343. Summary: Can This Nutrient Help Alzheimer's? - Life Extension
In this episode, Dr. Mike and Dr. Crystal discuss a recent pilot study on creatine supplementation as a potential therapy for Alzheimer's disease, featuring insights from lead author Aaron Smith. They explain how creatine, known for its role in muscle energy, also buffers energy in the brain, and how disruptions in the brain's creatine system may contribute to the disease's "energy crisis." The hosts highlight that Alzheimer's is multifactorial, noting past focus on amyloid and tau has yielded limited cognitive benefits, and suggest that targeting brain energy could open new research avenues.
Trial of Non-Invasive Endometriosis Scan Boosts Hopes for Quicker Diagnosis
A small trial of 19 women showed that the experimental radiotracer maraciclatide can illuminate endometriotic lesions on a Spect‑CT scan, matching surgical findings in 16 cases with no false positives. Current diagnosis in the UK often requires invasive laparoscopy, leading...
Tiny Biotech’s Experience Raises Questions About FDA’s Rare Disease Policies
BioCentury’s website now publishes a detailed cookie policy that separates cookies into five categories: strictly necessary, functional, marketing, advertising, and analytics. Strictly necessary cookies are always active and essential for authentication and navigation, while functional cookies enable personalization of the...
FDA Proposes AI-Driven Real-Time Trials, Ending Phase Gaps
No more Phase 1, 2, or 3 in clinical trials? The FDA is proposing using AI to get trial data in real-time from EHRs and giving trial design feedback based on what it sees. No more batch processing could eliminate the wait...
In Chiesi’s Biggest M&A Deal yet, Pharma Buys HAE Company KalVista
Italian pharmaceutical group Chiesi announced the acquisition of U.S. biotech KalVista for approximately $1.5 billion in cash, marking its largest M&A transaction to date. KalVista, a specialist in hereditary angioedema (HAE), brings a late‑stage monoclonal‑antibody program and a pipeline of complement‑targeted...
Long a Dream, It's Now Real: A Fast and Accurate TB Test that Doesn't Need Phlegm
A Chinese firm, Pluslife, has commercialized the MiniDock MTB, a portable tuberculosis test that works with a simple tongue swab or sputum and costs about $300 per device and $3‑4 per assay. In a study of nearly 1,400 patients across...
BIOTECanada Responds to Health Canada’s Gazette on Modernizing Clinical Trials Regulations
Health Canada has released a Gazette notice proposing modernized clinical‑trial regulations and draft guidance for decentralized trials. BIOTECanada welcomed the initiative but urged that the new rules align with the U.S. FDA and European EMA to avoid duplicative requirements. The...
Duodenal Mucosal Resurfacing Cuts Post‑GLP‑1 Weight Regain by 40% in First Trial
Researchers at Dartmouth Health presented the first sham‑controlled trial of duodenal mucosal resurfacing, showing participants who received the endoscopic “gut reset” regained 40% less weight than controls after stopping GLP‑1 drugs. The findings could address a major gap in obesity...
MIT's FINGERS-7B AI Model Predicts Pre‑Symptomatic Alzheimer’s with Four‑Fold Accuracy
A MIT‑led team released FINGERS-7B, an AI foundation model that integrates lifestyle, genomic and proteomic data to predict Alzheimer’s up to a decade before symptoms with four‑fold higher accuracy. The open‑source tool, showcased at ICLR in Rio, could reshape preventive...
GLP-1 Drugs May Lower CV Risk in TAVI Patients With Diabetes or Obesity
A retrospective analysis of 1,708 matched TAVI patients shows that glucagon‑like peptide‑1 (GLP‑1) receptor agonists cut the relative risk of major adverse cardiovascular events (MACE) by 37% and all‑cause mortality by 39% at one year. The benefit was consistent in...
Small Stem Cell Edit Generates Persistent Antibody Protection
Researchers showed that editing a small number of blood stem cells can reprogram the immune system to continuously produce therapeutic proteins, including powerful antibodies that are normally hard to generate. In mice, this approach created long-lasting, boostable protection against infections...
PTC Therapeutics Sees 52% Slowing of Huntington's Disease with Votoplam
PTC Therapeutics reported that participants with Stage 2 Huntington's disease receiving 10 mg of Votoplam experienced a 52% slowdown in disease progression over 24 months, compared with a matched natural‑history cohort. The data, presented in a press release on April 28, 2026, reinforce...
