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.
Guizhou Xinbang Pharma Posts $16.8M Full-Year Profit Rise as Revenue Slides 6.8%
Guizhou Xinbang Pharmaceutical Co., Ltd. announced a full‑year profit of RMB120.285 million ($16.8 million), up from RMB101.381 million a year earlier, while revenue fell 6.8% to RMB5.619 billion ($787 million). The mixed results underscore pressure on Chinese drug makers to balance cost control with growth.
STAT+: Insurers Refuse to Join Medicare Pilot Offering Weight Loss Drugs to Seniors at Steep Discount
The Trump administration negotiated a $245‑per‑month price with Eli Lilly and Novo Nordisk for obesity drugs, intending to offer seniors a $50 monthly copay through a Medicare pilot called BALANCE. Insurers refused to join, arguing the program would strain their finances. Consequently,...
Trump's Order Is a Milestone for Proponents of Using Psychedelics as Medicine
President Trump signed an executive order that mandates federal agencies to speed up research and regulatory approval of psychedelic compounds for mental‑health treatment. The order calls for the DEA to reassess scheduling of substances such as psilocybin and MDMA and...
Lilly's Retatrutide Achieves 28.7% Weight Loss, Higher Dropouts
Lilly’s triple G agonist boasts 28.7% weight loss in Phase III trial Lilly is investigating retatrutide in seven other Phase III trials, which are due to read out in 2026. 👨🏻⚕️“Discontinuation rates due to adverse events were 12.2% and 18.2% with retatrutide...
Zero Relapses Reported in Pre‑Surgery Immunotherapy Trial for Bowel Cancer
University College London and UCL Hospitals reported that none of the 32 stage II/III bowel‑cancer patients in the NEOPRISM‑CRC trial relapsed after a median 33‑month follow‑up. The pre‑operative pembrolizumab regimen shrank tumours in 59% of participants and could cut the need...
Discovery of a Small Molecule HPK1 Inhibitor for Immuno-Oncology
A biotech firm has disclosed a novel small‑molecule inhibitor of hematopoietic progenitor kinase 1 (HPK1) that demonstrates potent immuno‑oncology activity in preclinical models. The compound achieves sub‑micromolar potency, oral bioavailability, and drives up to 70% tumor regression when combined with...
Debiopharm Secures FDA Fast Track for Lunresertib/Zedoresertib in Platinum‑Resistant Ovarian Cancer
Debiopharm announced that the FDA granted Fast Track designation to its lunresertib‑zedoresertib regimen for adult patients with CCNE1‑amplified or FBXW7/PPP2R1A‑mutated platinum‑resistant ovarian cancer. The move follows Phase I data presented at AACR 2026, positioning the combo as a potential first‑in‑class...
Radiopharmaceutical Manufacturer Secures $30M to Bolster Domestic Isotope Production
Ionetix Corporation, a Michigan‑based cyclotron and radiopharmaceutical firm, announced a $30 million private‑placement raise at $3 per share. The capital will fund expansion of domestic radioisotope production for PET imaging and alpha‑emitter therapies and boost R&D on its superconducting cyclotron platform....
AACR 2026: Lung Cancer Immunotherapy Response Predicted by Pathomics AI Model
Researchers at UT MD Anderson unveiled Path-IO, a deep‑learning pathomics model that predicts outcomes and immunotherapy response in metastatic non‑small cell lung cancer (NSCLC). The AI was trained on 797 patients and externally validated on 280 cases, consistently outperforming the...
Scaling Bio 008: Serif Biomedicines' Jake Rubens on Turning Modified DNA Into a New Class of Medicine
In this episode, Jake Rubens of Serif Biomedicines explains how the company is turning DNA into a new class of medicines by using chemically modified DNA and a protein co‑factor to overcome DNA’s historic immunogenicity and delivery challenges. He contrasts...
LLMs Beat JEPA World Models on Sparse Biological Data
Sci-JEPA's and Biology: I'm testing & training LeCunn style JEPA's @SciRouterAI vs more classical Dual encoder LLMs (small 35k data sets) for novel molecule targets for disease quick scans. What's interesting is that even though world models have, in theory, powerful...
Beyond CAR T: Programmable Immune Cells Shaping Future Therapies
CAR T cells cured patients who had no other options. That was just the opening move. #SynBioBeta2026 is May 4-7th in San Jose, California, you can learn more about the conference and get your tickets here: https://t.co/8abYWJ1GbK The next generation of T...
