Other News to Note for March 2, 2026
At CROI 2026, researchers spotlighted the growing neurodegenerative burden among aging people living with HIV, emphasizing heightened risks of depression and cognitive vulnerability despite long‑term antiretroviral therapy. Parallelly, the University of Southern California announced a novel series of MAPT aggregation inhibitors based on a 2‑oxo‑2‑H‑chromen‑3‑yl scaffold, showing potent activity against tau‑driven pathology. Both developments underscore a shift toward addressing neurological complications in chronic disease contexts, from viral infection to neurodegeneration.
Regulatory Actions for March 2, 2026
On March 2, 2026 BioWorld published a regulatory snapshot covering biopharma and med‑tech firms such as AS Software, Asieris, Boehringer Ingelheim, Deephealth, Eli Lilly, Ipsen, Moderna, Neurogene, Novartis, Optellum, Photocure, Regeneron, Sanofi, Sentynl, Synergy Spine Solutions and X4. The roundup highlights...
Why Novo Nordisk's Ireland Expansion Is Key to Fighting Off Eli Lilly
Novo Nordisk announced a €432 million ($506 million) investment to expand its Athlone, Ireland facility, increasing capacity for oral products such as the newly launched Wegovy pill. The expansion is intended to secure supply outside the United States and help the company...
CPHI Middle East 2026 | 11-13 May, Riyadh
CPHI Middle East will return to Riyadh in May 2026, building on the 2024 edition that attracted over 30,000 visitors from more than 100 countries. The event promises expanded networking opportunities, direct market access, and the latest regulatory and innovation...
Bioxytran Reports Positive Phase 1b/2a Results for Antiviral ProLectin‑M
Bioxytran announced positive phase 1b/2a data for its oral antiviral ProLectin‑M in a randomized, double‑blind, placebo‑controlled trial of 39 mild‑to‑moderate COVID‑19 patients in India. The highest dose (16,800 mg/day) achieved viral clearance in 90% of participants by day 5 versus 20% on placebo,...
4 Large-Cap Pharma Stocks to Watch as Industry Recovery Gains Steam
The large‑cap pharmaceutical sector is rebounding in 2026 after a muted 2025, buoyed by strong quarterly results, aggressive M&A, and robust pipeline activity. Zacks ranks the industry at #172, but it posted a 10.8% gain over the past year, outpacing...
Vueway Expands Pediatric Use: Alberto Spinazzi Shares Bracco Group’s Vision
The European Union has granted approval for Vueway (gadopiclenol) to be used in neonates, infants, and toddlers, marking a pivotal expansion of pediatric MRI contrast agents. Vueway delivers diagnostic‑grade imaging at half the dose of conventional macrocyclic GBCAs, thanks to...
Safety Concerns Spur Aardvark to Halt Key Prader-Willi Drug Trial
Biotech Aardvark Therapeutics announced a voluntary pause of the Phase 3 HERO trial for its Prader‑Willi drug ARD‑101 after routine safety monitoring identified reversible cardiac observations in healthy volunteers receiving supratherapeutic doses. The pause affects both the main trial and an...
Merck, Pfizer’s Drug Combo ‘Rewrites the Standard of Care’ in Bladder Cancer
Merck and Pfizer’s Keytruda‑Padcev doublet delivered a dramatic survival advantage in the Phase 3 EV‑304 study of muscle‑invasive bladder cancer. The regimen cut the risk of disease progression, recurrence or death by 47% compared with gemcitabine‑cisplatin and lowered overall‑mortality risk by...
Big Pharma’s Next Entrant Could Come From China
Chinese drugmakers, led by Jiangsu Hengrui Pharmaceuticals, are emerging as global biotech contenders. Hengrui topped 2024 trial sponsorship, boasts a pipeline of 100 investigational drugs and 400 trials, and secured a $500 million partnership with GSK that could yield $12 billion. Analysts...
Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia
The U.S. FDA granted accelerated approval to Ascendis’ Yuviwel (navepegritide) for increasing linear growth in children aged two years and older with achondroplasia and open epiphyses. Approval rests on three placebo‑controlled trials and up to three years of open‑label extension...
