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.

What Makary’s Plan For Expanding OTC Drug Access Could Mean For Safety
FDA Commissioner Marty Makary argues that any drug deemed safe, non‑addictive and not prone to misuse should be sold over the counter. He cites anti‑nausea medicines, hormonal contraception and common analgesics as candidates, while urging regulators to abandon a paternalistic approach. The article warns that extending OTC status to antibiotics could exacerbate antimicrobial resistance, a growing public‑health crisis. It also highlights alternative models such as pharmacist‑prescribed antibiotics and the impact of the U.S. disengagement from WHO coordination.
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Given 1mg/week of Zepound showed 0.7% reduction in A1c in trials, and so is actually an efficacious dose, this microdose would just be $30/month. (Would imply using for longer than recommended after opening).
Hepta‑refractory Myeloma Arises via Sequential CD38
The evolution to hepta-refractory myeloma involves sequential loss of CD38, BCMA and GPRC5D [Feb 17, 2026] Riedhammer et al. @LeukemiaJnl https://t.co/EyGBz7sEQz #mmsm #PrecisionMedicine #caxtx

STAT+: Drugmakers Lay Out Their Legal Arguments Against Trump’s Drug Pricing Experiments
Pharmaceutical and biotech firms are mobilizing against two Trump administration proposals that would tie Medicare drug prices to those paid in other affluent nations. The initiatives – the GLOBE model for Part B physician‑administered drugs and the GUARD model for Part D...
What to Know About the ‘Anti-Aging’ Peptide Shots Flooding Social Media
A wave of unapproved anti‑aging peptide injections is sweeping social media, driven by influencers and celebrities. Most products are sold on the gray market, often from China, and lack FDA approval or robust clinical data. Experts warn of safety risks,...

Pharmaceutical Executive Daily: Novo Nordisk Announces Price Reductions for GLP-1 Products
Novo Nordisk announced steep price cuts for its GLP‑1 diabetes and obesity drugs, aiming to broaden patient access amid intensifying pricing scrutiny. AbbVie is committing $380 million to expand API manufacturing capacity, reinforcing supply‑chain resilience. Bora Pharmaceuticals and GSK sealed a...
Vir Surges After Astellas Partnership and T‑cell Data
Vir climbs on Astellas deal, study results for ‘masked’ T cell engager https://t.co/336c9FJdjt by @Lilah_Alvarado $VIR + 27% $JANX $ALPMY
Novo Slashes GLP‑1 Prices; Palvella Spikes on Data
Novo to cut GLP-1 drug prices; Palvella soars on study data https://t.co/UAs4IETgPX $NVO $PVLA+ 32% $GOSS $VNDA $PFE #biotech

Thermogeneration by White Fat Could Be Used to Treat Obesity
Researchers at Cornell uncovered a previously unknown thermogenic pathway in white adipocytes, where free fatty acids induce proton leakage through the mitochondrial ADP/ATP carrier (AAC). This AAC‑mediated uncoupling mirrors brown‑fat heat production without involving UCP1. In mouse models, enhancing intracellular...

Generic Drugs Program Monthly and Quarterly Activities Report
The FDA’s Generic Drugs Program reported 217 approvals for FY‑2026, including 23 first‑time generics and 45 first‑cycle approvals. Tentative approvals reached 89, while complete responses rose to 402, reflecting a busy review pipeline. Prior Approval Supplements (PAS) saw 532 approvals,...

List of Determinations Including Written Request
The FDA has published an updated list of 189 pediatric exclusivity determinations made under Section 505A of the Federal Food, Drug, and Cosmetic Act since September 2007. Each entry includes the drug name, sponsor, determination date, and links to the original Written...
Roctavian Withdrawn, Exposing Science‑to‑market Gap
Failing to find a buyer, BioMarin is voluntarily withdrawing Roctavian from the market. A fitting end for what was once one of the highest-profile gene therapies in development — and a reminder of the gap between promising science and a viable...

