Why CREST-2 Trial Results Should Inform, Not Replace, Clinical Judgment
The New England Journal of Medicine released the CREST‑2 results, a pair of parallel randomized trials that compared intensive medical management (IMM) alone with IMM plus either carotid stenting (TFCAS) or carotid endarterectomy (CEA) in patients with asymptomatic high‑grade carotid stenosis. Over four years, both revascularization strategies cut stroke risk versus IMM alone—2.8% versus 6.0% for stenting and 3.7% versus 5.3% for endarterectomy—but the study did not directly compare the two procedures. Researchers caution that the trial’s tightly controlled enrollment and idealized medical therapy do not mirror everyday practice, and that real‑world VQI data continue to show lower stroke rates with CEA. Consequently, CRECREST‑2 should inform, not replace, seasoned clinical judgment and the extensive evidence base supporting vascular surgeons.
Examining the Architecture of Next-Gen Biotherapeutic Modalities
BioPharm Drug Digest will host a free webinar on April 17, 2026, exploring how the biopharma sector is redesigning antibodies, RNA therapies, and cell therapies with multifunctional architectures. The session highlights programmable biology, next‑generation delivery platforms, and digitized biology models...
Biotech in New Jersey, Seven Companies Leading the Charge
New Jersey remains a heavyweight pharma cluster, home to giants like Johnson & Johnson and Merck, while nurturing a growing biotech startup scene. Companies such as ArrePath, BioAegis, Celularity, Enalare, EpiBone, Inaedis and Rocket Pharmaceuticals are advancing AI‑driven antibiotics, plasma‑protein...
Zongertinib a ‘Breakthrough’ for NSCLC with HER2 Mutations
Zongertinib (Hernexeos) received FDA accelerated approval for first‑line treatment of HER2‑mutant advanced NSCLC, based on Beamion LUNG‑1 data presented at the European Lung Cancer Congress. In previously untreated patients (cohort 2), the drug achieved a 76% objective response rate and a...
UK Biotech Day 2026 | May 27-28 | London, UK
UK Biotech Day 2026 will take place on May 27‑28 at the Radisson Hotel & Conference Centre London Heathrow. The two‑day conference convenes executives, R&D scientists, investors, legal and finance professionals from pharma, biotech, medtech, and tech‑bio sectors. Positioned as...
BIO CEO Hails Congressional Report on Threat of China Dominating Biotech
At a March 25 reception marking the first anniversary of the National Security Commission on Emerging Biotechnology report, BIO President John F. Crowley warned that China’s rapid biotech expansion threatens U.S. health security. The commission’s findings cite a 400‑fold rise...
US FDA Approves Higher-Dose of Biogen’s Genetic Disorder Drug
The U.S. FDA has approved a higher‑dose version of Biogen’s gene‑replacement therapy for a rare genetic muscle‑weakening disorder, likely spinal muscular atrophy. The new regimen starts with two 50 mg loading doses two weeks apart, followed by a 28 mg maintenance dose...
GLP-1s Are Not Going to Change Food Forever
GLP‑1 weight‑loss drugs are generating buzz as potential appetite suppressants, but current adoption remains modest—about 12% of U.S. adults and even lower in Europe. While the drugs can mute the so‑called “food noise” and trim a few percentage points off...
Study: Breath Test Could Transform Microbiome Diagnostics for Clinical Labs
Researchers at Washington University School of Medicine and Children’s Hospital of Philadelphia have demonstrated that volatile organic compounds (VOCs) in exhaled breath mirror gut microbiome activity. Published in Cell Metabolism, the proof‑of‑concept study showed breath profiles could differentiate children with...
African Trypanosomes Use a Molecular Shredder to Avoid Detection in the Bloodstream
Researchers at the University of York have identified ESB2, an RNA endonuclease that acts as a molecular shredder within Trypanosoma brucei. By selectively degrading transcripts, ESB2 fine‑tunes Variant Surface Glycoprotein expression, allowing the parasite to evade host immunity. The finding,...
Something of a Shopping Spree: Novartis to Acquire US-Based Excellergy for up to $2bn
Novartis announced a deal to acquire California‑based Excellergy for up to $2 bn, securing the Phase I antibody Exl‑111 that targets both free and cell‑bound IgE. The acquisition bolsters Novartis’ allergy pipeline, positioning the drug as a next‑generation complement to its existing...
Insilico, Tenacia Expand AI-Driven CNS Collaboration
Insilico Medicine and Tenacia Biotechnology have broadened their AI‑driven collaboration to create additional small‑molecule therapies for central nervous system disorders. Building on a March 2025 program that combined Insilico’s Pharma.AI platform with Tenacia’s proprietary data, the partners will use generative...
