Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech financings
Spanish biotech Ona announced a $86.6 million Series B round, ranking among the largest venture financings 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 funds will expand Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical pipeline.
Is the UK Set to Become a Radiopharma Leader?
In this episode, Bruno Quinney talks with Dr. Juliana Maynard, Head of Translational Imaging at Medicines Discovery Catapult (MDC), about the rapid growth of the radiopharmaceutical sector and the UK’s strategy to become a global leader. Maynard explains how radiopharmaceuticals deliver targeted radiation to tumors while sparing healthy tissue, offering a powerful diagnostic and therapeutic tool for hard‑to‑treat cancers. She highlights the challenges of translating pre‑clinical data to clinical trials, especially isotope supply and dosimetry, and describes MDC’s partnership with the UK National Nuclear Laboratory and the Alpha 10.6 programme to create a sovereign isotope supply chain and an integrated ecosystem. The discussion underscores the massive market potential—estimated at $21.8 billion by 2033—and how coordinated investment across the value chain could accelerate patient access to precision cancer therapies.
MHRA Proposes New Regulatory Pathway for Rare Disease Therapies
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on a new, technology‑agnostic regulatory pathway for rare disease therapies. Central to the proposal is an Investigational Marketing Authorisation (IMA) that merges clinical trial approval with a...
Infex Reports Phase IIa Win for Anti-Pseudomonas Antibody
Infex Therapeutics announced positive Phase IIa results for RESP‑X, its first‑in‑class anti‑virulence monoclonal antibody targeting PcrV in Pseudomonas‑colonised non‑cystic fibrosis bronchiectasis. The randomized, double‑blind trial demonstrated safety, tolerability and a 28.8‑day half‑life supporting quarterly dosing. While the study was not powered...
Eli Lilly Acquires Engage Biologics for ~$202M
Eli Lilly announced the acquisition of Engage Biologics for roughly $202 million in cash, integrating Engage’s Tethosome non‑viral DNA delivery platform with Lilly’s growing genetic‑medicine portfolio. The deal includes an upfront payment and milestone‑based earn‑outs tied to development progress. Tethosome combines engineered DNA...
The Next Era of Healthcare Is Personal
In this episode, McKinsey’s Eric Kutcher talks with Moderna CEO Stéphane Bancel about how mRNA technology and AI are reshaping healthcare from rapid vaccine development to truly personalized medicines. Bancel explains that mRNA is an "information molecule" that can be programmed...
Lantern Pharma Gets FDA Type C Clearance for LP-300 Phase 2 Trial in Never‑Smoker NSCLC
Lantern Pharma announced that the FDA issued a successful Type C meeting response, clearing protocol amendments for its LP-300 Phase 2 HARMONIC trial. The agency raised no objections to focusing enrollment on EGFR exon 21 L858R‑mutant never‑smokers and extending treatment...
Achieve Life Sciences Presents 52‑Week Cytisinicline Safety Data Ahead of FDA Decision
Achieve Life Sciences disclosed 52‑week safety results from its ORCA‑OL trial of Cytisinicline, a nicotine‑dependence therapy, at the ATS 2026 meeting. The data reinforce long‑term tolerability as the company approaches a June 20, 2026 FDA PDUFA deadline for its New...
Atyr Pharma Launches Global Phase 3 Trial C-006 of Efzofitimod for Pulmonary Sarcoidosis
Atyr Pharma announced the start of a global Phase 3 trial (C-006) of its anti‑inflammatory drug efzofitimod in pulmonary sarcoidosis, prioritizing forced vital capacity as the primary endpoint. The move follows a Type C meeting with the FDA that reshaped...
Guidance, Compliance, & Regulatory Information
The FDA’s Guidance, Compliance, & Regulatory Information hub aggregates key resources for drug manufacturers, ranging from compliance programs and inspection protocols to labeling and generic development guidance. Recent additions include an Environmental Impact Statement focused on sunscreen drug products and...
