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.
Effects of Glucagon-Like Peptide-1 Receptor Agonists on Perioperative Outcomes in Hip and Knee Arthroplasty: A Systematic Review and Meta-Analysis
Researchers performed a systematic review and meta‑analysis of six retrospective cohort studies covering over 48,000 hip and knee arthroplasty patients to assess the impact of pre‑operative glucagon‑like‑peptide‑1 receptor agonist (GLP‑1 RA) therapy. The analysis found a 20 % reduction in revision surgery odds (OR 0.8) and a 45 % decrease in blood‑transfusion odds (OR 0.55) within 90 days post‑operatively for patients receiving GLP‑1 RAs. Other complications—including respiratory events, acute kidney injury, deep‑vein thrombosis, and infection—showed no statistically significant differences. The authors conclude GLP‑1 RAs appear safe for pre‑operative use but emphasize that the evidence is of low certainty and call for prospective randomized trials.
One‑sentence AI Pipeline Transforms Drug Discovery Workflow
What if your next drug discovery pipeline started with one sentence, not 6 months of scripting? In this latest deep dive with @scispace, I saw a shift that feels bigger than incremental AI gains. Upload single-cell data and get clustered cell types,...
Re: The Power of the Markets: The Scandal that Keeps on Taking
Lenacapavir, a once‑monthly injectable for HIV, is priced at $28,000 per patient annually by Gilead Sciences. In a BMJ rapid response, surgeon Simon Bell argued the price reflects the high cost of drug development and that Gilead is not obligated...
AI Can Screen 15 Million Molecules in a Day. It Still Can’t Cure Alzheimer’s.
Novartis used generative AI to design 15 million molecular‑glue candidates for Huntington’s disease and synthesized about 60, yielding a promising scaffold. While AI can trim early‑stage drug discovery timelines by 30‑40 percent and lower costs, no AI‑discovered compound has secured FDA approval...
New Yellow Fever Vaccine Matches Safety and Effectiveness of Current Shot
Sanofi's new live‑attenuated yellow fever vaccine, vYF, demonstrated safety and efficacy comparable to the licensed YF‑VAX in a phase 2 trial of 485 healthy adults. Protective antibodies appeared in 99.7% of vYF recipients versus 99.4% for YF‑VAX within 28 days, with...
EV-RNAs Show Promise for IBD Diagnosis and Treatment
A review in *ExRNA* led by Professor Xiyang Wei outlines how extracellular vesicle‑associated RNAs (EV‑RNAs) influence inflammatory bowel disease (IBD) pathogenesis and progression. By synthesizing multi‑omics and animal data, the authors show EV‑RNAs can serve as highly accurate, non‑invasive biomarkers...
Insilico Medicine Launches Pharma AI Spring Kickoff 2026 Webinar
Insilico Medicine announced the Pharma.AI Spring Kickoff 2026 webinar for April 14, 2026, at 10:00 AM ET. The event will showcase the company’s latest AI-driven drug discovery tools, including the MMAI Gym training framework, upgraded PandaOmics with single‑cell integration, and new capabilities in...
Big Pharma Is Turning to China for the Newest Drug Ideas
Pfizer is intensifying its search for breakthrough cancer treatments by tapping Chinese biotech. Last summer the company paid $1.25 billion to Shanghai‑based 3SBio for rights to a promising oncology candidate. The move reflects a broader shift as China evolves from a...
Nanomedicine Offers Targeted Solutions for Breast Cancer Treatment
Nanomedicine is reshaping breast cancer therapy by using nanoscale carriers to improve drug solubility, targeting, and controlled release. Recent preclinical studies show lipid‑polymer hybrids boosting oral bioavailability over threefold and photothermal nanoparticles halving tumor growth when combined with chemotherapy. Metallic...
Amazon Pharmacy Launches Same‑day Delivery of Lilly's Foundayo Weight‑loss Pill in 3,000 U.S. Cities
Amazon Pharmacy has begun same‑day delivery of Eli Lilly’s newly approved oral GLP‑1 weight‑loss pill, Foundayo, covering nearly 3,000 U.S. cities and slated to reach 4,500 by year‑end. The move puts Amazon directly into the fast‑growing obesity‑drug market and challenges existing...
Annovis Raises $10 Million to Fund Phase 3 Alzheimer’s Trial and NDA Submission
Annovis Bio announced a $10 million financing round that extends its cash runway through the upcoming Phase 3 trial of its Alzheimer’s candidate and a planned NDA submission within six months. The capital raise aims to sustain development costs and position the...
