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.
Pharma R&D Embraces Data Lakehouses, Boosting Speed and Cutting Costs
AstraZeneca, Illumina and Pfizer are moving their research data onto lakehouse platforms such as Databricks, Snowflake and Apache Iceberg. Pfizer reports a four‑fold query speed increase and a 57% reduction in total cost of ownership, signaling a sector‑wide shift toward unified, cloud‑native analytics.
Sona Nanotech Reports 60% Complete Response Rate in First‑Human Melanoma Trial
Sona Nanotech Inc. presented first‑in‑human data showing six complete responses out of ten late‑stage melanoma patients at the AACR meeting in San Diego and secured a slot at the upcoming ASCO conference. The results, derived from the company’s gold‑nanorod Targeted...
STAT+: Erasca Touts Strong, Though Preliminary, Results in Trial of Pancreatic and Lung Cancer Therapy
Erasca announced that its oral RAS‑targeting drug ERAS‑0015 produced tumor shrinkage in 40% of patients with advanced pancreatic cancer and 62% of those with advanced non‑small‑cell lung cancer. The early‑stage data, gathered from trials in the United States and China,...
Federal Circuit Clarifies Written Description and Enablement Standards for Method-of-Treatment Patent Claims Using a Well-Known Antibody Genus
On April 16, 2026, the Federal Circuit reversed a district‑court ruling and held that Teva’s method‑of‑treatment patents for treating headache with anti‑CGRP antagonist antibodies met the written‑description and enablement requirements of 35 U.S.C. § 112. The court distinguished the Supreme Court’s Amgen decision,...
Pencil Beam Laser Could Help Researchers Design Brain-Targeted Therapies
MIT researchers have demonstrated that laser light can self‑organize into a tightly focused "pencil beam," enabling a new bioimaging modality that is both faster and high‑resolution. In proof‑of‑concept experiments the team captured three‑dimensional images of the human blood‑brain barrier 25...
FDA May Be Poised To Collaborate With Paradigm On AI Model
The FDA is reportedly preparing an announcement on real‑world evidence (RWE) that could involve a partnership with Paradigm on its new SPIRAL artificial‑intelligence model. SPIRAL is designed to generate RWE for post‑approval and late‑stage clinical studies, leveraging large‑scale health‑data sources....
Internet Pharmacy Warning Letters
The FDA has intensified its crackdown on unsafe online pharmacies, issuing more than 40 warning letters between 2023 and early 2026 to sites such as Beauty of Aztlan, RxGoodUSA and OnlineRxMedz. The letters cite violations like selling unapproved drugs without...
Future Antidepressant Could Transform Millions Like Tirzepatide
Imagine a drug for reducing depression or anxiety that is as powerful as Tirzepatide is for reducing hunger. I think tens of millions of people will be on drugs like this in the next 5 years and I think it...
Early Bets on Consumer Bio and Dog Longevity Validated
ideas loyal had at our incipience that have been proven right 6 years later: 1. consumer bio 2. D2C marketing & distribution of drugs by the pharma co 3. dog owner demand for interventions (Rx, food, etc) to extend healthy lifespan 4....
Randomized Radical Reaction Leads to Selective Cyclizations
A new “radical sampling” strategy reported in JACS (2026) enables selective formation of six‑membered nitrogen heterocycles such as piperidines and morpholines from simple aldehyde and amine precursors. The method uses a light‑activated catalyst to generate radicals that compete between rapid...
Reta Won't Become All-Time Top-Selling Drug
Reta will not be the best selling drug of all time. Someone please remember this a decade from now.
Withdrawn | Cancer Accelerated Approvals
The FDA has withdrawn 31 cancer drugs that were granted accelerated approval, spanning indications from lung and breast cancer to rare lymphomas. The most recent removal was Trodelvy for metastatic urothelial carcinoma on November 22, 2024. Withdrawals typically follow failed...
Exercise, Ibuprofen Reduce Cancer-Related Cognitive Impairment
A phase‑2 randomized trial of 86 chemotherapy patients found that a six‑week home‑based exercise program markedly improved cognitive performance, cutting Trail Making Test times by over 21 seconds compared with placebo. Low‑dose ibuprofen (200 mg twice daily) also yielded modest gains,...
