As New Rules Take Hold, What Does ‘Good AI Practice’ Look Like in Drug Development?
On January 14 2026 the EMA and FDA published joint guiding principles that define good AI practice for drug development. The technology‑neutral framework emphasizes context of use, risk‑based controls, data governance, documentation and lifecycle management rather than adding new regulatory requirements. It shifts the focus from whether AI can be used to how it can be run reliably, transparently and with accountable oversight. Organizations are now expected to embed AI within regulated workflows and treat it as a repeatable, auditable component of evidence generation.
Predicting Alzheimers & Dementia (and Minimizing Risk)
A wave of new research links environmental and immunological factors to dementia risk. Epidemiological data show heat‑related illness raises long‑term dementia incidence, while regular sauna exposure appears to cut Alzheimer’s risk by roughly two‑thirds. Observational studies also suggest the recombinant...
Pharmaceutical Executive Daily: FDA Approves Beqalzi and Inqovi
The FDA granted accelerated approval to BeOne Medicines' Beqalzi, the first BCL2 inhibitor for relapsed or refractory mantle‑cell lymphoma, after a Phase 1/2 trial showed a 52% overall response rate and median 15.8‑month durability. Taiho Oncology also received approval for Inqovi...
Transforming Clinical Trial Design and Avoiding AI Wrappers: Q&A with Angela Schwab
Trialynx CEO Angela Schwab explains how AI is reshaping clinical trial design by moving away from manual copy‑and‑paste protocols toward data‑driven, predictive modeling. AI can scan millions of past studies to suggest optimal endpoints, procedures, and patient pathways, reducing missed...
Cyclarity Unveils Oxidized Cholesterol Excretion Data
Cyclarity Therapeutics presented Phase 1 data for UDP-003, its cyclodextrin drug that binds and removes oxidized cholesterol (7‑ketocholesterol) from humans. The Monash Victorian Heart Institute trial showed dose‑dependent urinary excretion of 7KC, with no serious adverse events and a short...
Top 7 Fastest Growing Pharma & Biotech Companies in Asia for 2026
The Financial Times’ 2026 ranking spotlights the seven fastest‑growing Asian pharma and biotech firms, each posting double‑digit revenue surges and landmark milestones. SillaJen earned an FDA IND for its oncolytic virus BAL0891, while Oscotec leveraged lazertinib royalties to boost 2024...
The Case for Smarter Neuroinflammation Clinical Trials
INmune Bio, led by CEO David Moss, is developing non‑immunosuppressive therapies that target innate immune pathways, including the XPro1595 program for neurodegenerative disease and the CORDStrom mesenchymal stromal cell platform for recessive dystrophic epidermolysis bullosa (RDEB). The company argues that...
Cell and Gene Therapy Catapult Invests in Lir Therapeutics to Accelerate Development of Its AI-Driven AAV Design Platform
The UK’s Cell and Gene Therapy Catapult is investing in Lir Therapeutics through Innovate UK’s Cross‑Catapult Investment Pilot to fast‑track Lir’s AI‑driven AAV capsid design platform, nAAVigator. The funding will support biological validation, benchmarking, and data generation to prove the platform’s...
AMX-883
Amphista Therapeutics announced AMX-883, an oral degrader that recruits the DCAF16 E3 ligase to eliminate the epigenetic reader BRD9. The preclinical program demonstrates selective BRD9 degradation in acute myeloid leukemia (AML) cell models, leveraging a previously identified BRD9 binder for...
Enveric Biosciences Expands IP Portfolio with New U.S. Patent Issued for Methods of Treating Psychiatric Disorders
Enveric Biosciences announced the issuance of U.S. Patent No. 12,605,361 covering its carboxylated psilocybin‑derived EVM301 series for treating psychiatric disorders. The new patent expands the company’s intellectual‑property moat by protecting method claims that build on its earlier patent (No. 11,752,130). Enveric is...
Catalent and Elpida Therapeutics Enter Strategic Partnership for Late-Phase AAV Manufacturing
Elpida Therapeutics and contract manufacturer Catalent have entered a strategic partnership to handle late‑phase manufacturing of Elpida’s lead AAV9 gene therapy for Spastic Paraplegia Type 50 (SPG50). Catalent will also receive exclusive rights to produce Elpida’s other adeno‑associated virus (AAV) programs,...
How Pharma Can Adjust to Global Market Uncertainty
In the closing segment of Pharmaceutical Commerce’s interview series at Asembia AXS26, Jessica Lovett, VP of commercial strategy at Innomar Strategies, examined how pharma manufacturers are reshaping market‑access and commercialization plans amid heightened political, regulatory and reimbursement uncertainty. She illustrated the growing...