Why It’s Critical to Close Open Steps in Cell Therapy Manufacturing
Cell therapy manufacturing is vulnerable to contamination because living cells cannot be terminally sterilized. Regulatory bodies such as EU GMP Annex 1 and the FDA now require risk‑based contamination control strategies that prioritize closed, sterile, and automated processes. Closing open steps...
Sanofi Receives CHMP Recommendation for Dupixent Expansion in Europe
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Dupixent (dupilumab) for paediatric chronic spontaneous urticaria (CSU) in children aged 2‑11. The recommendation is based on robust Phase III data from the LIBERTY‑CUPID...
STAT+: Trump’s Drive to Get Europe to Pay More for Drugs Creates Uncertainty for Countries, Patients
President Trump has pressed European nations to raise their drug spending, arguing that higher foreign prices would allow the United States to lower its own prescription costs. While no clear price hikes have materialized yet, the demand has sparked uncertainty...
Opus Genetics Reports Phase I/II Trial Results of OPGx-BEST1 Gene Therapy
Opus Genetics presented early Phase I/II data for its OPGx‑BEST1 gene therapy targeting best vitelliform macular dystrophy and autosomal‑recessive bestrophinopathy. In a sentinel 63‑year‑old participant, the treatment was well tolerated and delivered a 12‑letter gain in best‑corrected visual acuity after...
BioMarin Receives FDA Approval for Palynziq Use in Adolescents
BioMarin’s enzyme substitution therapy Palynziq received FDA approval for use in adolescents aged 12 and older with phenylketonuria (PKU). The decision was based on Phase III PEGASUS trial results showing 44.4% of participants lowered blood phenylalanine below guideline levels, with a...
How America’s Former Steel Heartland Secured a $3.5bn Eli Lilly Facility
Eli Lilly announced a $3.5 billion life‑sciences manufacturing complex in Lehigh Valley, Pennsylvania, slated to open in 2031. The facility will produce the company’s next generation of weight‑loss drugs and employ roughly 850 engineers, scientists and technicians. The deal, the largest life‑sciences...
18 UK Biotech Companies You Should Know About
The article profiles 18 UK biotech firms spanning oncology, immunology, regenerative medicine and AI‑driven drug design, highlighting recent milestones such as Amphista’s $30 million upfront deal with BMS, Autolus’ FDA and EU approvals for obe‑cel, and Isomorphic Labs’ $600 million raise to...
X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome
X4 Pharmaceuticals’ Xolremdi (mavorixafor) received a positive opinion from the European CHMP, recommending approval under exceptional circumstances with an EC decision expected in Q2 2026. The recommendation is based on the global Phase III 4WHIM trial involving 31 patients aged 12 and...
Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending conditional approval of Ipsen’s Ojemda (tovorafenib) as monotherapy for pediatric low‑grade glioma with BRAF fusions, rearrangements or V600 mutations. The recommendation is based on...
FDA Action Alert: BMS, GSK, Aldeyra and More
The FDA will render decisions this March on five high‑profile drug applications, including two delayed from last year. Bristol Myers Squibb seeks a psoriatic arthritis label for Sotyktu, backed by Phase 3 data showing a 54.2% ACR20 response. Aldeyra, Rhythm, GSK...
Quanterix Corp (QTRX) Q4 2025 Earnings Call Transcript
Quanterix (QTRX) reported FY 2025 revenue of $16.1 million, down $11 million from the prior year, driven by steep declines in collaboration and contract‑manufacturing income. R&D spending fell modestly to $140.7 million, while SG&A rose to $65.5 million due to higher professional fees for...
Xeris Biopharma Holdings Inc (XERS) Q4 2025 Earnings Call Transcript
Xeris Biopharma reported record Q3 2025 product revenue of $74.1 million, a 40% year‑over‑year increase driven primarily by Recorlev’s 109% revenue jump. The company posted its first quarterly net income and an adjusted EBITDA of $17.4 million, reflecting strong operating leverage and...
Uniqure NV (QURE) Q4 2025 Earnings Call Transcript
UniQure reported a regulatory setback as the FDA now deems the Phase 1/2 external‑control data for AMT‑130 insufficient for a Biologics License Application, creating uncertainty around the U.S. filing timeline. Despite this, the high‑dose AMT‑130 achieved a statistically significant 75% slowdown...
