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.
Natural Compound Obakulactone Shows Therapeutic Potential for Rheumatoid Arthritis
Researchers have identified obakulactone, a natural tetracyclic triterpenoid from Phellodendri cortex, as a promising therapeutic for rheumatoid arthritis (RA). In a CFA‑induced rat model, oral dosing (50‑200 mg·kg⁻¹·d⁻¹) over 21 days markedly reduced joint swelling, restored cartilage integrity, and modulated immune cell infiltration. Multi‑omics analyses revealed that obakulactone promotes ubiquitin‑proteasome degradation of ACOT1, normalizing unsaturated fatty‑acid metabolism and dampening JAK‑STAT/PI3K‑AKT signaling. The findings position ACOT1 inhibition and fatty‑acid reprogramming as novel anti‑RA strategies.
Nanophotonic Chips Finally Make the Proteome Visible
We sequence genomes and map transcriptomes with ease. Why is the proteome still invisible? Proteins are where biology actually happens. But until now, we have lacked the tools to read them at scale. @jendionne and her team are building nanophotonic chips that...
Deuruxolitinib Demonstrates Consistent Efficacy, Early Hair Regrowth in Severe Alopecia Areata
Deuruxolitinib (Leqselvi), an oral JAK1/JAK2 inhibitor from Sun Pharma, demonstrated robust efficacy in two pooled Phase 3 trials (THRIVE‑AA1 and THRIVE‑AA2) involving 867 adults with severe alopecia areata. At 24 weeks, 31% of treated patients achieved a SALT score of 20...
MASH Cirrhosis Trials Lack Consistent End Points
A new systematic review of phase 2 and 3 trials for metabolic dysfunction‑associated steatohepatitis (MASH) cirrhosis finds that endpoint selection is highly variable, with most studies relying on histologic improvement and few incorporating patient‑centered outcomes. The analysis identified only nine eligible...
CAR Therapies Could Offer New HBV, HIV Treatments
A new systematic review in Frontiers in Medicine evaluates 43 studies of virus‑directed CAR‑T and CAR‑NK therapies for chronic hepatitis B and HIV. Preclinical data show significant reductions in HIV p24 antigen, HBV surface antigen, and viral DNA, while early...
New Trial Prevents Cognitive Decline in Older Cancer Patients
A multicentric randomized controlled trial in India, called GOCog, tested a culturally tailored multidomain intervention to prevent chemotherapy‑induced cognitive decline in patients aged 60 and older. The program combined cognitive training, physical activity, nutrition guidance, and psycho‑educational support, and was...
KMT2C/D Loss Creates Targetable Cancer Weaknesses
Researchers have identified that loss of the histone‑modifying genes KMT2C or KMT2D creates exploitable weaknesses in cancer cells. Using a genome‑wide synthetic‑lethal screen, they uncovered a set of 12 drug candidates that selectively kill KMT2C/D‑deficient tumors. In mouse xenograft models,...
BIOOCUS Reports Breakthrough Dual CD19/BCMA CAR‑T Success in Refractory Myasthenia Gravis
BIOOCUS Medical Group announced that its autologous dual‑target CD19/BCMA CAR‑T therapy induced deep clinical remission in a 20‑year‑old patient with refractory Myasthenia Gravis. The treatment, delivered in November 2025, showed rapid CAR‑T expansion, a marked drop in autoantibodies, and resolution of...
Senseonics Rolls Out Eversense 365, First One‑Year CGM, Across Europe
Senseonics Holdings launched the Eversense 365 continuous glucose monitor in Europe, beginning with Sweden. The implantable sensor offers a 12‑month lifespan—double the previous six‑month model—and reduces calibration to once a week, promising a new standard for long‑term diabetes management.
PE/PPE Proteins Drive Tuberculosis Drug Resistance
Researchers have identified the PE/PPE protein families as key drivers of drug resistance in Mycobacterium tuberculosis. Genetic analyses reveal that specific PE/PPE variants up‑regulate efflux pumps and alter cell‑wall permeability, reducing the efficacy of first‑line antibiotics such as isoniazid and...
PBMs' Formulary Tactics Drive Billion‑Dollar Patient Costs
The same companies you say are denying claims, are the ones you prop up buying access to formularies. Tell your members to stop being afraid of the PBMs and the insurance companies that own them, or they own. Your...
Sanofi and Regeneron Win FDA Approvals as AbbVie Faces Rejection; Lilly Buys Kelonia
Sanofi and Regeneron received FDA approvals on Thursday, while AbbVie’s submission was turned down. In the same day, Eli Lilly announced a strategic acquisition of Kelonia, a gene‑therapy developer. The mixed regulatory outcomes and the deal highlight shifting dynamics in biotech...
