Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC
Daiichi Sankyo and Merck have secured FDA priority review for ifinatamab deruxtecan (I‑DXd) under the Real‑Time Oncology Review and Project Orbis programs. The decision follows a successful Biologics License Application based on the Phase II IDeate‑Lung01 trial, which enrolled 187 extensive‑stage small‑cell lung cancer (ES‑SCLC) patients previously treated with platinum‑based chemotherapy. In the study, I‑DXd demonstrated meaningful objective responses, especially at the 12 mg/kg dose, building on its earlier Breakthrough Therapy Designation in August 2025. The PDUFA target date is set for October 10, 2026.
Eli Lilly Reports P-III (BRUIN CLL-322) Trial Data on Jaypirca Combination for CLL/SLL
Eli Lilly announced that its phase‑III BRUIN CLL‑322 trial showed the Jaypirca (pirtobrutinib) + venetoclax + rituximab regimen significantly extended progression‑free survival in relapsed or refractory CLL/SLL compared with venetoclax + rituximab alone. Patients were treated for roughly two years before entering a therapy‑free interval, and the benefit...
Novo Nordisk Partners with OpenAI to AI-Power Drug Development
Novo Nordisk announced a strategic partnership with OpenAI to embed advanced artificial‑intelligence across its drug discovery pipeline. The collaboration will leverage OpenAI’s models to sift through massive datasets, accelerate candidate selection and shorten regulatory submission timelines via the NovoScribe platform....
Rollout of Powerful New HIV Prevention Tool in Lower Income Countries Gets a Boost
The U.S. State Department and the Global Fund announced a major scale‑up of Gilead’s long‑acting HIV prevention drug lenacapavir, targeting 3 million people in low‑income countries over the next three years—a 50 % increase from the original 2 million commitment. Lenacapavir, which showed...
Federal Circuit’s Holding on Patent Eligibility for Engineered Host Cells Dovetails With PERA
The Federal Circuit ruled in REGENXBIO v. Sarepta that a host cell engineered to contain an AAV capsid gene plus a heterologous non‑AAV sequence is patent‑eligible under 35 U.S.C. §101. The opinion leans on the Chakrabarty precedent and distinguishes Myriad by emphasizing the material...
Entropy Neurodynamics' TRP-8803 Trial Shows Repeatable Psychedelic Effects in BED Study
Entropy Neurodynamics (ASX: ENP) reported that the third patient in its TRP‑8803 IV‑infused psilocin trial for binge‑eating disorder completed two doses and exhibited a repeatable psychedelic response. The trial, designed for 12 participants across two cohorts, is nearing the end...
STAT+: Maryland State Affordability Board Sets Its First Price Cap for a Medicine
Maryland's Prescription Drug Affordability Board announced its first price cap, targeting the type‑2 diabetes drug Jardiance. Starting January 2027 the state will limit a 30‑day supply to $204, roughly $6.80 per pill. The cap, modeled after Medicare’s maximum fair price...
RevMed’s Pancreatic Cancer Win Strengthens the Case for Targeting RAS(ON)
RevMed reported a positive Phase 2 trial of its RAS(ON) inhibitor in patients with advanced pancreatic ductal adenocarcinoma, showing a 23% objective response rate and a median progression‑free survival of 5.8 months. The study enrolled 45 heavily pre‑treated patients and...
Legato Merger Corp III (LEGT) Q1 2026 Earnings Call Transcript
Legend Biotech reported a 66% year‑over‑year jump in CARVYKTI net trade sales to $555 million, driving total revenue to $306 million and narrowing the operating loss to $20 million. Gross margins held at 61% while manufacturing capacity reached 10,000 doses with a 97%...
Clinical Innovations and Future Directions of Nanoparticles in the Treatment of Psychiatric and Neurological Disorders
Nanoparticles are emerging as a transformative platform for treating psychiatric and neurological disorders such as depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease. Their physicochemical design enables crossing the blood‑brain barrier, targeted drug delivery, and enhanced imaging for early diagnosis. The...
2026 340B Program Update – 340B Rebate Model RFI Comments Due and Manufacturers Continue Restricting 340B Pricing
The Health Resources and Services Administration (HRSA) has extended the comment deadline for its proposed 340B rebate‑model pilot to April 20, 2026, giving covered entities extra time to outline operational and financial impacts. At the same time, Eli Lilly and Novo Nordisk have instituted...