The BioPharm Brief: AI, Immunology, and Regulatory Momentum
AstraZeneca announced consistent Phase III data showing its IL‑33 biologic cuts COPD exacerbations, reinforcing the cytokine as a therapeutic target. Boehringer Ingelheim disclosed a broadened AI program that will be embedded across early discovery and development stages to speed target identification. The...
1 Parkinson’s Drug Can Hinder the Gold-Standard Treatment
Researchers at Yale School of Medicine discovered that catechol‑O‑methyltransferase inhibitors (COMT‑Is), commonly added to levodopa therapy for Parkinson's disease, can unintentionally reshape the gut microbiome. The altered microbiome favors growth of Enterococcus faecalis, a bacterium that metabolizes levodopa before it...
RFK Jr. Says China Is 'Eating Our Lunch' In Biotech Advances
HHS Secretary Robert F. Kennedy Jr. warned Congress that China is outpacing the United States in biotech, citing faster new‑drug approvals and a surge in clinical‑trial starts. He highlighted that China approved more than 70 novel therapies in 2025, compared with roughly 45...
CMS’ Chris Klomp, Stephanie Carlton Talk Affordability, Prior Authorization, Drug Pricing
CMS Deputy Administrator Chris Klomp and Chief of Staff Stephanie Carlton outlined the agency’s recent policy agenda, emphasizing four pillars—fraud reduction, affordability, health‑initiative programs, and AI‑driven streamlining. They highlighted a voluntary agreement to overhaul prior‑authorization processes and a 2025 most‑favored‑nation drug‑pricing pledge...
Why Managing Potency and Degradation Are Crucial in ADC Cleaning Validation
At INTERPHEX 2026, Paul Lopolito of STERIS highlighted the unique cleaning‑validation challenges posed by antibody‑drug conjugates (ADCs). He explained that ADCs merge highly potent small‑molecule payloads with large‑molecule biologics, creating divergent degradation profiles that demand product‑specific, risk‑based cleaning strategies. Lopolito...
Merck's Welireg Combo Fails in First-Line Kidney Cancer
Merck reported that adding Welireg (lenvatinib) to Keytruda (pembrolizumab) did not improve outcomes for treatment‑naïve patients with advanced renal cell carcinoma. In the phase‑3 CLEAR trial, the combination failed to meet its primary progression‑free survival endpoint, showing a median of...
Merck’s Fast-Ascending Kidney Cancer Drug Hits a Setback
Merck announced that Welireg, combined with Keytruda and Lenvima, failed to meet primary endpoints in a Phase 3 first‑line clear‑cell renal cell carcinoma trial, missing both progression‑free and overall survival benefits. The setback curtails Merck’s plan to use Welireg to offset...
Scaling AI in Pharma Requires More Than Algorithms
Pharma companies are racing to embed AI, reporting productivity lifts such as 28% faster target identification and 22% quicker biomarker discovery. However, fewer than half of executives feel their firms are truly ready to scale these technologies. Capgemini’s Sheetal Chawla...
What Does It Take to Scale Cell and Gene Therapies From Discovery to Commercialization
MaxCyte CEO Maher Masoud says scaling cell and gene therapies requires developers to partner with manufacturers that can move seamlessly from R&D to commercial production. Integrated, best‑in‑class platforms eliminate the need for repeated process re‑optimization, enabling consistent, automated manufacturing. Advances...
FDA Public Meeting on Increasing Access to Nonprescription Drugs - 04/23/2026
The FDA announced a public meeting on April 23, 2026 to discuss expanding access to nonprescription, or over‑the‑counter (OTC), drugs. The agency is soliciting comments through May 8, 2026, with an earlier deadline of Feb 2, 2026 to shape the agenda. Topics include identifying conditions that...
FDA Accepts BLA for Gazyva/Gazyvaro for Systemic Lupus Erythematosus
Roche has received FDA acceptance of its supplemental Biologics License Application for obinutuzumab (Gazyva/Gazyvaro) as a treatment for systemic lupus erythematosus, with a regulatory decision expected by December 2026. The approval request is backed by the Phase III ALLEGORY trial, which...
Apeloa Pharmaceutical Q1 Profit Rises to RMB249 Million as Revenue Falls 10%
Apeloa Pharmaceutical reported a slight rise in first‑quarter profit to RMB249 million ($35 m) versus a year earlier, even as revenue dropped 10.4% to RMB2.45 billion ($343 m). The results underscore both growth in earnings per share and pressure on top‑line sales in China’s...
Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval - 05/09/2024
On May 9, 2024, the FDA’s Office of Generic Drugs hosted a webinar on the redesigned pre‑submission meetings under GDUFA III. The session outlined new scope, procedural updates, and illustrated a hypothetical case to help sponsors prepare effective meeting requests. Speakers...
AI Can Streamline Drug Approval, Boost Biotech Valuations
That is an interesting idea. This doesn't seem catered to investors per se, but with two partners in the summer of 25, we explored building an “AI-powered AlphaSense for biopharma” ultimately concluding it was too much work to do as...
Complex Generics News
The FDA’s Center for Drug Evaluation and Research is intensifying its focus on complex generic drugs, which feature intricate active ingredients, formulations, or delivery systems. Recent milestones include the July 2023 approval of the first generic Vivitrol injectable and the March 2026...
Genflow and Acuitas Forge Fully Funded LNP Collaboration to Accelerate SIRT6 Gene Therapies
Genflow Biosciences announced a strategic, fully funded collaboration with Acuitas Therapeutics to apply Acuitas' lipid‑nanoparticle (LNP) delivery platform to Genflow's SIRT6 mRNA payload. The non‑dilutive agreement lets Genflow generate preclinical data without cash outlay, signaling strong external validation of its...
Xenon’s Azetukalner Clears Phase III Hurdle in Focal Epilepsy, Eyes FDA Filing
Xenon Pharmaceuticals reported on 19 April at the American Academy of Neurology that its KV7 potassium‑channel opener azetukalner met primary endpoints in the Phase III X‑TOLE2 trial for focal onset seizures. The study enrolled 380 adults, with 374 completing safety and...
The $500,000 Drug and the Cost of Modern Medicine
A 70‑year‑old man with no cardiac symptoms was diagnosed with wild‑type transthyretin amyloid cardiomyopathy after a routine coronary calcium scan revealed a score over 600. The diagnosis triggered a cascade of advanced imaging and a biopsy, leading to approval of...
Rapamycin Might Blunt Exercise Response in Humans
A double‑blind, placebo‑controlled trial gave 40 sedentary adults aged 65‑85 a weekly 6 mg dose of rapamycin alongside a 13‑week home‑based exercise program. Participants receiving rapamycin showed smaller gains in chair‑stand performance and trended worse on six‑minute walk and grip strength,...
Top 15 Specialty Pharmacies of 2025: Report
The Drug Channels report shows the specialty pharmacy market remains tightly concentrated, with PBM‑affiliated chains capturing roughly two‑thirds of dispensing revenue in 2025. Specialty drug spending rose 9.6% to $293.4 billion, while accredited locations topped 1,900, a 3% year‑over‑year increase. Hospital‑owned...
'It's Just the Beginning' For Pancreatic Cancer's Long-Awaited Breakthrough
Revolution Medicines’ KRAS‑G12D inhibitor daraxonrasib has entered late‑stage trials as a potential first‑in‑class therapy for pancreatic cancer, a disease that still carries a five‑year survival rate below 12%. Early data show tumor shrinkage in roughly a third of heavily pre‑treated...
SMMT Spikes as Akeso OS Data Lands Plenary
Summit Thera. $SMMT Well… that answers that. SMMT shares initially popped (as much as ~15%) on today’s release of ASCO abstract titles with the unexpected news that the much-anticipated OS data from Akeso’s HARMONi-6 will be released in a Plenary slot...
Monoclonal Antibodies Boost Fight Against Infectious Diseases
This is a great conversation w @Invivyd chairman and @politico today on why monoclonal antibodies will enhance our war against infectious diseases.
