AAPS National Biotechnology Conference
The AAPS National Biotechnology Conference will take place May 11‑14, 2026 in San Diego, gathering leading pharmaceutical scientists to discuss the latest advances in biologics, biotechnology products, and advanced therapies. The four‑day event offers sessions on new modalities, technologies, and novel strategies for biotherapeutic development. Hosted at the Sheraton San Diego Resort, the conference provides a platform for industry networking, regulatory updates, and knowledge exchange. Registration is open through the AAPS website, with contact available via meetings@aaps.org.
Lilly Stockpiles $1.5B Worth of Weight Loss Pill Ahead of US Approval
Eli Lilly has amassed roughly $1.5 billion worth of its experimental obesity drug orforglipron. The company began stockpiling the product months before the U.S. Food and Drug Administration is expected to grant approval later this year. Orforglipron, a GLP‑1 receptor agonist, joins...
STAT+: Pediatricians Confront HHS in Vaccine Showdown
The FDA unexpectedly refused to review Moderna’s mRNA‑based flu vaccine, sparking alarm across biotech firms. Pediatricians are confronting the Department of Health and Human Services (HHS), demanding transparent guidance on pediatric flu immunization. The decision highlights perceived regulatory volatility under...
Immunic's Private Placement; Vertex's Cystic Fibrosis Data in Young Kids
Immunic announced an oversubscribed private placement raising up to $400 million to fund its shift toward a commercial‑stage biotech. The capital injection will support late‑stage development programs and accelerate the search for a new chief executive officer. Meanwhile, Vertex Pharmaceuticals disclosed...
Bankruptcy Threat Looms as Quince Runs Out of Options
Quince Therapeutics warned investors it may need bankruptcy protection after its lead drug eDSP failed a pivotal phase 3 trial for ataxia‑telangiectasia. The SEC filing disclosed less than $6 million in cash, $12 million in short‑term investments and a $16 million unsecured line of...
Ovid Takes Another Big Swing in Neuroscience Under a New CEO
Ovid Therapeutics, under new CEO Meg Alexander, is re‑orienting its neuroscience pipeline toward first‑in‑class KCC2 modulators while advancing a drug‑resistant epilepsy candidate toward Phase 2. The company’s earlier flagship, soticlestat, failed in Phase 3, eliminating $600 million in potential milestones, prompting a strategic...
All Eyes on Vertex’s Kidney Franchise, as Painkiller Journavx Tops Half a Million Scripts
Vertex Pharmaceuticals reported that its late‑stage RAINIER trial of povetacicept in IgA nephropathy is proceeding without safety concerns, with primary data expected in the first half of 2026. The company is leveraging a priority‑review voucher for the upcoming FDA filing...
Startup Organotics Fast Tracks Personalized Brain Drug Trials
Organotics, a new biotech startup, is leveraging patient‑derived brain organoids to accelerate early‑stage testing of neuropsychiatric drugs. By reprogramming a patient’s blood or skin cells into induced pluripotent stem cells, the company creates vascularized, multi‑region mini‑brains that reflect individual genetics....
Paul Hudson Couldn’t Quite Get Sanofi over the Hump; PROTAC Developer Arvinas Appoints CEO
Paul Hudson has struggled to revitalize Sanofi’s R&D engine despite a series of high‑profile acquisitions since becoming CEO in 2019. The French group’s pipeline has underperformed, and recent buyouts have failed to deliver the expected boost in innovative drug candidates....
PTC Pulls File for Duchenne Therapy on FDA Feedback
PTC Therapeutics has withdrawn its FDA filing for Translarna (ataluren) as a treatment for nonsense‑mutation Duchenne muscular dystrophy after the agency indicated the data would not meet the threshold for substantial evidence of effectiveness. The decision ends a decade‑long effort...
Medicare Part B Lab Spending Hits $8.4 Billion as Genetic Testing Captures 43% of Dollars
Medicare Part B lab spending reached $8.4 billion in 2024, up 5 % year‑over‑year. Genetic tests, though only 5 % of test volume, accounted for 43 % of the dollar value, driving a $3.6 billion surge. Utilization of molecular diagnostics jumped 160 % since 2018, while routine...
Lyell Doses First Patient in Phase III Trial for LBCL
Lyell Immunopharma has administered the first dose of its investigational CAR‑T therapy, ronde‑cel (LYL314), in the Phase III PiNACLE‑H2H trial for relapsed or refractory large B‑cell lymphoma. The head‑to‑head study randomizes roughly 400 patients to receive either ronde‑cel at 100 × 10⁶ cells...
