🎯Today's Pharma Pulse
Updated 1h agoWhat's happening: Merck and Pfizer’s Keytruda‑Padcev combo reshapes bladder cancer treatment
In the Phase 3 EV‑304 trial, the Merck‑Pfizer doublet cut the risk of disease progression, recurrence or death by 47% versus gemcitabine‑cisplatin and lowered overall‑mortality risk by 35% in muscle‑invasive bladder cancer, with pathological complete response rising to 55.8%.
Also developing:
By the numbers: Kairos Pharma acquires exclusive worldwide rights to CL‑273
News•Feb 25, 2026
SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America
SteinCares has signed a strategic licensing agreement with Shilpa Biologicals to commercialize a biosimilar across Latin America. Under the deal, SteinCares receives exclusive rights to register, market and distribute the product throughout the region, while Shilpa Biologicals will complete development and manufacture the drug at its Dharwad, India facility. The partnership blends Shilpa’s biologics expertise and high‑quality manufacturing with SteinCares’ integrated LATAM platform, accelerating market entry. It expands the availability of advanced biologics in key Latin American markets.
By PharmaShots
News•Feb 25, 2026
Vico Therapeutics Initiates Patient Dosing for VO659 Phase I/IIa Trial
Vico Therapeutics has initiated patient dosing in an expanded European cohort for its Phase I/IIa VO659 trial, targeting Huntington's disease, spinocerebellar ataxia type 3 and type 1. The study employs a twice‑annual intrathecal regimen and will monitor safety, tolerability, pharmacodynamics and pharmacokinetics...
By Hospital Management
News•Feb 25, 2026
NorthX Biologics and Demeetra Collaborate on GMP Manufacturing and CLD
NorthX Biologics and Demeatriz have formed a strategic alliance to deliver an end‑to‑end platform that couples Demeatriz’s CleanCut CHO cell line development with NorthX’s GMP manufacturing capabilities. The partnership leverages a high‑titre GS‑knockout CHO cell line that carries no royalty...
By Pharmaceutical Technology (GlobalData)
News•Feb 25, 2026
Evolution Summit By Marcus Evans | May 7-8, 2026 | The Ritz-Carlton, Fort Lauderdale, Florida
The Evolution Summit, organized by Marcus Evans, will take place May 7‑8, 2026 at the Ritz‑Carlton in Fort Lauderdale. The invitation‑only event convenes senior clinical‑trial executives with innovative suppliers to discuss pressing challenges in clinical operations and drug development. Featured speakers include...
By PharmaShots
News•Feb 25, 2026
STAT+: GSK Picks up Pulmonary Hypertension Drug with 35Pharma Acquisition
GlaxoSmithKline announced a $950 million cash acquisition of 35Pharma, a privately held biotech focused on lung diseases. The deal brings the experimental compound HS235, slated to enter pulmonary arterial hypertension (PAH) trials, into GSK’s pipeline. PAH has become a lucrative target,...
By STAT News — Pharma
News•Feb 25, 2026
J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia
Johnson & Johnson has filed a supplemental Biologics License Application (sBLA) with the U.S. FDA for Imaavy (nipocalimab‑aahu), a monoclonal antibody intended to treat warm autoimmune hemolytic anemia (wAIHA). The filing is supported by the Phase II/III ENERGY trial, which demonstrated...
By PharmaShots
News•Feb 25, 2026
In Brief SOTU Remarks, Trump Asks Congress to "Codify" MFN
President Donald Trump used a brief four‑minute segment of his State of the Union address to push Congress to codify his Most‑Favoured Nations (MFN) drug‑pricing program. He claimed the voluntary agreements would give Americans the lowest prescription prices worldwide, though...
By pharmaphorum
News•Feb 25, 2026
Opinion: Balancing Safety Access in Rare Disease—Lessons From Sarepta
In July 2025 the FDA ordered a complete halt of Sarepta’s gene‑therapy Elevidys after two non‑ambulatory Duchenne muscular dystrophy (DMD) patients died, sparking a market plunge and patient access concerns. Sarepta argues that ambulatory patients, who had been receiving Elevidys...
By BioSpace
News•Feb 25, 2026
Cashing In on ‘Creative Fundamentals’ To Fund Rare Disease R&D
The FDA reauthorized its rare pediatric disease priority review voucher program, bolstering a wave of regulatory incentives that include new guidance on plausible mechanisms and a Rare Disease Evidence Principles framework. Yet ultra‑rare indications still struggle to attract traditional venture...
