The New Chapter Added to My Vaccine Book
Dr. Gator’s latest update adds a new chapter to *Between a Shot and a Hard Place*, reflecting a year of rapid shifts in U.S. vaccine policy, legal battles, and scientific debate. The chapter details CDC schedule changes that now mirror Denmark, the removal of routine newborn Hep B shots, and a move toward single‑dose HPV recommendations. It also outlines a surge in vaccine‑related litigation, including the AAP’s lawsuit against HHS and a landmark VICP encephalopathy case. The author positions the update as a non‑partisan guide to the evolving terrain.
Imatinib
Imatinib (Gleevec®/Glivec®) is an oral ATP‑competitive inhibitor of the BCR‑ABL fusion tyrosine kinase, approved by the FDA in 2001 for Philadelphia chromosome‑positive chronic myeloid leukemia and other malignancies. The drug emerged from high‑throughput screening, structure‑activity relationship optimization, and structure‑based drug...
Pharma M&A Roundup: Novartis to Acquire Pan-Mutant-Selective PI3Kα Inhibitor From Synnovation Therapeutics, Collegium to Acquire Azstarys From Corium Therapeutics
Novartis announced a deal worth up to $3 billion to acquire SNV4818, a pan‑mutant‑selective PI3Kα inhibitor aimed at hormone‑receptor‑positive, HER2‑negative breast cancer. The transaction includes $2 billion upfront and potential milestones exceeding $1 billion, with closing expected in early 2026. Collegium Pharmaceutical agreed...
How to Get Specialty Drug Launches Right From Pre-Launch to Patient Access
ConnectiveRx VP Kristine McGaughey emphasizes that an 18‑to‑24‑month pre‑launch window is critical for specialty drug rollouts. Early alignment of market access, patient services, pricing, and hub teams prevents day‑one friction and enables rapid patient access. She contrasts emerging biopharma, which...
AI Model Uses 3D Lipid Structures to Improve mRNA Nanoparticle Delivery
Researchers at China’s National Center for Nanoscience and Technology have developed an AI‑driven platform that screens ionizable lipids based on their three‑dimensional conformations. The model identified a novel lipid, P1, which delivers mRNA 14.8 times more efficiently than the clinically...
The Ron Lanton Report: When Policy Becomes a Capital Event
The Ron Lanton Report highlights a fundamental shift where regulatory signals now drive company valuations and strategic choices before formal rules are enacted. Investors are pricing policy risk early, treating anticipated regulations as a capital‑allocation factor. The discussion spans FDA...
Pharma Pulse: FDA Greenlights Higher-Dose Wegovy with Pricing Commitments, and the State of the US Generics Market
The FDA granted a 54‑day fast‑track approval for Wegovy HD, a 7.2 mg semaglutide injection that delivered a 20.7% average weight loss in trials, under the National Priority Voucher program. In return, the maker committed to specific Medicare and Medicaid pricing...
Glioblastoma Hijacks Sugar Metabolism to Evade Immune Attack
Northwestern researchers discovered that microglia within glioblastoma uniquely express the fructose transporter GLUT5 and metabolize fructose to suppress immune activity. In mouse models, genetic deletion of GLUT5 halted tumor growth and provoked a strong CD8⁺ T‑cell response. The study, published...
First-of-Its-Kind Implant Could Transform Tissue Loss Treatment
Researchers at Technion’s Levenberg Laboratory have created a first‑of‑its‑kind three‑dimensional implant that merges muscle, fat, a hierarchical blood vessel network and, uniquely, a lymphatic system. The construct is printed with a custom extracellular‑matrix bio‑ink and matured in a flow‑controlled bioreactor....
First Surrogate Endpoint in Osteoporosis Clinical Trials with FNIH’s Dr. Tania Kamphaus — Episode 247
On December 2025 the FDA officially qualified dual‑energy X‑ray absorptiometry (DXA) bone density scans as the first surrogate endpoint for fracture outcomes in osteoporosis trials involving post‑menopausal women. The qualification, achieved through a request from the Foundation for the National...
Thermal Stability Assays as Tools to De-Risk Discovery
Thermal stability assays, especially differential scanning fluorimetry, are gaining traction as early‑stage de‑risking tools in drug discovery. By measuring protein melting temperatures, these assays reveal ligand‑induced stabilization, enabling rapid hit validation and prioritization. The article outlines best‑practice workflows, data‑interpretation guidelines,...
FDA’s New Program Injects Politics Into Drug Approval
The FDA has introduced the Commissioner’s National Priority Voucher (CNPV) pilot, offering ultra‑fast approval pathways for drugs that align with the current White House policy agenda. The program could slash review times for qualifying products, giving participating companies a market...