University of Chicago Study Finds Zeaxanthin May Supercharge Cancer Immunotherapy
Scientists at the University of Chicago Medical Center reported that zeaxanthin, a carotenoid found in leafy greens, strengthens CD8+ T‑cell responses and amplifies the effect of checkpoint inhibitor drugs. The finding points to a low‑cost, diet‑based adjunct that could raise...
FDA Rejects Replimune's RP1 Melanoma Therapy for Second Time
The U.S. Food and Drug Administration has rejected Replimune Group's RP1 (vusolimogene oderparepvec) therapy for unresectable advanced cutaneous melanoma for a second time, saying the data still fails to demonstrate substantial evidence of effectiveness. The agency highlighted the trial’s inability...
Self‑immunized Man’s Blood Yields Universal Antivenom
A truck mechanic from Wisconsin spent 18 years injecting himself with venom from the world's deadliest snakes. 700 doses. 200+ bites. He taught himself immunology from a textbook. His name is Tim Friede. His blood may end up saving hundreds of...
Acting CDC Chief Stalled Release of Vaccine Benefit Study
Acting CDC director delayed release of study showing benefit of Covid vaccines - NBC News https://t.co/JsxUVy7Cpj
Pyrazole-Derived TRPC3 Antagonist Ameliorates Synaptic Dysfunctions and Memory Deficits in Alzheimer’s Disease Models
Researchers have engineered a pyrazole‑derived, metabolically stable TRPC3 antagonist that readily penetrates the CNS. In cultured neurons, amyloid‑beta oligomers up‑regulate TRPC3, leading to calcium overload and toxicity. Administration of the compound to 5xFAD and APPKI mouse models reversed synaptic deficits...
MIT Discovers Hundreds of Bacterial CRISPR-Like Tools
MIT Mined Bacteria for the Next CRISPR—and Found Hundreds of Potential New Tools https://t.co/n4cJpB8dVk https://t.co/Vq57AKw6XD
Corcept Presents Complete Data From Pivotal ROSELLA Trial in SGO Late-Breaker with Simultaneous Publication in The Lancet: Lifyorli™ (Relacorilant) Plus...
Corcept Therapeutics presented final overall survival results from the phase 3 ROSELLA trial, showing that Lifyorli™ (relacorilant) combined with nab‑paclitaxel cuts the risk of death by 35 percent and adds 4.1 months to median survival versus chemotherapy alone. The regimen met both overall...
Reprogrammed Tregs Turn Pancreatic Tumors Immunotherapy‑Friendly
Reprogramming regulatory T cells within pancreatic tumors may transform them from immune suppressors into supporters of anti-tumor activity, offering a potential strategy to enhance immunotherapy effectiveness in this challenging cancer. immunotherapy
Reprogramming Regulatory T Cells Could Help Immunotherapy Work in Pancreatic Cancer
Researchers at Oregon Health & Science University discovered that pancreatic tumors suppress immunotherapy by recruiting large numbers of regulatory T cells (Tregs). In mouse models, an agonistic CD40 therapy not only activated tumor‑killing immune cells but also reprogrammed Tregs into...
CMS Releases Proposed Rule Establishing Electronic Standards for Drug Prior Authorizations
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on April 10 to create electronic standards for drug prior authorizations, extending the 2024 rule that standardized medical‑service prior authorizations. The proposal requires payers to accept API‑driven requests, shorten...
REPL RP1 Melanoma Trial Flawed; New CRL
I've never covered the REPL RP1 data in melanoma, mainly due to dislike of the trial design w/ its lack of a monotherapy arm. Sometimes you can see where things are likely headed and kicking a dog when it's down...
Finerenone Reduces Clinical Events in Patients With Heart Failure Regardless of CHD History
A prespecified analysis of the FINEARTS‑HF trial evaluated finerenone in 6,001 patients with heart‑failure with mildly reduced or preserved ejection fraction, 54% of whom had a history of coronary heart disease. Finerenone reduced the composite of cardiovascular death and heart‑failure...
Predictors of Rapid, Complete Skin Clearance With Psoriasis Biologics
A real‑world analysis of 299 moderate‑to‑severe psoriasis patients treated with biologics found that 76.3% achieved an early super‑response (PASI 100 by week 4 and maintained PASI < 1 through week 48). The strongest positive predictors were biologic‑naïve status and higher baseline neutrophil counts, while palmoplantar...
