LEO Pharma Announces New Long-Term Data for SPEVIGO® (Spesolimab-Sbzo) Injection in Adults with Generalized Pustular Psoriasis at AAD 2026
LEO Pharma presented long‑term results from the five‑year EFFISAYIL ON extension, showing subcutaneous SPEVIGO® reduced generalized pustular psoriasis (GPP) flares from an average of two per year to 0.13, with 74.6% of patients experiencing no flares over three years. Intravenous SPEVIGO provided rapid rescue, achieving a pustulation subscore of zero in half of flare treatments by week one. Safety remained consistent, though serious adverse events were reported in 36.6% of IV‑treated patients. The data were unveiled at the 2026 American Academy of Dermatology meeting.
Going ‘Golden’: K-Biotech May Be Prepping for Its Moment on the Global Stage
Korean biotech is gaining global visibility after the East‑West Biopharma Summit highlighted its first‑in‑class pipelines. The Korean Ministry of Health and Welfare announced that Eli Lilly will invest $500 million over the next five years to collaborate with domestic firms. The deal...
Rubedo Announces Positive Preliminary Results for RLS-1496
Rubedo Life Sciences reported positive preliminary Phase 1 data for RLS‑1496, the first human‑tested GPX4 modulator designed to clear senescent cells. The 4‑week, double‑blind study in the EU showed the drug was well‑tolerated, produced a clear dose‑response, and reduced epidermal thickness...
CHMP Recommends Subcutaneous Form of Sanofi's Sarclisa and Four New Drugs
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions on five products: a subcutaneous formulation of Sanofi’s multiple‑myeloma therapy Sarclisa and four entirely new drugs pending approval. The subcutaneous version aims to simplify...
Tapinarof Shows Early, Sustained Gains in Moderate to Severe Atopic Dermatitis: Linda Stein Gold, MD
At the 2026 American Academy of Dermatology meeting, phase 3 ADORING 1 and 2 trials demonstrated that once‑daily tapinarof cream significantly improves rash and itch in moderate to severe atopic dermatitis, with effects evident by week 1 and sustained through eight weeks. The studies...
Ruxolitinib Cream Improves Repigmentation, QOL in Vitiligo, but Better Patient Education, Guidance Are Needed
Ruxolitinib cream (Opzelura) demonstrated significant facial repigmentation and quality‑of‑life gains in vitiligo patients, especially those reaching F‑VASI75/90 thresholds, according to post‑hoc analyses of the TRuE‑V trials presented at the 2026 AAD meeting. Real‑world survey data revealed that just over one‑fifth...
GLP-1 Drugs: Brain‑targeted Cure for Obesity and Addictions
In 1992, scientists discovered a chemical in Gila monster venom that mimicked GLP-1, the hormone your gut releases to signal fullness. By tinkering with its structure, pharma companies extended its duration from two hours (the Gila monster version) to one...
Jesse Roth, Who Advanced the Understanding of Diabetes, Dies at 91
Renowned endocrinologist Dr. Jesse Roth, who proved that diabetes stems from defective insulin receptors, died at 91. Over a 50‑year career he led groundbreaking research at the NIH, Johns Hopkins, and the Feinstein Institutes, reshaping how scientists view hormone signaling....
Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim
In a recent FDA Q&A, Dr. Sarah Yim explained that the agency has now approved 50 biosimilars covering 15 reference biologics, spanning treatments from oncology to diabetes. She clarified the distinction between biosimilars and interchangeable biosimilars, noting that the latter...
FDA Approves Update to Neffy 1 Mg Label, Removing Age Requirement
The FDA has approved an update to the neffy 1 mg epinephrine nasal spray label, eliminating the previous age minimum of four years. The only remaining eligibility criterion is a patient weight of at least 33 lb, covering children as young as...
How Real-World Data Is Reshaping the NSCLC Patient Journey
Pharma firms are leveraging real‑world data (RWD) to map the patient journey of non‑small cell lung cancer (NSCLC) and uncover social determinants of health that hinder care. The new eBook highlights how gaps in biomarker testing, socioeconomic barriers, and incomplete...
Akeso Posts 51% Revenue Jump, Starts Phase II ADC Trials
Akeso Inc. announced a 51.5% year‑on‑year increase in 2025 commercial sales to RMB3.033 bn (about $425 m) and secured Chinese regulator clearance to launch Phase II trials of two first‑in‑class antibody‑drug conjugates. The results underscore the biotech’s rapid commercial expansion and its strategic...