Tracking Leishmaniasis with New PCR Test
A team at the Hebrew University of Jerusalem has unveiled a high‑resolution melting (HRM) PCR assay that simultaneously identifies sand‑fly species, detects Leishmania parasites, and determines the insect's blood‑meal source from a single specimen. The method was applied to nearly...
Glaukos Announces Commercial Availability of Epioxa™, a Transformative Innovation in Interventional Keratoconus Care
Glaukos announced that Epioxa™ HD/Epioxa™ is now commercially available, marking the first FDA‑approved, incision‑free topical drug for keratoconus. The therapy uses a riboflavin solution with the O₂n™ System and Boost Goggles, eliminating the need to remove the corneal epithelium. By...
TALZENNA Plus XTANDI Significantly Improves Radiographic Progression-Free Survival in Metastatic Prostate Cancer
Pfizer announced that the Phase 3 TALAPRO‑3 trial met its primary endpoint, showing that TALZENNA (talazoparib) combined with XTANDI (enzalutamide) significantly improved radiographic progression‑free survival (rPFS) in patients with HRR gene‑mutated metastatic hormone‑sensitive prostate cancer. The combination achieved a hazard ratio...
Building Agent Studio: How Medable Is Using Agentic AI to Accelerate Clinical Trials
Medable has launched Agent Studio, a no-code/low-code platform that lets pharmaceutical companies configure and deploy AI agents across the clinical trial lifecycle. The platform currently powers two agents—a document‑classification ETMF agent that processes over 80,000 records a year, and a...
Overcoming Drug Development Obstacles for Some of the Most Challenging Ischemic Conditions
DiaMedica Therapeutics is advancing a recombinant tissue kallikrein (KLK1) to treat ischemic stroke and preeclampsia, leveraging the kallikrein‑kinin pathway to restore microvascular flow. Early trials show maternal blood‑pressure reductions, improved uterine‑artery Doppler indices, and no detectable drug in fetal circulation,...
Pharma Pulse: FDA Approval of Icotyde for Plaque Psoriasis and CCT’s MedAssure Debut
The FDA has approved Icotyde, the first targeted oral peptide therapy for moderate‑to‑severe plaque psoriasis, offering a once‑daily pill that blocks the IL‑23 receptor. In pivotal trials, roughly 70% of patients achieved clear or almost clear skin by week 16,...
CANCER RESEARCH - TOCOTRIENOLS - 2025 Review - Therapeutic Potential of Tocotrienols as Chemosensitizers in Cancer Therapy (Why They Are...
The 2025 review examines tocotrienols, a subset of vitamin E, as chemosensitizers that boost the effectiveness of conventional cancer drugs. Pre‑clinical studies show that combining tocotrienols with antiparasitic agents such as fenbendazole or mebendazole markedly increases tumor cell death. The analysis...
Is the Tide Turning for Pharmaceutical Patent Preliminary Injunctions in Australia?
After eight years of denying pharmaceutical preliminary injunctions, Australia’s Federal Court granted two rare orders in 2025‑26, favoring originators Janssen and AstraZeneca. The court applied the traditional two‑factor test—prima facie infringement and balance of convenience—but placed greater weight on the...
FDA Approves BRAVECTO® QUANTUM (Fluralaner for Extended-Release Injectable Suspension) From Merck Animal Health to Treat and Control Asian Longhorned Tick...
Merck Animal Health announced that the FDA has approved an expanded label for its once‑yearly injectable parasite control, Bravecto Quantum, adding treatment and control of Asian longhorned tick (Haemaphysalis longicornis) and Gulf Coast tick (Amblyomma maculatum) for 12 months. The product...
What Does Next-Generation Copay Assistance Look Like?
Matthew Turner, President of Patient Affordability at Paysign, says next‑generation copay assistance relies on ecosystem partnerships rather than a single‑vendor model, combining best‑in‑class services such as messaging, hub operations, and nursing education. He highlights financial threats like accumulator and maximizer...
FDA Investigating: US Patient Dies After Use of Placental Extract Laennec, Russian Med Student Also Died
The U.S. Food and Drug Administration has opened an investigation after a patient died following self‑injection of Laennec, an allogeneic placental extract imported from Japan. A similar fatality occurred in Russia involving health influencer Anna Kolyada, whose companion fell seriously...
Pharmaceutical Executive Daily: Federal Judge Halts Vaccine Advisory Council Appointments
A federal district court judge issued a preliminary injunction halting the Trump administration’s overhaul of the Advisory Committee on Immunization Practices, finding violations of the Federal Advisory Committee Act and gaps in vaccine expertise. The order pauses pending recommendations on...
