Low‑Fat Vegan Diet Cuts Emissions by Over Half and Boosts Metabolic Health
Two recent randomized clinical trials led by the Physicians Committee for Responsible Medicine found that a low‑fat vegan diet cuts diet‑related greenhouse‑gas emissions by more than half and delivers measurable metabolic health benefits, outperforming Mediterranean and omnivore controls.
Caris Life Sciences Secures MolDX Approval for Ultra-Deep Myeloid Cancer Sequencing Test
Caris Life Sciences announced that its Caris ChromoSeq test has earned MolDX approval, a CMS‑backed endorsement that could unlock broader reimbursement for comprehensive genomic profiling of acute myeloid leukemia and related blood cancers. The clearance validates the assay’s ultra‑deep sequencing depth—up...
Seer Names Anthony Bazarko CCO to Accelerate Global Proteomics Sales
Seer, Inc. announced the appointment of Anthony Bazarko as chief commercial officer, tasking him with leading sales, marketing and customer experience worldwide. The veteran life‑sciences executive brings more than 20 years of commercial leadership, including a recent stint as CEO...
OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration - 05/05/2026
The FDA’s Center for Drug Evaluation and Research hosted a May 5, 2026 webinar to explain the Over‑the‑Counter Monograph Drug User Fee Amendments (OMUFA) for fiscal year 2026. The session covered fee structures, registration requirements for OTC monograph facilities, payment timelines, and penalties...
FDA Blocks Proven Therapies, Permits Untested Peptides
So let me get this straight - this FDA 1) won’t approve life saving melanoma and Huntington’s disease drugs based on BS objections related to control groups that would not be ethical 2) blocks large study showing exquisite safety of...
The BioPharm Brief: Breakthrough Biologics and Long-Term Wins in IBD and Beyond
Viridian Therapeutics reported positive Phase III REVEAL‑2 data for veligrotug (VRDN‑001) in chronic thyroid eye disease, showing statistically significant reductions in proptosis and higher overall response rates. Eli Lilly presented four‑year long‑term results for mirikizumab (Omvoh) in ulcerative colitis, with a substantial...
ADMA Biologics Wins FDA Label Expansion for ASCENIV, Adding Pediatric Patients 2+ Years
ADMA Biologics announced that the FDA approved a supplemental BLA expanding ASCENIV’s indication from patients 12 years and older to include pediatric immune‑compromised patients two years of age and up. The move opens a new market segment for the company’s patented...
When the Data Favor Motion Preservation, How Long Does It Take for Surgeon Culture to Catch Up?
Recent IDE trial data on the Total Posterior Spine (TOPS) System suggest that motion‑preserving implants can match or exceed outcomes of traditional fusion for grade I degenerative spondylolisthesis at L4‑5. The study showed comparable pain relief, functional scores, and lower rates...
BofA Raises Cytokinetics Price Target on ACACIA Trial Results
Bank of America raised its price target for Cytokinetics (CYTK) to $83 from $67 while keeping a neutral rating. The move follows the company’s positive Phase 3 ACACIA‑HCM trial, where aficamten met both primary endpoints in non‑obstructive hypertrophic cardiomyopathy. CYTK shares...
Pharmaceutical Executive Daily: BioNTech Reports 2026 First Quarter Results
Cellenkos secured FDA clearance to start a Phase 1b/2a trial of its off‑the‑shelf allogeneic T‑reg therapy CK0802 for steroid‑refractory graft‑versus‑host disease, with enrollment slated for late 2026. BioNTech reported first‑quarter 2026 revenue of $138 million, a 35% drop from the prior year,...
Questions and Answers on Current Good Manufacturing Practice Regulations | Production and Process Controls
The FDA released a detailed Q&A clarifying current Good Manufacturing Practice (CGMP) expectations for pharmaceutical manufacturers. It addresses equipment labeling, warehouse sampling of containers, media‑fill contamination sources, and the number of validation batches required for new products. The guidance also...
FDA Clears Investigational New Drug Application for Phase Ib/IIa Trial of CK0802 in Steroid-Refractory Graft-Versus-Host Disease
The U.S. Food and Drug Administration has cleared Cellenkos' investigational new drug application for CK0802, paving the way for a Phase Ib/IIa trial in patients with steroid‑refractory graft‑versus‑host disease (GVHD). The mid‑stage study will evaluate safety, tolerability and early efficacy, using...