How Rare Earths Enabled MRI Contrast Agents to Advance Medical Imaging
MRI contrast agents, primarily based on the rare‑earth element gadolinium, have revolutionized diagnostic imaging by highlighting blood flow, blood‑brain barrier disruption, and active disease. By chelating gadolinium into macrocyclic or linear compounds, manufacturers make the metal safe for intravenous use...
Viking Therapeutics Targets 170% Upside as Dual-Agonist Obesity Drug Shows 14.7% Weight Loss
Wall Street analysts have lifted Viking Therapeutics' one‑year price target to $93.59, implying a 170% upside from its current share price. The boost follows phase‑3 data showing the GLP‑1/GIP dual agonist VK2735 cut weight by 14.7% in 13 weeks, positioning...
TrumpRx Has Signed Deals With Nearly Every Major Drugmaker. Are Prices Actually Falling?
President Trump launched TrumpRx, a direct‑to‑consumer portal that leverages most‑favored‑nation (MFN) pricing agreements with drugmakers. The administration has signed 17 MFN deals covering about 86% of the branded market, granting tariff exemptions to participants. Discounts are steep—Pfizer’s cuts range from...
How Does Integrated Fluid Management Enable Flexible Bioproduction Across Modalities?
At INTERPHEX 2026, Avantor senior vice president Jerry Keybl highlighted how integrated fluid management underpins scalable bioproduction across cell, gene and other therapeutic modalities. He argued that consistent, well‑characterized fluid paths from early development through commercial scale reduce variability and...
Veradermics Soars on Positive Data for Baldness Treatment
Veradermics announced that its experimental oral minoxidil pill, VDPHL01, achieved the primary endpoint in a Phase 3 trial, delivering a 30‑33 hair‑per‑cm² increase over six months versus placebo. The drug was well tolerated, with side‑effect rates matching placebo and no cardiac...
Eli Lilly Acquires Ajax to Strengthen JAK Pipeline
Lilly to buy startup Ajax in bid for a better JAK drug https://t.co/RMQQZ4mRFG $INCY $BMY $LLY $TAK #biotech #startups
Dispatch Biotherapeutics Launches First Clinical Trial
Remember Car June's new venture, Dispatch Biotherapeutics (raised $216 m since 2022)? Here's its first clinical trial: https://t.co/EIrZHSeHT8
Lilly to Acquire Ajax Therapeutics
Eli Lilly announced a definitive agreement to acquire Ajax Therapeutics for up to $2.3 billion in cash. Ajax’s lead candidate, AJ1-11095, is a first‑in‑class Type II JAK2 inhibitor currently in a Phase 1 study (AJX‑101) for myelofibrosis patients who have failed Type I JAK2...
Compass Shares Crash as ‘Confounding’ Survival Data Raise Approvability Questions for Bispecific
Compass Therapeutics reported that its bispecific antibody tovecimig failed to meet the secondary overall survival (OS) endpoint in the Phase 2/3 COMPANION‑002 trial, though it achieved a 56% reduction in progression risk, extending progression‑free survival (PFS) to 4.7 months versus 2.6...
University of Southampton and UCB to Develop Digital Antibodies with AI
The University of Southampton and biopharma firm UCB have launched the Digital Antibody Research Collaboration (DARC), a three‑year AI‑driven platform for in‑silico therapeutic antibody design. DARC aims to compress the typical ten‑to‑twelve‑year development timeline by automating molecule modeling, testing and...
Samsung Bioepis Releases Second Quarter 2026 US Biosimilar Market Report
Samsung Bioepis released its Q2 2026 U.S. Biosimilar Market Report, the thirteenth edition of the quarterly series. The report documents 92 FDA‑approved biosimilars across 20 molecules, with 67 (73 %) already launched, and notes a 60 % adoption rate for adalimumab biosimilars. It...
GDC-4198
Regor Therapeutics discovered GDC‑4198, an oral CDK4/2 inhibitor now owned by Genentech. The drug is in Phase 1/2 trials for advanced solid tumors, with a focus on breast cancer. It combines low‑nanomolar CDK4 potency with comparable CDK2 activity and roughly 20‑fold...