Podcast: European Biotech Rallies Against US and China Powerhouses
The BIO Europe Spring podcast recorded in Lisbon highlighted Europe’s push to reclaim biotech leadership amid dominant US and Chinese pharma giants. Host Robert Barrie distilled insights from investors and executives, emphasizing the continent’s strategic focus on gene‑therapy and mRNA...
Mitochondria Delivery Method Rescues Parkinson’s in Mice
Scientists have engineered red‑blood‑cell membrane capsules to ferry healthy mitochondria into diseased cells, dramatically improving delivery efficiency. In vitro, the capsules restored mitochondrial function in mtDNA‑deficient and mutant fibroblasts, reducing pathogenic DNA fractions and boosting ATP production. In vivo, mice...
Agentic AI, Virtual Cell, LNP Vaccine Boosters, Engineered Organs, and Mergers
Agentic AI is emerging as a pivotal technology in healthcare, building on generative AI momentum. Xaira Therapeutics unveiled the largest virtual cell model to date, enhancing complex biology simulations. Researchers redesigned lipid nanoparticles to avoid the liver and concentrate in...
Lonza Media Development Lab Set Up in Singapore
Lonza has opened a dedicated media development laboratory at its Singapore campus to help bioprocessing customers fine‑tune cell‑culture media and smoothly transition formulations to GMP manufacturing. The facility applies a systematic, early‑stage optimization workflow that evaluates scalability, raw‑material readiness, and...
Regulatory Actions for March 27, 2026
On March 27, 2026 BioWorld reported a flurry of regulatory actions affecting a broad swath of biopharma and med‑tech companies. The snapshot lists approvals, designations and submissions for firms such as 3D Systems, Agilent, Deciphera, Royal Philips and several others....
J&J’s Darzalex Nets First Self-Administered Cancer Injectable Approval
Johnson & Johnson’s Darzalex (daratumumab) received European Medicines Agency approval for self‑administration, becoming the first oncology injectable cleared for home use. The Type II label change allows patients or caregivers to give the subcutaneous injection after the fifth dose, covering all...
AnaptysBio Spins Out Biotech Operations; Affibody's Data in Hidradenitis Suppurativa
AnaptysBio announced the spin‑out of its biotech operations into a newly formed independent public company, First Tracks Biotherapeutics. The separation isolates AnaptysBio’s early‑stage pipeline, giving First Tracks a focused platform to advance its candidates. The announcement also highlighted promising data...
Integrating Computational and Experimental Techniques to Decipher Neuronal Heterogeneity
Andreas Pfenning’s lab at Carnegie Mellon is merging single‑nucleus RNA‑seq, ATAC‑seq and high‑resolution spatial transcriptomics to map neuronal and glial subtypes without the shape‑bias of traditional droplet methods. AI algorithms then design cell‑type‑specific enhancers, which are screened on the 10x...
Designing Proteins by Their Motion, Not Just Their Shape
MIT researchers unveiled VibeGen, an AI diffusion model that designs proteins by specifying desired motion rather than static structure. The system pairs a designer AI that proposes amino‑acid sequences with a predictor AI that evaluates whether the sequences exhibit the...
Drug Trials Snapshots: CARDAMYST
Milestone Pharmaceuticals received FDA approval on December 12, 2025 for CARDAMYST, a 70 mg nasal spray of etripamil designed to rapidly convert acute paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm. The pivotal RAPID trial enrolled 255 adults across eight countries, showing...
Drug Digest: Examining the Growing Role of Partnerships in Modern Bioprocessing and Biopharma R&D with Bristol Myers Squibb's Dr. Manisha...
In a debut interview for BioPharm Drug Digest, Bristol Myers Squibb’s senior vice‑president of Product Development, Manisha P. Desai, explains how strategic, end‑to‑end partnerships are reshaping bioprocessing and biopharma R&D. She highlights a shift from traditional fee‑for‑service outsourcing to deep collaborations that integrate...
Celldex Reports Quality of Life Gains in Urticaria Trials
Celldex Therapeutics reported Phase 2 data showing its KIT‑targeting antibody barzolvolimab dramatically improves quality‑of‑life scores for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). At Week 52, 94 % of CSU patients achieved a Dermatology Life Quality Index (DLQI) of 0‑1, and...