New AI Research Reshapes Neuroprotective Drug Discovery Funding
BCC Research’s new Pulse report, “AI Impact on Neuroprotective Agents,” outlines how artificial intelligence is reshaping the discovery, development, and delivery of neuroprotective therapies. The study projects a 4.5% CAGR for the North American market through 2030 and documents hundreds...
Scalable Biotech Manufacturing Targets $14B Cell Therapy Market
Research forecasts the global cell‑therapy manufacturing market to exceed $7 billion in 2026 and reach $14 billion by 2035. The FDA has introduced new manufacturing flexibility to accelerate approval timelines for cell and gene therapies, addressing a capacity bottleneck that analysts expect...
The Future of Sex as a Biological Variable in Health Research
On Jan. 20, 2025 President Donald Trump signed an executive order that recognizes only two sexes and mandates federal agencies use the term “sex” instead of “gender.” The order abruptly removed the NIH Sex as a Biological Variable (SABV) policy webpages, unsettling...
Europe’s Pivotal Choice: Vaccination Is Health Security
Europe is positioning vaccination as a strategic asset, linking political will, science, and capital to secure health and economic resilience. The European Commission has pledged €225 million to fast‑track next‑generation flu vaccines, including the NOFLU consortium’s mRNA mucosal candidate. By integrating...
10 European Startups to Watch in 2026
A curated list of ten European biotech startups founded since 2021 showcases rapid progress toward clinical milestones and sizable financing. Companies such as Isomorphic Labs, Draig Therapeutics and Adcytherix are moving from platform development to first‑in‑human trials, backed by funding...
AEON Biopharma Inc (AEON) Q4 2025 Earnings Call Transcript
Abeona Therapeutics reported 2025 results highlighting the commercial launch of ZevaSkin, its first autologous cell‑based gene therapy for recessive dystrophic epidermolysis bullosa. Total revenue reached $5.8 million, driven by $2.4 million product sales and a $1.5 billion gain from selling a priority‑review voucher,...
Actinium Pharmaceuticals Inc (ATNM) Q4 2025 Earnings Call Transcript
Actinium Pharmaceuticals reported adjusted 2025 revenue of $1.08 billion, a 14% increase year‑over‑year, driven by strong performance of its two core brands. NUPLAZID generated $692 million in adjusted net sales, up 15%, while DAYBUE posted $391 million, up 12%, aided by a 30%...
DeFi Development Corp (DFDV) Q4 2025 Earnings Call Transcript
Definium Therapeutics reported that its lead psychedelic candidate DT120 ODT is on track for three pivotal Phase III readouts in 2026. The EMERGE MDD study is fully enrolled with top‑line data expected in late Q2, while the VOYAGE GAD trial...
Unicycive Therapeutics Inc (UNCY) Q4 2025 Earnings Call Transcript
Unicycive Therapeutics reported a 40% revenue drop to $16.1 million for 2025, primarily from lost collaboration and contract manufacturing income, while license revenue modestly rose. R&D spending slipped slightly to $140.7 million, but SG&A surged $12.8 million as the company ramps up...
Guided Therapeutics Inc (GTHP) Q4 2025 Earnings Call Transcript
G1 Therapeutics announced FDA approval of COSELA, a first‑in‑class therapy that reduces chemotherapy‑induced myelosuppression in extensive‑stage small cell lung cancer. The company began commercial launch in early February 2021, reporting rising physician awareness and positive payer feedback. It also outlined...
Stress-Induced Plasminogen Activator Inhibitor-1 (PAI-1) as a Blood Biomarker and Brain Risk Factor for PTSD
Researchers identified plasminogen activator inhibitor‑1 (PAI‑1) as a stress‑responsive protein that rises in the dorsal hippocampus of mice and in the blood of humans with post‑traumatic stress disorder (PTSD). Using a restraint‑stress model, they showed that corticosterone triggers PAI‑1 up‑regulation...
Neumora Therapeutics Inc (NMRA) Q4 2025 Earnings Call Transcript
Neumora Therapeutics reported Q4 2025 revenue of $41.9 million, bringing full‑year sales to $62.9 million driven by the rapid commercial uptake of its ROS1‑positive NSCLC therapy Iptrozi. The drug saw 432 new U.S. patients start treatment, with 216 in the quarter, a...
INmune Bio Inc (INMB) Q4 2025 Earnings Call Transcript
INmune Bio announced the first patient dosing in its phase‑2 XPro trial targeting neuroinflammation‑driven Alzheimer’s disease and outlined parallel phase‑2 studies in mild AD and MCI that leverage biomarker‑guided endpoints. The company also detailed a six‑week phase‑2 trial for treatment‑resistant...
USA Rare Earth Inc (USAR) Q4 2025 Earnings Call Transcript
Ultragenyx Pharmaceutical reported 2025 revenue of $673 million, a 20% year‑over‑year increase that topped the upper end of guidance. The company announced a 10% workforce reduction to streamline costs and focus on near‑term value drivers. Pipeline highlights include resubmission of...