How Policy Pressures Are Driving DTP Adoption
Policy pressures such as Medicare price negotiations, Most Favored Nation rules, and new transparency mandates are reshaping how life‑science companies sell medicines. These forces are accelerating adoption of direct‑to‑patient (DTP) models that bypass traditional intermediaries to deliver drugs more affordably....
Valbenazine
Valbenazine (Ingrezza®), an oral selective VMAT2 inhibitor from Neurocrine Biosciences, received FDA approval for treating tardive dyskinesia and Huntington’s disease‑associated chorea. In the Phase 3 KINECT‑3 trial, a once‑daily 80 mg dose produced a statistically significant reduction in AIMS dyskinesia scores after...
Seaweed Shield: Marine Molecules May Block Norovirus Infection
Researchers from Griffith University and biotech firm Marinova evaluated brown and green seaweed polysaccharides for their ability to block norovirus attachment. Fucoidan, a sulfated fiber from brown seaweed, demonstrated the strongest and most consistent inhibition of virus‑like particles binding to...
How Is eClinical Positioning Its Platform Capabilities to Help Sponsors?
eClinical Solutions is leveraging its elluminate platform to help sponsors adapt to the FDA’s new requirement for a single pivotal trial, a move aimed at strengthening efficacy evidence and patient safety. The platform offers highly customizable centralized monitoring, AI‑driven risk...
What Does a Sustainable Affordability Model Look Like in the Current Landscape?
Shivani Patel of ConnectiveRx explains how the Inflation Reduction Act forces pharmaceutical manufacturers to redesign patient‑assistance programs with a focus on gross‑to‑net protection rather than static access solutions. She emphasizes continuous program evaluation, cap adjustments, and alignment with channel‑distribution strategies...
Zalsupindole
Delix Therapeutics announced the results of a Phase 1b study of zalsupindole, a selective 5‑HT2A receptor partial agonist, in patients with major depressive disorder. The trial, published in the January 2026 issue of ACS Chemical Neuroscience, demonstrated favorable safety, tolerability, and early...
Designing Clinical Trials to Address Asthma and COPD Flare-Ups
Acute asthma and COPD exacerbations remain a costly, life‑threatening gap despite advances in chronic therapies. Connect Biopharma, led by Barry Quart, is the first biotech targeting these flare‑ups with a biologic that blocks IL‑4Rα, aiming to curb upstream inflammation. The...
Huntington’s Disease Gene Therapy: FDA Reversal Delays AMT-130
A Phase I/II trial of AMT‑130, an AAV‑delivered microRNA gene therapy, showed a 75% reduction in Huntington's disease progression over three years in 12 patients. The FDA initially supported using external control data from the Enroll‑HD database for the Biologics...
Revolutionizing Data Capture Through Integrated Patient Experience Platforms
Clinical trials are adopting integrated eCOA platforms that connect medical devices directly to digital systems, eliminating manual data entry and improving data quality. Interoperability enables real‑time monitoring and AI‑driven insights, reducing patient burden especially in long‑duration obesity studies. The obesity...
ION717 Trial Re-Opens with 3rd Dosing Regimen
Ionis Pharmaceuticals announced that its Phase 1/2a PrProfile trial of ION717, the first PrP‑lowering antisense oligonucleotide for symptomatic prion disease, has reopened with a third dosing regimen. The study, which enrolled 56 patients in 2024, will now recruit at three...
BREAKING: Federal Bill Introduced to Strip COVID-19 “Vaccine” Manufacturers of Liability Protection
Representative Chip Roy introduced the Let Injured Americans Be Legally Empowered (LIABLE) Act, which would strip COVID‑19 vaccine manufacturers of the federal immunity granted under the PREP Act. The bill would permit civil lawsuits against Pfizer, Moderna and others, even...
Maker of Ozempic Failed to Report Strokes, Suicidal Ideation and Deaths
The FDA issued a formal warning letter to Novo Nordisk, citing serious violations for failing to report adverse events such as strokes, suicidal ideation, and patient deaths linked to its GLP‑1 drugs Ozempic, Wegovy and Saxenda. Inspectors found the company...
Sentynl Therapeutics Enters Licensing Agreement with PRG S&T to Advance Progerinin
Sentynl Therapeutics, a Zydus Lifesciences subsidiary, has licensed Progerinin, an oral small‑molecule candidate for Hutchinson‑Gilford Progeria Syndrome, from PRG S&T. The agreement grants Sentynl full development rights, making Progerinin its second HGPS therapy and giving it orphan‑drug status from the FDA....
Lebrikizumab Delivered Significant Skin Clearance and Improved Disease Severity in Children With Moderate-to-Severe Atopic Dermatitis
Almirall reported that lebrikizumab met both co‑primary endpoints in the Phase 3 ADorable‑1 trial, with 63% of pediatric participants achieving EASI‑75 and 44% attaining clear or almost clear skin (IGA 0/1) after 16 weeks. Key secondary outcomes showed significant itch reduction, higher...