Compact CRISPR System Unlocks Targeted In-Body Gene Editing, with up to 90% Efficiency
Researchers at UT Austin have engineered a compact CRISPR enzyme, Al3Cas12f RKK, that fits into AAV vectors and achieves up to 90% editing efficiency in human cells. The enzyme’s small size overcomes the delivery bottleneck that limits most CRISPR systems...
Biotech Executive, Combative Conservative Hemmati May Head CBER
The FDA is nearing a leadership transition at its Center for Biologics Evaluation and Research (CBER) as Vinay Prasad prepares to depart at month‑end. Houman David Hemmati, a biotech executive known for his combative conservative views, tops Commissioner Marty Makary’s shortlist. Several other candidates...
Combining Ion Pumps and Click Chemistry Enables Precise Drug Release in the Body
Researchers at TU Wien have merged electronic ion pumps with click‑to‑release chemistry, creating an "iontronic click‑to‑release" system that delivers tiny trigger molecules instead of the drug itself. The triggers cleave immobilized drug linkers at the implant site, enabling precise, on‑demand...
White House Urges Mississippi To Reject Rx Fee Bill Over Drug Price Concerns
The White House is urging Mississippi legislators to reject a Senate‑amended bill that would impose a uniform $11.29 dispensing fee on every prescription. Federal officials argue the flat charge could raise out‑of‑pocket costs and undermine national drug‑price reduction efforts. The...
Office of Infectious Diseases Research Activities
The FDA’s Office of Infectious Diseases outlines its antimicrobial regulatory science agenda, referencing the 2020‑2025 National Action Plan that steers U.S. efforts against antibiotic‑resistant bacteria and fungi. It announces FY26 funding opportunities through a Broad Agency Announcement, with proposals due...
Why Has Marijuana Not Been Rescheduled? The Answer Is Obvious, Kinda
President Trump issued an executive order to move cannabis from Schedule I to Schedule III, yet the Department of Justice has not finalized the rule after more than three months. A senior Trump adviser and GOP operative Roger Stone has publicly urged...
From Our Perspective: The Orange Book at 40: A Valued FDA Resource Continually Enhanced by User Input
The FDA celebrated the Orange Book’s 40th anniversary, highlighting its role as the sole official source for therapeutic equivalence evaluations and reference listed drug data. The database, updated daily for generic approvals and monthly for NDA changes, underpins generic substitution,...
Inactive Ingredients Database Download
The U.S. Food and Drug Administration has published its latest Inactive Ingredients Database for April 2026, offering both CSV and Excel formats that each weigh under 2 MB. The database is refreshed quarterly—April, July, October and January—and provides detailed fields such as...
FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
The FDA has sent reminders to more than 2,200 medical‑product companies and researchers, covering over 3,000 registered trials, to file required results on ClinicalTrials.gov. An internal analysis shows that 29.6% of studies likely subject to mandatory reporting still have no...
Quarterly Inactive Ingredient Database (IID) Change Log
The FDA’s Inactive Ingredient Database (IID) is updated each quarter, and the Change Log records all corrected, deleted, and Maximum Daily Exposure (MDE) replacement entries. The log spans 2020‑2026, with file sizes ranging from 21 KB to 357 KB, reflecting the volume...
Salk to Lead $41.3M ARPA-H Effort to Advance Sonogenetics Therapies
The Salk Institute secured a $41.3 million ARPA‑H award to advance sonogenetics, a technique that uses low‑intensity ultrasound to control engineered cellular proteins. Over the next five years, Salk’s Dr. Sreekanth Chalasani and a multi‑institutional team will develop ultrasound‑responsive proteins, wearable...
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
The FDA issued final guidance titled “Cannabis and Cannabis‑Derived Compounds: Quality Considerations for Clinical Research,” clarifying how sponsors can use both hemp and cannabis with THC levels above 0.3% in human drug trials. The guidance outlines source options—including the NIDA...
Review and Approval
The FDA approves biosimilars through an abbreviated pathway that relies on demonstrating high similarity to an existing reference biologic, rather than repeating full safety and efficacy trials. Manufacturers must provide analytical, animal, and clinical data, and the agency can waive...
Vivatides Therapeutics Raises $54M for RNA Expansion
Vivatides Therapeutics announced a $54 million Series A round, led by Qiming Venture Partners and backed by several other investors. The funding will accelerate its proprietary extrahepatic delivery platform, designed to transport RNA molecules such as siRNA and antisense oligonucleotides beyond the...