By BioSpace
News•Feb 25, 2026
Soleno Therapeutics Inc (SLNO) Q4 2025 Earnings Call Transcript
Soleno Therapeutics reported $190.4 million in net revenue for fiscal 2025, representing less than nine months of commercial sales of its VICAT XR therapy. The company turned profitable, posting $20.9 million net income and generating $48.7 million of operating cash in Q4, ending the...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
Ironwood Pharmaceuticals Inc (IRWD) Q4 2025 Earnings Call Transcript
IQVIA reported fourth‑quarter 2025 revenue of $4.34 billion, a 10.3% year‑over‑year increase, driven by strong organic growth and roughly two percentage points from recent acquisitions. Adjusted EBITDA rose 5% to $1.046 billion and adjusted diluted EPS climbed 9.6% to $3.42. The company...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
United Therapeutics Corp (UTHR) Q4 2025 Earnings Call Transcript
United Therapeutics reported record Q4 2025 revenue of $800 million, a 7% year‑over‑year increase driven by double‑digit growth of its Tyvaso DPI inhaler and Orenitram. The company unveiled new 80‑112 µg Tyvaso DPI cartridges, expanding dosing flexibility, and highlighted unprecedented results from...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
Geron Corp (GERN) Q4 2025 Earnings Call Transcript
Geron Corp reported full‑year 2025 Rytelo net revenue of $184 million, with Q4 sales of $48 million, and projected 2026 revenue between $220 million and $240 million. Operating expenses are expected to dip to $230‑$240 million, a $20 million reduction year‑over‑year, while cash balances sit at...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
Schrodinger Inc (SDGR) Q4 2025 Earnings Call Transcript
Schrödinger reported Q2 FY2025 revenue of $54.8 million, up 16% year‑over‑year, driven by 15% software growth to $40.5 million and 19% drug‑discovery growth to $14.2 million. Gross margin slipped to 68% as the mix shifted toward lower‑margin services and new predictive‑toxicology investments. Net...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
Sarepta Therapeutics Inc (SRPT) Q4 2025 Earnings Call Transcript
Sarepta Therapeutics reported a blockbuster fourth quarter, with ELEVIDYS gene‑therapy sales of $384 million, surpassing guidance by $60 million, and total net product revenue of $1.79 billion for 2024, up 56% year‑over‑year. The company achieved GAAP profitability and cash‑flow positivity, confirming the financial...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
Revolution Medicines Inc (RVMD) Q4 2025 Earnings Call Transcript
Revolution Medicines reported that its lead KRAS inhibitor doraxonrasib secured breakthrough therapy, orphan drug, and a FDA National Priority Voucher, underscoring its potential in pancreatic cancer. Phase I data revealed median overall survival of 13.1‑15.6 months and a 47% objective...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
Biomarker for Craving and Acamprosate Treatment Response in Patients with Alcohol Use Disorder: Insights From Multi-Omics
A multi‑omics investigation identified molecular signatures that link alcohol craving to acamprosate treatment response in patients with alcohol use disorder (AUD). The study highlighted IL17RB genetic variants and elevated plasma TNFSF10 as robust predictors of therapeutic success, while proteomic and...
By Nature (Biotechnology)
News•Feb 25, 2026
Mirum Pharmaceuticals Inc (MIRM) Q4 2025 Earnings Call Transcript
Mirum Pharmaceuticals reported $521 million in 2025 net product sales, a 55% year‑over‑year increase driven by Livmarli and bile‑acid medicines, surpassing guidance. Operating expenses rose to $543 million, yet the company generated positive cash flow and ended the year with $391 million in...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
ACADIA Pharmaceuticals Inc (ACAD) Q4 2025 Earnings Call Transcript
ACADIA Pharmaceuticals reported record adjusted 2025 revenue of $1.08 billion, up 14% year‑over‑year, driven by strong performance of NUPLAZID and DAYBUE. The company forecast 2026 total revenue between $1.22 billion and $1.28 billion, with NUPLAZID sales expected to reach $760‑$790 million and DAYBUE $460‑$490 million....
By Motley Fool – Earnings Transcripts
News•Feb 24, 2026
AI-Powered Platform Accelerates Discovery of New mRNA Delivery Materials
University of Toronto researchers unveiled LUMI‑lab, an AI‑driven self‑driving lab that combined a 28‑million‑molecule foundation model with active‑learning robotics to synthesize and test over 1,700 lipid nanoparticles. The system independently identified brominated lipid tails as a potent new class for...
