🎯Today's Pharma Pulse
Updated 2h agoWhat's happening: Merck and Pfizer’s Keytruda‑Padcev combo slashes progression risk in bladder cancer
In the Phase 3 EV‑304 trial, the doublet cut the risk of disease progression, recurrence or death by 47% versus gemcitabine‑cisplatin and lowered overall‑mortality risk by 35%. Pathological complete response rose to 55.8% compared with 32.5% in the control arm.
Also developing:
News•Feb 26, 2026
Emergent BioSolutions Inc (EBS) Q4 2025 Earnings Call Transcript
Emergent BioSolutions reported a successful completion of its stabilization phase, cutting net debt by $156 million and improving leverage to 3.3x adjusted EBITDA. Adjusted EBITDA surged to $183 million, a $205 million swing from the prior year, while operating cash flow rose to $59 million. The company highlighted strong NARCAN nasal spray sales—22 million doses—and secured $550 million in medical countermeasure contracts. For 2025, Emergent projects revenue of $750‑$850 million with adjusted EBITDA between $150 million and $200 million, emphasizing margin expansion and continued growth in its core product lines.
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
Rhythm Pharmaceuticals Inc (RYTM) Q4 2025 Earnings Call Transcript
Rhythm Pharmaceuticals reported a strong Q4 2025, with product revenue rising to $57.3 million—a 12% sequential increase and 37% year‑over‑year growth. Full‑year revenue jumped 50% to $194.8 million, driven by expanding U.S. sales and broader international access for IMCIVREE. The company highlighted...
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
Kymera Therapeutics Inc (KYMR) Q4 2025 Earnings Call Transcript
Kymera Therapeutics reported Q4 2025 revenue of $2.8 million, entirely from its Gilead collaboration, while maintaining a cash balance of $978.7 million that extends runway into the second half of 2028. Adjusted R&D and G&A expenses fell 7% and 3% quarter‑over‑quarter, respectively....
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
Amphastar Pharmaceuticals Inc (AMPH) Q4 2025 Earnings Call Transcript
Amphastar Pharmaceuticals reported full‑year 2025 net revenues of $719.9 million, a modest 2% decline, while its flagship product Baqsimi grew 12% to $185.4 million. The company secured FDA approval for ipratropium bromide HFA (AMP‑007), gaining 180‑day generic exclusivity, and announced a major...
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
Intellia Therapeutics Inc (NTLA) Q4 2025 Earnings Call Transcript
Intellia Therapeutics announced that the FDA has placed a clinical hold on its nex‑z MAGNITUDE and MAGNITUDE‑2 Phase III trials after a patient death and liver enzyme abnormalities. The company is implementing intensified safety monitoring and data reviews while awaiting regulatory...
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
Ligand Pharmaceuticals Inc (LGND) Q4 2025 Earnings Call Transcript
Ligand Pharmaceuticals reported a breakout 2025, delivering $268 million total GAAP revenue and $240 million core revenue, driven by a 48% surge in royalty income. Adjusted earnings per share rose 42% to $8.13, surpassing guidance by more than 30%, while cash and...
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
Definium Therapeutics Inc (DFTX) Q4 2025 Earnings Call Transcript
Definium Therapeutics reported that its lead psychedelic candidate DT120 ODT has fully enrolled the EMERGE Phase III trial for major depressive disorder, with top‑line results expected in late Q2 2026. The VOYAGE Phase III study for generalized anxiety disorder is...
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
This Compound Enhances Long-Term Memory of Mice — but only in Females
Researchers injected acetate, a common metabolic by‑product, into mice and tested long‑term memory using spatial and object‑recognition tasks. Female mice that received acetate showed significantly better performance 24 hours later, while male mice displayed little to no improvement. The memory...
By Nature – Health Policy (topic)
News•Feb 26, 2026
Puma Biotechnology Inc (PBYI) Q4 2025 Earnings Call Transcript
Puma Biotechnology reported total 2025 revenue of $75.5 million, driven by $59.9 million net product revenue from its HER2‑positive breast cancer drug NERLYNX and a surge in royalty income to $15.6 million after a large shipment to a Chinese partner. Ex‑U.S. inventory rose...
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
OPKO Health Inc (OPK) Q4 2025 Earnings Call Transcript
OPKO Health reported a $369 million cash position for Q4 2025, driven by asset sales, BARDA funding and partnership payments. The company repurchased 34.6 million shares for $47 million and allocated $109 million to stock and convertible note buybacks. Diagnostics revenue dropped to $71.1 million, but...