Using AI to Crack Undruggable Drug Targets
ProPhet, an Israeli AI‑driven startup founded in late 2024, leverages a novel machine‑learning platform that projects proteins and small molecules into a common interaction space. This approach allows the company to screen billions of compounds against targets previously deemed undruggable,...
Novocure Wins FDA Approval to Treat Pancreatic Cancer with Electric Fields
Novocure received FDA clearance for its Optune Pax tumor‑treating‑field device in locally advanced pancreatic cancer, marking the company’s first indication beyond brain tumors. The pivotal trial of 571 patients showed a statistically significant two‑month overall‑survival gain (16.2 vs 14.2 months) when the device was...
Antigen Orientation Boosts HPV Cancer SNA Vaccine, Slows Tumors in Models
Northwestern researchers engineered a spherical nucleic acid (SNA) vaccine in which the HPV16 E7 peptide is displayed at the nanoparticle surface via its N‑terminus. This N‑terminal orientation (N‑HSNA) generated up to eight‑fold higher interferon‑γ secretion and 2.5‑fold greater cytotoxicity than...
Vaccine Play Iliad Draws Nine-Digit B Round; Denmark’s Gubra Launches Venture Creation Unit
Iliad Biotechnologies announced a $115 million Series B round, the largest venture deal of the week, led by RA Capital Management. New investors Janus Henderson and BNP Paribas Asset Management Alts also participated. The funding will accelerate Iliad’s intranasal vaccine program targeting pertussis...
3-Year EPCORE NHL-1 Data Published Showing 53% Have Deep, Durable Remission
The EPCORE NHL‑1 trial released three‑year data showing that epcoritamab (Epkinly) delivers deep, durable remissions in heavily pre‑treated large B‑cell lymphoma. Among patients who achieved a complete response, 53% remained progression‑free at the data cutoff, with a median CR duration...
Loberamisal Scores a Rare Win for Stroke Neuroprotection
The phase III LAIS trial showed that loberamisal, a novel neuroprotectant, raised the proportion of acute ischemic‑stroke patients achieving an excellent functional outcome (mRS 0‑1) to 69.7% versus 56.4% with placebo when given within 48 hours of symptom onset. The study enrolled 997...
ASPR Announces Competition for Antiviral Drug Development Targeting Certain Viruses
The Administration for Strategic Preparedness and Response (ASPR) has unveiled a $100 million Small Molecule Approaches for Rapid and Robust Treatment Prize to spur antiviral drug development. The competition targets viruses in the Togaviridae and Flaviviridae families, including dengue, Zika, West...
Kainova Closes $32 Million to Advance Cancer and Inflammation Therapies
Kainova Therapeutics announced a CAD 32 million first close of its Series B financing, led by Investissement Québec and supported by existing backers. The funding brings total venture capital to about $90 million USD and will accelerate development of its GPCR‑focused drug candidates. Lead...
Pharma CEOs Should Demand Prasad’s Departure
BioCentury’s editorial warns that the current director of the FDA’s Center for Biologics Evaluation and Research (CBER) is jeopardizing patient safety and destabilizing the pharmaceutical industry. The author cites the director’s handling of Moderna’s flu vaccine as a recent example...
Seres to Lay Off Staff, Pause Top Program in Latest Reboot
Seres Therapeutics, a cash‑strapped microbiome drug developer, will cut about 30 % of its workforce and suspend its lead program SER‑155, which targets graft‑versus‑host disease. The company will redirect resources toward earlier‑stage immunology candidates such as SER‑603, aiming to extend its...
Terray’s AI Model Accelerates Drug Potency Prediction, Pose Not Needed
Terray Therapeutics unveiled TerraBind, an AI model that predicts small‑molecule potency without generating a binding pose. The model delivers roughly 20% higher accuracy and a 26‑fold efficiency boost versus the open‑source Boltz‑2 benchmark. By eliminating the computationally intensive pose step,...
Blinded by Science: The Importance of RWD and Post-Market Surveillance
The explosive uptake of GLP‑1 drugs—now used by roughly 12% of U.S. adults—has spotlighted both their therapeutic benefits and emerging safety concerns. Post‑market surveillance, leveraging real‑world data (RWD), is uncovering rare vision‑related adverse events that clinical trials missed. AI‑driven analytics...