CDER Guidance Agenda
The Center for Drug Evaluation and Research (CDER) released its February 2026 Guidance Agenda, outlining the draft and revised guidances it plans to develop this calendar year. The agenda features the first issuance of a Level 1 draft guidance alongside updates to...
Novo Highlights New Data on Triple‑Target Obesity Therapy
Novo, searching for a spark, spotlights new data for three-pronged obesity drug https://t.co/pPo9Oc1wlF $NVO $LLY #obesity
FDA Draft Guidance Boosts Individualized Therapy Innovation
FDA Issues Plausible Mechanism Pathway Draft Guidance to Spur Innovation for Individualized Therapies https://t.co/OZW6Q27zMa via @Inside_PM

MedisourceRx - 717970 - 12/12/2025
The FDA issued a warning letter to MedisourceRx after an inspection found the facility’s compounded sterile drugs failed to meet 503B outsourcing‑facility requirements. Specific violations include marketing unapproved new drugs, misbranding due to inadequate labeling, and inadequate adverse‑event reporting. The...
Immedica Secures Accelerated Approval, Plans PRV Sale
Immedica wins accelerated approval for once-rejected rare disease drug, plans to sell PRV - https://t.co/wU3AfqQzjw

Pfizer’s Strategy: How the Company Is Evolving After Its COVID Success
Pfizer’s post‑COVID strategy pivots from vaccine and antiviral sales to rebuilding growth through oncology and metabolic assets. The 2026 guidance excludes COVID revenue, projects modest 4% operational growth, and anticipates a $1.5 billion patent‑cliff hit. To offset these pressures, Pfizer completed...
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Stäubli Robotics unveiled the next‑generation Sterimove at INTERPHEX 2026, positioning it as the world’s first mobile robot certified for Grade A, B, C and D cleanroom environments. The platform combines sealed, cleanroom‑compatible construction with advanced collision‑avoidance sensing, dual emergency stops...

Agentic AI Revolutionizes Biomedical Research, Featured in Nature Biotechnology
Our perspectives piece on Agentic AI for biomedical research has been published in Nature Biotechnology https://t.co/PpFeGcvv0x #agenticAI #artificialintelligence #agents https://t.co/xoADUc7T7K
Slate Secures $130M, Launches Chinese Headache Drug
Slate starts up with $130M and a headache drug from China https://t.co/6DEltQAI8s by @gwendolynawu #biotech #startups $HLUBF

Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China
Sciwind Biosciences granted Pfizer China exclusive rights to commercialize ecnoglutide injection in Mainland China. Sciwind will keep the marketing authorization and handle R&D, registration, manufacturing, and supply, receiving up to $495 million in milestone payments. Ecnoglutide, a cAMP‑biased GLP‑1 receptor agonist,...

NVO Triple G Shows Higher 24‑Week Response Than LLY
Cross trial and China data caveats, but 19.7% at 24 weeks for $NVO triple G looks quite good. Probably a few % points better than $LLY triple G at 24-week timepoint. https://t.co/ylgf4vTEOq

Camel Antimicrobials Could Get Us over the Hump of Antibiotic Resistance
Researchers at Sultan Qaboos University have isolated three antimicrobial peptides from dromedary camels, with CdPG-3 and CdCATH showing potent activity against methicillin‑resistant Staphylococcus aureus and multidrug‑resistant Escherichia coli. The peptides kill bacteria by disrupting their membranes while exhibiting low toxicity...

The Effectiveness of TV Advertising for Pharma
Pharma TV advertising is encountering stricter regulatory limits, especially since the Trump administration tightened rules around black‑box warnings and ad volume. While TV still reaches broad audiences, its effectiveness is waning as digital platforms enable far more precise, N‑of‑1 targeting....

Revealing the Structural Fingerprints of Disease: Q&A with Faraz Choudhury
Immuto’s CEO Faraz Choudhury explains that conventional target discovery, which focuses on gene mutations and protein abundance, overlooks disease‑specific protein conformations. The company’s platform maps surface protein conformations (SPCs) in living, patient‑derived models using high‑resolution mass spectrometry and AI‑driven analysis,...
FDA Accepts Beren Therapeutics’ NDA for Niemann-Pick Disease
Beren Therapeutics announced that the U.S. Food and Drug Administration has accepted its New Drug Application for adrabetadex, an investigational therapy aimed at treating infantile‑onset Niemann‑Pick disease type C (NPC). The agency set a target action date of 17 August 2026 under the...

