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.
Hims & Hers Health, Inc. Dba Hers - 716825 - 09/09/2025
The FDA issued a warning letter to Hims & Hers Health, Inc., alleging that the company’s website falsely marketed its compounded semaglutide as equivalent to FDA‑approved products like Ozempic and Wegovy. The agency cites violations of FDCA sections 502(a), 502(bb) for misbranding and 301(a) for illegal interstate commerce. Hims & Hers is required to cease the misleading claims and submit a corrective action plan within 15 working days or face enforcement actions such as seizure or injunction. The notice underscores that compounded GLP‑1 products are not FDA‑approved and must be marketed with appropriate disclosures.
About the Quantitative Medicine Center of Excellence (QM CoE)
The FDA’s Center for Drug Evaluation and Research (CDER) has launched the Quantitative Medicine Center of Excellence (QM CoE) to centralize quantitative expertise across its offices. Governance includes senior leaders from the Offices of Generic Drugs, New Drugs, Pharmaceutical Quality,...
Cancer Dependency Map Consortium Launches Phase 3 to Accelerate Next-Generation Therapeutics
The Broad Institute’s Cancer Dependency Map Consortium (DMC) has entered Phase 3, expanding its mission beyond cataloguing tumor vulnerabilities to tackling drug resistance, surface‑protein targets, and high‑dimensional readouts. Backed by 23 pharma partners, the consortium builds on DMC 2.0’s expansion to over...
Elahere Combination Achieves 62.7% ORR in Phase 2 Trial for Platinum-Sensitive Ovarian Cancer at SGO 2026
AbbVie’s Elahere (mirvetuximab soravtansine) combined with carboplatin produced a confirmed objective response rate of 62.7% in patients with FRα‑positive, platinum‑sensitive ovarian cancer, meeting the primary endpoint of the Phase 2 IMGN853‑0420 trial presented at SGO 2026. The study enrolled 125 participants,...
Physics‑Based Sensors and AI Transform Bioreactor Monitoring
Bioreactors are billion-dollar processes monitored by pH probes and dissolved oxygen sensors. That's like running a semiconductor fab with a thermometer. @schmidtsciences is adapting physics tools that don't usually touch biology: fluorescent nanodiamonds, single-cell Raman spectroscopy, and optical frequency combs that...
GLP-1 Drug Improves Liver Health Independent of Weight Loss, Mouse Study Finds
Researchers at Toronto’s Sinai Health discovered that semaglutide, a GLP‑1 agonist, improves liver function by acting directly on liver sinusoidal endothelial cells, independent of weight loss. The study, published in Cell Metabolism, used mouse models of metabolic dysfunction‑associated steatohepatitis (MASH)...
Targeting Aging: Epigenetic Reprogramming Tackles Disease Root
Aging is arguably the root cause of most major diseases. Our cells lose function as we age, allowing various conditions to manifest, which is why most major diseases correlate with age. Yes, it is more complex than this, but this is...
Low‑cost Vaccines Bypass Big Pharma, Influencers Profit
No, the opposite. I develop low cost vaccines that bypass big pharma. The only shills are those connected to the corrupt wellness influencer industry, which buys whatever it can in bulk cheap so they can jack up the price with...
Pharmaceutical Executive Daily: AbbVie and Haisco Enter $745 Million Licensing Agreement
AbbVie signed an exclusive licensing deal with China’s Haisco Pharmaceutical to develop, manufacture and sell a suite of novel pain compounds outside mainland China, Hong Kong and Macau. The agreement provides Haisco $30 million upfront and up to $715 million in milestone payments,...
FDA Bolsters Bespoke Therapy Framework with New Draft Safety Guidelines
The FDA’s Center for Biologics Evaluation and Research issued draft guidance to standardize safety assessments for genome‑editing therapies, covering both ex vivo and in vivo products that use next‑generation sequencing to detect off‑target effects. The recommendations target nonclinical studies supporting IND and...
Nasal EV Spray Reverses Neuroinflammation and Boosts Memory
A nasal spray delivering extracellular vesicles reversed neuroinflammation, restored mitochondrial function, and improved memory in aging brain models, suggesting a noninvasive approach to counteract cognitive decline. neuroscience
Fordham 33 (Report 4): Life Sciences and Healthcare Innovation
A multinational panel at Fordham’s IPKat event dissected life‑science patent strategies across the U.S., Europe, Japan and the upcoming Unified Patent Court. Speakers highlighted how European protocol disclosures reveal methods but not results, making anticipatory rejections rare, while U.S. product‑for‑use...