STAT+: BridgeBio Drug for Genetic Cause of Dwarfism Succeeds in Key Study
BridgeBio Pharma's oral drug infigratinib met its primary endpoint in a pivotal trial of more than 100 children with achondroplasia, delivering an average growth increase of 2.1 cm per year versus placebo. Adjusted analysis showed a 1.74 cm per year advantage, both...
STAT+: European VCs Band Together to Improve the Landscape for Biotech Startups
European venture capital firms have launched the European Life Sciences Coalition, a new alliance aimed at strengthening funding pipelines for biotech startups across the continent. The coalition highlights a stark financing gap: of the 67 EU‑based biotech firms that went...
Robots on the Red Line: A Video Update From SLAS 2026
The Society for Laboratory Automation and Screening (SLAS) 2026 conference in Boston highlighted a surge in laboratory robotics and AI-driven automation. Speakers showcased new modular robot platforms and discussed scaling high‑throughput omics workflows. The keynote underscored how intelligent automation can...
OPTION: IV Tenecteplase Boosts Outcomes Late After Non-LVO Stroke
The randomized OPTION trial showed that intravenous tenecteplase given 4.5 to 24 hours after symptom onset improves functional outcomes in patients with acute non‑large‑vessel‑occlusion (non‑LVO) strokes. At 90 days, 43.6% of tenecteplase recipients achieved a modified Rankin Scale score of...
Anti-Epileptic Drug May Prevent Early Plaque Formation in Alzheimer’s Disease
Scientists at Northwestern University identified that the toxic amyloid‑beta 42 peptide accumulates inside neuronal synaptic vesicles and that the FDA‑approved anti‑epileptic drug levetiracetam can halt this process. By binding to the SV2A protein, levetiracetam alters APP trafficking, keeping the precursor...
Streamlining Research Antibody and Reagent Selection
CiteAb unveiled the Explore Platform, combining its long‑standing reagent search engine with a new image‑search capability. The platform draws on a database of more than 16 million research tools cited in over 40 million publications, spanning antibodies, proteins, models and kits. Its...
Mayo Clinic Platform Standardizes Cancer Data to Speed Up Trials
Mayo Clinic Platform’s Orchestrate tool has added new capabilities that deliver standardized, research‑ready cancer data. The upgrade leverages the OMOP Oncology common data model to transform unstructured inputs such as pathology reports and imaging into consistent tumor characteristics, biomarkers, and...
STAT+: The Unusual Prasad Missive in the FDA’s Rejection of the Moderna Flu Shot Application
Moderna announced that the FDA rejected its mRNA‑based flu vaccine, a move that caught the company off guard. The decision sparked a public critique from oncologist Vinay Prasad, who questioned the agency’s evaluation process. At the same time, regulators are...
Seven Influential Women in Biotech in 2026
The article spotlights seven women reshaping biotech in 2026, from Shehnaaz Suliman’s $29 million‑funded mRNA program at ReCode to Julie Kim’s historic appointment as Takeda’s first female CEO. It details their strategic wins—such as Vertex’s CRISPR therapy approval under Reshma Kewalramani...
NIH Researchers Identify Four-Marker Blood Test That May Improve Early Pancreatic Cancer Detection
NIH‑backed researchers reported a four‑marker blood test that improves early detection of pancreatic ductal adenocarcinoma. The panel combines CA19‑9, THBS2, ANPEP and PIGR, achieving 91.9% overall accuracy at a 5% false‑positive rate and 87.5% sensitivity for stage I‑II disease. The study...
BioRestorative Concludes Phase II BRTX-100 Trial Enrolment for cLDD
BioRestorative Therapies announced completion of patient enrollment for its Phase II BRTX‑100 trial in chronic lumbar disc disease, enrolling 99 subjects at 15 U.S. sites. The double‑blind, sham‑controlled study randomizes participants 2:1 to receive an autologous hypoxically cultured mesenchymal stem cell...
Eight Biotech Companies Spearheading the Antibody Drug Conjugate New Wave
A new wave of eight biotech firms is redefining antibody‑drug conjugates (ADCs) by pursuing unconventional targets, advanced linker chemistries, and novel cytotoxic payloads. Companies such as Adcendo, Adcentrx, and Tubulis are advancing phase 1/2 programs that address sarcoma, Nectin‑4, NaPi2b, and...
Developing a Risk-Scoring Tool for Artificial Intelligence-Enabled Biological Design
Researchers at RAND released a risk‑scoring framework to evaluate AI‑enabled biological design threats. The tool separates biological modification impact across five functions—host range, replication, immune evasion, environmental stability, and transmission—and an actor capability dimension that gauges technical skill and AI...