By Motley Fool – Earnings Transcripts
News•Feb 26, 2026
A Nuclei-Specific Fronto-Amygdala Pathway and Its Neurotransmitter Receptor Distribution: Implications for Antidepressant Selection
Recent neuroimaging and tract‑tracing studies have identified a nuclei‑specific fronto‑amygdala pathway that links distinct amygdala subregions with ventromedial prefrontal cortex. The work maps serotonin, norepinephrine and dopamine receptor densities across these nuclei, revealing divergent pharmacological profiles for SSRIs and SNRIs....
By Nature (Biotechnology)
News•Feb 26, 2026
Synaptic Correlates of Benzodiazepine Tolerance
Recent pre‑clinical work has mapped the synaptic changes that underlie benzodiazepine tolerance. Chronic exposure uncouples GABA(A) receptors from their benzodiazepine binding site, down‑regulates α1‑subunit mRNA, and reshapes receptor trafficking through auxiliary proteins such as Shisa7. These alterations weaken inhibitory signalling,...
By Nature (Biotechnology)
News•Feb 26, 2026
Akebia Therapeutics Inc (AKBA) Q4 2025 Earnings Call Transcript
Akebia Therapeutics reported 2025 total revenue of $236.2 million, a 47% increase driven by the commercial launch of Vafseo and higher Auryxia sales. Net product revenue reached $227 million, with Vafseo contributing $45.8 million and gaining prescribing access for 290,000 dialysis patients. The...
By Motley Fool – Earnings Transcripts
News•Feb 25, 2026
Radiopharmaceutical Targeted Toward Treatment-Resistant Cancer Put on FDA's Fast Track
Aktis Oncology announced that its investigational radiopharmaceutical AKY-1189 has earned FDA Fast Track designation. The drug targets Nectin‑4, present in 80‑90 % of urothelial cancers, and delivers the alpha‑emitter actinium‑225 directly to tumors. AKY-1189 is in a Phase 1b trial covering urothelial,...
By Radiology Business
News•Feb 25, 2026
An Endangered Natural Pharmacy Hidden in Coral: Hundreds of Reef-Dwelling Microbes Reveal Untapped Potential
A new Nature study led by ETH Zurich researchers sequenced the genomes of 645 bacteria and archaea from over 800 coral samples, revealing that more than 99% of these reef‑dwelling microbes were previously unknown. The analysis showed that each coral...
By Phys.org – Biotechnology
News•Feb 25, 2026
CAB+RPV LA Is Versatile, Preferred in Treatment-Naive Patients
Long‑acting cabotegravir/rilpivirine (CAB+RPV LA) demonstrated strong virologic control and high patient preference in both treatment‑naïve and treatment‑experienced cohorts presented at CROI 2026. In the VOLITION trial, 85% of ART‑naïve adults switched early from DTG/3TC to a q2‑month injectable, achieving 95% overall suppression...
By AJMC (The American Journal of Managed Care)
News•Feb 25, 2026
Iron Nanoparticle Eliminates Tuberculosis in Mice and May Pave the Way for New Treatments
Brazilian researchers have shown that an iron‑based compound, ferroin, encapsulated in lipid nanoparticles, completely eradicated Mycobacterium tuberculosis from mouse lungs after a 30‑day course. The formulation, LNP@FEP, stabilizes the drug, enhances the activity of existing antibiotics, and targets bacterial cell‑wall synthesis....
By Phys.org – Nanotechnology
Blog•Feb 25, 2026
Leading Women CEOs Across Pharma and Biotech: A 2026 Snapshot
2026’s leading women CEOs in pharma and biotech are steering some of the industry’s biggest strategic moves, from multi‑billion‑dollar investments to landmark FDA approvals. The list includes Julie Kim’s upcoming Takeda leadership, Emma Walmsley’s transition at GSK, Reshma Kewalramani’s growth...
By Xtalks – Biotech Blogs
News•Feb 25, 2026
Withdrawn | Non-Malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
The FDA has removed several accelerated approvals for non‑malignant hematological, neurological, and other disorder indications after post‑marketing requirements were withdrawn. These withdrawn indications are not reflected in official listings until a Federal Register notice or label update is issued. The...