MIMEDX Announces First Quarter 2026 Operating & Financial Results
MiMedx Group reported first‑quarter 2026 net sales of $59 million, a 33% drop from the prior year, as new Medicare reimbursement rules crippled its wound‑care segment, which fell 60%. The surgical franchise bucked the trend, posting a 13% year‑over‑year increase. Management...
Rocket Pharmaceuticals Secures $180 Million From Priority Review Voucher Sale
Rocket Pharmaceuticals sold its FDA rare‑pediatric‑disease priority review voucher for $180 million, extending its cash runway into the second quarter of 2028 and providing non‑dilutive capital for its cardiovascular gene‑therapy pipeline. The deal underscores the growing market for FDA vouchers as...
Medtronic Wins FDA Approval for Updated Mitral Replacement Valve
Medtronic announced FDA approval for its next‑generation Mosaic Neo bioprosthetic mitral valve and has begun U.S. launches. The valve can be implanted via traditional sternotomy or minimally invasive approaches, and the company performed the first combined implant with its Penditure left‑atrial‑appendage...
Smallest-of-Its Kind Probe Tracks Several Key Health Signals
Researchers at the University of Texas at Austin have unveiled a 1.1 mm diameter fiber probe that can simultaneously monitor glucose, lactate, and ethanol in tissue. The mid‑infrared device uses two silver‑halide fibers and a quantum cascade laser to deliver real‑time,...
Rockwell Automation and Cytiva Launch Platform to Accelerate Digital Transformation for Biopharma Companies
Rockwell Automation and Cytiva have launched Figurate, a supervisory control and data acquisition (SCADA) platform aimed at streamlining digital integration in biopharmaceutical manufacturing. The system combines Cytiva’s bioprocessing hardware with Rockwell’s FactoryTalk software, offering an open‑architecture layer that connects third‑party...
AI Drug Target Platform Pairs Prediction with Benchmarking to Improve Early Discovery
Insilico Medicine unveiled an integrated AI framework that couples its Target Identification Pro (TargetPro) predictive engine with the TargetBench 1.0 benchmarking suite to improve early‑stage drug target discovery. The system uses disease‑specific models trained on 22 omics and text scores,...
Early Data Links Wegovy to Risk of 'Eye Stroke' — Here's What to Know
Early signals from a British Journal of Ophthalmology analysis suggest Wegovy, the semaglutide‑based weight‑loss injection, may be linked to ischemic optic neuropathy (ION), a rare form of eye stroke that can cause rapid vision loss. The study examined 31,774 FDA...
BREAKING: Senate Investigation Finds FDA Officials Covered-Up 25 COVID Shot Safety Signals
The episode examines a Senate investigation revealing that FDA officials allegedly suppressed about 25 statistically significant safety signals linked to COVID‑19 vaccine adverse events, including serious conditions such as Bell's palsy, cardiac failure, sudden cardiac death, and strokes. It details...
Revolving Doors and Efficient Engines: How Proteins Escape a Molecular Tangle
Researchers at the Weizmann Institute revealed that the AAA+ disaggregase ClpB moves protein substrates via a Brownian‑motor, revolving‑door mechanism rather than the previously assumed hand‑over‑hand pulling. Real‑time three‑color fluorescence tracking showed a protein segment threading through the channel in just...
New York Center Ranks Academic Institutions for ‘Industrial Readiness’
The Cure innovation center in New York City unveiled an "industrial readiness" index that evaluates more than 300 U.S. academic institutions on their ability to turn biomedical research into commercial products. Rankings place Harvard, Stanford, Penn, MIT and UCSF at...
AbbVie Faces Questions About Skyrizi Competition From J&J
AbbVie’s first‑quarter earnings call highlighted growing pressure on its immunology franchise as analysts probed the company’s defense against Johnson & Johnson’s upcoming IL‑23 inhibitor. Skyrizi, AbbVie’s flagship psoriasis drug, posted $1.2 billion in Q1 sales, a 12% year‑over‑year increase, but faces...
Pharmaceutical Executive Daily: Rocket Pharmaceuticals Sells Pediatric Disease Priority Review Voucher
Rocket Pharmaceuticals agreed to sell its rare‑pediatric disease priority‑review voucher for $180 million in cash, providing non‑dilutive funding as the PRV program was reauthorized in early 2026. Teva Pharmaceutical announced a definitive agreement to acquire Emalex Biosciences for up to $900 million,...