Gilead Dips as ‘Strong’ Earnings Outweighed by High Expectations for New HIV Drug
Gilead Sciences reported a strong fourth‑quarter, with product sales reaching $7.9 billion, a 5% year‑over‑year increase, and its flagship HIV treatments Biktarvy and Descovy surpassing analyst forecasts. The company projected full‑year sales of $29.6‑$30 billion and EPS of $8.45‑$8.85, staying within consensus...
A Thousand Physicians Call on FDA to Reverse CRL for Myopia Drug
More than a thousand physicians have signed a citizen petition urging the FDA to overturn its complete response letter (CRL) rejecting SYD‑101, Sydnexis Inc.'s pediatric myopia treatment. The company met the agency‑specified primary endpoint, but the FDA concluded the data...
FDA’s Accelerated Approval Messaging Collides with CRL Reality
The FDA issued a complete response letter (CRL) rejecting Regenxbio’s accelerated‑approval application for clemidsogene lanparvovec, a gene therapy targeting Hunter syndrome (MPS II). The decision underscores a growing disconnect between the agency’s public messaging on accelerated pathways and its actual regulatory...
Moderna Says FDA Refuses to Review Its Application for Experimental Flu Shot
Moderna announced that the FDA will not begin a review of its experimental mRNA‑1010 flu vaccine, citing concerns over the trial's comparator design rather than safety or efficacy. The decision triggered a roughly 7% drop in Moderna’s after‑hours share price....
Software Tool Can Detect Hidden Errors in Complex Tissue Analyses
A new software tool called ovrlpy, developed by the Berlin Institute of Health at Charité, detects hidden errors in spatial transcriptomics by identifying vertically overlapping cells and tissue folds. Published in Nature Biotechnology, the tool is the first to analyze...
Brain Stimulation Encourages More Altruistic Behavior, Study Finds
Researchers applied transcranial alternating current stimulation to synchronize gamma oscillations between frontal and parietal cortices, leading participants to share more money in the Dictator Game. The experiment involved 44 adults who each made 540 allocation decisions, providing a robust behavioral...
Isomorphic Claims Major Advance with New AI Drug Design Engine
Isomorphic Labs, the DeepMind spin‑off behind AlphaFold 3, announced a new AI‑driven drug design engine that builds on its protein‑structure predictions. The platform claims to generate novel small‑molecule candidates up to ten times faster while achieving sub‑nanomolar binding‑affinity accuracy. Early validation...
Researchers Discover Molecular Switch Regulating T Cell Exhaustion in Cancer
An international team led by Prof. Guideng Li and Dr. Philip D. Greenberg identified a molecular switch that drives CD8⁺ T‑cell exhaustion in cancer. Chronic TCR signaling phosphorylates FOXO1, suppressing transcription of the E3 ligase KLHL6, which normally degrades the...
Google's AI Drug Discovery Spinoff Isomorphic Labs Claims Major Leap Beyond AlphaFold 3
Isomorphic Labs, the AI medicine arm of Google DeepMind, unveiled the Isomorphic Labs Drug Design Engine (IsoDDE), claiming it outperforms AlphaFold 3 in protein‑ligand structure prediction. The company reports that IsoDDE doubles AlphaFold 3’s accuracy on novel protein‑ligand pairs and delivers rapid...
AbbVie, AstraZeneca Lose Appeal in Louisiana 340B Contract Pharmacy Fight
A U.S. appeals court upheld Louisiana's law that restricts how 340B‑discounted drugs can be dispensed through contract pharmacies. The ruling rejected the challenge mounted by AbbVie and AstraZeneca, marking another defeat for drugmakers contesting state oversight of the federal 340B...
NIH Stops Low-Dose Xarelto Arm of Large Stroke Study Due to Safety Concerns
The National Institutes of Health has stopped the low‑dose Xarelto arm of a large, multi‑center stroke trial after an interim safety analysis revealed excess bleeding. The study, which enrolled roughly 5,000 patients with recent ischemic stroke, was testing rivaroxaban 2.5 mg...
University of South Alabama Research Recognized Among Top 10 Scientific Breakthroughs of 2025
The University of South Alabama’s research portfolio was named one of the top ten scientific breakthroughs of 2025. The accolade highlights a suite of studies ranging from a novel photofission method for producing medical isotope 99Mo to a molecular switch...