Nuvation Bio Inc (NUVB) Q4 2025 Earnings Call Transcript
Nuvation Bio reported $7.7 million net product revenue for Iptrozi in Q3 2025, driven by 204 new patient starts and payer coverage expanding to over 80% of U.S. lives. Clinical data showed an 89% overall response rate and a median...
Urogen Pharma Ltd (URGN) Q4 2025 Earnings Call Transcript
UroGen Pharma reported over $127 million in cash at the end of Q4 2025, affirming sufficient liquidity to reach profitability if current plans hold. The company highlighted steady month‑over‑month growth in Zasturi enrollment, with community treatment share now around 35‑40% and institutional...
Drug Discovery Bottleneck? Cell-Free Platform Screens Peptides Faster, Even in Harsh Conditions
Researchers at the Innovation Center of NanoMedicine unveiled PL‑display, a cell‑free platform that immobilizes individual peptides on magnetic beads for rapid screening. The method delivers over ten‑fold efficiency gains versus traditional cell‑based displays and can operate under high‑temperature, high‑salt, or...
GoodRx Launches Employer Program to Help Subsidize High-Cost Brand Drugs
GoodRx introduced GoodRx Employer Direct, a new service allowing employers to directly subsidize the manufacturer‑sponsored price of high‑cost brand medications such as GLP‑1 drugs without adding them to health‑plan formularies. The model, first piloted with retailer Hy‑Vee, lets employers contribute...
Hidden Ingredient in Ozempic and Wegovy Tablets Raises New Gut Health Questions
Researchers at Adelaide University conducted the first in‑vivo study of salcaprozate sodium (SNAC), the absorption enhancer used in oral semaglutide tablets such as Ozempic and Wegovy. Over a 21‑day period in rats, repeated SNAC exposure reduced fibre‑degrading gut bacteria, lowered...
In China, Phase 2 Study of Relma-Cel in R/R MCL Finds Durable Responses
A phase‑2 trial of relmacabtagene autoleucel (relma‑cel), a CD19‑directed CAR‑T therapy, enrolled 59 Chinese patients with relapsed/refractory mantle‑cell lymphoma after BTK‑inhibitor failure. The study reported a 71.2% overall response rate and a 59.3% complete response rate, with median time to...
Analysis Finds Efficiencies, Savings of Using a Single Bispecific for DLBCL and FL
A new analysis quantifies the operational and financial benefits of using Genmab’s epcoritamab, a dual‑indication bispecific antibody, for both relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) and follicular lymphoma (FL). In a community‑practice model of 100 patients, the study projects 3,110...
Mixed Immune Signature Identified in Chronic Hand Eczema
A phase‑2b trial enrolling 94 adults with chronic hand eczema (CHE) without etiologic pre‑selection uncovered a mixed immune signature spanning type 2, type 3 and type 1 pathways. Dupilumab, an IL‑4Rα antagonist, delivered a 59.8% mean improvement in modified Total Lesion Symptom Score...
GLP-1 News Galore; Top 100 Venture Investors; Doug Ingram to Step Down; and More
This week’s Endpoints Weekly highlighted a surge of GLP‑1 developments, including new trial data and expanded indications that reinforce the class’s dominance in obesity and diabetes treatment. The newsletter also released its annual Top 100 venture investors list, showing a notable...
EMA’s CHMP Recommends Three New Orphan Drugs, Rebuffs Two FDA-Approved Programs
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, including three orphan drugs already approved by the FDA—Ojemda for pediatric low‑grade glioma, Palsonify for acromegaly, and Xolremdi for WHIM syndrome. The agency also gave a...
Emerging Models Point to a New Operating System for Rare Disease Innovation
BioCentury’s cookie policy details five categories of cookies—strictly necessary, functional, marketing, advertising, and analytics—each serving distinct purposes on its website. Strictly necessary cookies support authentication, registration, and navigation, while functional cookies enable personalization of services. Marketing and advertising cookies help...