AbbVie Tops Q1 Estimates, Raises Outlook and Discontinues Cancer Candidate
AbbVie reported $15 billion in first‑quarter revenue, a 12.4% year‑over‑year increase, driven by strong immunology and a 26% surge in neuroscience sales. Immunology products Skyrizi and Rinvoq generated $7.29 billion, while the migraine drug Qulipta boosted neuroscience revenue to $2.87 billion. The company...
“Click Clotting” Technique Rapidly Creates Stronger Blood Clots
Researchers at McGill University unveiled a "click clotting" method that chemically links red blood cell surface proteins, forming a biocompatible cytogel within five seconds. The engineered blood clots are 13 times more fracture‑tough and four times more adhesive than natural...
Molecular Quantum Nanosensors Reveal Temperature and Radical Signals Inside Living Cells
Researchers at Japan's National Institutes for Quantum Science and Technology, the University of Tokyo, and Kyushu University have unveiled molecular quantum nanosensors (MoQNs) that operate inside living cells. The sensors, built from pentacene spin qubits in para‑terphenyl nanocrystals and coated...
Axoft Secures $55M Series A Financing
Axoft, a Cambridge‑based neurotechnology firm, announced a $55 million Series A round led by C.P. Group Innovation, bringing its total funding to over $60 million. The capital will finance global expansion of clinical trials for its implantable brain‑computer interfaces (iBCIs) and support U.S....
Genome Editing Can Be Risky. Meet the Epigenome Editors
Scientists are turning to epigenome editors—tools that rewrite gene activity without altering the DNA sequence—to sidestep the safety concerns of traditional genome editing. By coupling dead Cas9 (dCas9) with epigenetic modifiers, researchers can turn genes on or off with high...
Mimio Health’s Fasting‑Mimetic Supplement Cuts Cholesterol and Glucose in RCT
Mimio Health’s fasting‑mimetic supplement Mimio lowered total cholesterol, LDL, oxidized LDL and fasting glucose in an eight‑week, double‑blind trial of 42 older adults. The study, published in Scientific Reports, also reported improved appetite regulation and reduced abdominal discomfort, suggesting a...
AbbVie Submits FDA NDA for Upadacitinib (RINVOQ) to Treat Severe Alopecia Areata
AbbVie announced it has submitted a new drug application to the U.S. FDA for upadacitinib (RINVOQ) in severe alopecia areata, based on Phase 3 results showing significant scalp hair regrowth. The filing targets both adult and adolescent patients, a population...
Ageing Forms Gene Network Linking Diseases via Two Pathways
Ageing isn't one disease, it's a network. Excited to share our latest study exploring the genetic links between ageing and age-related diseases 🧬 We show how shared pleiotropic genes connect disease clusters, revealing two distinct genetic architectures: one driven by ageing-related...
FDA to Pilot Real-Time Clinical Drug Trials Through Cloud and AI
The FDA announced a pilot that will stream clinical‑trial data to the agency in real time using cloud platforms and artificial‑intelligence analytics. Commissioner Marty Makary said the effort could shave up to 40% off the time between Phase 1 trials and...
FDA Launches Real‑Time Clinical Trial Tracking Pilot with AstraZeneca and Amgen
The FDA announced a pilot that will stream real‑time data from two pharmaceutical trials—AstraZeneca’s mantle‑cell lymphoma study and Amgen’s early‑stage lung cancer trial. The effort seeks to shrink the decades‑long lag between trial results and regulatory decisions, creating new IT...
MIT Team Unveils Magnetically‑controlled Soft Hydrogel Microrobots for Medical Use
Researchers from MIT, EPFL and the University of Cincinnati have 3D‑printed soft magnetic hydrogel structures that transform into microrobots controllable by external magnets. The “magno‑bots” can deform and grip at sub‑millimeter scales, opening pathways for biopsy retrieval and targeted drug...
Supply Chain Digital Twins: An Evolution, Not a Breakthrough
Researchers at NIST and EMD Millipore argue that digital twins can model the intricate biopharmaceutical supply chain, from demand shocks to distribution bottlenecks. By creating in‑silico replicas of cells, raw materials, and logistics flows, twins could identify alternative distribution centers and...
Milk Exosomes Transform Therapeutic Bioprocessing
Milk-derived extracellular vesicles, known as milk exosomes, are emerging as a biocompatible platform for therapeutic delivery. Researchers have loaded the JAK inhibitor tofacitinib into exosomes (mEXOs@TOF) for ulcerative colitis, achieving high drug‑loading efficiency, stability and strong anti‑inflammatory effects without toxicity....