First Patient Enrolled in Massive Heart Failure Trial
CVRx has begun enrolling patients in BENEFIT‑HF, a pivotal trial of its Barostim implant for heart failure. The study plans to enroll roughly 2,500 NYHA Class II‑III patients across the United States and Germany and will run through 2032. Participants must...
F.D.A. Blocked Publication of Research Finding Covid and Shingles Vaccines Were Safe
The U.S. Food and Drug Administration blocked publication of several agency‑conducted studies that found Covid‑19 and shingles vaccines to be safe. The withdrawn research, funded with public dollars, had been slated for peer‑review journals and a drug‑safety conference. FDA officials...
Austin Russian: How Fragmentation Delays Rare Disease Therapy Access
Austin Russian, SVP of Program Excellence at PANTHERx Rare, warned that fragmentation across prescribers, insurers, pharmacies and manufacturers slows patient access to orphan drugs. As more rare‑disease therapies reach the market, the lack of a single coordinating entity creates miscommunication...
Partial Reprogramming Concern Altos Labs Is Becoming Less Stealthy
Altos Labs, launched in 2022 with roughly $3 billion in private funding, is intensifying its public profile as it pursues partial cellular reprogramming to reverse organ aging. The company is racing alongside rivals such as Life Biosciences, which has just begun...
PharmaLogic Expands Radiopharmaceutical Footprint With New Atlanta Facility
PharmaLogic announced the opening of a new PET radiopharmaceutical manufacturing facility in Atlanta, Georgia, as part of its $250 million US expansion. The state‑of‑the‑art plant will increase production capacity, accelerate delivery to Southeast hospitals, and serve as an innovation hub for...
How AI Tools Could Enable Bioterrorism
Recent advances in generative AI are lowering the barrier for creating biological weapons. Large language models can now design DNA sequences that encode harmful pathogens, while cheap gene‑editing kits like CRISPR are readily purchasable online. The convergence of open‑source genetic...
5th Circuit Reinstates In‑Person Mifepristone Rule, Prompting Supreme Court Stay
The 5th U.S. Circuit Court of Appeals reinstated an in‑person dispensing requirement for the abortion pill mifepristone, prompting Danco Laboratories to seek a stay from the Supreme Court, which granted a one‑week pause. The back‑and‑forth highlights how even long‑approved drugs...
FDA Approvals for Aging Therapies: Updated Insights
My 20min talk on FDA approvals of aging therapies & more coming soon from the Dec 2025 Longevity Summit at the Buck Institute is now on YouTube: https://t.co/L024jUz9iT It's an updated version of the one I gave at Vitalist Bay May'25. I'll be...
Viridian Data Lift Prospects for Thyroid Eye Disease Drug
Viridian Therapeutics announced that its subcutaneous drug elegrobart met primary endpoints in a Phase 3 trial for chronic thyroid eye disease, showing 50%‑54% response rates versus 15% for placebo. The once‑monthly regimen also improved double vision in 61% of patients, while...
FDA Commissioner Defends Agency's Drug Approval Decisions After Wave of Backlash
FDA Commissioner Marty Makary faced intense media and political backlash after the agency rejected Replimune’s melanoma drug candidate. In a CNBC interview, Makary emphasized that three independent FDA panels reached the same safety conclusion and rejected accusations of bias toward...
Ascidian Completes Adult Dose Escalation, Opens Pediatric Enrollment in STELLAR Gene Therapy Trial
Ascidian Therapeutics announced the completion of the adult dose‑escalation portion of its Phase 1/2 STELLAR trial for the RNA‑editing gene therapy ACDN-01 and opened enrollment to pediatric patients 12 years and older. The move adds a 10‑patient adult cohort and launches...
Bio Korea 2026 Kicks Off with Spotlight on Oligonucleotides
In early May 2026, several biotech firms announced pivotal milestones. Axsome Therapeutics received FDA clearance for Auvelity (AXS‑05) to treat agitation in Alzheimer’s disease, a condition affecting up to 75% of patients. Sonire Therapeutics began its U.S. Sunrise II trial of...
Pfizer Scrubs Trillium Pipeline, CD47 Concept Proves Bust
Sometimes in biotech you can get lucky and win even though you were dead wrong. $PFE just dumped the rest of the Trillium ( $TRIL) pipeline - it all came to naught. I made out nicely when PFE bought TRIL,...
