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.
Zenkuda Superior to Sham in Phase 3 Diabetic Retinopathy Study
Kodiak Sciences reported that its intravitreal biologic Zenkuda (tarocimab tedromer) outperformed sham in the phase 3 GLOW2 trial for diabetic retinopathy. At week 48, 62.5% of patients receiving Zenkuda achieved a two‑step or greater improvement on the Diabetic Retinopathy Severity Scale versus just 3.3% in the control arm. The therapy also cut the incidence of sight‑threatening complications by 85%, dropping from 15.8% to 2.4%. Safety was favorable, with low rates of ocular adverse events and no cases of intraocular inflammation.
Trump's Pharma Tariff Won't Lower Prices, Study Finds
Trump's proposed 100% tariff on pharma imports would have limited impact, analysis says. Why? 68% of U.S. prescription drugs are already made domestically. Prices are driven by patents & rebates, not import costs. Healthcare
ARS Pharma Secures FDA Label Expansion for Neffy Needle‑Free Epinephrine Spray
ARS Pharmaceuticals (ticker SPRY) received FDA approval to broaden the label of its Neffy 1 mg needle‑free epinephrine nasal spray, eliminating the previous age restriction and allowing use by anyone weighing at least 33 lb. The change expands market access for the...
Pharma Pulse: Shionogi’s $2.5B Radicava Acquisition and the Industry Monitors U.S.-Iran Conflict for Supply Disruptions
Shionogi has completed a $2.5 billion purchase of global rights to the ALS drug Radicava from Tanabe Pharma. The deal adds a rare‑disease asset and an established U.S. commercial platform, projecting roughly $700 million in revenue beginning fiscal 2026. Simultaneously, the escalating...
Revolution Medicines Initiates P-III (RASolute 303) Trial of Daraxonrasib in Pancreatic Ductal Adenocarcinoma (PDAC)
Revolution Medicines has launched the global Phase III RASolute 303 trial to evaluate daraxonrasib, a direct RAS(ON) multi‑selective inhibitor, in previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). The study tests the drug as monotherapy and alongside chemotherapy, with progression‑free survival and overall...
100% Pharma Tariffs, Lilly's Oral GLP-1 Approval, and a $12B Week in Biotech M&A – This Week in Biotech #94
The White House announced 100% tariffs on branded drug imports from countries lacking trade agreements, prompting biotech firms to reassess supply‑chain and pricing strategies. Eli Lilly secured a rapid FDA approval for Foundayo, the first oral small‑molecule GLP‑1 for chronic weight...
BioNTech Starts Shuttering Singapore mRNA Manufacturing Site Amid Pipeline Pivot
BioNTech announced it will shut its Singapore mRNA manufacturing plant by the end of February 2027, ending a venture that began with a $355 million investment in 2022. The site, originally slated to create over 100 jobs and produce several hundred...
Python Blood Could Hold the Secret To Healthy Weight Loss
Researchers at the University of Colorado Boulder have identified a python‑derived metabolite, para‑tyramine‑O‑sulfate (pTOS), that spikes dramatically after the snakes eat and appears to suppress appetite. In mouse studies, high doses of pTOS triggered weight loss without the gastrointestinal side...
Debating Brainless Clones as Personal
Are you pro-bodyoid or anti-bodyoid? For the purpose of this poll, a bodyoid is: a newborn clone of you lacking a cortex, a.k.a. a brainless clone, gestated by a paid surrogate. It's organs are a perfect match (isogenic) to you...
Henlius Receives the NMPA IND Clearance for HLX319 (Biosimilar, Phesgo)
Henlius has received IND clearance from China’s NMPA for HLX319, a biosimilar of Roche’s Phesgo that combines pertuzumab, trastuzumab and hyaluronidase for subcutaneous delivery. The product targets neoadjuvant, adjuvant and metastatic HER2‑positive breast cancer, mirroring Phesgo’s five‑to‑eight‑minute injection without weight‑based...
Superpower Partners with Grail to Add Galleri Cancer Screening
Superpower, a technology‑driven health benefits platform, announced a partnership with Grail to incorporate the Galleri multi‑cancer blood test into its member offerings. Galleri screens for more than 50 cancer types using DNA methylation signatures and has received FDA clearance for...
Annovis Wins US Patent for Buntanetap in Brain Infection Injuries
Annovis Bio has been granted a United States patent for its compound Buntanetap, specifically covering its use in treating brain infection‑related injuries. The patent expands the drug's previously explored Alzheimer’s indication to a novel therapeutic area. This intellectual‑property win bolsters...
