimizing Manufacturer Strategies as PBMs Gain Power
The 2026 Consolidated Appropriations Act forces pharmacy benefit managers (PBMs) to pass 100% of rebates, fees and discounts through to employer‑sponsored health plans, ending spread‑pricing and increasing transparency. To protect revenue, PBMs will lean on more aggressive formulary tiering, expanded...
Under-the-Skin Tepezza Comparable to Infused Version in Key Study, Amgen Says
Amgen announced that its subcutaneous on‑body injector version of Tepezza, called Tepezza OBI, met both primary and key secondary endpoints in a late‑stage trial, showing 77% of patients achieved a meaningful reduction in eye bulging. The efficacy was comparable to...
VDyne Secures FDA Nod to Start Pivotal Trial for Tricuspid Valve
VDyne received FDA approval for an investigational device exemption to launch its pivotal TRIVITA trial of a transcatheter tricuspid valve replacement system. The study will assess safety and efficacy in patients with severe symptomatic tricuspid regurgitation, a condition affecting roughly...
FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds - 08/25/2026
On August 25, 2026 the FDA will host a hybrid Patient‑Focused Drug Development meeting dedicated to non‑healing chronic wounds. The public session runs from 10 a.m. to 4:30 p.m. ET and combines a virtual webcast with an in‑person gathering at the White Oak Campus....
Proposed FDA Budget Sets Makary up to Boost US Biotech
The White House’s FY budget proposes a sizable increase for the FDA, positioning Dr. Robert Makary to spearhead regulatory reforms aimed at accelerating U.S. biotech development. The plan includes policy changes that would shorten clinical‑trial timelines, lower fees for early‑stage...
Immune Training Against Senescent Cells Reduces Tumor Growth
Here's my take on your paper: Cellular senescence or "zombie cell" events happen when a cell experiences too much genetic or epigenetic noise, caused by cellular damage (e.g. DNA breaks) or telomere erosion Your study of a Lewis Lung Carcinoma (LLC) mouse...
Academic Clinical Trials for Rapamycin to Answer Questions on Dosing for Anti-Aging Use
Researchers at UT Health San Antonio have launched a multi‑phase academic clinical trial to evaluate rapamycin’s biological effects in older adults. The program begins with a younger‑cohort benchmark study, then seeks the optimal dose that restores immune and metabolic markers...
Can Medicinal Cannabis Help Kids’ Autism, ADHD or Tourette’s? Here’s What We Know so Far
Interest in medicinal cannabis for children with autism, ADHD and Tourette's has grown, prompting the Australian Therapeutic Goods Administration to confirm that doctors are prescribing it for these conditions. While parents hope it could reduce reliance on stimulants, antidepressants and...
Global Cohort Data Bolster Confidence in Dolutegravir for Pediatric HIV Care
A new analysis presented at CROI 2026 used International Epidemiology Databases to Evaluate AIDS (IeDEA) data from Africa, Asia‑Pacific, and Latin America, covering over 90% of the world’s children with HIV. The study found that dolutegravir initiates modest early weight gain...
Tozorakimab Scores Double Win in Phase III COPD Trials
AstraZeneca announced that its IL‑33 monoclonal antibody tozorakimab achieved its primary endpoints in two Phase III COPD trials, Oberon and Titania. The drug significantly reduced the annual rate of moderate‑to‑severe exacerbations versus placebo across former and current smokers. AstraZeneca positions tozorakimab...
Startup Approved to Let AI System Prescribe Psychiatric Medication
Legion Health, a San Francisco startup, received Utah regulatory approval to let its AI chatbot renew psychiatric prescriptions for a limited set of antidepressants such as Prozac and Zoloft. The system can only prescribe drugs previously authorized by a human...
The Fatal Conceit of Cheap Drugs
The U.S. Supreme Court granted certiorari in Hikma v. Amarin, a dispute over whether a generic maker can be liable for inducing patent infringement when it markets a “skinny‑label” version that omits a patented use. The case spotlights the broader...
Diabetes Drug Replicates Exercise Effects in Prostate Cancer Patients
How a Diabetes Drug May Echo the Benefits of Exercise in Prostate Cancer Care “From a clinical standpoint, seeing a metabolic signal that mirrors what we associate with intense exercise was striking… For patients whose treatments or symptoms limit physical activity,...