By FDA
Blog•Feb 25, 2026
Dotinurad (FYU-981)
Dotinurad (FYU‑981), marketed as Urece®, is a URAT1 inhibitor approved for gout and hyperuricemia in Japan and China. The drug was chemically refined from the older uricosuric benzbromarone to retain potency while eliminating rare hepatotoxic events. Crystalys Therapeutics is now...
By Drug Hunter
News•Feb 25, 2026
Ongoing | Non-Malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
The FDA’s ongoing accelerated‑approval list details 30+ drugs for non‑malignant hematologic, neurologic and other rare disorders that remain contingent on post‑marketing requirements (PMRs). Each entry cites the indication, approval date, specific confirmatory trial design, and a projected completion date ranging...
By FDA
News•Feb 25, 2026
Accelerated Approval Program
The FDA’s Accelerated Approval Program permits earlier market entry for drugs treating serious conditions by relying on surrogate endpoints that predict clinical benefit. Companies must later complete confirmatory trials; positive results convert the approval to traditional status, while negative outcomes...
By FDA
News•Feb 25, 2026
ADMET Predictions Get AI Boost, Federated Data Network Unites Pharma
Apheris has launched the ADMET Network, a federated learning platform that lets pharmaceutical companies jointly train ADMET prediction models without exposing raw data. Five founding members—Lundbeck, Orion Pharma, Recursion, Servier and an undisclosed partner—have each contributed roughly 80% of their...
By GEN (Genetic Engineering & Biotechnology News)
Blog•Feb 25, 2026
Rare Disease Day Insight: Epilepsy Care Gaps in Pregnancy with UCB’s Andrea Wilkinson — Episode 244
The Xtalks Life Science Podcast’s Episode 244 spotlights a persistent gap in epilepsy care for pregnant women, noting that fewer than 5% of clinical trials include this population. Andrea Wilkinson, UCB’s Global Head of Patient Engagement & Advocacy, discusses new...
By Xtalks – Biotech Blogs
News•Feb 25, 2026
STAT+: A Rare Disease Drug Was Approvable, Then It Wasn’t. Inside a Surprise Rejection by the FDA
An experimental cell therapy for a rare post‑transplant blood cancer, developed by Atara Biotherapeutics and Pierre Fabre, was initially deemed approvable by FDA reviewers but was abruptly rejected in February 2026 over alleged clinical data deficiencies. The disease affects roughly...
By STAT (Biotech)
Blog•Feb 25, 2026
Pharmaceutical Executive Daily: FDA Approves Braftovi
The FDA has approved Braftovi for patients with BRAF V600E‑mutant metastatic colorectal cancer, expanding targeted options in a genetically defined subset. The clearance underscores the momentum of biomarker‑driven oncology and combination‑therapy strategies. In parallel, Novo Nordisk announced a $2 billion partnership with Vivtex...
By Pharmaceutical Executive (independent trade outlet)
Blog•Feb 25, 2026
Menopausal Hormone Therapy Does Not Increase Mortality
A Danish register study of over 800,000 women examined the long‑term safety of menopausal hormone therapy (MHT). About 12% of participants used MHT for a median of 1.7 years, and the analysis found no association between MHT use and all‑cause...
By SENS Research Foundation – The SENSible Blog
News•Feb 25, 2026
Bridging the Translation Gap for Regenerative Tissues
Muvon Therapeutics, a clinical‑stage company developing regenerative muscle treatments, is confronting the translation gap between academic discovery and commercial manufacturing. The firm highlights three core hurdles: co‑developing evolving regulatory frameworks, automating novel manufacturing processes, and recruiting personnel with GMP expertise....
By GEN (Genetic Engineering & Biotechnology News)
News•Feb 25, 2026
Samsung Joins CEPI Vaccine Network to Prepare for Next Pandemic
Samsung Biologics has joined the Coalition for Epidemic Preparedness Innovations (CEPI) Vaccine Manufacturing Facility Network, committing to develop a ready‑to‑activate recombinant protein vaccine platform. Backed by a $20 million budget, Samsung will pre‑agree manufacturing processes, run simulated outbreak drills, and prepare...
By GEN (Genetic Engineering & Biotechnology News)
News•Feb 25, 2026
United Unveils Newly Partnered Soft Mist Inhaler; Mannkind Sinks
United Therapeutics announced a partnership to launch a soft‑mist inhaler, targeting more efficient pulmonary drug delivery for its pipeline. The collaboration marks a strategic pivot away from traditional propellant‑based devices and positions United in the growing soft‑mist market. Investors reacted...