Apotex and Orbicular Secure First FDA Tentative Approval for Generic Ozempic
Apotex Corp., in partnership with Orbicular Pharmaceutical Technologies, has earned the first U.S. FDA tentative approval for its generic semaglutide injection, a biosimilar to Novo Nordisk's Ozempic. The milestone opens the door to a lower‑cost alternative for a blockbuster diabetes...
The Insight Partners Forecasts 12.4% CAGR for Nanotech Drug Delivery Market to 2031
The Insight Partners released a market outlook projecting a 12.4% compound annual growth rate for nanotechnology-enabled drug delivery platforms from 2025 to 2031. The report cites rising chronic disease prevalence, personalized medicine, and R&D spending as key catalysts, while noting...
Daito Pharmaceutical Posts 86% Nine‑Month Profit Surge on New Drug Sales
Daito Pharmaceutical Co Ltd announced an 86% increase in nine‑month net profit to ¥2.267 billion, propelled by sales of recently launched drugs. Revenue edged up 0.3% to ¥36.732 billion, and the company issued full‑year EPS guidance of ¥84.38 per share.
Imeglimin. A New and Novel Drug Thats Better than Metformin
Imeglimin, a novel oral antidiabetic approved in Japan and the EU, improves mitochondrial bioenergetics and reduces HbA1c more effectively than metformin. Its renal excretion bypasses the CYP3A4 pathway, eliminating pharmacokinetic conflicts with rapamycin, an mTOR inhibitor used in longevity protocols....
Real-World Evidence
The FDA is expanding its use of real‑world data (RWD) and real‑world evidence (RWE) to inform regulatory decisions beyond post‑market safety, including new drug indications and post‑approval study requirements. A 2018 framework, mandated by the 21st Century Cures Act, formalizes...
AI Analyzes Reddit Posts to Find Underreported GLP-1 Side Effects
Penn researchers used AI to scan over 400,000 Reddit posts from roughly 70,000 users, uncovering side‑effects of GLP‑1 drugs that are not fully captured in clinical trials. While gastrointestinal distress dominated, about 4% of users reported menstrual irregularities and a...
PreCheck Pilot Program Structure
The FDA’s PreCheck Pilot Program introduces a two‑phase pathway to speed the launch of new U.S. pharmaceutical manufacturing sites. Phase 1 delivers early, structured Pre‑Operational Reviews (POR) and builds a Type V Drug Master File that captures facility design, equipment qualification, and...
Oricell Therapeutics Secures $110 Million to Take on One of Oncology's Most Vexing Problems
Oricell Therapeutics closed a pre‑IPO financing round exceeding $110 million, led by Vivo Capital and a slate of international investors. The capital will fund global clinical expansion and further development of its proprietary CAR‑T platform targeting solid tumors. Oricell’s lead candidate,...
University of Cincinnati Launches Clinical Trial to Test New Drug for Prosthetic Joint Infections
The University of Cincinnati has begun enrolling patients in Peptilogics' RETAIN trial, a randomized, double‑blind study evaluating a novel peptide solution designed to penetrate biofilm in prosthetic joint infections (PJI). The trial will compare the peptide irrigant against a saline...
Cryo-EM Structural Biology Facility Opened in San Diego by FairJourney Bio
FairJourney Bio has launched an advanced cryo‑electron microscopy (cryo‑EM) structural biology facility in San Diego, featuring two 300 kV ThermoFisher Titan Krios 5 systems. The lab brings atomic‑resolution imaging directly into the company’s antibody discovery platform, supporting everything from epitope mapping to...
5 Vaccines Under Development That Would Change the World As We Know It
Recent advances in vaccine technology are targeting five of the world’s most persistent health threats: HIV, tuberculosis, cancer, influenza, and coronaviruses. Early-phase trials show mRNA‑based germline‑targeting approaches can induce broadly neutralizing antibodies against HIV, while the M72/AS01E candidate achieved roughly...
FDA Clears Investigational New Drug Application to Test sCAR-T Therapy for Autoimmune Conditions
The FDA has cleared Calibr‑Skaggs Institute’s investigational new drug application to test its switchable CAR‑T therapy, CLBR001 + SWI019, in a phase 1 trial for autoimmune diseases. The study will enroll patients with myositis, systemic sclerosis, lupus and rheumatoid arthritis, aiming to demonstrate...