Bees Trained to Detect Explosives, Security Breakthrough
Bees Trained to Detect Explosives: A Breakthrough in Biotech Security by @zackdfilms1 #EmergingTech #Technology #Innovation https://t.co/LKDx2dGVFM
This Hand-Held Cancer Probe Feels What Surgeons May Miss and Changes How Tumors Are Found in Real Time
Researchers from Australian universities and a Polish institute have created a wireless, hand‑held probe that uses optical elastography to differentiate cancerous from healthy tissue during breast‑conserving surgery. The device, called stereoscopic optical palpation (SOP), measures tissue stiffness and displays a...
CD47 Blocks Mouse but Not Human Macrophage Phagocytosis
"the classic “don’t eat me” signal CD47 has minimal impact on human macrophage phagocytosis. By contrast, CD47 strongly suppressed mouse macrophage phagocytosis."
Awaiting Faster
Looking forward to the implementation of quicker/less bureaucratic path to first in human and only one pivotal study required for approval. Question is when these changes will happen and will all FDA offices/divisions support.
Second Life for Gene Therapy; Takeda Phase 2/3 Win; UK Cancer Biotech's $83M
A Cleveland‑based biotech announced a revamped gene‑therapy platform that could give a previously stalled program a second chance, while Takeda disclosed positive Phase 2/3 results for its oncology candidate. Across the Atlantic, a UK cancer‑focused biotech raised roughly $83 million to accelerate...
BioNTech's Remarkable Vaccine Supply Chain: A Bittersweet Legacy
For those of us (OK, mainly me) obsessively tracking the details of BioNTech's *INCREDIBLE* vaccine supply chain buildout during COVID-19, this piece is bittersweet. What BioNTech achieved for humanity in 2020-21 is simply an incredible story. https://t.co/H0YcTszLjr
Viridian Data Boosts Thyroid Eye Disease Drug Prospects
Viridian data lift prospects for thyroid eye disease drug https://t.co/fjfkebQ99D by @Lilah_Alvarado $VRDN + 28% $AMGN
ADAPT OCULUS Trial Shows Promising Results in Treatment Efficacy for Ocular MG: Carolina Barnett-Tapia, MD, PhD
The ADAPT OCULUS Phase III trial evaluated efgartigimod alfa (VYVGART) in patients with ocular myasthenia gravis (oMG). In a double‑blind, placebo‑controlled arm, participants receiving the drug showed statistically significant reductions in ptosis and diplopia versus placebo. An open‑label extension confirmed continued...
Biotech Poised to Create Universal Anti‑venom Breakthrough
Day 1 @SynBioBeta first panel on building a universal anti-venom "We haven't innovated in 125yrs, since injecting horses with venom worked okay" We're now on the cusp of a universal anti-venom thanks to modern biotech https://t.co/wNbPwXjHPi
Chemical Reprogramming Triggers Toxic Lipid Droplets In Vivo
https://t.co/F6dZ4lFcUZ problem is that most groups don't publish negative results here's a recent paper from @gladyshev_lab showing that chemical reprogramming (yes, different thank OSKM) causes lipid droplet formation and significant in vivo toxicity
Genome Mining Unlocks the Chemistry of Biocontrol Fungi
Researchers at the Technical University of Denmark applied genome‑mining tools to 82 Hypocreales fungi, uncovering dozens of secondary metabolites, many of which are non‑ribosomal peptides. The study revealed both common small peptides and rare large 18‑member structures, and successfully linked...
Prolific Machines Sets Monoclonal Antibody (mAb) Manufacturing Record with Light-Controlled Platform
Prolific Machines, an SOSV portfolio company, announced a record 21 g/L monoclonal antibody titer in a 15‑day intensified fed‑batch CHO run using its light‑controlled optogenetic platform. The photomolecular system lets operators toggle gene expression in real time with light, offering reversible,...
Orexin Therapies Unlock New Horizons Beyond Narcolepsy
Orexin drugs for narcolepsy and more. Listen to Richard Pops @popsalks discuss the emerging opportunity, and his 35-year-career, on The Long Run. Sponsored by @AlphaSenseInc & Dash Bio. https://t.co/Qr6oJ8AwzB
Emcure Doubling Down on Biosimilars Pipeline: MD Satish Mehta
Emcure Pharmaceuticals is expanding its biosimilars pipeline as a wave of biologic patent expiries creates market tailwinds. The company currently sells six biosimilars through its Gennova Biopharmaceuticals subsidiary and will now seek external partners to bring additional products to India...