Congress Stalls, Xylazine Spreads
Xylazine, a veterinary sedative, remains unscheduled under the Controlled Substances Act, allowing unrestricted importation despite its presence in roughly 25% of the U.S. fentanyl supply and its link to thousands of preventable amputations each year. The DEA has detected the...
GLP‑1 Drugs May Trigger New Restrictive Eating Disorders
"There is also compelling preliminary evidence suggesting that the use of these drugs [GLP-1] could exacerbate and lead to new diagnoses of restrictive eating disorders, including anorexia nervosa." @NEJM today https://t.co/PeTLgyRXiL
GLP‑1 Weight Loss Drugs Lower HRV, Raise Heart Rate
Reducing body weight with GLP-1 agonists isn't a free lunch: negative impacts on HRV, RHR GLP-1 receptor stimulation depresses heart rate variability and inhibits neurotransmission to cardiac vagal neurons https://t.co/4QNy141TtK
Eli Lilly to Acquire Kelonia Therapeutics for Up to $7 Billion, Boosting In‑Vivo CAR‑T Portfolio
Eli Lilly agreed to purchase Kelonia Therapeutics for up to $7 billion, adding an in‑vivo CAR‑T platform to its cell‑therapy portfolio. The acquisition, pending regulatory clearance, underscores Lilly’s push into next‑generation immunotherapies and marks one of the largest biotech deals of the...
NVO Shows Fewer AEs; LLY Wins on Lower COGS
The $NVO drug has fewer AEs (based on comparative discontinuation rates) - only real advantage $LLY has here is much lower COGS (small molecule vs poorly absorbed peptide).
FDA Clears Regeneron's Otarmeni, First Gene Therapy to Restore Hearing
Regeneron Pharmaceuticals received FDA approval for Otarmeni, the first gene therapy targeting inherited hearing loss caused by OTOF mutations. The one‑time treatment restored hearing in 16 of 20 pediatric trial participants and will be offered free of charge to eligible...
Repeated Doses of Psilocybin Show Promise for Treating Obsessive-Compulsive Disorder
A randomized clinical trial found that weekly high‑dose psilocybin significantly reduced obsessive‑compulsive symptoms in treatment‑resistant patients. Fifteen adults received up to four doses over eight weeks, with 73 % achieving at least a 35 % drop in Yale‑Brown scores and 40 % attaining...
The Stanford Professor Behind an FDA-Cleared Cardiac AI Wants $1 Billion for His Next Company
Stanford associate professor James Zou is reportedly raising about $100 million at a $1 billion target valuation for his new startup Human Intelligence, which will apply AI across the entire biomedical discovery pipeline. Zou’s portfolio includes the FDA‑cleared cardiac‑AI EchoNet, a Nature‑published...
GLP-1 Drugs Linked to Cognitive Impairment, Though the Reason Why Probably Isn’t What You Expect
A retrospective analysis of nearly 65,000 type‑2 diabetes patients over ten years found that users of GLP‑1 agonists such as semaglutide experienced cognitive impairment at twice the rate of non‑users (2.6% vs 1.3%). Researchers attribute the higher incidence to a...
What Does 17 Pharma MFN Deals Are Underneath the Press Releases: The Real Primary Source Stack, the GLP1 Numbers, TrumpRX...
A White House‑driven most‑favored‑nation (MFN) pricing initiative has secured agreements with 17 major pharmaceutical companies, representing roughly 86% of the U.S. branded drug market. The deals, reconstructed from demand letters, rolling announcements and third‑party reports, lock Medicaid and direct‑to‑consumer (TrumpRx)...
Florida Judge Orders Oscar Health to Cover $48,500 Pancreatic Cancer Drug
Miami-Dade Circuit Judge Migna Sanchez‑Llorens ordered Oscar Health to authorize and pay $48,500 for an oral medication prescribed to Pablo Langesfeld’s advanced pancreatic cancer. The ruling challenges the insurer’s denial policy and could affect thousands of cancer patients facing similar...
Epigenetic Plasticity Enables Precision Targeting of Senescent Cells
Epigenetic regulation of cellular senescence "This review proposes a roadmap for leveraging epigenetic plasticity, offering a precision medicine approach to target specific senescent cell populations and extend health span." https://t.co/UAuBP8WEeR https://t.co/i0XzhPM0NB
Chemical Frontiers: The Hidden Risks of the Psychedelic Renaissance
On April 18, President Donald Trump signed an executive order to accelerate the development of psychedelic medicines. The order directs the FDA to give expedited review to qualifying psychedelic drugs and instructs the Department of Health and Human Services to...