By BioWorld (Citeline) – Featured Feeds
Blog•Feb 25, 2026
Medicines and Healthcare Products Regulatory Agency Confiscates 2,000 Doses of Illegal Weight-Loss Drugs: Report
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) seized nearly 2,000 doses of illegal weight‑loss drugs in raids on sites in Lincolnshire and Nottinghamshire, marking its second major operation in four months. The confiscated products were labelled as containing tirzepatide...
By Pharmaceutical Executive (independent trade outlet)
News•Feb 25, 2026
Alkermes’ Richard Pops to Step Down After Three-Decade Run as CEO
Richard Pops will step down as Alkermes CEO on July 31 after a 32‑year tenure, remaining as board chair. COO Blair Jackson will succeed him and join the board during the transition. Under Pops, Alkermes shifted from drug‑delivery to commercial...
By BioPharma Dive
News•Feb 25, 2026
New Insights Into Hypertension and MACE Reduction in HIV: Steven Grinspoon, MD
A recent analysis of the REPRIEVE randomized trial shows that pitavastatin reduces incident hypertension by 17 % and cuts major adverse cardiovascular events (MACE) by 36 % in adults living with HIV. The findings extend statins’ benefit beyond LDL‑cholesterol lowering, highlighting a...
By AJMC (The American Journal of Managed Care)
News•Feb 25, 2026
Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
The FDA’s Center for Drug Evaluation and Research has launched the Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative under its Accelerating Rare disease Cures (ARC) program. LEADER 3D provides a suite of educational videos, downloadable...
By FDA
News•Feb 25, 2026
Gibson Oncology and NIH Launch Phase 2 Trials of LMP744 Targeting First-Time Recurrent Glioblastoma
Gibson Oncology has launched a Phase 2 trial of its dual‑action drug LMP744 in patients with first‑time recurrent glioblastoma. The compound simultaneously inhibits topoisomerase 1 and down‑regulates the cMYC oncogene, aiming to disrupt tumor proliferation. The study will enroll about 40 patients,...
By Bioengineer.org
News•Feb 25, 2026
Antibacterial Effects of Crude Extracts From Tithonia Diversifolia and Solanum Torvum on Selected Shigella Species Demonstrated In Vitro
Researchers evaluated crude extracts from the African weed Tithonia diversifolia and the nightshade Solanum torvum for antibacterial activity against several Shigella strains. In vitro assays demonstrated clear zones of inhibition, with minimum inhibitory concentrations between 125 µg/mL and 250 µg/mL. Both extracts...
By Bioengineer.org
News•Feb 25, 2026
Engineered Nanoplatform with Dual Anti‐Inflammatory and Microbiota‐Modulating Actions for Targeted Therapy in Chronic Inflammatory Bowel Disease
The study introduces BG/SOD@ZIF‑zc, a multifunctional nanoplatform that encapsulates superoxide dismutase within a copper‑doped ZIF framework and coats it with bacterial ghosts for targeted delivery to the colon. The formulation retains SOD activity in the harsh gastrointestinal tract, efficiently scavenges...
By Small (Wiley)
Blog•Feb 25, 2026
Emerging Key Trends in Hematologic Malignancies
The article argues that the next wave of hematologic‑malignancy therapies will be shaped by early‑stage signals emerging from conference hallways rather than headline‑grabbing late‑phase trial data. It identifies five nascent trends—advanced immunotherapies, precision genomics, micro‑environment targeting, novel biomarker platforms, and...
By Biotech Strategy Blog
News•Feb 25, 2026
Verdiva Bio Completes Enrolment for Phase 2b Study of Oral GLP‑1 Candidate VRB‑101
Verdiva Bio announced that enrollment for its phase 2b EVOLVE‑2 trial of VRB‑101, a once‑weekly oral GLP‑1 peptide analog for weight loss, is complete with more than 200 participants across 22 U.S. sites. The double‑blind, placebo‑controlled study will assess safety, tolerability...
By PharmaTimes
News•Feb 25, 2026
Male Infertility Care to Shift Treatment Burden From Women
Infertility has long been framed as a women's issue, yet about half of cases stem from male factors. New treatments such as Igyxos' IGX12 monoclonal antibody, which enhances follicle‑stimulating hormone activity, aim to improve sperm production and reduce the physical...