Single 25 Mg Psilocybin Dose Triggers Month-Long Brain Changes
A single 25 mg dose of psilocybin leads to brain structural changes that were seen at 1 month. From a cross-over study of 28 healthy volunteers, no prior psychedelic, who also were also assessed after 1 mg. Behavioral results in...
Study Surveys Dysfunctional Gene Splicing in Metastatic Kidney Disease
Researchers at City of Hope and its TGen division found that a tumor’s “splicing burden” – the frequency of aberrant gene‑splicing events – strongly correlates with clinical response in metastatic renal cell carcinoma (mRCC). By RNA‑sequencing 101 patient samples, they...
Bracco Launches BubbleGen™ Early Access Program for Microbubble-Based Cell Selection and Activation at ISCT
Bracco Imaging announced an Early Access Program for its new BubbleGen™ technology, which uses buoyant microbubbles to isolate and activate specific cell subtypes. The platform offers a one‑step, magnetic‑residue‑free alternative to traditional bead‑based cell separation, initially demonstrated with CD3⁺ T‑cell selection...
NImmune Biopharma Announces Presentations at Digestive Disease Week 2026 Supporting a Differentiated Profile and Superior Efficacy of Oral, Once-Daily NIM-1324...
NImmune Biopharma presented Phase 1 data for its oral LANCL2 drug NIM‑1324 at Digestive Disease Week, showing safety, tolerability, target engagement and superior efficacy versus existing IBD therapies. The study met all primary and secondary endpoints with no dose‑limiting toxicities and...
Hepta Reveals Blood-Based Epigenetic Signatures of GLP-1 Response, Enabling Precision Medicine in Obesity and MASH
Hepta unveiled a blood‑based cfDNA methylation assay at Digestive Disease Week 2026 that can identify patients who will lose at least 10% of body weight on semaglutide before the first dose. The SAMARA trial showed baseline epigenetic signatures distinguished responders...
Infigratinib
Infigratinib, a pan‑FGFR inhibitor previously approved for cholangiocarcinoma, is being repurposed to treat achondroplasia. After its FDA accelerated approval was rescinded in 2024 due to enrollment challenges, BridgeBio reported that the Phase 3 PROPEL 3 trial met its primary endpoint in February 2026....
Rebecca Crews Talks About Getting New Parkinson’s Disease Treatment
Rebecca King Crews, a Parkinson’s disease patient and fashion entrepreneur, underwent MRI‑guided focused ultrasound thalamotomy in July 2025 and reported rapid symptom relief. The FDA expanded the device’s indication in July 2025 to allow staged bilateral treatments, which Crews completed...
Connected by Design: How AI and Automation Are Transforming Drug Discovery at BMS
Bristol Myers Squibb (BMS) is shifting from isolated AI tools to an integrated, learning‑driven ecosystem that connects data, models, and automation across discovery and development. The company highlights its shared data backbone, AI co‑scientists, and lab‑in‑the‑loop automation as foundational layers,...
STAT+: Are Analysts Too Quick to Gloss over Lilly’s Liver Case?
Analysts are being criticized for downplaying a recent liver safety issue at Eli Lilly, raising concerns about market oversight. Meanwhile, biotech earnings showed mixed results, with Vertex shelving an mRNA cystic fibrosis candidate and Pfizer and Alkermes delivering near‑consensus Q1 numbers....
From Telecom to Longevity: Big Science Aging Talk
TODAY @ 10AM PT: LBF Conversation with Todd White @DToddWhite (Director @ Thalion Initiative). We'll be discussing Big Science for Aging Biology, fundraising, and his founder story pivoting from a career in telecom to longevity biotech. 👉 RSVP: https://t.co/UJP8xs8nrc
Viridian Reports Positive Phase III REVEAL-2 Data for Elegrobart in Chronic Thyroid Eye Disease
Viridian Therapeutics announced that its subcutaneous IGF‑1R antibody elegrobart met the primary endpoint in the phase 3 REVEAL‑2 trial for chronic thyroid eye disease (TED). Patients receiving the drug every four or eight weeks showed 50‑54% proptosis responder rates and 55‑61%...