What Success Can Look Like, Darn It
Vepdegestrant, marketed as Veppanu, became the first FDA‑approved bifunctional degrader, a new PROTAC‑type therapy that eliminates target proteins. A Phase III trial showed it works but delivered no clear efficacy advantage over the existing degrader fulvestrant. Pfizer and Arvinas have now...
Physionic Podcast Videos and Summaries / Transcripts
A 2023 meta‑analysis of 29,913 patients shows that pure EPA, administered as icosapent ethyl, significantly reduces myocardial infarction, cardiovascular death and all‑cause mortality. The REDUCE‑IT trial, using 4 g daily of prescription EPA, delivered a 25 % relative risk reduction and a...
Makary Out at FDA. Independent Doctors Urge the Next Commissioner to Confront America’s Prescription Drug Crisis — and End Big...
The Independent Medical Alliance (IMA) is urging the White House to appoint a new FDA commissioner who will prioritize patient safety over pharmaceutical profits following Marty Makary's departure. IMA’s president, Dr. Joseph Varon, highlighted that 69% of American adults take...
Dual-Ligase Strategy Adds New Layer of Control to Targeted Protein Degradation
Researchers at CeMM, AITHYRA and the University of Dundee have identified a small‑molecule degrader that simultaneously engages two distinct E3 ligases to eliminate SMARCA2/4, key subunits of the BAF chromatin‑remodeling complex. The dual‑ligase mechanism acts as a molecular backup: degradation...
Small Cell Lung Cancer Research Moves Toward a More Precision-Driven Era
Small cell lung cancer (SCLC) is transitioning toward precision oncology as researchers uncover distinct molecular subtypes and high‑frequency targets such as DLL3. Amgen’s DLL3‑directed T‑cell engager tarlatamab and emerging antibody‑drug conjugates illustrate a shift from conventional chemotherapy to targeted immunotherapies....
RESEARCH: TOCOTRIENOLS in COLORECTAL CANCER - 2024 Review Paper From Malaysia
A 2024 review from Malaysia examined 38 peer‑reviewed articles on tocotrienols, a subclass of vitamin E, and their effects on colorectal cancer. The analysis highlighted two isoforms, gamma‑ and delta‑tocotrienol, which consistently inhibited tumor cell proliferation, induced apoptosis, and reduced metastatic...
Justice Alito Extends Administrative Stay of Mifepristone Order
Justice Samuel Alito extended the administrative stay on the Fifth Circuit's order halting telemedicine prescriptions of the abortion medication mifepristone, setting a new deadline for Thursday. The extension maintains the status quo while the Supreme Court considers whether to issue...
Pharmaceutical Executive Daily: GSK Enters Collaboration to Support Launch of Bepirovirsen
GlaxoSmithKline (GSK) has signed a 5.5‑year exclusive partnership with Chia Tai Tianqing Pharmaceutical Group to launch bepirovirsen, a chronic hepatitis B candidate, across more than 5,000 Chinese hospitals. The drug is currently in priority regulatory review in mainland China, while GSK...
Is Longevity a $1.2 Quadrillion Opportunity?
Peter Diamandis released the 2026 Longevity Metatrend Report, a free 200‑page analysis of the rapidly advancing health‑span sector. The report highlights breakthroughs such as human trials of partial epigenetic reprogramming, AI‑engineered proteins achieving 50‑fold efficacy gains, and the first pig‑organ...
Endometriosis Inspires Re-Examination of Known Targets at the Inaugural HERS Meeting
The inaugural Hormone Endometriosis Research Society (HERS) meeting used endometriosis as a lens to revisit established drug targets, revealing fresh therapeutic angles. Researchers presented data linking progesterone‑receptor modulators, anti‑inflammatory pathways, and the emerging biomarker GDF15 to disease regression. Genetic profiling...
CEL-SCI Enters Strategic Agreement with Amarox for the Registration, Commercialization, and Distribution of Multikine in Saudi Arabia
CEL‑SCI Corp. has signed a strategic partnership with Saudi firm Amarox to register, commercialize, and distribute its immunotherapy Multikine in Saudi Arabia, with a 50/50 revenue‑sharing model. Amarox will act as the local regulatory representative, seeking the Saudi Food and...
Avenacy Announces Launch of Ready-to-Use Tranexamic Acid in 0.7% Sodium Chloride Injection in the U.S. Market
Avenacy, a specialty injectable drug company, has launched a ready‑to‑use Tranexamic Acid 0.7% Sodium Chloride Injection in the United States. The product mirrors the active ingredient of Pfizer’s CYKLOKAPRON® and is indicated for short‑term use in hemophilia patients undergoing tooth...
Therorna to Showcase Clinical-Ready Circular RNA in Vivo CAR-T and CircRNA Pipeline at the 2026 American Society of Gene &...