Retail Pharmacies Fill Less than 2% of Mifepristone Orders
The FDA’s January 2023 removal of the in‑person dispensing rule let pharmacies, including mail‑order and retail outlets, fill mifepristone prescriptions. A USC study published in JAMA finds that only about 2,700 prescriptions are filled monthly, with mail‑order pharmacies handling more than...
TANGENT Phase 3 Study Meets Primary and Secondary Endpoints, SynOx Reports
SynOx Therapeutics reported that its Phase 3 TANGENT study of emactuzumab met both primary and secondary endpoints in tenosynovial giant cell tumor (TGCT). The five‑dose, eight‑week regimen achieved statistically significant RECIST responses and tumor volume reductions at six months. Patients also...
F.D.A. Calls on Drug Developers to Publish Missing Data From Thousands of Trials
The FDA announced it has dispatched more than 2,200 letters to drug makers, device manufacturers and researchers, demanding the publication of clinical‑trial results that remain absent from ClinicalTrials.gov. An internal analysis shows roughly 30 % of studies under FDA review have...
ROIS Expands US Injectable Manufacturing Capacity
ROIS has completed the acquisition of a 370,000‑square‑foot injectable manufacturing facility in Phoenix, Arizona, adding high‑potent fill/finish and lyophilization capabilities for biologics and antibody‑drug conjugates (ADCs). The site already holds FDA, EMA and Japanese regulatory approvals, enabling immediate support for...
FDA Narrows in on Search for New Biologics and Vaccines Leader
The U.S. Food and Drug Administration is close to naming a new director for its Center for Biologics Evaluation and Research (CBER), ending the turbulent tenure of Vinay Prasad. Sources say the leading candidate is Dr. Susan K. Lee, a...
October - December 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System...
The FDA’s Adverse Event Reporting System (FAERS) prompted a wave of labeling revisions between 2023 and 2025, adding new safety warnings to dozens of drugs. Notable changes include hypersensitivity alerts for cabotegravir injectables, fecal incontinence risks for several atypical antipsychotics,...
A Novel Approach To The Treatment Of Antibiotic Resistant Infections
Researchers have engineered microscopic, cell‑like particles that hunt drug‑resistant bacteria while sparing healthy microbes. The particles use protein‑based recognition to bind unique bacterial markers and deliver toxic proteins or bactericidal chemicals in a two‑step process. Laboratory tests showed a single...
Allogene’s First Cut of Data on ‘Off-the-Shelf’ CAR-T Shows Promise
Allogene Therapeutics reported that its off‑the‑shelf CAR‑T candidate cleared all detectable lymphoma cells in just over half of trial participants. The interim analysis stems from the pivotal ALLO‑501/ALLO‑501A study in relapsed or refractory B‑cell lymphoma. Researchers highlighted a complete molecular...
GSK Reports Strong Results for B7-H4 ADC in Gynecological Cancers
GSK’s investigational antibody‑drug conjugate mocertatug rezetecan (Mo‑Rez) demonstrated robust activity in its Phase 1 BEHOLD‑1 trial, achieving a 62% objective response rate in platinum‑resistant ovarian cancer and 67% in recurrent or advanced endometrial cancer. The drug targets the B7‑H4 immune checkpoint,...
USP Adds Tamiflu, Trulicity to Vulnerable List as Upstream Analysis Reshapes Supply Concerns
The United States Pharmacopeia (USP) has refreshed its vulnerable medicines list, adding Tamiflu (oseltamivir) and Trulicity (dulaglutide) after expanding its risk assessment to include key starting materials (KSMs). The new analysis shows 48 of the 100 flagged drugs depend on...
Allogene Stock Sails After CAR T Clears Residual Lymphoma in Early Data Cut
Allogene Therapeutics reported interim results from its Phase 2 ALPHA3 trial showing its off‑the‑shelf CAR‑T product cema‑cel cleared measurable residual disease in 58.3% of patients versus 16.7% in the observation arm. The therapy also achieved a 97.7% drop in circulating tumor...
How This Biotech Stock Skirted Today's Selloff
Revolution Medicines (RVMD) surged 35.5% to $131.35, briefly touching a record $135.81 after reporting that its pancreatic‑cancer pill daraxonrasib cut death risk by 60% in a Phase 3 trial. Leerink and Guggenheim raised price targets to $147 and $174, respectively. The...
Hidden Antivirals Discovered in a Plant-Derived Supplement
Researchers identified a new family of trace molecules, dubbed dicitriosides, hidden in a 90 %‑purity isoquercitrin supplement. These triterpenoid‑cinnamate compounds exhibit nanomolar potency against Ebola, Zika and SARS‑CoV‑2, outperforming the original mixture by roughly 25‑fold. The antiviral activity was isolated to...