Multipurpose Anti-Viral Pill May Treat Colds, Norovirus, Flu and Covid
Artificial intelligence flagged a long‑neglected breast‑cancer medication as a candidate to block multiple viruses, and subsequent animal studies confirmed it can inhibit coronaviruses, RSV, norovirus, influenza and hepatitis viruses. Model Medicines, a California biotech, is advancing the compound toward a...
Researchers Develop Nasally Delivered DNA Vaccine for Tuberculosis
Johns Hopkins researchers have created an intranasal DNA vaccine that fuses the relMtb and Mip3α genes to target drug‑tolerant tuberculosis persisters. In mouse models the vaccine accelerated bacterial clearance, lowered lung inflammation and prevented relapse when combined with standard therapy....
Tirzepatide vs Semaglutide: Which One Burns More Fat?
Recent comparative studies indicate tirzepatide outperforms semaglutide in accelerating fat loss. Tirzepatide’s dual activation of GLP‑1 and GIP receptors delivers stronger appetite suppression, improved insulin sensitivity, and enhanced lipid metabolism, leading to higher average weight‑loss percentages. Semaglutide remains effective by...
Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration
Merck has launched the pivotal Phase IIb/III MALBEC trial to evaluate MK‑8748 (Tiespectus/EYE201) in patients with neovascular age‑related macular degeneration (NVAMD). The study pits two intravitreal dose levels of the bispecific TIE2‑agonist/VEGF‑inhibitor against aflibercept 2 mg, beginning with quarterly injections for three...
Japan Approves Conditional Stem‑cell Parkinson’s Replacement Therapy
Woah. I'm slightly embarrassed that I missed this for a few weeks. Finally there is approval, in a Large Nation, for a stem cell-based REPLACEMENT therapy for an age-related condition. The condition is, no surprise, Parkinson's, which I always highlight...
FDB Launches MedProof MCP to Ground AI Agents in Clinical Drug Knowledge
First Databank (FDB) has released MedProof MCP, the first Model Context Protocol server designed to embed AI agents with its clinical‑grade drug database. The open‑source MCP standard lets large language models query trusted medication intelligence in real time, cutting integration...
PTSD Is Almost Incurable. Psychedelics Can Help — but only in Three U.S. States and Australia
Australia has opened a regulated pathway for MDMA‑assisted psychotherapy to treat post‑traumatic stress disorder, making it one of the few countries where the drug can be used medically. Early data from Dr. Ranil Gunewardene’s practice show more than 50 % of...
Personalized NAD Boosting Needed; Redox Fingerprints Reveal Disease
Dynamics of blood NAD and glutathione in health, disease, aging and under NAD-booster treatment “In healthy population (n=299;18-70 year-olds) redox metabolites follow normal distribution in blood and remain unchanged during aging. NAD-boosting increased 4-6 fold the blood NAD+ depending on individual,...
Earendil Labs Begins Phase 2a Trial of Ulcerative Colitis Therapy
Earendil Labs has dosed the first patient in a Phase IIa, randomized, placebo‑controlled trial of its half‑life‑extended anti‑TL1A antibody HXN‑1001 for ulcerative colitis. The company also completed enrollment for the Phase I study in healthy volunteers in Australia, where single doses up...
Levothyroxine Shows No Benefit in Older Adults
A new systematic review in BMC Geriatrics finds that levothyroxine offers no measurable benefit for older adults with subclinical hypothyroidism. Patient‑reported quality‑of‑life, cognitive function, physical performance, and major cardiovascular events were unchanged compared with observation or placebo. The analysis also...
Bipartisan INSULIN Act Seeks $35 Monthly Cap for Privately Insured Patients
Senators Jeanne Shaheen, Raphael Warnock, Susan Collins and John Kennedy introduced the INSULIN Act, which would cap out‑of‑pocket insulin costs at $35 per month for people with private insurance. The proposal also creates a pilot program for uninsured patients in...
BillionToOne Shares Tumble 3.7% After Appointing New Oncology Chief
BillionToOne, Inc. saw its Nasdaq‑listed shares drop 3.66% to $79.92 following the announcement that Allen Chen will lead medical affairs and clinical development for oncology. The move comes as the company expands its Northstar liquid‑biopsy platform, and investors are weighing...