Hopes Raised for More Sustainable Oligonucleotide Manufacturing
QurAlis CTO Hagen Cramer says enzymatic synthesis could make large‑scale oligonucleotide production far more sustainable than the solvent‑intensive solid‑phase method. While solid‑phase synthesis remains fast and automated, it generates high process mass intensity due to extensive solvent washes. Enzymatic, aqueous‑based...
Adaptive, Agent-Oriented Control for Biomanufacturing Systems
The Adaptive Agent‑Oriented System Control (AAOSC) framework, created by the Technical University of Denmark and SiC Systems, adds a decentralized layer of autonomous agent "hives" to biomanufacturing plants. By linking digital twins, IoT sensors and enterprise systems, AAOSC can reduce...
Sandoz Q1 Net Sales Rise 3% to $2.76 Bn, Biosimilars Up 18% and 2026 Guidance Reaffirmed
Sandoz reported first‑quarter net sales of $2.76 billion, a 3% increase at constant currency, and confirmed its 2026 financial guidance. The growth was driven by an 18% jump in biosimilar sales, while generic sales slipped modestly.
Prenatal Surgery for Spina Bifida May Get a Boost From Stem Cells
Researchers at UC Davis have performed the first in‑utero repair of spina bifida using a stem‑cell‑infused patch on six fetuses. The procedure appeared safe, with no infections, tumors, or delayed healing reported in the initial cohort. While early safety data...
Late‑Stage Drug Development Trends: Phase III, AI, Global Partnerships
LOOKING forward to tomorrow's webinar on late-stage drug development trends with Susan Galbraith (AstraZeneca), Levi Garraway (Roche) and Ken Getz (Tufts). We'll be discussing the fundamentals of Phase III, with thoughts on efficiencies, interplay with biotech partners, China, AI, and...
Semaglutide Restores Lacrimal Gland, Relieves Age‑Related Dry Eye
Semaglutide alleviates age-related dry eye disease by restoring lacrimal gland structure and function https://t.co/EDvPtdeiqg https://t.co/Kpku8SHEOH
Astellas’s R&D Head Talks Strategy Ahead of Looming Patent Cliff
Astellas Pharma faces a looming patent cliff as its blockbuster prostate‑cancer drug Xtandi, which generated about $4.6 billion in the 2025 fiscal year, loses U.S. patent protection next year. To offset the expected revenue hit, chief R&D officer Tadaaki Taniguchi is accelerating...
Biotech Momentum Stalls as XBI Dips Below January Highs
Still tough to hold momentum in biotech. $XBI slipping back below its January highs. Lets see if the weekly close can save it. https://t.co/zbU6jtuq35
Polygenic Scores Predict Cardiovascular Risk, but Remain Unused Clinically
Polygenic risk scores for 8 cardiovascular traits in both @MassGenBrigham and @AllofUsResearch—superimposable— strongly indicate risk. Yet still not implemented in clinical practice https://t.co/DwWpwXknbJ
Henlius and Organon Gain EC Approval for Pertuzumab Biosimilar
Henlius and Organon have received the first European marketing authorization for a pertuzumab biosimilar, Poherdy, targeting HER2‑positive breast cancer. The EC approval mirrors the product’s earlier U.S. clearance and covers all indications of Roche’s reference drug, Perjeta, including metastatic, neoadjuvant...
FDA Pilots Real-Time Trials as AbbVie Eyes KRAS Biotech
FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech https://t.co/diuieVTJ3g $ABBV $LLY $GSK $IONS $PFE #biotech
Pfizer Earns Positive Phase 3 in Multiple Myeloma; ICON Overstated Revenue
Pfizer announced that its antibody‑drug conjugate Elrexfio achieved a statistically significant and clinically meaningful improvement in progression‑free survival for patients with double‑class exposed relapsed or refractory multiple myeloma. The Phase 3 trial met its primary endpoint, positioning the drug as a...
FDA to Relax Peptide Rules After High‑profile Endorsement
FDA moves toward easing restrictions on certain peptides The agency’s decision to hold an advisory committee meeting on the topic comes after HHS Secretary Robert F. Kennedy Jr. told podcaster Joe Rogan he’s a “big fan” of peptides. https://t.co/wynhLuBUPE https://t.co/y9dgG0xWAq