One Psychedelic Dose Quickly Eases Depression, Trial Shows
Single dose of a psychedelic drug can rapidly reduce depressive symptoms, clinical trial suggests https://t.co/c72qpfwQPm https://t.co/xR7hbj4v8e
Semaglutide Cuts Cardiac Risk 20% and Retatrutide Hits All Diabetes Endpoints
Eli Lilly announced that its triple‑agonist retatrutide met all primary and key secondary endpoints in the phase‑3 TRANSCEND‑T2D‑1 trial, delivering significant HbA1c and weight reductions. In parallel, the SELECT trial confirmed that semaglutide lowered major adverse cardiovascular events by 20% in...
Repurposing Approved Drugs: Small Trials Explore New Uses
Great reporting from @Philanthropy on our grantee @CuresWReach, which runs small trials testing whether existing, approved drugs might work for entirely different diseases.
Egg Bioreactors Replace CHO Cells in Biologics Production
We’ve optimized drug design with AI. Why are we still manufacturing with CHO like it’s the 1980s? Neion Bio is rethinking biologics production using chicken eggs as bioreactors. Excited to hear Sam Levin at #SynBioBeta2026. Visit the SynBioBeta website to read the full...
Pfizer's Late-Stage Lyme Vaccine Shows 73% Efficacy but Misses Primary Endpoint
Pfizer announced a late‑stage Lyme disease vaccine candidate that achieved 73.2% efficacy 28 days after the fourth dose, but the study missed its primary endpoint because of lower-than-expected case numbers. The vaccine, a monoclonal antibody developed with MassBiologics, will now...
Study Shows Subcutaneous Tepezza Matches Infused Version
Under-the-skin Tepezza comparable to infused version in key study, Amgen says https://t.co/rOQqbRmEpL $AMGN $VRDN - 25%
Meta-Analyses Reveal Psychedelics Boost Brain Circuits
Two systematic, meta-analyses on psychedelic drugs today Brain Circuit Function @NatureMedicine https://t.co/nBmjreYEXU Depression @NatMentHealth https://t.co/zJR06AsC0Z https://t.co/qpWdjzBR4D
CRISPR Therapeutics' One‑Time Gene Edit Cuts LDL by 49% in Early Trial
CRISPR Therapeutics reported that a one‑time CRISPR‑based therapy turned off the liver gene ANGPTL3, dropping LDL cholesterol by 49% and triglycerides by 55% in the highest‑dose cohort of a 15‑patient trial. The results, published in the New England Journal of...
Neurocrine to Acquire Soleno Therapeutics for $2.9 Billion in Cash
Neurocrine Pharmaceuticals has signed a definitive agreement to buy Soleno Therapeutics for $2.9 billion in cash, paying $53 per share—a 34% premium to Soleno’s April 2 close. The deal brings VYKAT XR, the only FDA‑approved drug for hyperphagia in Prader‑Willi syndrome, into Neurocrine’s...
BIO’s Comments for USTR Report Highlight Global Threats to Intellectual Property
The Biotechnology Innovation Organization (BIO) submitted comments to the USTR’s 2026 Special 301 Report urging stronger global enforcement of intellectual‑property (IP) rights for biotech. BIO argues that weak IP protections in markets such as Colombia, Russia and Brazil create barriers...
Other News to Note for April 6, 2026
Jiangsu and Shanghai Hengrui have patented selective Nav1.8 sodium‑channel blockers that show pre‑clinical analgesic efficacy with fewer side effects. New hematopoietic stem‑cell research links chronic inflammation to early leukemic transformation, identifying inflammatory pathways as therapeutic targets. Infinimmune presented pre‑clinical data...
Biopharma Financings Nearly Double Vs. 2025 to $25.1B
Biopharma financing nearly doubled year‑over‑year, reaching about $25.1 billion, fueling a wave of early‑stage research. Jiangsu and Shanghai Hengrui patented novel Nav1.8 sodium‑channel blockers aimed at chronic pain relief. New hematopoietic stem‑cell studies link inflammation to the earliest stages of leukemia,...
Regulatory Actions for April 6, 2026
BioWorld’s April 6, 2026 regulatory snapshot aggregates the day’s key FDA and global health authority actions across biopharma, medical technology, and diagnostics. The page links to data snapshots, special reports, infographics and trend analyses covering topics such as mRNA vaccine research, GLP‑1...