Lexeo Therapeutics Inc (LXEO) Q4 2025 Earnings Call Transcript
Exelixis reported record cabozantinib franchise revenue of $2.12 billion in the U.S. and $2.89 billion globally for 2025, a 17% year‑over‑year increase. Total Q4 2025 revenue reached $599 million, driven by $546.6 million from cabozantinib net product sales and $52.8 million in partner royalties. The...
Circuit-Targeted Modulation of Anxiety Symptoms in Individuals with Major Depression: A Randomized Head-to-Head TMS Trial
A randomized head‑to‑head trial compared two transcranial magnetic stimulation (TMS) targeting strategies in patients with major depressive disorder who also exhibit significant anxiety. Using circuit‑specific maps that differentiate anxiosomatic from dysphoric networks, the study found that the anxiosomatic‑targeted protocol produced...
RenovoRx Inc (RNXT) Q4 2025 Earnings Call Transcript
RenovoRx reported Q4 2025 revenue of $266,000, bringing year‑to‑date sales to roughly $900,000 as it expands the RenovoCath platform across 14 approved cancer centers, up from five earlier in the year. The company ended the quarter with over $10 million in...
Correction: A Brain-Enriched circRNA Blood Biomarker Can Predict Response to SSRI Antidepressants
A correction was issued for the March 30 2026 paper on a brain‑enriched circRNA blood biomarker that predicts SSRI antidepressant response. The original manuscript mistakenly marked only one of three co‑corresponding authors, omitting the other two and their contact details. The update...
Kailera Plans IPO for Phase 3 Obesity Drug From Hengrui
Kailera Therapeutics, one of biotech’s best‑funded startups, announced plans to go public to finance the Phase 3 trial of its obesity drug co‑developed with China’s Hengrui. The IPO aims to raise capital that will position the company against heavyweight rivals such...
Li Ka-Shing’s CK Life Unit Eyes China Fast Track for Cancer Vaccine Pipeline
CK Life Sciences, the Li Ka‑shing‑backed unit, has created Sequencio Therapeutics in Hong Kong to fast‑track its cancer‑vaccine pipeline in mainland China using investigator‑initiated trials (IITs). The fast‑track channel can cut trial start‑up time from 18‑24 months to a few months,...
SPIRIT-HF: Spironolactone’s Benefit Still Uncertain in HF With Preserved, Mildly Reduced EF
The SPIRIT‑HF trial, designed to test spironolactone in heart‑failure patients with preserved or mildly reduced ejection fraction, enrolled only 730 of the planned 1,564 participants and therefore lacked statistical power. Over two years, the composite of cardiovascular death or total...
Why Allogene Therapeutics (ALLO) Says Its Lead Cancer Program Is Still on Track in 2026
Allogene Therapeutics announced that its lead CAR‑T candidate cemacabtagene ansegedleucel (cema‑cel) stays on track in the pivotal Phase 2 ALPHA3 trial for first‑line consolidation in large B‑cell lymphoma, enrolling over 60 sites globally. An interim futility analysis is slated for April 2026...
Scientists Intrigued by Microbe That That Makes Mice Swole
Researchers identified the gut bacterium Roseburia inulinivorans as a factor that boosts muscle strength in both humans and mice. In a cohort of 90 young adults and 33 seniors, individuals harboring the microbe exhibited up to 29% greater grip strength...
![[Articles] Aspirin versus Clopidogrel for Chronic Maintenance Monotherapy After Percutaneous Coronary Intervention: 10-Year Follow-Up of the HOST-EXAM Trial](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/f4390aa942546562889e73ef6cd4e624.webp)
[Articles] Aspirin versus Clopidogrel for Chronic Maintenance Monotherapy After Percutaneous Coronary Intervention: 10-Year Follow-Up of the HOST-EXAM Trial
Ten‑year extended follow‑up of the HOST‑EXAM trial compared clopidogrel 75 mg daily with aspirin 100 mg daily as chronic monotherapy after PCI. Among 5,438 patients, clopidogrel achieved a 25.4% incidence of the composite of death, MI, stroke, ACS readmission, or major bleeding...
![[Comment] Moving Beyond Aspirin After Percutaneous Coronary Intervention: 10-Year Results From the HOST-EXAM Trial](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/8acb026fc2949304b649926f35a196b8.webp)
[Comment] Moving Beyond Aspirin After Percutaneous Coronary Intervention: 10-Year Results From the HOST-EXAM Trial
The HOST-EXAM trial, with ten-year follow‑up, compared clopidogrel monotherapy to aspirin after percutaneous coronary intervention. Results showed clopidogrel achieved lower rates of major adverse cardiovascular events and major bleeding. The study enrolled over 5,000 patients from diverse centers, reinforcing the...