STAT+: New Treatment Approach Could Give IBD Patients Hope, and Be a Bonanza for Drugmakers
A new combination‑therapy approach for inflammatory bowel disease (IBD) aims to boost remission rates beyond the current 30 % success benchmark. By pairing agents that target distinct immune pathways, early trials show remission climbing to roughly 55 % and faster mucosal healing....
Every Cure and Computational Pharmacophenomics: A New Field of Medicine
The nonprofit Every Cure is launching computational pharmacophenomics, an AI‑driven approach that systematically evaluates all 4,000 FDA‑approved drugs for the 14,000 diseases lacking treatments. Its MATRIX platform integrates massive biomedical knowledge graphs, generates graph embeddings, and ranks 75 million drug‑disease pairs,...
Comparing Senescence in Articular Chondrocytes: Phenotype & Molecules
Researchers published a comparative analysis of replicative versus chemically‑induced senescence in articular chondrocytes, revealing divergent molecular signatures, secretory profiles, and mitochondrial dynamics. Replicative senescence displayed a controlled, anti‑inflammatory SASP and stable epigenetic marks, while chemically‑induced senescence produced a pro‑inflammatory secretome,...

Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal
Sebela Pharmaceuticals has licensed its hormone‑free copper intrauterine device, Miudella, to Organon for exclusive global rights. The agreement provides Sebela with a $27.5 million cash payment at closing and up to $505 million in sales‑based milestone payments, plus double‑digit royalties on net...

Hims Reports 2025 Earnings, Shares Details on GLP-1 Pill Decisions
Hims & Hers disclosed its fourth‑quarter earnings and announced that it has withdrawn the controversial GLP‑1 weight‑loss pill it briefly launched. The decision followed conversations with key ecosystem stakeholders, including regulators and partner pharmacies. The company highlighted modest revenue growth...
Kinase-Inactive RIPK3 Model Unveils Scaffold Role in Inflammation
Researchers created a kinase‑inactive RIPK3 D143N mouse that remains viable, revealing that RIPK3’s scaffold function alone can drive TNF‑induced inflammatory pathology. The mutant protein continues to recruit RIPK1, FADD and activate NF‑κB, producing cytokine storms without necroptotic cell death. In...
Cut Down on Oncology Drug Waste With Better Forecasting
Oncology drug waste reaches up to 30%, costing over $2 billion annually in the U.S. A 2023 CMS rule now forces manufacturers to refund Medicare for discarded volumes beyond a 10% threshold, adding financial pressure. Traditional forecasting relies on static sales...

Australia-Based Manufacturing to Deliver Custom mRNA Vaccines for Brain Cancer Trial
Southern RNA and Providence Therapeutics announced the PaedNEO‑VAX trial, a world‑first personalized mRNA vaccine study for children with advanced brain tumors. The multi‑site trial, funded by Providence, the Australian government and donors, will launch in March 2026 across eight pediatric...
Drug-Controlled CAR T Cells May Enable Safer Immunotherapy
Researchers at EPFL have created a drug‑controlled CAR‑T platform called DROP‑CAR that can be turned off on demand with the FDA‑approved BCL‑2 inhibitor venetoclax. The system places a reversible protein‑protein interaction on the cell surface, causing the CAR to dissociate...