Cell‑Free DNA Production Ends Decades‑Old Cloning Bottleneck
Most of synthetic biology has been completely transformed in the last decade. DNA manufacturing? Still running on cloning workflows from the 1970s. That's the bottleneck Jodi Barrientos, CEO of @ribbonbiolabs, is tackling head-on — and she's on the @SynBioBeta Main Stage on...
GEN's First Top‑10 Organoid Companies and Growth Drivers
3April: Which are GEN's first-ever Top 10 Organoid Companies (5 publicly traded, 5 privately held)? And what's driving growth for these and other organoid companies? Check out my latest A-List for @GENbio: https://t.co/6D589lVk9s
Machine Learning-Based Prediction of SARS-CoV-2 Bioactivity: Integrating IC50 Regression and Activity Classification Using Multi-Task Neural Networks
Researchers introduced an integrated machine‑learning framework to predict SARS‑CoV‑2 compound potency. The system combines an IC50 regression model, a binary activity classifier, and a multi‑task neural network that performs both tasks simultaneously. Incorporating ligand efficiency as a classification criterion, the...
Black‑Box Warnings Can Slash Drug Revenues—Investors Beware
Approved drugs can have a "black box" (aka boxed) warning, the highest safety-related warning that FDA can put on an approved drug Usually applied to multiple drugs in the same class it can hamper revenue potential if alternatives exist Investors should be...
Mitochondrial Therapies Surge After First FDA Approval of Forzinity
Stealth BioTherapeutics secured the FDA's accelerated approval for elamipretide, branded Forzinity, the first drug that directly targets mitochondria. The milestone is igniting a broader push among biotech firms and academic teams to develop mitochondrial‑focused treatments for age‑related diseases.
Science Spotlight: Three Teams Converge on RNU2‑2 as Targetable for Neurodevelopmental Epilepsies
Three independent research teams reported in Nature Genetics that variants in the non‑coding RNA RNU2‑2 cause both a dominant neurodevelopmental epilepsy syndrome and a prevalent recessive childhood disorder with epilepsy. By analyzing overlapping international cohorts and shared genomic datasets, they...
Sunshine Biopharma Inc (SBFM) Q4 2025 Earnings Call Transcript
Sunshine Biopharma reported a $713 million cash balance and zero debt at year‑end, while GAAP operating expenses fell to $225 million, driven by lower stock‑based compensation. The company’s Biologics License Application for ivonesumab in EGFR‑mutant NSCLC was accepted by the FDA, with...
Hydrogel-Based Axon Model Improves Early Testing for MS Remyelination Therapies
University College London researchers have created a hydrogel‑based axon model that mimics the ~5 kPa softness and three‑dimensional geometry of real brain axons. The tunable micropillar arrays enable human oligodendrocytes to form compact, multilayered myelin, a first for fully hydrogel systems....
Vedanta Biosciences Announces the Phase 3 RESTORATiVE303 Study of VE303 for the Prevention of Recurrent C. Difficile Infection Will Continue...
Vedanta Biosciences announced that the independent Data Monitoring Committee has completed the first prespecified interim analysis of its Phase 3 RESTORATiVE303 trial and recommended the study continue unchanged. The interim data showed efficacy surpassing the futility threshold with no new safety...
Biotech Innovation Makes Inroads Against Bleeding Disorders
Biotech breakthroughs have transformed bleeding disorders from fatal diagnoses into manageable chronic conditions, with extended‑half‑life clotting factors, subcutaneous non‑factor drugs, and emerging gene therapies extending dosing intervals to weeks or months. The National Bleeding Disorders Foundation’s Pathway to Cures fund...
UCB's $14M Land Buy Clears Way for $2B Drug Manufacturing Plant: The Atlanta Deal Sheet
UCB’s U.S. arm purchased 117 acres from the Rowen Foundation for $14.3 million, clearing the site for a planned 460,000‑square‑foot drug manufacturing complex in Gwinnett County. The $2 billion plant, slated for completion in five to six years, will employ roughly 330...
Boston University to Apply Machine Learning to Alzheimer’s Biomarker and Cognitive Data
Boston University, leading the AI for Alzheimer’s Disease (AI4AD) consortium, is coordinating 11 research institutes to apply machine learning to massive genomic, biomarker and cognitive datasets. The team is building the PreSiBO database, which tags predictor, signature, biomarker and outcome...
Trump's Obesity Drug Plan for Medicare Would Cost Insurers Billions
President Donald Trump’s proposal to add GLP‑1 obesity drugs to Medicare would impose billions of dollars in costs on private insurers during the first year. The administration claims negotiated drug‑price cuts will offset expenses, but a Vanderbilt‑led analysis estimates only...