Eton Pharmaceuticals Secures U.S. Rights to IMPAVIDO, Adds 2026 Leishmaniasis Launch
Eton Pharmaceuticals announced an exclusive U.S. commercialization agreement for IMPAVIDO, the only FDA‑approved oral treatment for multiple forms of leishmaniasis, with rights effective Sept. 26, 2026. The deal adds a new 2026 launch to Eton’s rare‑disease pipeline and is tied to a...
Collaborative Drug Discovery Inks Deal with Eli Lilly to Accelerate Biotech Innovation
Eli Lilly’s TuneLab AI platform will be embedded into Collaborative Drug Discovery’s (CDD) Vault system, giving biotech companies access to Lilly’s proprietary ADMET predictive models. The integration will appear in both the core and AI modules of CDD Vault, allowing researchers...
FDA Offers New Details On Real-Time Clinical Trial Pilot, But Questions Remain
The FDA released new operational details for its real‑time clinical‑trial pilot, clarifying that raw patient‑level data will not be transmitted directly to the agency. Instead, sponsors must use their own data‑capture systems to send predefined safety, efficacy, dosing, or operational...
Longevity Biotech Matures: Precise Indication‑Focused Drug Development
The longevity biotechnology field is coming of age in the best possible way. A recent analysis captures how the sector has learned to speak pharma’s language fluently—moving from broad claims about “slowing aging” to precise, indication-focused drug development with conventional endpoints,...
IL-6 Blocker Shows Promise for Treating Depression
Would depression respond to an anti-inflammation drug (interleukin-6 blocker)? A small pilot, placebo-controlled randomized trial suggests this might be possible https://t.co/zKO76yvRAo https://t.co/e8K9YLEAQj
STAT+: Biotech Execs, Academic Expert Lament Impact of FDA Turnover on Rare Disease Drug Development
Biotech leaders and an academic expert warned that recent turnover among senior FDA officials is creating heightened uncertainty for rare‑disease drug developers. At the STAT Breakthrough Summit West, Mahzi Therapeutics CEO Yael Weiss described constant investor inquiries and a “roller‑coaster”...
FDA Clears INTERACT Meeting for Glafabra’s Fabry Gene Therapy, Paving Way for Single‑Shot Treatment
The U.S. Food and Drug Administration accepted Glafabra Therapeutics’ request for a face‑to‑face INTERACT meeting on July 16, 2026, to discuss its lead Fabry disease gene therapy GT-GLA‑S03. The meeting, granted to only about 30% of applicants, moves the company...
Monopar's ALXN1840 Cuts Copper in Wilson Disease Phase 2 Trial
Monopar Therapeutics announced that its experimental drug ALXN1840 achieved rapid, statistically significant copper reduction in a nine‑patient Phase 2 trial for Wilson disease. The open‑label study, published in Hepatology Communications, marks a key milestone for the first‑in‑class ATC activator. The data...
Mutating Antibodies for Easier Drug-Conjugate Manufacturing
Scientists at Johns Hopkins University have engineered a general‑purpose antibody by mutating its fragment crystallizable (Fc) region, creating up to four new attachment sites for molecules such as drugs, dyes, or nanoparticles. Six precise Fc mutations enable consistent, site‑specific conjugation,...
In the Clinic for May 20, 2026
The May 20, 2026 clinic roundup aggregates the latest clinical trial readouts and publications from a cross‑section of biopharma and med‑tech firms, including Boston Scientific, Sanofi, and emerging players like Elixir and Sensome. Companies disclosed early‑stage data on cardiovascular devices, oncology immunotherapies,...
BARDA Ships Experimental Ebola Antibody to Protect High‑risk Americans
BARDA is coordinating shipment of an experimental antibody treatment for potential use in high-risk Americans exposed to #ebola, HHS tells CNN While they didn't name the treatment, Mapp's MBP134 has shown activity in animal studies against Bundibugyo strain
FDA Sends Warning Letter After Chinese Supplier Breaks GLP-1 Import Restrictions
The FDA issued a warning letter to Harbin Jixianglong Biotech after inspectors found the Chinese API maker importing semaglutide from a non‑green‑list source and mislabeling it as produced in‑house. Jixianglong had been added to the FDA’s newly created “green list”...
FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint
Guardant Health announced FDA approval of Guardant360® Liquid CDx, the largest liquid‑biopsy panel on the market, featuring a 100‑fold expanded genomic footprint. The test merges genomic and epigenomic profiling from a single blood draw, delivering several‑fold higher circulating tumor DNA...
IntraBio Receives Regulatory Authorization to Begin Pivotal Phase III Trial of Levacetylleucine in CACNA1A-Related Disorders Across Participating Regions
IntraBio announced regulatory authorization to launch its pivotal Phase III trial of levacetylleucine (AQNEURSA) in CACNA1A‑related disorders across the United States, United Kingdom, European Union and Switzerland. The 12‑week, randomized, double‑blind, placebo‑controlled crossover study will be conducted at twelve multinational sites...
Incyte and Genesis Expand Molecular AI Collaboration to Accelerate Drug Discovery
Incyte and Genesis Molecular AI have broadened their partnership, granting Genesis access to Incyte's proprietary experimental data to train the next‑generation GEMS AI platform. The deal includes a $120 million upfront payment—$80 million in cash and $40 million in equity—plus recurring research funding....
WVE-006 RNA Editing Therapy Achieves MZ-Like Phenotype in Alpha-1 Antitrypsin Deficiency Phase 1b/2a Trial
Wave Life Sciences reported that its investigational RNA‑editing drug WVE‑006 generated major‑variant alpha‑1 antitrypsin (M‑AAT) levels comparable to the protective heterozygous Pi*MZ phenotype in patients with homozygous Pi*ZZ AAT deficiency. The Phase 1b/2a RestorAATion‑2 trial showed 64%–59% of circulating AAT was...
EQS-News: GeoVax Comments on Escalating Bundibugyo Ebola Outbreak and Growing Need for Flexible Biodefense Vaccine Platforms
GeoVax Labs warned that the escalating Bundibugyo Ebola outbreak in Central Africa highlights the lack of licensed vaccines for less‑common Ebola strains. The company pointed to its Modified Vaccinia Ankara (MVA) platform, which has shown single‑dose protection against Zaire and...
FDA Approves Baxdrostat, First‑in‑Class Aldosterone Synthase Inhibitor for Hypertension
The U.S. Food and Drug Administration has approved baxdrostat, AstraZeneca's first‑in‑class oral aldosterone synthase inhibitor, as an add‑on treatment for adults whose hypertension remains uncontrolled despite existing therapy. The decision follows a Phase III trial that demonstrated statistically significant systolic blood‑pressure...
Ipsen’s Dysport Outlasts Botox in First Head‑to‑Head Spasticity Trial
Ipsen announced that its botulinum toxin product Dysport delivered significantly longer symptom control than rival Botox in the Phase IV DIRECTION trial, a randomized head‑to‑head study of 464 adults with upper‑limb spasticity across 72 sites in the U.S., France and Canada.
Why Patient Engagement Is Clinical Trials’ Next Strategic Frontier
The article argues patient engagement is the next strategic priority for clinical trials, especially as decentralized and hybrid models reduce face‑to‑face contact. Simple reminder emails are insufficient; effective engagement requires tailored gamification, real‑time financial incentives, and transparent feedback showing participants...
Annovis Bio Raises $175 Million in Share and Warrant Offering to Advance Alzheimer’s Drug Buntanetap
Annovis Bio disclosed a $175 million public offering of shares and warrants to finance the Phase 3 development of its Alzheimer’s candidate Buntanetap. The financing move coincided with a 5.4% drop in the company’s stock, reflecting market caution. Proceeds will support the...