ESCMID Global 2026: Pritelivir Excels in Immunocompromised Refractory HSV Patients
Aicuris presented Phase III data for its oral helicase‑primase inhibitor pritelivir at ESCMID Global 2026. In the PRIOH‑1 trial of 101 immunocompromised adults with acyclovir‑refractory HSV, pritelivir achieved significantly higher lesion‑healing rates than investigator‑chosen IV or topical therapies. The drug also...
The Bad Ad Program
The FDA’s Bad Ad Program, run by the Office of Prescription Drug Promotion, educates clinicians on spotting false or misleading prescription‑drug advertising and provides a streamlined way to report violations. It targets a broad audience of physicians, nurses, pharmacists and...
Mundipharma Announces Positive Topline Results From Phase III ReSPECT Trial Assessing ▼REZZAYO® (Rezafungin) for the Prophylaxis of Invasive Fungal Diseases...
Mundipharma reported that its Phase III ReSPECT trial met the primary endpoint, showing rezafungin (REZZAYO®) was non‑inferior to standard antifungal regimens for fungal‑free survival at Day 90 (60.7% vs 59.0%). The once‑weekly echinocandin demonstrated a comparable safety profile with fewer drug‑drug interactions...
MFN Changing the Rules of the Game for the Nordic Countries
GlobalData’s Price Intelligence analysis links the U.S. Most Favored Nation (MFN) policy to a 35% decline in pharmaceutical product launches across Europe within ten months of its introduction. In the Nordics, oncology drugs are priced roughly 5% below the European...
Missouri Analytical Laboratories Inc - 615319 - 10/09/2024
The U.S. Food and Drug Administration issued a closeout letter to Missouri Analytical Laboratories Inc., confirming that the company’s corrective actions have addressed the violations cited in a 2021 warning letter. The FDA noted that while the immediate issues appear...
Lilly to Buy Startup Ajax in Bid for a Better JAK Drug
Eli Lilly announced it will acquire New York‑based biotech Ajax Therapeutics for up to $2.3 billion. The deal centers on Ajax’s experimental JAK inhibitor AJ1‑11095, which binds an inactive JAK2 conformation to overcome resistance seen with existing therapies for myelofibrosis and...
Fathom Therapeutics Scores $47 Million Series A
Fathom Therapeutics, previously known as Atommap Corp., announced an oversubscribed $47 million Series A round. The financing was led by Sutter Hill Ventures with participation from Chemistry, Alexandria Venture Investments, and NY Ventures. Fathom leverages quantum chemistry and artificial intelligence to design...
Digital Twins Will Accelerate Drug Development via Virtual Trials
How digital twins and in silico clinical trials can change the future of drug development https://t.co/lEhJNwrSlH
A Single Dose of Psilocybin Outperforms Nicotine Patches for Quitting Smoking
A Johns Hopkins pilot trial found that a single, weight‑adjusted dose of psilocybin combined with cognitive‑behavioral counseling helped 40% of smokers remain abstinent for six months, far surpassing the 10% quit rate achieved with standard nicotine patches. The psychedelic group...
Multiple GLP-1 Drugs Linked to Lower AFib Risk
A retrospective analysis of 13,034 patients who started GLP‑1 receptor agonist therapy between 2020 and 2024 found a significant reduction in atrial fibrillation (AFib) incidence compared with a propensity‑matched cohort of over 385,000 untreated individuals. The benefit persisted regardless of...
Asembia AXS26: What the Rise in CGTs Means for the Supply Chain
Cardinal Health’s VP Joel Wayment told Pharmaceutical Commerce that the surge in cell and gene therapies is forcing a redesign of the supply chain toward reusable, multi‑use shipping systems and geographically closed packaging models. These changes aim to cut waste,...
FDA Clears Subcutaneous Anifrolumab Autoinjector for Moderate to Severe SLE
The FDA has cleared AstraZeneca’s subcutaneous anifrolumab autoinjector (Saphnelo) for adults with moderate to severe systemic lupus erythematosus (SLE) on standard therapy. The new formulation mirrors the approved intravenous product but allows weekly self‑administration at home. Approval rests on the...