GPs to Get £3,000 Bonus to Maximise Weight Loss Drug Prescriptions
The UK government will add a £3,000 average annual bonus to GP contracts for prescribing the weight‑loss drug Mounjaro, plus a £1,000 incentive for referrals to weight‑loss programmes, starting in April 2026. The scheme targets patients who meet current NHS...
System Isolates Single Extracellular Vesicle Surface Proteins to Map Function
UC Davis engineers unveiled VESSEL, a cell‑free platform that produces extracellular vesicles bearing a single surface protein. By isolating individual proteins, the system enables direct functional mapping, exemplified by the discovery that CADM1 promotes vesicle uptake. The approach is scalable...
Jazz Pharmaceuticals PLC (JAZZ) Q4 2025 Earnings Call Transcript
Jazz Pharmaceuticals reported a record $1.126 billion Q3 2025 revenue, propelled by double‑digit growth in its sleep franchise and the successful launch of the rare‑disease drug Modesto. Xywav and Epidiolex sales rose 11% and 20% year‑over‑year, while oncology product Zepzelca saw an...
Cytokinetics Inc (CYTK) Q4 2025 Earnings Call Transcript
Cytokinetics announced rapid global regulatory clearance for MYCorzo, securing FDA, China NMPA, and European Commission approvals within a single week. The company launched the drug in the U.S. with over 700 REMS‑certified physicians and more than 12,000 customer engagements in...
Day One Biopharmaceuticals Inc (DAWN) Q4 2025 Earnings Call Transcript
Day One Biopharmaceuticals reported a breakout 2025, with Ojemda generating $155.4 million in net product revenue—a 172% year‑over‑year increase—and over 4,600 prescriptions. The company achieved its first profitability milestone as Ojemda’s revenue exceeded combined cost of sales and SG&A, while ending...
Revolve Group Inc (RVLV) Q4 2025 Earnings Call Transcript
Revvity reported Q4 2025 revenue of $772 million, delivering 4% organic growth and a 7% rise in its diagnostics segment. Adjusted EPS came in at $1.70, topping the high end of guidance, while adjusted operating margin held at 29.7% despite...
BridgeBio Pharma Inc (BBIO) Q4 2025 Earnings Call Transcript
BridgeBio Pharma reported Q4 2025 revenue of $120.7 million, a surge driven primarily by Attruby net product sales of $108.1 million and expanding royalty streams. The company announced statistically significant Phase III readouts for BBP-418 in limb‑girdle muscular dystrophy and...
Harmony Biosciences Holdings Inc (HRMY) Q4 2025 Earnings Call Transcript
Harmony Biosciences reported $714.7 million net product revenue for 2024, a 23% year‑over‑year increase, with Q4 sales of $201.3 million driven largely by its flagship narcolepsy drug Wakix. The company announced a generic settlement with Novogen that postpones competition until at least...
Vaxcyte Inc (PCVX) Q4 2025 Earnings Call Transcript
Incyte reported a strong Q4 2025, delivering $1.51 billion in revenue, a 28% year‑over‑year increase, and $5.14 billion for the full year, up 21%. Core products drove the surge: Jakafi posted $828 million in Q4 sales, Opsilura $207 million, and hematology/oncology sales jumped 121%...
Abcellera Biologics Inc (ABCL) Q4 2025 Earnings Call Transcript
AbCellera Biologics reported a transformative 2024, shifting from a partnership platform to a clinical‑stage biotech. The company advanced two internal antibody programs, ABCL635 and ABCL575, toward CTA filings in Q2 2025 and highlighted a $800 million liquidity position. It outlined a...
Iovance Biotherapeutics Inc (IOVA) Q4 2025 Earnings Call Transcript
Iovance Biotherapeutics reported third‑quarter product revenue of about $68 million, a 13% sequential increase, driven primarily by $58 million in Amtagvi sales and $10 million in Proleukin revenue. Gross margin improved to roughly 43% after a restructuring that cut cost of sales by...
Fulcrum Therapeutics Inc (FULC) Q4 2025 Earnings Call Transcript
Fulcrum Therapeutics reported a strong fourth‑quarter, posting $1.51 billion in revenue, a 28% year‑over‑year increase, and a full‑year 2025 revenue of $5.14 billion, up 21%. Core product sales accelerated, led by Jakafi’s $828 million Q4 revenue and Opsilura’s 28% sales jump to $207 million....
Supernus Pharmaceuticals Inc (SUPN) Q4 2025 Earnings Call Transcript
Vanda Pharmaceuticals reported a 9% rise in total revenue to $216.1 million for 2025, driven primarily by a 24% jump in Fanapt sales and a successful bipolar disorder launch. The company secured FDA approval for tradipitant (Nirius) for motion‑sickness prevention, marking...
Vevye Rapidly Narrows Gap to Miebo Despite Head Start
So the key here is look at how quickly $HROW's Vevye is catching up with $BLCO's Miebo - this is happening despite the Miebo head start (which provides a waterfall effect from refills) and way more extensive detailing and DTC...