What Determines Success in Complex MASH Clinical Research Today?
Recent FDA approvals of resmetirom and semaglutide have shifted MASH care from a treatment‑void to a therapeutic reality, prompting sponsors to redesign trial endpoints and enrollment strategies. Non‑invasive diagnostic tools are emerging as potential primary endpoints, reducing reliance on liver...
Malicious Metals Muddy Fragment-to-Lead Optimization
Researchers at the Cleveland Clinic pursued fragment‑based inhibitors of SARS‑CoV‑2 NSP14, a viral exonuclease essential for replication and immune evasion. Initial crystal‑guided merges appeared active in a biochemical assay, prompting optimism about fragment linking. Subsequent resynthesis and rigorous purification revealed...
Module 2 Quiz
Drug Hunter’s online curriculum includes a Module 2 Quiz that tests learners on target identification and validation concepts. The quiz is part of a broader course designed for drug discovery professionals and requires full platform access via subscription or sign‑in. It...
The Antibacterials of Tomorrow
The blog recaps the 2026 New Antibacterial Discovery and Development conference in Tuscany, where researchers presented emerging strategies against antimicrobial resistance (AMR). Dr. Quave highlighted her lab’s plant‑derived natural products targeting Gardnerella vaginalis, a key cause of bacterial vaginosis. The...
RevnaBio Secures Triple International Laboratory Accreditation to Expand Precision Medicine and Clinical Research Infrastructure in Africa
RevnaBio received triple accreditation from the American Association for Laboratory Accreditation (A2LA) for ISO 15189, ISO 20387 and ISO/IEC 17043, validating its medical laboratory, biobanking and proficiency‑testing operations. The certifications boost diagnostic quality, enable local molecular testing, and provide a trusted platform for...
KERENDIA® (Finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease
Bayer announced that Kerendia® (finerenone) met its primary endpoint in the Phase III FIND‑CKD trial, showing a statistically significant slowing of eGFR decline versus placebo in non‑diabetic chronic kidney disease patients. The study enrolled over 1,500 participants and represents the fifth...
#384 – Special Episode — Obicetrapib: The CETP Inhibitor with Cardiovascular Benefits and Potential Alzheimer’s Prevention
Obicetrapib, a next‑generation CETP inhibitor, has demonstrated potent LDL‑C, apoB, and Lp(a) reductions in a large phase III lipid trial. A pre‑specified biomarker sub‑study reported a marked attenuation of p‑tau217 progression, especially among APOE4/4 carriers, hinting at a potential Alzheimer’s‑related benefit....
Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-Acting Semaglutide
Samsung Bioepis and its sister firm Epis NexLab have signed a research collaboration and exclusive license agreement with G2GBIO to develop a long‑acting semaglutide formulation using G2GBIO’s proprietary microsphere technology. The deal grants Samsung Bioepis full rights to the semaglutide...
YolTech Therapeutics Receives FDA Clearance to Initiate Phase 2/3 Study of In Vivo Gene-Editing Therapy YOLT-202 in Alpha-1 Antitrypsin Deficiency...
YolTech Therapeutics announced FDA approval of its IND for YOLT-202, an in vivo adenine base‑editing therapy targeting Alpha‑1 Antitrypsin Deficiency. The clearance permits an open‑label, single‑dose Phase 2/3 expansion study across the U.S. and other regions. In the ongoing first‑in‑human trial,...
No Broad Autism Approval for Leucovorin, Despite FDA Commissioner’s Prior Suggestions
The FDA on March 10 expanded leucovorin’s label to cover a very rare genetic folate‑transport disorder, not autism. Earlier, Commissioner Marty Makary suggested the drug could help “hundreds of thousands of kids” with autism, creating expectations of a broad approval. FactCheck.org...
How Dompé Is Innovating in Neuro-Ophthalmology with the FDA’s CNPV Program
Dompe, a privately owned biopharma, is advancing an intranasal nerve growth factor (NGF) therapy to treat non‑arteritic anterior ischemic optic neuropathy (NAION), a leading cause of sudden vision loss affecting roughly 6,000 U.S. patients annually. The approach leverages NGF’s neuroprotective...
Pharmaceutical Executive Daily: FDA Expands Approval for Arexvy
A West Health‑Gallup survey reveals that over 82 million Americans have reduced daily spending to afford healthcare, highlighting deepening affordability pressures across income levels. The FDA has broadened GSK’s RSV vaccine Arexvy to cover high‑risk adults aged 18‑49, a group responsible...