Oncolytics Could Re-Rate As Pelareorep Focuses On Registrational Paths
Oncolytics Biotech is refocusing its reovirus therapy Pelareorep on anal cancer and metastatic colorectal cancer, sharpening its commercial narrative. A colorectal cancer trial reported a striking 33% objective response rate, far exceeding the 6‑11% historical standard, prompting the FDA to...
Clinical Trial Finds No Difference in Fluid Treatment Options for Pediatric Sepsis
A NIH‑backed trial involving more than 9,000 children across five countries compared balanced crystalloid fluid with standard 0.9% saline for pediatric septic shock. The study found no significant differences in mortality, persistent kidney dysfunction, or need for renal‑replacement therapy between...
Shilpa Medicare Appoints Dr. Vellaian Karuppiah as COO to Drive Operational Growth
Shilpa Medicare Limited announced the appointment of Dr. Vellaian Karuppiah as chief operating officer. The veteran pharma executive will steer manufacturing, quality, regulatory compliance and supply‑chain functions as the company expands its global footprint.
Johnson & Johnson Beats Q1 2026 Earnings, Raises Full-Year Outlook
Johnson & Johnson reported first‑quarter 2026 revenue of $24.1 billion and adjusted earnings per share of $2.70, exceeding analyst expectations. The health‑care mega‑cap also lifted its full‑year sales forecast to $100.8 billion, driven by strong performance of Darzalex, Tremfya and early uptake...
DEA Reschedules FDA-Approved Marijuana Products and State-Licensed Medical Marijuana to Schedule III
On April 22, 2026, Acting Attorney General Todd Blanche signed a final order moving FDA‑approved marijuana products and state‑licensed medical cannabis from Schedule I to Schedule III. The change eliminates the Section 280E tax disallowance for medical operators and creates an expedited DEA...
Inhaled Treprostinil Improves FVC in IPF Phase 3 Trial: Steven D. Nathan, MD
A phase 3 double‑blind trial (TETON‑2) evaluated inhaled treprostinil in 539 idiopathic pulmonary fibrosis patients and demonstrated a statistically significant preservation of forced vital capacity versus placebo. At 52 weeks, the treprostinil arm showed a median FVC decline of –49.9 mL compared with...
Efficacy of a Combination of Fipronil and Permethrin in Reducing the Risk of Dirofilaria Immitis Transmission to Dogs in Field...
A field trial in northern Greece evaluated Frontline Tri‑Act®, a topical fipronil‑permethrin blend, for heartworm prevention in dogs. Twenty‑four heartworm‑naïve Beagles were split 1:1 between monthly IVP treatment and an untreated control over seven months of peak mosquito activity. At study...
FDA Grants Quick Review Psychedelic Drugs, First Approvals Could Come As Soon As Summer
The FDA announced an accelerated review pathway for psychedelic therapies, aiming to clear the first approval by the end of summer. The move follows President Trump’s executive order, which allocates $50 million for state‑level research partnerships and directs faster rescheduling of...
Yifan Pharmaceutical Posts 4% Profit Rise on New Drug Launches
Yifan Pharmaceutical Co., Ltd. announced a full‑year profit of RMB402.02 million, up 4% from the prior year, as new product launches boosted earnings. Revenue slipped 0.5% to RMB5.132 billion, highlighting a shift toward higher‑margin offerings.
Samsung Biologics Q1 Profit Jumps 46% as Biopharma Demand Surges, but Labor Unrest Looms
Samsung Biologics posted a 45.9% jump in first‑quarter profit to KRW 640.6 billion (≈$493 million) on 25.8% revenue growth, underscoring booming biotech manufacturing demand. At the same time, its labor union warned of a May 1 strike if management does not address accountability concerns,...
Roche Q1 Sales Slip 5% to $18.7B as Swiss Franc Gains Offset Drug Gains
Swiss pharma giant Roche posted first‑quarter sales of 14.7 bn Swiss francs ($18.7 bn), a 5% decline driven by adverse foreign‑exchange effects that wiped out underlying growth in its flagship drugs. The company confirmed full‑year targets, while its shares rose about 2%...
UC Irvine Nanotech Exosome Therapy Reverses MS Symptoms in Mice
Scientists at the University of California, Irvine have demonstrated that bone‑marrow‑derived exosomes can deliver anti‑inflammatory cargo across the blood‑spinal cord barrier, fully reversing motor deficits and nerve damage in a mouse model of multiple sclerosis. The pre‑clinical results, published in...