BioNTech's HER2 ADC Succeeds in Phase 2 Study, FDA Filing Planned
BioNTech announced that its HER2‑targeted antibody‑drug conjugate, trastuzumab pamirtecan (formerly BNT323), achieved robust efficacy in a Phase 2 trial of HER2‑positive metastatic breast cancer. The study reported a 45% overall response rate and a median progression‑free survival of 8.2 months, with...
Revolution Rises 40% as Pancreatic Cancer Drug Doubles Survival
Revolution Medicines announced that its oral RAS inhibitor daraxonrasib doubled overall survival in patients with previously treated metastatic pancreatic ductal adenocarcinoma, achieving 13.2 months versus 6.7 months on chemotherapy. The Phase 3 RASolute 302 interim analysis was declared final, prompting the company...
The AI Value Gap and Why Validation Is a Practical First Win for Life Sciences
AI adoption in life‑sciences is hampered by a wide value gap, with only about 40% of firms seeing EBIT impact and most gains under 5%. A practical entry point is FDA‑oriented computer system validation (CSV) and computer software assurance, where...
IDEAYA/Servier PKC Drug Aces Uveal Melanoma Trial
IDEAYA’s PKC inhibitor darovasertib, combined with Pfizer’s crizotinib, achieved a statistically significant improvement in progression‑free survival in the phase 2/3 OptimUM‑02 trial for HLA‑A*02:01‑negative metastatic uveal melanoma. Median PFS extended to 6.9 months versus 3.1 months for investigator‑chosen immunotherapy, and the...
STAT+: Pharmalittle: We’re Reading About a Pancreatic Cancer Pill, FDA Rejecting a Replimune Drug Again, and More
Revolution Medicines reported that its KRAS‑targeting oral pill daraxonrasib more than doubled median overall survival for metastatic pancreatic cancer patients, achieving 13.2 months versus 6.7 months on standard chemotherapy. The company will leverage a FDA priority‑review voucher to seek accelerated...
CMS Proposes New Deadlines for Prior Authorizations for Drugs
The Centers for Medicare & Medicaid Services (CMS) has proposed a rule that would impose firm deadlines on federally regulated insurers for electronic prior authorizations (PA) of prescription drugs. Medicaid and CHIP plans would have 24 hours to respond, while ACA...
AbbVie Enters World of Pain in up to $715M Deal with China’s Haisco
AbbVie has signed an exclusive licensing agreement with China’s Haisco Pharmaceutical Group that could be worth up to $715 million. The deal grants AbbVie rights to a portfolio of pain‑related compounds ranging from preclinical to Phase 1 stages in China. This marks...
Amgen Pipeline’s Next Growth Cycle: Replacing Its Old Blockbusters
Amgen posted $36.8 billion in 2025 revenue, a 10% year‑on‑year rise, but its legacy blockbusters such as Enbrel, Xgeva and Otezla are under pressure from biosimilars and U.S. pricing reforms. Growth is now being driven by cardiovascular drugs, rare‑disease assets acquired...
Regeneron Enters Radiopharma Ring with up to $4.3B Telix Alliance
Regeneron Pharmaceuticals has struck a partnership with Australian biotech Telix, committing $40 million to launch four initial radiopharmaceutical programs and securing an option for four more. The deal splits development and commercialization costs and profits equally, while Telix stands to earn...
STAT+: Revolution Medicines Touts ‘Unprecedented’ Data for Pancreatic Cancer Pill
Revolution Medicines reported that its oral KRAS‑G12C inhibitor daraxonrasib more than doubled survival for patients with metastatic pancreatic cancer. In a head‑to‑head trial, the daily pill yielded a median overall survival of 13.2 months versus 6.7 months for standard chemotherapy....
The Era of Big Pharma’s One-Size-Fits-All Pipeline Is Fading
Big Pharma’s pipeline volume remained steady in early 2026, but its composition is fragmenting. While the ten largest developers still dominate, the number of boutique firms with one or two candidates surged past 4,000, reflecting investor appetite for niche innovation....
STAT+: Allogene Therapeutics’ CAR-T Treatment Eliminates Residual Cancer Cells in B-Cell Lymphoma Patients
Allogene Therapeutics reported that its off‑the‑shelf CAR‑T therapy, cema‑cel, eliminated residual cancer cells in B‑cell lymphoma patients at three times the rate of standard care, meeting the interim goal of its Phase 3 trial. In the interim analysis, 58% of treated...