Reproxalap Safe for Use in Patients With Dry Eye Disease
A Phase 3 trial of 0.25 % reproxalap eye drops in 757 dry‑eye disease patients found no serious treatment‑related adverse events. Mild ocular irritation was the most common side effect, occurring more often in older women. Visual acuity showed modest improvement, especially...
AWS Launches Amazon Bio Discovery for AI-Powered Scientific Experimentation
Amazon Web Services unveiled Amazon Bio Discovery, a cloud‑based platform that supplies scientists with a curated library of biological foundation models (bioFMs) for generating and evaluating drug molecules. The service lets researchers train custom models on their own experimental data...
Updated: FDA Asks for Data on Lilly’s Foundayo to Assess Heart, Liver Risks
The U.S. Food and Drug Administration has asked Eli Lilly for additional safety data on its newly approved obesity medication, Foundayo. The agency is specifically seeking information on any cardiovascular events and liver‑related adverse effects observed in clinical trials and post‑marketing...
Replimune Looks Ahead as Repeat CRL Speeds the Company's Decline
Replimune received a second complete response letter (CRL) from the FDA for its lead oncolytic cancer therapy, citing additional data gaps and manufacturing concerns. The regulatory setback triggered a wave of layoffs affecting roughly 30% of its workforce and pushed...
Max Hodak’s Science Corp. Is Preparing to Place Its First Sensor in a Human Brain
Science Corp, the neurotechnology startup founded by former Neuralink president Max Hodak, has recruited Yale neurobiologist Murat Günel as a scientific adviser to oversee its first U.S. human trials of a bio‑hybrid brain‑computer interface. The company recently closed a $230 million Series C...
NEW STUDY: Frog-Derived Gut Bacterium Completely Eradicates 100% of Tumors After a Single Dose in Mice
A peer‑reviewed study in *Gut Microbes* reports that a single intravenous dose of the frog‑derived gut bacterium Ewingella americana eradicated colorectal tumors in 100% of immunocompetent mice. The live microbe outperformed both doxorubicin chemotherapy and anti‑PD‑L1 checkpoint blockade, achieving complete...
Neuralink Shifts to Speech‑Focused Brain‑Computer Interface Trials, Raising Viability Questions
Neuralink announced new speech‑restoration clinical trials at the University of Texas Southwestern Medical Center and Cleveland Clinic Abu Dhabi, moving away from its long‑standing motor‑cursor interface. The pivot follows criticism that its original brain‑computer interface (BCI) strategy lags behind competitors...
FDA Grants Full Approval to Travere’s FILSPARI for FSGS, Unlocking $2B Market
Travere Therapeutics announced that the FDA has granted full approval to FILSPARI (sparsentan) for focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. The decision makes FILSPARI the first approved therapy for the rare kidney disease and expands the drug’s addressable U.S....
In the Clinic for April 14, 2026
The "In the clinic for April 14, 2026" page serves as a centralized hub that aggregates the latest Bioworld data snapshots, special reports, and infographics across biopharma, medical technology, and emerging therapeutic areas. It links to analyses on mRNA vaccine...
New CellCelector CLD Takes You From Thousands of Candidates to the Top Clone, Faster
German biotech equipment maker Sartorius has launched the CellCelector CLD, an automated imaging and cell isolation platform that accelerates monoclonal cell line development. The system combines high‑speed scanning, advanced imaging and gentle clone retrieval to screen up to 885 nanowell...
Gaps in Persistence, Coverage Limit GLP-1 Impact in Obesity
Two AMCP 2026 posters highlighted persistent gaps in GLP‑1 therapy for obesity. A claims‑based analysis of 53,183 patients showed persistence falling from 65% at 120 days to 34% at one year, with higher out‑of‑pocket costs and fewer clinician visits driving...
BHV-2100
Researchers from KU Leuven, CISTIM Leuven and Biohaven Therapeutics have announced that an oral TRPM3 antagonist has entered Phase 2 clinical testing for the acute treatment of migraine. The program leveraged a cell‑based high‑throughput screen of more than 200,000 compounds to...
Medical Claims Require Trials, Not AI Hype
-AI has nothing to do with it. You are selling bullshit. If your AI can determine which person ‘needs’ which peptide, you will need a trial to show that. -Palantir has nothing to do with it - You can sell...