William Blair Reiterates Outperform on ARS Pharma Stock After FDA Label Update
William Blair reaffirmed an Outperform rating on ARS Pharmaceuticals (NASDAQ: SPRY) after the FDA removed an age restriction for neffy patients weighing 33‑66 lb, opening the drug to roughly 25% of current epinephrine prescriptions. The firm highlighted the label change as...
Blocking TIE2 Protein May Prevent Blood Vessel Defects in the Brain
Researchers at the University of Pennsylvania identified the endothelial receptor TIE2 as a pivotal link between the MEKK3‑KLF2/4 and PI3K signaling cascades that drive cerebral cavernous malformations (CCMs). In mouse models, oral inhibition of TIE2 with the tyrosine‑kinase inhibitor rebastinib...
FDA Approves Novo Nordisk's Once-Weekly Insulin
The U.S. Food and Drug Administration has approved Novo Nordisk’s once‑weekly insulin, the first longer‑acting basal therapy for type‑2 diabetes in the United States. The product, insulin icodec, demonstrated non‑inferior HbA1c reduction and comparable safety to daily basal insulins in...
Novella Taps New CEO and Bets on ‘Precision Botanicals’ for Consistent Ingredients
Novova has appointed Antonio Martínez Descalzo as CEO and is betting on its AuraCell precision‑cultivation platform to produce standardized, waste‑free phytonutrients. The technology grows plant cells in closed bioreactors, delivering pure bioactives without soil or climate constraints. Its first product,...
In‑vivo CAR‑T Achieves 4/5 MRD‑Negative Remissions
Outstanding piece here from @leilei_wuu on AstraZeneca's in vivo CAR-T for multiple myeloma. There's data on 5 patients, which is pretty lean, but 4 come out MRD negative in two months, which is extraordinary. We're going to see a lot...
AstraZeneca's Lung Drug Scores Unexpected COPD Trial Win
AstraZeneca lung drug gets ‘surprise’ win in COPD trials https://t.co/QuRlOQtzdT @ByJonGardner $AZN $RGN $SNY $RHHBY
EU Regulator Backs Sanofi’s Injectable Version of Blood Cancer Drug
The European Medicines Agency has issued a positive opinion on Sanofi’s subcutaneous version of Sarclisa, a drug for multiple myeloma, citing late‑stage trials that proved non‑inferior efficacy to the intravenous formulation. If the European Commission follows the EMA’s recommendation, the...
Novartis Acquires Excellergy to Secure Xolair Successor
Novartis targets Xolair successor in buyout of startup Excellergy https://t.co/eGYQ2AxTd5 by @gwendolynawu $NVS $RHHBY #startups #biotech
UCLA Health Omits Patient Polygenic Risk Scores From Study
Kudos to @UCLAHealth for assessing genomics of their patient population, published @CellCellPress today. But why weren't the results of increased polygenic risk scores (PGS) provided to the patient participants? https://t.co/F15isJfDQy https://t.co/3AW7peHa1C
Brightseed Launches Enterprise AI Solution to Streamline Formulation and Manufacturing Success
Brightseed unveiled the world’s first clinically validated enterprise AI platform, designed to unite discovery, development, and commercialization for health‑science products. The system targets the industry’s 75% early‑stage failure rate by eliminating fragmented workflows and late‑stage risk discovery. Powered by the...
Aging Research Gains Momentum: Collaboration Fuels Therapeutic Breakthroughs
Now at 1M+ views. What struck me most here wasn’t the views. It was the engagement. People are ready to engage seriously with aging biology. Now the opportunity is to turn that energy into stronger collaboration, better translational science, and...
Tech Experts Overestimate Their Grasp of Cancer Biology
As someone who has covered cancer drug development for 25 years, one of the few things I am sure of is that the odds of technology folks thinking they understand biology are much higher than the odds they actually do.
Broker’s Call: Dr Reddy’s Lab (Add)
Dr Reddy’s Lab launched India’s first DCGI‑approved semaglutide, branded Obeda, at a premium price of ₹4,200 per month (≈$51) compared with peer products around ₹1,300 (≈$16). The stock trades at ₹1,281.95 (≈$15.4) against a target of ₹1,315 (≈$15.8). The company leverages advanced...