#ACC26: Merck Leans Toward Lower Winrevair Dose in Phase 3 Trial for Rare Form of Heart Failure
Merck announced that its experimental drug Winrevair will move into a pivotal Phase 3 trial for a rare form of heart failure, focusing on the lowest dose tested in Phase 2. The Phase 2 data showed a "pretty profound" efficacy signal at that...
Tralokinumab Shows Strong Real-World Efficacy in Atopic Dermatitis for Patients With Skin of Color: April Armstrong, MD, MPH
At the American Academy of Dermatology 2026 meeting, researchers presented TRACE, a real‑world study of tralokinumab in atopic dermatitis. The trial enrolled over 800 patients, with roughly 16% representing skin‑of‑color individuals (Fitzpatrick types 4‑6). After 12 months, 80% of this subgroup achieved...
Deeper Insights Into RT Could Help Spark New CLL/SLL Therapies
Researchers report that Richter transformation (RT) can be identified years before clinical onset in chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) patients through multi‑omics profiling of tiny subclones. Current anthracycline‑based chemoimmunotherapy delivers median overall survival under one year,...
New Advances in Diabetes Drugs Are Transforming Treatment of Liver Disease
Emerging diabetes therapies are reshaping treatment of metabolic dysfunction‑associated steatotic liver disease (MASLD), especially its severe form MASH. GLP‑1 receptor agonists such as semaglutide and dual‑action agents like tirzepatide have shown significant liver‑fat reduction and histologic improvement. SGLT2 inhibitors and...
Eli Lilly to Sign $2bn Deal for AI Drug Development with Hong Kong Biotech
Eli Lilly has agreed to a roughly $2 billion partnership with a Hong Kong‑based biotech firm to develop new medicines using artificial‑intelligence platforms. The deal will give Lilly access to the startup’s AI‑driven discovery tools while providing the biotech with Lilly’s clinical expertise...
New Scalable Platform Illuminates Mechanisms of Cancer Spread
Rice University researchers unveiled the Advanced Tumor Landscape Analysis System (ATLAS), a superhydrophobic 3D‑printed microwell platform that reliably generates large numbers of three‑dimensional cancer‑cell clusters mimicking metastatic conditions. The system reproduces mechanical stresses of blood flow and enables co‑culture with...
This New Therapy Turns Off Pain without Opioids or Addiction
Researchers at the University of Pennsylvania and collaborators have developed a preclinical gene therapy that selectively silences pain‑processing circuits in the brain, mimicking morphine’s analgesic effect without activating reward pathways. Using an AI‑driven system to map morphine‑responsive neurons in mice,...
Very Low LDL Levels Best in Secondary Prevention: Ez-PAVE
New randomized data from the Ez‑PAVE trial in South Korea show that lowering LDL cholesterol to below 55 mg/dL in patients with established atherosclerotic cardiovascular disease reduces major cardiovascular events by 33% compared with a target of less than 70 mg/dL. The...
#AAD26: Biogen Declares Phase 2 Lupus Success for Anti-BDCA2 Antibody
Biogen announced positive Phase 2 results for litifilimab, its anti‑BDCA2 antibody targeting systemic lupus erythematosus. After 24 weeks, 14.7% of patients achieved complete clearance of skin lesions, meeting the trial’s primary endpoint. The data suggest the drug could become a...
KARDINAL: Monthly Tonlamarsen May Not Enhance BP Lowering in Resistant Hypertension
The phase II KARDINAL trial evaluated monthly versus single‑dose tonlamarsen, an angiotensinogen‑targeted nucleic‑acid therapy, in patients with resistant hypertension on multiple drugs. While monthly injections achieved a 67% reduction in plasma AGT compared with 23% after a single dose, both regimens...
Thousands of Americans Treated With Psilocybin in 2025
Psilocybin therapy is rapidly expanding across U.S. states, with Oregon reporting 5,935 patients in 2025 and Colorado opening its first regulated healing center. New Mexico is developing its own medical program while the federal government maintains prohibition. Scientific evidence shows...
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care
Takeda announced Phase 3 data for its oral TYK2 inhibitor, zasocitinib, showing rapid and durable skin clearance in moderate‑to‑severe plaque psoriasis. At week 16, 71% of patients achieved clear or almost clear skin (sPGA 0/1) versus roughly 10% on placebo and 30% on...
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care
Takeda announced that its oral TYK2 inhibitor zasocitinib delivered rapid and durable skin clearance in two global Phase 3 LATITUDE trials involving 693 and 1,108 moderate‑to‑severe plaque psoriasis patients. The drug met both co‑primary endpoints—sPGA 0/1 and PASI 75 at week 16—showing statistically significant...