Beam One-Ups Wave as Both Show Promise of Editing for AATD
Beam Therapeutics presented Phase 1/2 data for its DNA editor BEAM‑302, showing an 80% drop in mutated alpha‑1 antitrypsin (AAT) protein and lifting total AAT above the 11 µM protective threshold, with effects lasting 12 months. Wave Life Sciences reported its RNA editor...
AbbVie’s New Immunology Standard-Bearer Skyrizi Kneels to UCB’s Bimzelx in Psoriatic Arthritis
UCB’s Bimzelx outperformed AbbVie’s Skyrizi in a Phase 3 head‑to‑head trial for psoriatic arthritis, achieving 49.1% ACR50 versus 38.4% for Skyrizi at week 16. While Bimzelx also showed numerically higher minimal disease activity (43% vs 39.9%), the difference missed statistical significance. Skyrizi...
Ketamine‑Buprenorphine Regimen Cuts Suicide Ideation by 76% in Trial
Researchers reported that a single ketamine infusion followed by four weeks of low‑dose buprenorphine lowered suicidal ideation by 76% in adults with major depressive disorder, far surpassing the 43% reduction seen with placebo. The double‑blind trial, published in the American...
Relay Therapeutics Posts 60% Response in Phase 2 Trial of Zovegalisib for Rare Vascular Anomalies
Relay Therapeutics said 60% of evaluable patients achieved a volumetric response in its Phase 2 ReInspire trial of zovegalisib for PIK3CA‑driven vascular anomalies. The data, presented at the ISSVA World Congress, outpace Novartis' prior 11% response and could position the...
Airway Therapeutics CEO on Rethinking Bronchopulmonary Dysplasia Trials
Airway Therapeutics is advancing zelpultide alfa, an investigational biologic aimed at preventing bronchopulmonary dysplasia (BPD) in extremely preterm infants born between 22 and 27 weeks gestation. CEO Marc Salzberg highlighted the clinical and operational hurdles of neonatal trials, including limited...
Clinical Trials Day 2026: ‘Research Rising’ Theme Reflected in Q1 Study Growth
Clinical Trials Day 2026 highlighted a 1.3% rise in global Phase I‑III trial initiations in Q1, with China accounting for one‑third of the new studies and posting a 6.5% year‑on‑year increase. Europe and the United States also accelerated, growing 9.8%...
DeepMind's Co‑Scientist AI Tackles Cancer Drug Discovery with Big‑data Analytics
Google DeepMind unveiled Co‑Scientist, a multi‑agent AI platform designed to accelerate biomedical research. In a pilot for acute myeloid leukemia, the system shortlisted 30 drug candidates, three of which showed promising activity in lab tests. The launch signals a new...
QIAGEN and NVIDIA Partner on AI Drug Discovery
Qiagen’s Digital Insights division will embed NVIDIA’s accelerated computing and BioNeMo platform into its bioinformatics suite, creating a graph‑based AI environment for drug discovery. The integration is designed to streamline target identification, biomarker discovery, and multi‑omics hypothesis generation for pharma...
BioMarin’s ENERGY 3 Trial of BMN 401 Meets One Co-Primary Endpoint
BioMarin Pharmaceutical announced that its Phase III ENERGY 3 trial of BMN 401 met one of two co‑primary endpoints, showing a statistically significant rise in plasma inorganic pyrophosphate (PPi) levels in children with ENPP1 deficiency through week 52. The trial failed to demonstrate any...
Proactivity for Drug Safety: A New Service or a New Mindset?
The letter argues that proactive drug‑safety surveillance cannot fix a system that approves drugs with insufficient benefit data and overlooks rare, severe harms. It cites historic delays in risk‑management actions for valproate and topiramate, noting that formal REMS were only...
Tuneable Peptide Biotech Parabilis Files IPO
Parabilis Medicines, the Cambridge‑based tuneable peptide biotech, filed a Nasdaq prospectus to raise roughly $100 million in an IPO under the PBLS ticker. The offering follows a $305 million private round and a multi‑billion‑dollar alliance with Regeneron, which contributed $50 million upfront and...