There’s an Estrogen Patch Shortage. Here’s What to Do If You’re Affected
A nationwide shortage of estrogen patches is leaving many U.S. women without a key menopause treatment. Prescriptions for hormone replacement therapy have surged 86% since 2021, spurred by the FDA’s removal of a black‑box warning in November. The patch’s popularity...
Pharmaceutical Giant Pfizer Forced To Shut Down Updated COVID Vaccine Trials
Pfizer announced it is halting development of its updated COVID‑19 vaccine candidates, ending ongoing Phase 2/3 trials that targeted newer variants. The decision follows mixed efficacy data and waning commercial demand as the pandemic recedes. Pfizer will redirect resources toward...
FDA Clears Eli Lilly’s Once‑Daily GLP‑1 Pill Foundayo, Expanding Oral Obesity Options
The U.S. Food and Drug Administration approved Eli Lilly’s oral GLP‑1 obesity medication Foundayo on April 1, 2026. The once‑daily pill can be taken any time of day without food or water restrictions and is priced between $149 and $349 a month,...
Bipartisan INSULIN Act Targets $35 Monthly Cap for Private‑Insurance Users
A coalition of Democratic and Republican senators has introduced the INSULIN Act, aiming to cap insulin prices at $35 per month for people with private insurance. The bill also proposes a pilot program for uninsured patients in ten states, sparking...
Lipocine Shares Plunge 78% After Phase 3 Oral Brexanolone Trial Misses Primary Endpoint
Lipocine Inc.'s stock fell 78% to $2.00 after its Phase 3 placebo‑controlled trial of oral brexanolone (LPCN 1154) missed the primary efficacy endpoint for postpartum depression. The company said it will preserve capital and engage stakeholders to evaluate next steps, underscoring...
Sirolimus DCB in Peripheral Disease Makes Strides in Hard Outcomes: SirPAD
The SirPAD trial showed that a sirolimus‑coated drug‑coated balloon (MagicTouch) significantly lowered major adverse limb events (MALE) to 8.8% versus 15% with uncoated balloons in femoropopliteal and below‑the‑knee peripheral artery disease patients. At one year, the composite of unplanned amputation...
Blocking KDM4 Reactivates Tumor Suppressor, Halts AML
Scientists have restored a silenced tumor-suppressor gene in mice with acute myeloid leukemia by blocking KDM4 enzymes, suggesting a potential new therapeutic approach that avoids harming normal blood cells. leukemia
FDA's Future: New CBER Chief & Rare Disease Flexibility
On this week’s pod, we chatted with @docrodwong about the FDA, the next CBER chief and regulatory flexibility for rare diseases https://t.co/f6L7gwcNsr via @statnews
Combining Novel Dual HIF Inhibitors with Immunotherapy Erases Multiple Tumor Types in Mice
Researchers at Johns Hopkins and the University of Maryland have created first‑in‑class small‑molecule inhibitors that simultaneously block hypoxia‑inducible factors 1 and 2. In mouse models, the dual HIF‑1/2 inhibitors eradicated breast, colorectal, melanoma and prostate tumors when paired with checkpoint antibodies such...
Seeking List of Pharma Firms Without US Agreements
Any one know which pharma companies have yet to strike a deal with the US? (I don't ... my sense is that most have but haven't kept a tally) 1/2 https://t.co/bYYde5ZaIm
Small Pharma Must Strike Pricing Deal in 180 Days
New: Small pharma companies are in talks with the White House to sign drug pricing deals of their own. Small companies will have to cut a deal in the next 180 days to fully avoid tariffs on branded drugs. https://t.co/XFalvi3i3D
Part 1—Jason Aldred, MD: Understanding Possible Side Effects When Treating Patients with Parkinson’s Disease
Dr. Jason Aldred of Selkirk Neurology highlights the safety profile of Vyalev (foscarbidopa/foslevodopa), a subcutaneous therapy for Parkinson's disease. He notes that injection‑site reactions such as erythema, swelling, tenderness, bruising, and induration are the most common adverse events. Aldred advises...
Cell Line Development Has to Evolve
Cell line development (CLD) remains a hidden bottleneck that dictates speed to clinic, manufacturability, and long‑term product performance. Traditional random‑integration and lengthy clone screening are giving way to engineered platforms, especially glutamine synthetase (GS) knockout systems, which reduce heterogeneity and...