By Phys.org – Nanotechnology
News•Feb 24, 2026
New Protein-Like Polymers Target, Degrade “Undruggable” Proteins Driving Cancer
Researchers at Northwestern University have created HYDRACs, hybrid degrading copolymers that bind and eliminate traditionally "undruggable" oncogenic proteins such as MYC and KRAS. The polymers display target‑recognizing peptides on one side and degron motifs on the other, directing the proteins...
By GEN (Genetic Engineering & Biotechnology News)
News•Feb 24, 2026
FDA Approves Drug for Adult and Pediatric Patients Aged 6 and Older with Allergic Fungal Rhinosinusitis
The FDA has granted approval for Dupixent (dupilumab) to treat allergic fungal rhinosinusitis (AFRS) in adults and children six years and older, marking the first indication for this rare sinus disease. The approval follows a 52‑week trial that demonstrated significant...
By FDA
Blog•Feb 24, 2026
Filkri Becomes Fifth FDA-Approved Neupogen Biosimilar
Accord BioPharma’s Filkri (filgrastim‑laha) received FDA approval as the fifth biosimilar to Amgen’s Neupogen. The indication set mirrors Neupogen’s, covering chemotherapy‑induced neutropenia, AML, bone‑marrow transplant, severe chronic neutropenia, and radiation‑induced syndrome. Approval was based on two randomized trials in healthy...
By Xtalks – Biotech Blogs
News•Feb 24, 2026
Sustained HIV Viral Suppression Restores Immune Potential: Victor Appay, PhD
New data presented at CROI 2026 show that people living with HIV who have maintained viral suppression for 25‑30 years on antiretroviral therapy regain robust HIV‑specific CD8⁺ T‑cell function. Using flow cytometry and single‑cell RNA sequencing, researchers found these cells display...
By AJMC (The American Journal of Managed Care)
News•Feb 24, 2026
Verified Clinical Benefit | Cancer Accelerated Approvals
The FDA has granted traditional approvals to ten oncology drugs that originally received accelerated approval after post‑marketing studies verified clinical benefit. The list includes agents such as Braftovi, Epkinly, and Padcev, with conversion dates ranging from 2022 to 2026. These...
By FDA
News•Feb 24, 2026
Engineered Bacteria Can Consume Tumors From the Inside Out
University of Waterloo researchers have engineered the anaerobic bacterium Clostridium sporogenes to eat solid tumors from the inside out. By inserting an oxygen‑tolerant gene and coupling it to a quorum‑sensing circuit, the bacteria survive at the tumor periphery only after...
By Phys.org – Biotechnology
News•Feb 24, 2026
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...
By Forbes – Healthcare
News•Feb 24, 2026
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...
By STAT (Biotech)
News•Feb 24, 2026
FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer with a BRAF V600E Mutation
The FDA granted traditional approval to encorafenib (Braftovi) combined with cetuximab and fluorouracil‑based chemotherapy for adult patients with metastatic colorectal cancer carrying a BRAF V600E mutation. The decision rests on the phase 3 BREAKWATER trial, which reported median progression‑free survival of...
By FDA
Blog•Feb 24, 2026
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...
By Pharmaceutical Executive (independent trade outlet)
Blog•Feb 24, 2026
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...
By SENS Research Foundation – The SENSible Blog
News•Feb 24, 2026
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,...
By FDA
News•Feb 24, 2026
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...
By FDA
News•Feb 24, 2026
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...
By FDA
News•Feb 24, 2026
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...
By FDA
News•Feb 24, 2026
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...
By Labiotech.eu
News•Feb 24, 2026
Untitled
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...
By RoboticsTomorrow
News•Feb 24, 2026
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,...
By PharmaShots
Blog•Feb 24, 2026
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...
By BioTechniques (independent journal site)
Blog•Feb 24, 2026
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,...
By Pharmaceutical Executive (independent trade outlet)
Blog•Feb 24, 2026
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....
By Pharmaceutical Executive (independent trade outlet)
News•Feb 24, 2026
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...
By Pharmaceutical Technology (GlobalData)
News•Feb 24, 2026
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....
By STAT (Biotech)
News•Feb 24, 2026
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,...
By healthcare.digital
News•Feb 24, 2026
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,...
By Bioengineer.org
News•Feb 24, 2026
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...
By PharmaShots
News•Feb 24, 2026
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...
By Endpoints News
News•Feb 24, 2026
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...
By Bioengineer.org
News•Feb 24, 2026
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...
By BioSpace
News•Feb 24, 2026
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...
By Australian Manufacturing