Tempest Therapeutics Hits Key Manufacturing Milestone for Dual-Targeting CAR‑T TPST‑2003
Tempest Therapeutics announced that its manufacturing partner, Cincinnati Children’s Applied Gene and Cell Therapy Center, received the TPST‑2003 lentiviral vector, a critical component for the dual‑targeting CD19/BCMA CAR‑T therapy. The milestone clears the path for a potential registrational trial later...
![[Comment] Antibody-Based Malaria Prevention in an Intense Perennial Transmission Setting](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/a3263fcd8d733301ef10712d19f5c34a.webp)
[Comment] Antibody-Based Malaria Prevention in an Intense Perennial Transmission Setting
A recent phase‑2 trial of the monoclonal antibody L9LS in Kenyan children demonstrated high efficacy against Plasmodium falciparum in an intense, year‑round transmission setting. The study reported roughly 70% protection after a single dose, with a safety profile comparable to...
Classified Information Finds A Side Hustle
The FDA unveiled a new voucher program that will fast‑track psychedelic drug approvals, potentially bringing treatments for depression and PTSD to market as early as this year, though safety experts warn the accelerated timeline could compromise thorough review. In a...
Undetected Antibodies Can Undermine Phage Therapy Effectiveness
Hidden antibodies in patients can neutralize bacteriophages, limiting the effectiveness of phage therapy for drug-resistant infections and highlighting the need for pre-treatment antibody screening. infectiousdisease
CMS Proposes Electronic Prior Authorization for Drugs
The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule to extend electronic prior authorization (e‑PA) to pharmaceuticals covered under both medical and pharmacy benefits. The rule mandates the use of Fast Healthcare Interoperability Resources (FHIR) APIs...
Targeting iNOS‑IRG1 Binding Offers Precise Anti‑Inflammatory Therapy
A newly discovered interaction between iNOS and IRG1 proteins directly regulates inflammation, suggesting that targeting their physical binding could offer more precise therapies for Crohn's disease, arthritis, and cardiovascular conditions. immunology
Patent Analysis Is Increasingly Shaping AI-Driven Target and Drug Candidate Selection
A new review in Nature Reviews Drug Discovery outlines how AI is expanding target identification by merging multi‑omics, knowledge graphs, and foundation models. The authors argue that patentability, commercial tractability, and competitor analysis should be evaluated alongside druggability and safety...
EXPOSED: One in Seven Vaccinated People Report Serious Adverse Events — And the Cover-Up Continues
A UK Medicines and Healthcare products Regulatory Agency (MHRA) active‑surveillance study of 30,281 COVID‑vaccine recipients reported that 13.7% experienced medically serious adverse events, while over half reported any reaction. The data, collected between 2020 and 2022, were released only in...
Invest in Proven Canine Cardiac Reversal Biotech
I co-founded @RejuvenateBio & have enjoyed the science from day one. Cardiac disease reversal in dogs. 3 years of safety data. Zero safety signals. They’ve opened a unique opportunity for the biotech community to invest & secure equity at this early...
Liquid Metal Nanoparticles Freeze Into Spikes that Kill Drug-Resistant Cancer
Researchers have engineered bismuth‑doped gallium liquid‑metal nanoparticles that become spiky during freezing, puncturing cancer cells and killing drug‑resistant lung, colorectal and ovarian tumor organoids. The alloy reduces supercooling, raising the fraction of deformable particles from 2% to roughly 10% and...
Bioprocessing Method Is a Critical Factor for IgM Oligomerization
Researchers compared fed‑batch and semi‑continuous perfusion bioprocesses for recombinant IgM production in CHO DG44 and CHO K1 cell lines, generating either pentameric (5IgM) or hexameric (6IgM) antibodies with or without a J‑chain. The perfusion approach, which continuously supplies fresh medium...
White House Announces MFN Agreement with Drug Manufacturer Regeneron
The White House unveiled a most‑favored‑nation (MFN) pricing agreement with Regeneron covering its blockbuster eye‑disease drug Eylea. The pact obligates Regeneron to extend to Medicare the lowest net price it offers any private payer, with annual price reviews built into...
FDA Fast-Tracks the Development of Psychedelic Medications Following President’s Executive Order
The FDA announced an accelerated regulatory pathway for psychedelic‑based therapies after the April 18 executive order targeting serious mental illness. It will prioritize serotonin‑2A agonists for treatment‑resistant depression, PTSD and substance‑use disorders, and issue national‑priority vouchers for psilocybin and methylone studies...