Bioanalytical Method Validation for Biomarkers
The U.S. Food and Drug Administration issued final Level 2 guidance (Docket FDA‑2017‑D‑6821) on bioanalytical method validation for biomarkers. It outlines the evidentiary standards for measuring biomarker concentrations in clinical trials and non‑clinical studies. The guidance applies to IND, NDA, BLA, ANDA,...
Alpheus Medical Advances to Phase 2b Testing of Experimental Brain Cancer Therapy
Alpheus Medical has enrolled 10 patients in a Phase 2b randomized trial of its Porphyrin Metabolite Activation (PoMA) therapy for newly diagnosed glioblastoma. PoMA uses a tumor‑selective drug activated by low‑intensity diffuse ultrasound to treat the entire affected brain hemisphere,...
Bayer Pharma Executive Predicts US-Europe Price Spreads Will Narrow
Bayer's chief operating officer for pharmaceuticals warned that the long‑standing price gap between the United States and European markets will shrink sharply. He attributes the change to the Trump administration's push for “most‑favored‑nation” (MFN) pricing agreements, which compel manufacturers to...
Influenza Vaccination Reduces Cardiovascular Risk Following Infection
A new Danish register‑based self‑controlled case series spanning 2014‑2025 shows that influenza infection triggers a sharp, short‑lived surge in acute myocardial infarction and stroke, especially within the first three days. Prior influenza vaccination cuts the excess cardiovascular risk dramatically, with...
Ezetimibe Shows Unexpected Potential to Prevent Alzheimer’s
Ezetimibe might help prevent Alzheimer's disease... but not in the way that you think. These data really caught me off guard. But the data are the data. (long-form video linked below)
FDA Approves First Gene Therapy for LAD‑I Children
FDA approves first gene therapy, Kresladi, offering a breakthrough treatment for children with the rare immune disorder LAD-I https://t.co/ezWPPEgtd0
Replimune’s Advanced Melanoma Drug Rebuffed by FDA for Second Time
Replimune’s oncolytic immunotherapy RP1, aimed at unresectable advanced cutaneous melanoma, was rejected by the FDA for a second time on April 6, 2026. The agency’s complete response letter said the data, derived from a single‑arm trial, were insufficient to demonstrate substantial effectiveness,...
Investors Demand Immediate Release of Market-Sensitive Data
This is getting quite tiresome: first $ORIC, now $ALLO & $IDYA. Why are you sitting on market-sensitive data rather than releasing it now? https://t.co/N8q95re7ho
Reasoning Models Accelerate Science via Autonomous Lab Loops
Awesome to see. Reasoning models are going to be a massive accelerant to science. Important to connect them to autonomous labs so we can close the loop of design, experiments, data analysis and back around again.
Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That with...
John Butler, CEO of Akebia Therapeutics, explained the stark contrast between rapid innovation in rare kidney diseases and the near‑absence of new dialysis therapies, blaming regulatory uncertainty and a Medicare bundle that discourages drug development. FDA clarity on endpoints sparked...
BMS and Oxford BioTherapeutics Join Forces in TCE Discovery Pact
Bristol Myers Squibb has entered a discovery partnership with Oxford BioTherapeutics to develop T‑cell engager (TCE) therapies for solid tumours. BMS will pay an undisclosed upfront fee to access OBT’s OGAP‑Verify platform, while OBT will design and deliver pre‑clinical candidates....
Simulations Plus Posts 8% Q2 Revenue Rise, Raises FY2026 Outlook Amid AI Partnerships
Simulations Plus (SLP) posted Q2 2026 revenue of $24.3 million, up 8% year‑over‑year, and lifted its full‑year revenue guidance to $79‑$82 million. The biotech‑software firm highlighted strategic AI collaborations with three large pharmaceutical companies, while trimming its FY2026 EPS outlook due to...
Trinity Capital Secures $395 Million New Commitments, Deploys $306 Million in Q1 Biotech Investments
Trinity Capital reported $395 million of new commitments and $306 million of funded investments in the first quarter, with the bulk directed to secured loans for emerging biotech firms. The inflow and deployment signal robust capital appetite for early‑stage drug development amid...
MGNX Restarts LINNET Gene‑Therapy Trial as GSK Wins China Nod and NBIX Acquires SLNO
MacroGenics announced the FDA lifted a partial hold on its Phase 2 LINNET gene‑therapy trial, while GSK secured Chinese regulatory clearance for a new product, the FDA approved Waters' submission, and Neurocrine Biosciences completed its acquisition of SLNO. The cluster of...