ERAS Pan‑Ras Data Released; RVMD Alleges Patent Infringement
$ERAS pan-Ras data update this afternoon after market close. also, $RVMD sent Erasca a letter claiming ERAS-0015 violates certain RevMed patents. https://t.co/QTmyUhT89n
FDA Priority Review Advances Nipocalimab for Adults With Warm Autoimmune Hemolytic Anemia
The FDA has granted priority review to Johnson & Johnson’s nipocalimab‑aahu (IMAAVY) for adults with warm autoimmune hemolytic anemia (wAIHA), a rare disease lacking any approved U.S. therapy. The designation compresses the review clock to roughly six months, marking the...
STAT+: Astellas Retries XLMTM Gene Therapy After Deaths
Astellas Pharma announced it will restart its next‑generation gene therapy trial for X‑linked myotubular myopathy (XLMTM) after pausing the program following two patient deaths. Meanwhile, Intellia Therapeutics reported its one‑time CRISPR treatment lonvo‑z reduced hereditary angioedema attacks by 87% in...
Pilot Study Finds 300 Mg NMN Cuts Post‑Exercise Inflammation in Young Men
Researchers in Taiwan reported that a six‑day regimen of 300 mg NMN lowered key inflammatory cytokines in young men after intense blood‑flow‑restriction resistance training. The crossover trial suggests NMN could become a targeted supplement for athletes and biohackers seeking faster recovery.
STAT+: Pharmalittle: We’re Reading About a Lilly Deal, an Intellia CRISPR Rare-Disease Treatment, and More
Intellia Therapeutics reported that a single dose of its CRISPR‑based therapy lonvo‑z dramatically reduced swelling attacks in hereditary angioedema patients during a Phase 3 trial, positioning it for a rolling FDA submission as the potential second approved CRISPR drug. The treatment...
Fragments vs DsbA: Towards a Chemical Probe
Researchers targeting the bacterial oxidoreductase DsbA—a key virulence factor—have advanced fragment‑based efforts toward a chemical probe. Initial screens identified fragments binding a shallow groove and a hidden cryptic pocket, but affinities were modest (~150 µM). By designing molecules that extend beyond...
85% of Patients Want Alzheimer’s Blood Test, Doctors Remain Skeptical
A recent Chicago‑area survey of nearly 600 adults found 85% would take a blood test for Alzheimer’s risk if their doctor recommended it. Physicians, however, warn the tests lack proven benefit for asymptomatic patients, highlighting a growing gap between patient...
FDA Review Sought for Subcutaneous Risankizumab Induction in Crohn Disease
AbbVie has filed a supplemental NDA with the FDA to add subcutaneous (SC) risankizumab induction for adults with moderate‑to‑severe Crohn disease. The request relies on the phase 3 AFFIRM trial, which enrolled 289 patients—65% of whom had failed prior advanced therapies—and...
WuXi AppTec Q1 Profit Jumps 31% on Booming CRO and Manufacturing Demand
WuXi AppTec posted a first‑quarter profit of RMB4.651 billion ($651 million), up 31% year‑over‑year, and revenue of RMB12.435 billion ($1.74 billion), a 28.8% increase, driven by expanding contract research and manufacturing work for biotech firms worldwide.
Sun Pharma to Acquire Organon for $11.75 Billion, Expanding B2B Drug Portfolio
Sun Pharmaceutical Industries has signed a definitive agreement to acquire Organon & Co. for $11.75 billion in cash, paying $14 per share. The deal will lift combined revenue to $12.4 billion, push Sun into the top three global women’s‑health players and make...
Gilead’s Pipeline Strategy in 2026: A Broadening Focus Beyond HIV
Gilead Sciences is accelerating a diversification push in 2026, adding $12.6 billion of oncology and immunology assets to a portfolio still dominated by HIV drugs. The company completed three major acquisitions—Arcellx for $7.8 billion, Tubulis for $3.15 billion, and Ouro Medicines for $1.67 billion—bolstering...
T‑cell Engagers Need Missing Design Tricks for Success
With the rise and rise of ADCs, T cell engagers have taken something of a back seat of late. What if the bigger problem is some of them may be missing a key trick? Here we highlight some design...
Eli Lilly to Acquire Ajax Therapeutics for ~$2.3B
Eli Lilly has signed a definitive agreement to acquire Ajax Therapeutics for roughly $2.3 billion in cash, covering an upfront payment and future clinical and regulatory milestones. Ajax’s lead candidate, AJ1‑11095, is a Type II JAK2 inhibitor currently in a Phase‑I trial (AJX‑101)...