Webinar: Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises
A BioSpace webinar highlighted how biotech firms can close the expectation gap with the FDA to avoid last‑minute decision‑day setbacks. Speakers emphasized the FDA’s recent pledge—led by Commissioner Marty Makary and CBER Director Vinay Prasad—to provide regulatory navigation for small companies,...
Oral GLP‑1 Pill Orforglipron Beats Ozempic in Weight‑Loss Trial
Researchers reported that the oral GLP‑1 tablet orforglipron achieved greater weight loss and blood‑sugar reduction than injectable semaglutide (Ozempic) in a 52‑week phase‑3 study. The findings could shift prescribing patterns for obesity and type‑2 diabetes.
UT Health San Antonio Launches Precision Rapamycin Trial in 84 Seniors
UT Health San Antonio has started a National Institute on Aging‑funded, randomized trial of rapamycin and everolimus in roughly 84 adults 65 to 90 years old. The six‑week study will assess safety, optimal dosing and biological markers of healthy aging,...
Resource Capacity Planning and Modernized Time Reporting
Under PDUFA VI, BsUFA II and GDUFA II, the FDA has launched a Resource Capacity Planning (RCP) capability and modernized time‑reporting to better match staffing with the growing volume and complexity of drug and biologic submissions. The RCP system quantifies needed resources, while...
Pharma Rushes Into Psychedelics, M&A Activity Surges
Pharma’s appetite for psychedelic therapies is rapidly accelerating, with M&A interest heating up across the sector.
GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B
GlaxoSmithKline announced that the European Medicines Agency has accepted the marketing authorization application for bepirovirsen, an antisense oligonucleotide targeting chronic hepatitis B. The acceptance follows positive Phase III data from the B‑Well 1 and B‑Well 2 trials, which enrolled patients...
AstraZeneca’s in Vivo CAR-T Led to Early Responses, but One Death in China Trial
AstraZeneca’s in‑vivo CAR‑T platform, acquired last year, has entered a Phase I/II trial in China for relapsed/refractory multiple myeloma. Early data show a 33% overall response rate with several partial remissions, but the study also reported one death due to severe...
The Expanding Role of Checkpoint Inhibitors in CSCC Management
The NCCN has revised its guidelines to place checkpoint inhibitors at the forefront of cutaneous squamous cell carcinoma (CSCC) treatment, extending their use beyond metastatic disease to neoadjuvant and adjuvant settings. PD‑1/PD‑L1 agents such as cemiplimab, cosibelimab and pembrolizumab are...
Biologics for Asthma Underused in Multinational Survey
A multinational GAAPP survey of 1,401 adults with uncontrolled asthma found that only 11% of patients who meet guideline eligibility are currently using biologic therapies. The most common reason for discontinuation was difficulty fitting injections into daily routines (37%), followed...
Novartis to Spend up to $2B on Excellergy and Its Next-Gen Xolair Candidate
Novartis announced it will pay up to $2 billion upfront to acquire Excellergy Inc., securing the biotech’s next‑generation anti‑IgE candidate. The move comes as Xolair, Novartis’ blockbuster allergy drug, prepares for imminent biosimilar competition that could erode its market share. By...
Recursion Appoints Former Exelixis CMO; More Executive Moves at Incyte
Recursion Therapeutics announced the appointment of Vicki Goodman as its new chief medical officer, bringing her extensive oncology and drug‑development experience from a decade as CMO at Exelixis. Goodman will oversee clinical strategy for Recursion’s AI‑driven pipeline, aiming to accelerate...
Triple Pre-Surgery Therapy May Boost Immunity Against Soft Tissue Sarcoma
Researchers at UCLA Health and Stanford Medicine reported that a neoadjuvant regimen combining hypofractionated radiation, the experimental immunomodulator BO‑112, and anti‑PD‑1 therapy (nivolumab) can reshape the tumor microenvironment of soft‑tissue sarcoma. Preclinical mouse work and a Phase I trial in 14...
‘Milestone’ Research Method Measures Gene Activity Across Whole Mice
Researchers at the University of Chicago have unveiled a whole‑body spatial transcriptomics method that slices frozen mice and maps gene expression across millions of cells in a single cross‑section. Using a cryomacrotome and 600,000 spatial spots, the technique captured activity...