Johnson & Johnson’s Spravato Sales Growth Signals Upside for Psychedelics Peers
Johnson & Johnson reported Spravato generated $468 million in Q1 2026, a 46% year‑over‑year increase that translates to an annualized run rate above $1.9 billion. Quarterly sales slipped 7% versus the prior quarter due to seasonal insurance resets, but the company reaffirmed guidance...
Continuous Fermentation Cuts Costs, Beats Traditional Bioreactors
The biomanufacturing bottleneck isn't biology. It's economics. Building bigger bioreactors doesn't fix unit costs. https://t.co/2RAcw704uk's bet: continuous fermentation decouples growth from production, keeps cells in an ultra-productive state for weeks, and runs like a conveyor belt instead of a batch process. ...
EU Sees 2025 Pharma Export Uptick Amid Competitiveness Concerns
EU pharmaceutical exports surged 16% in 2025, reaching €366.2 bn (≈$429 bn) and generating a record trade surplus of €220.5 bn (≈$257 bn). The United States remained the top destination, accounting for 44% of shipments – roughly €160.6 bn (≈$188 bn). Tariff pressures, including a 15%...
How GLP-1s Are Shifting Pharma Commercialization Trends
The GLP‑1 class has evolved from a niche injectable therapy to a high‑volume market that now includes oral formulations, prompting pharma to pivot toward larger total addressable markets. Over the past decade the industry focused on ultra‑rare, high‑price drugs, but...
J&J Increasingly Confident It Can Manage Stelara Cliff, but Work Remains
Johnson & Johnson says the most intense biosimilar pressure on its blockbuster drug Stelara is largely behind it, and the company now projects robust growth through the late 2020s. Executives cite new therapeutic indications, expanded global reach, and strategic pricing...
Re: Weight “Regain” In Obesity Shifts Responsibility From Biology to Personal Inadequacy
The author agrees with recent criticism of the term “weight regain,” emphasizing that obesity is a chronic, biologically driven condition. She highlights that GLP‑1 receptor agonists cause loss of both fat and lean tissue, triggering adaptive reductions in energy expenditure...
Why Synthetic Data Is the Antidote to Clinical Trials
Synthetic data, digital twins, and AI are reshaping medical‑device trials by generating virtual patient cohorts that reduce enrollment needs and cut validation costs. The FDA’s in‑silico guidance and EMA’s acceptance of AI tools are paving regulatory pathways for these simulations....
Lilly Investing Billions to Prepare for Overseas Oral GLP-1 Launches
Eli Lilly announced a $3 billion investment in China and a $125 million spend in Japan to build capacity for its newly approved oral GLP‑1 drug, orforglipron. The moves aim to localize production, shorten lead times and hedge against geopolitical disruptions. Analysts see...
The US FDA New Drug Approvals in March 2026
In March 2026 the U.S. FDA approved five new therapies spanning hepatology, dermatology, rare genetics, oncology, and endocrinology. GSK’s Lynavoy treats cholestatic pruritus in primary biliary cholangitis, while Johnson & Johnson’s Icotyde targets moderate‑to‑severe plaque psoriasis. Denali Therapeutics earned accelerated...
Lilly Wants to Bridge Cancer Care Gap with $300M ADC Biotech Buy
Eli Lilly announced an acquisition of Houston‑based CrossBridge Bio, offering up to $300 million in cash and performance‑based biobucks. The early‑stage biotech is developing a dual‑payload antibody‑drug conjugate, CBB‑120, that targets the TROP2 protein found in many solid tumors. CrossBridge plans to...
In‑vivo Base Editing Rescues Zellweger Disorder in Mice
Today in @natBME we report an in vivo base editing strategy that corrects a common disease-causing mutation and rescues pathology in a mouse model of Zellweger spectrum disorder (ZSD) and restore peroxisomal function in patient derived cells. This work highlights...
REPL CEO Skips
$REPL CEO tells me they’re not going to appeal the 2nd CRL but will try to work with FDA - for now, commercial team/other layoffs, cash runway til Q1 of next year, stock price -75% from Fri https://t.co/FLAiOcAAQB
This Biotech Firm Has Room to Run, Even as Its Drug Royalties Are Set to Shrink
Biogen was upgraded to overweight by Piper Sandler, which lifted its price target to $214, implying about 21% upside. The firm anticipates a dip in Ocrevus royalty income as exclusivity expires between 2028 and 2029, but expects new launches—Syfovre, Empaveli—and a...