Therorna Inc. will present three posters at the 2026 ASGCT meeting, highlighting its lead in‑vivo CAR‑T candidate TI‑0032, a circRNA‑encoded CD19×CD3 T‑cell engager, and the HPV16 therapeutic vaccine TI‑0093. TI‑0032 has just entered a first‑in‑human investigator‑initiated trial for refractory autoimmune...
How MFN Impacts Drug Development and Launch Planning
President Trump’s Most Favored Nation (MFN) drug‑pricing proposals, still pending congressional approval, would cap Medicaid, Medicare Part B and Part D prices at the lowest GDP‑adjusted price among a list of 20 reference nations. The rule would force pharmaceutical companies to reassess...
Late Line RCC: Where Darlifarnib Fits and Why LITESPARK-012 Matters
At the International Kidney Cancer Symposium, Kura presented phase 1 data showing its next‑generation farnesyl transferase inhibitor darlifarnib combined with cabozantinib achieved a 44% objective response rate in clear cell renal cell carcinoma patients previously treated with cabozantinib. The cohort was...
Noncovalent Fragments vs WRN
Researchers at Merck and Proteros reported a noncovalent fragment‑based campaign against the Werner syndrome helicase (WRN), a synthetic‑lethal cancer target. Using a 1,020‑compound fluorine‑fragment library screened by 19F‑NMR and a separate 500‑compound SPR screen, they identified seven primary hits, three...
What the Six Hundred Billion Dollar MFN Headline Misses: The Best Price Carveout, the IQVIA Net Price Hole, and the...
The Council of Economic Advisers released a report projecting up to $600 billion in drug‑price savings over ten years, but the headline masks three critical flaws. First, the voluntary MFN agreements rely on the GENEROUS carve‑out that isolates supplemental rebates from...
Overmedicalization? RFK Jr.’s Antidepressant Crackdown Raises Conflict Questions over His Fee Stake in Wisner Baum, the Tort Firm Built on...
Robert F. Kennedy Jr., now heading the U.S. Health and Human Services Agency, unveiled a "MAHA Action Plan" to curb psychiatric overprescribing, especially among children, and to promote non‑drug therapies. The initiative follows his controversial statements linking antidepressants to mass...
When Superbugs Threaten Vulnerable Children: Can AI Help Solve Antibiotic Resistance?
A wave of drug‑resistant bloodstream infections is killing newborns in Southeast Asia, highlighting the accelerating global antibiotic resistance crisis. The World Health Organization warns that the pipeline for new antibiotics is dangerously thin, leaving clinicians with few treatment options. MIT...
The Adiponectin Paradox: Fat’s Secret Longevity Signal or a Bio-Marker of Decline?
Adiponectin, a hormone secreted by fat cells, is celebrated for its anti‑inflammatory and insulin‑sensitizing effects, yet epidemiological data reveal a paradox: while centenarians exhibit high levels, elevated adiponectin in most older adults correlates with higher mortality and frailty. Researchers attribute...
Gilead’s $11.5B Bet: What Two Companies Saw in One Week
Gilead Sciences disclosed $11.5 billion in acquisition charges for three deals, notably Ouro Medicines and Tubulis, on May 7, 2026. In the same week UCB paid $2.2 billion for Candid Therapeutics, a company with an almost identical dual‑target autoimmune platform. Both firms are betting...
Gene Editing Has the Science Figured Out and Now Needs an Entire Stack of New Business Models, Reimbursement Mechanics, and...
Gene editing has moved from scientific proof‑of‑concept to commercial reality, highlighted by Vertex's CASGEVY therapy earning $43 million in Q1 2026 and treating over 500 patients at a $2.2 million list price. While the science is solid, the therapy’s multi‑step delivery—spanning screening, cell...
Is Novo Nordisk Turning the Page on CagriSema?
Novo Nordisk says its launch timeline for the dual‑agonist CagriSema remains unchanged despite scrapping a single‑chamber delivery device. The Phase 3 trial showed a 23% average weight loss over 84 weeks, impressive but still below Lilly’s tirzepatide at 25.5%. Meanwhile, Novo...
Drug Development Funnel: What I Learnt Building One From Scratch
A new D3.js funnel visualizes drug‑development attrition, showing that the headline billions‑dollar cost reflects cumulative failures rather than a single success. The plot reveals that pre‑clinical spending (~$430 M per approved drug) rivals the cost of late‑stage trials, and that only...
TriSalus (TLSI) Initiates Patient Enrollment for PREDICTT Liver Tumor Clinical Trial
TriSalus Life Sciences announced on May 4 that patient enrollment has begun for the PREDICTT trial, a prospective study of its Pressure‑Enabled Drug Delivery (PEDD) platform in liver tumors. The investigator‑led trial at MD Anderson Cancer Center will enroll about 20...