Justin Rebo's KindBio Grows Organs On Demand
The Man Growing Organs On Demand Justin Rebo, KindBio and their fantastic sacks 🔗https://t.co/ed4bZbZV0T @Justin_Rebo https://t.co/nCffjjaqJH
Daraxonrasib Beats Chemo in Pre‑treated Metastatic Pancreatic Cancer
#ASCO26 LBA5 - Wolpin - Daraxonrasib RAS(ON) multi-selective inhibitor vs chemo in prior Tx metastatic pancreatic adenocarcinoma (mPDAC) - Ph3 RASolute 302 [May 31, 2026] https://t.co/oWEeVo2oyq #NCT06625320 #pancsm #caxtx #PrecisionMedicine https://t.co/adz922fg5z
Ivonescimab Plus Chemo Rivals Tislelizumab in First‑line sqNSCLC
#ASCO26 LBA4 - Zhiwei - Ivonescimab + chemo vs tislelizumab + chemo 1L sq NSCLC - Ph3 HARMONi-6 [May 31, 2026] Zhiwei et al. https://t.co/oWEeVo2oyq #NCT05840016 #lcsm #ImmunoOnc https://t.co/NP2qr2gPuY
Adjuvant Selpercatinib Shows Promise
#ASCO26 LBA3 - Goldman - EFS w/ adjuvant sepercatinib in stage IB-IIIA RET fusion-positive NSCLC: Ph3 LIRETTO-432 trial https://t.co/oWEeVo2oyq #NCT04819100 #lcsm #PrecisionMedicine https://t.co/HWIS9mg57w
Phase 3 Trial Shows Abemaciclib Benefits Advanced Liposarcoma
#ASCO26 LBA2 - Dickson -SARC041: Ph3 DBRCT abemaciclib vs placebo in Pts w/ adv dedifferentiated liposarcoma [May 31, 2026] https://t.co/oWEeVo2oyq #NCT04967521 #scmsm https://t.co/uD6A9JmBCn
Genomic Profiling Boosts Survival for Advanced Sarcoma Patients
Using Tumor Genomic Profiling to Guide Treatment Selection Extends Survival in Advanced Sarcoma [May 10, 2019] @ASCO Daily News #scmsm #PrecisionMedicine https://t.co/8625ixTvQu
Perioperative
#ASCO26 LBA1 - Taplin - Perioperative APA + ADT - prostate CA [May 31, 2026] https://t.co/oWEeVo2oyq #NCT03767244 #pcsm https://t.co/8o91ntAwL9
Two Decades of Evolving ASCO Clinical Trial Trends
Trends and characteristics of clinical trials presented in ASCO plenary sessions (2011–2025) [] Overheu #ASCO26 Abstract # 11024, Poster Bd # 7 https://t.co/JYI0LY7FbU #ClinicalTrials #ctsm @ASCO
Labor Dept Demands PBM Payment Transparency Amid Legal Pushback
The Labor Department wants pharmacy benefit managers to disclose, for the first time, all the different ways they get paid. PBMs are warning this proposal is illegal. Supporters want the proposal to go further. The black box of Rx prices...
Scientists Save Billions; CRISPR Cures Sickle Cell
You live in luxury. Without scientists, 6 billion of us would not be alive & the rest would live in hell. Remember that Great choices @brkthroughprize 🏆 Congrats to my colleague @Harvard, Stu Orkin, who won the prize for helping cure...
WGS Uncovers Clinically Relevant Findings Missed in MDS
Whole genome sequencing [WGS] to identify novel, clinically relevant findings missed by standard of care for Pts w/ myelodysplastic syndrome [MDS] - @AlexBataller etal @garciamanero @UTMDAnderson @TempusAI #ASCO26 abst 6570 Pst 363 https://t.co/t7aNW89eRL #MDSsm #leusm #cagenome
First Trial Shows Best‑in‑Class NLRP3 Inhibitor Promise
Excited to complete our first clinical trial for BGE-102. Clinical data supporting best-in-class potential, built on new chemistry and a novel binding site targeting NLRP3 - a central driver of of chronic inflammation in aging. On to Phase 2!
AQUARIUS Registry Uncovers Biomarkers in Blood Cancers
AQUARIUS: A longitudinal multi-center molecular biomarker discovery registry for Pts w/ hematologic malignancies - @mtmdphd et al. @TempusAI & IFLI - Instit Follicular Lymphoma Innovation #ASCO26 abstr TPS7105, Poster 599a https://t.co/70G0v1P968 #NCT07154823 #lymsm #cagenome
ASCO26 Unveils Pancreatic
#ASCO26 abstract titles were released today: $RVMD RASolute Ph3 study in pancreatic cancer will be presented during the plenary session. Also, Akeso $SMMT ivonescimab HARMONi-6 trial in lung cancer. China-only data.
BioAge's Inflammation Drug Shows Best‑in‑class Promise
BioAge says early data suggest ‘best-in-class’ potential for inflammation drug https://t.co/D2owlYxCRa by Kristin Jensen $BIOA $LLY $NMRA