GLP‑1 Drugs Show Weight‑loss‑independent Benefits, Study Finds
Great work by @DanielJDrucker and team; biologically plausible mechanism of GLP1-RA benefit independent of weight loss. Excellent article by @megtirrell @CNN describing the publication. Could it justify new approaches for these drugs? I think so. https://t.co/pHudk7lkAR
Novo Partners OpenAI as Ideaya's Eye Data Disappoints
Novo teams with OpenAI; Ideaya gets muted response to eye drug data https://t.co/U6sDZlMxyQ $NVO $IDYA $REGN $GSK
Federal Judge Allows Mail-Order Mifepristone Abortions to Continue, Signals Challenge to FDA
U.S. District Judge David Joseph ruled that the FDA's mail-order mifepristone rule will remain in effect, granting the agency a pause but noting Louisiana's lawsuit has standing and is likely to succeed. The decision keeps medication abortions accessible while pressuring...
Comprehensive Genomic Panel Broadens Oncology Treatment Options
Unique Features of a Comprehensive Genomic Profiling Panel: Expanding Treatment Options in a Value-Based Community Oncology Network [Mar 9, 2026] La Porte et al. @DrEzraCohen @JCOPO_ASCO https://t.co/tDi3kbxdvX #PrecisionMedicine #hemeonc @TempusAI https://t.co/zgEw8hfFia
Real-World Data Reveal Molecular Profile of Metastatic ILC
Molecular Characterization of Patients with Metastatic Invasive Lobular Carcinoma: Using Real-World Data to Describe This Unique Clinical Entity [Sep 10, 2025] Davis et al. @CCR_AACR https://t.co/eY0etUfQhQ #bcsm #PrecisionMedicine #camoldx @TempusAI https://t.co/oDkC1Ua6DS
A Modular, Synthetic Origin of Replication
Researchers at Rice University have engineered a synthetic origin of replication, SynORI, that replaces the native ColE1 feedback loop with programmable RNA regulators. The modular design yields six orthogonal plasmid compatibility groups that can coexist in E. coli for at least...
PurIST Classifier Validated for Pancreatic Cancer Therapy
Real-World Validation of the Purity Independent Subtyping of Tumors Classifier for Informing Therapy Selection [PurIST @TempusAI] in Pancreatic Ductal Adenocarcinoma [Sep 4, 2025] @stephwen et al. @JCOPO_ASCO https://t.co/R24DErvaB4 #pancsm #PrecisionMedicine https://t.co/40LqNDQJHo
RUNX1 Identified as Key to Rejuvenate Aging T Cells
Discovery of a factor (RUNX1) that pinpoints T cell senescence and restoring its functionality achieves T cell rejuvenation. Significant implications in older adults with loss of immune system protection. https://t.co/X58DvzIUXY @ImmunityCP https://t.co/hzL3zFiPMm
STAT+: Pharmalittle: We’re Reading About an FDA Push for Trial Transparency, a Novo-OpenAI Deal, and More
The FDA has dispatched reminder letters to more than 2,200 companies and researchers, warning that failure to post required clinical trial results to the federal database could trigger fines. An internal review found that nearly 30% of studies likely subject...
GLP‑1 Receptors Protect Liver in Mouse MASH Model
Adding to the GLP-1 drug weight-loss independent effect benefit : impact on liver sinusoidal endothelial cell GLP-1 receptors for liver protection in mouse MASH model @Cell_Metabolism @DanielJDrucker @ChusaGzlzRellan https://t.co/0A13QYgm05
Low P‑tau217 Indicates Minimal Alzheimer’s Risk in Seniors
Another study indicative of predictive power of p-tau217 for Alzheimer's disease in cognitively unimpaired older adults (mean age 71 at baseline) A very low p-tau217 denoted minimal risk https://t.co/6RPJcCloWI https://t.co/XikzsvJjhM
Merck Under Fire as $162,000 Keytruda Dose Highlights Pricing Controversy
Merck & Co. is drawing national attention after a California patient received a $162,568 bill for a single 400 mg Keytruda infusion. The drug, which generated $31.7 billion in worldwide sales in 2025, is under investigation for tactics that keep its U.S....