By Labiotech.eu
News•Feb 25, 2026
Division of Applied Regulatory Science
The Division of Applied Regulatory Science (DARS) operates within the FDA’s Office of Clinical Pharmacology and the Office of Translational Sciences. Its mandate is to translate emerging scientific advances into the agency’s regulatory framework, tackling complex questions that hinder drug...
By FDA
News•Feb 25, 2026
Valo Health CEO: We Don’t Want Investors To Drive the Science
Valo Health is reshaping drug development by applying AI to human causal biology, aiming to raise clinical success rates from roughly 10% to 20%. The company leverages over 17 million de‑identified patient records and Mendelian randomization to pinpoint genetically validated targets....
By MedCity News
News•Feb 25, 2026
Novo Nordisk Inks A $2.1 Billion Deal To Develop Next Generation Obesity Pills
Novo Nordisk has struck a deal with Boston biotech Vivtex worth up to $2.1 billion to develop next‑generation oral GLP‑1 obesity and diabetes pills. The partnership leverages Vivtex’s AI‑driven gastrointestinal‑on‑a‑chip platform that can boost drug absorption by orders of magnitude. Novo...
By Forbes – Healthcare
Blog•Feb 25, 2026
Generate Biomedicines (GENB) IPO Deck
Generate Biomedicines (GENB) filed its IPO prospectus, unveiling a programmable biology platform that engineers therapeutic proteins previously considered undruggable. The company highlighted a pipeline featuring oncology and immunology candidates that have progressed to Phase 2 trials, supported by early efficacy signals....
By IPO Candy
News•Feb 25, 2026
Patient Death Forces Partial Freeze on MacroGenics’ Gynecologic Cancer Study
A patient in MacroGenics' Phase 2 LINNET trial of the bispecific antibody lorigerlimab suffered grade 4 neutropenia and septic shock, leading to a fatality and prompting the FDA to place a partial clinical hold on the study. The company also reported three...
By BioSpace
News•Feb 25, 2026
IDEAYA Biosciences Reports the First Patient Enrolment in P-I Trial of IDE034
IDEAYA Biosciences announced the enrollment of the first patient in a Phase‑I dose‑escalation and expansion study of IDE034, a bispecific B7H3/PTK7 TOP1 antibody‑drug conjugate for solid tumours. The trial will assess safety, tolerability and pharmacokinetics of IDE034 as a monotherapy...
By PharmaShots
Blog•Feb 25, 2026
Tooth Whitening without Enamel Damage? Vibration-Activated Powder Protects Pearly Whites for Better Oral Health
Researchers at Shanghai Xuhui District Stomatological Hospital and the Chinese Academy of Sciences have engineered a vibration‑activated teeth‑whitening powder (BSCT) that works with electric toothbrushes. The ceramic powder uses piezoelectric catalysis to generate reactive oxygen species for stain removal while...
By BioTechniques (independent journal site)
News•Feb 25, 2026
IQVIA Signs Agreement to Acquire Drug Discovery Assets From Charles River Laboratories, Expanding End-to-End Drug Discovery Capabilities
IQVIA Holdings announced an agreement to acquire five drug discovery service sites from Charles River Laboratories, adding in‑vitro capabilities, New Approach Methodologies and a small‑molecule AI platform. The assets, built on more than 20 years of data, have helped launch...
By Business Wire — Executive Appointments
News•Feb 25, 2026
Lilly Bests Novo Again, Rare Disease Week Goes Regulatory, More CDC Leadership Upheaval
Eli Lilly’s obesity drug Zepbound achieved a 25.5% weight loss in a head‑to‑head Phase 3 trial, outpacing Novo Nordisk’s CagriSema and sending Novo’s shares down 20%. The FDA launched Rare Disease Week, issuing draft guidance for a new Plausible Mechanism Pathway that...
By BioSpace
Blog•Feb 25, 2026
FDA Enforcement on Copycat GLP-1's Could Reshape Retail Pharmacy Economics: Q&A with David Graziano
The FDA’s crackdown on non‑approved or “copycat” GLP‑1 drugs is expected to push patients toward FDA‑approved therapies, elevating the role of retail pharmacies as primary access points. GoodRx’s head of retail network, David Graziano, says the company’s cost‑plus pricing model...
By Pharmaceutical Executive (independent trade outlet)