Lexicon (LXRX) Reports $21.1M Q1 Revenue Driven by Novo Nordisk Milestones
Lexicon Pharmaceuticals reported Q1 2026 revenue of $21.1 million, up sharply from $1.3 million a year earlier, largely due to $20 million in development milestones from its LX9851 partnership with Novo Nordisk. Net loss narrowed dramatically to $1.0 million from $25.3 million in Q1 2025, aided...
AtaiBeckley (ATAI) Reports Positive Phase 2a Results for Social Anxiety Treatment EMP-01
AtaiBeckley announced expanded Phase 2a results for EMP‑01, an oral R‑MDMA formulation targeting Social Anxiety Disorder. The study showed a 38% reduction in patient‑reported symptoms and a 32% drop in real‑world avoidance behaviors by Day 43, with 49% of participants classified as...
Glucose Nanoparticles Help CBD Cross the Blood-Brain Barrier
Researchers have engineered glucose‑coated polymer nanoparticles that dramatically improve cannabidiol (CBD) delivery across the blood‑brain barrier. The particles use a PEG‑PHB core to solubilize CBD and a surface glucose layer to hijack GLUT‑1 transport, while reactive‑oxygen‑species triggers release in inflamed...
Trump’s Psychedelic Executive Order Is the Beginning of the End of Prohibition
On April 18, President Trump signed an executive order to accelerate research, regulatory review, and patient access to psychedelic therapies for serious mental illness. The order does not legalize or de‑criminalize psychedelics but directs the FDA to issue priority vouchers...
The $1 Trillion Cardiovascular Reset
The blog highlights Eli Lilly's $1.3 billion acquisition of Verve Therapeutics, targeting a one‑shot PCSK9 gene‑editing therapy that could replace daily statins. It underscores the massive adherence problem—up to 75% of statin users stop within two years—and the untapped 1.4 billion‑person market for...
LANL: Scientists Map the Shape of RNA That Can Shut Down Genes
Los Alamos National Laboratory and an international team have mapped the three‑dimensional structure of the SINE B2 ribozyme, a self‑cleaving RNA that acts as a molecular switch in mammalian cells. By integrating X‑ray scattering, biochemical mutagenesis, and biophysical probing with simulations...
Pharmaceutical Executive Daily: FDA Extends Review of Leqembi's sBLA
The FDA has extended the priority review of Eli Lilly's subcutaneous Leqembi by three months, delaying the agency's action date while requesting additional information. The once‑weekly injection is designed to replace the current infusion regimen for patients with early Alzheimer’s...
Electromagnetic Field Activation of Gene Therapy as an Approach to Reprogramming
Researchers have engineered an electromagnetic‑field (EMF)‑responsive DNA element that remotely activates partial cellular reprogramming genes in mice. By cycling EMF exposure, the system triggers the Oct4‑Sox2‑Klf4 cassette without permanent gene integration, extending median lifespan to 108 weeks—about 70 human years....
Kanvas Biosciences Receives New Funding to Develop First-In-Category Microbiome Therapeutic for Improving Maternal, Newborn and Child Health
Kanvas Biosciences announced a new investment from the Gates Foundation to develop the world’s first fully synthetic microbiome therapeutic targeting maternal environmental enteric dysfunction (EED). The product will use a complex, multi‑strain consortium designed with AI‑driven discovery and spatial microbiome...
Vistagen Announces Completion of Last Patient Visit in PALISADE-4 Phase 3 Public Speaking Challenge Study of Fasedienol for Acute Treatment...
Vistagen announced that the final participant has finished the randomized, double‑blind portion of its Phase 3 PALISADE‑4 trial evaluating fasedienol nasal spray for acute social anxiety disorder. The company expects to release topline efficacy and safety data in the second quarter...
Etripamil
Etripamil (Cardamyst®) received FDA approval as a rapid‑acting, intranasal L‑type calcium channel blocker for converting acute paroxysmal supraventricular tachycardia (PSVT) episodes to sinus rhythm in adults. The drug leverages an ester‑sensitive phenylalkylamine scaffold to achieve fast onset and a short...
Bristol Myers Squibb Receives European Commission Approval of Sotyktu (Deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults
Bristol Myers Squibb announced that the European Commission has approved Sotyktu (deucravacitinib) for adults with active psoriatic arthritis, either as monotherapy or with methotrexate. The approval follows positive Phase 3 POETYK PsA‑1 and POETYK PsA‑2 trials, which demonstrated statistically significant improvements in ACR20...
The Peptide Split: How GLP-1s, Lutathera, Vosoritide, and Peptide Cancer Vaccines Are Quietly Rewriting Medicine While BPC-157, TB-500, MOTS-C, and...
Peptide therapeutics are diverging into two distinct trajectories. Clinically validated drugs such as GLP‑1 agonists, Lu‑177 radioligands, vosoritide, and emerging peptide cancer vaccines are delivering hard‑outcome data across cardiometabolic disease, oncology and rare disorders. In parallel, a booming wellness market...