Beyond Senolytics: Senoadaptive Drugs & Clinical Data on GPX4 Modulation (Dr. Marco Quarta, Rubedo)
In this episode, Dr. Marco Quarta, co‑founder and CSO of Rubedo Life Sciences, discusses the company’s breakthrough first‑in‑class GPX4‑modulating drug RLS1496, which has just reported preliminary Phase 1 basket‑trial data across multiple skin indications. He explains how Rubedo’s AI‑enabled single‑cell multi‑omics...
Atossa Therapeutics, Inc. (ATOS) Discusses Challenges in Breast Cancer Drug Development and Innovation in Clinical Research Transcript
Atossa Therapeutics used a May 19, 2026 analyst call to outline its lead breast‑cancer candidate, Z‑endoxifen. CEO Steven Quay and UCSF oncology pioneer Dr. Laura Esserman discussed the scientific hurdles of endocrine‑resistant disease and the company’s push for innovative trial designs. The conversation...
The BioPharm Brief: Smarter Platforms, Safer Therapies, AI Acceleration
Biopharma firms are accelerating the adoption of next‑generation platforms to boost therapeutic precision and speed. JCR Pharmaceuticals unveiled preclinical data for its JUST‑AAV system, which enhances central nervous system delivery while limiting liver exposure. Hansa Biopharma signed a deal worth...
Merck and Kelun‑Biotech’s Sac‑TMT ADC Cuts Death Risk in Phase III Endometrial Cancer Trial
Merck and China‑based Kelun‑Biotech announced that their TROP2‑directed ADC sacituzumab tirumotecan (sac‑TMT) met primary endpoints in the TroFuse‑005 Phase III trial, delivering statistically significant overall‑survival and progression‑free‑survival improvements versus physician‑chosen chemotherapy in 776 patients with advanced or recurrent endometrial cancer. The...
GeoVax Labs Raises $3 Million Private Placement, Emphasizes MVA Platform for Pandemic Preparedness
GeoVax Labs announced a $3 million private placement on May 19, 2026, and used the filing to stress the strategic value of its Modified Vaccinia Ankara (MVA) platform for rapid, scalable vaccine responses to emerging infectious threats. The financing will back ongoing development...
AI‑Powered Consulting Cuts FDA Approval Time and Cost
Getting FDA approval is slow and very expensive. @Panacea_Bio hires the best FDA regulatory consultants in the industry, and pairs them with their AI platform, to deliver the fastest and lowest-cost pathway to FDA approval for Biotechs and MedTechs. https://t.co/OvR0zEYr7Y https://t.co/eIaiDbwmSx
New Shell Helps Gold Nanoparticles Keep Shape Under Laser Heat Longer
Researchers from Córdoba, Strasbourg and the Sorbonne have developed a polymer‑based shell that preserves the distinctive bipyramidal shape of gold nanoparticles during laser‑induced heating. The protective layer outperforms traditional sodium citrate ligands, keeping the particles stable longer and maintaining their...
Greek Courts Deliver Landmark Justice: State Held Liable for COVID Shot Harms
Greek administrative courts have begun holding the Hellenic Republic liable for COVID‑19 vaccine injuries, ordering $324,000 in compensation to a family after a woman died from AstraZeneca‑induced thrombosis with thrombocytopenia syndrome (TTS). The decision builds on a 2025 ruling that...
Sustained Therapeutics – Presents Positive Phase 2 Data for ST-01 in Podium Presentation at the American Urological Association 2026 Annual...
Sustained Therapeutics presented Phase 2 data showing its ST‑01 polymer‑lidocaine formulation significantly reduced pain in men with chronic scrotal content pain (CSCP). At the 70 mg/mL dose, 67% of patients achieved a ≥2‑point pain reduction and 83% met clinical response criteria, far...