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[Review] Autosomal Dominant Polycystic Kidney Disease
Autosomal dominant polycystic kidney disease (ADPKD) remains the most common hereditary cause of chronic kidney disease, imposing substantial morbidity, mortality, and healthcare costs worldwide. Recent advances in molecular genetics and high‑resolution imaging have sharpened diagnostic criteria and enabled more accurate...
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[Comment] Safeguarding Genomic Integrity in Pluripotent Stem-Cell Therapies
Human pluripotent stem cells (hPSCs) are emerging as a transformative platform for Parkinson’s disease, with recent phase I/II trials showing successful engraftment of hESC‑ and iPSC‑derived dopaminergic neurons. Yet extensive data reveal that cultured hPSCs frequently acquire recurrent genetic lesions—most...
STAT+: Minnesota Report Shows Large Hospitals Continue to Dominate the 340B Drug Discount Program
Minnesota’s Department of Health reports that hospitals and clinics in the state earned at least $1.34 billion in 2024 from the 340B drug discount program. Participants received $3.045 billion in discounted medicines but paid $1.53 billion plus $165 million in administration fees. The largest...
The Science of Controlling Drug Release in Implants with Ultrasonic Spray Coating
Ultrasonic spray coating is emerging as a core engineering discipline for drug‑eluting implants, with parameters such as drug‑to‑polymer ratio, nitrogen carrier‑gas flow, nozzle height, and spray power dictating coating thickness, profile, and elution behavior. The article explains how variations in...
Promoters and Enhancers: Tool Catches Gene-Controlling DNA Sequences Doing Each Other's Jobs
Researchers at Cornell’s Weill Institute introduced QUASARR‑seq, a high‑throughput assay that measures promoter and enhancer activity simultaneously. The study found that most human regulatory elements can function as both promoters and enhancers, following a unified regulatory logic. A bidirectional feedback...
IHE: U.S. Pharmaceuticals ETF With Excellent GARP Features
The iShares U.S. Pharmaceuticals ETF (IHE) is anchored by Johnson & Johnson and Eli Lilly, whose earnings per share have nearly doubled in the past year. IHE’s aggregate one‑year EPS growth estimate is an impressive 19.07% while trading at a modest...
STAT+: Trump Most-Favored Nation Drug Pricing Deals End After Three Years for some Companies
President Trump’s "most‑favored nation" (MFN) drug pricing agreements, touted as a safeguard against excessive prescription costs, have been revealed to run for three years for several participants. SEC filings show that 16 pharmaceutical firms have entered these deals, each with...
Size-Shifting Nanoparticles Successfully Deliver mRNA Medicine to the Pancreas
Researchers have engineered size‑shifting lipid nanoparticles that grow from ~100 nm to >300 nm after intraperitoneal injection, exploiting a capsule‑filter mechanism that blocks entry into the liver and spleen while allowing passage to the pancreas. The enlarged particles deliver mRNA payloads—including CRISPR‑Cas9...
Lilly Launches LillyPod NVIDIA DGX SuperPOD for Genomics and Drug Discovery AI
Eli Lilly unveiled LillyPod, a DGX SuperPOD built with 1,016 NVIDIA Blackwell Ultra GPUs delivering more than 9,000 petaflops of AI performance. The system powers genomics, protein‑diffusion, small‑molecule graph neural networks and foundation models, allowing billions of in‑silico experiments. Constructed...
Drug Trials Snapshot: HYRNUO
Bayer's HYRNUO (sevabertinib) received accelerated FDA approval on November 19, 2025 for adult patients with HER2‑mutated, non‑squamous non‑small cell lung cancer who have progressed after prior therapy. The approval is based on the single‑arm SOHO‑01 trial, which enrolled 122 patients across 78...
A New Antibody Treatment For Breast Cancer
A year-long trastuzumab emtansine (T‑DM1) regimen showed 98% three‑year invasive‑disease‑free survival in early‑stage HER2‑positive breast cancer, comparable to standard paclitaxel‑plus‑trastuzumab. The ATEMPT trial of nearly 500 patients found similar overall survival but markedly lower neuropathy and hair loss with T‑DM1,...
Boehringer Wins Speedy Lung Cancer Approval Under Commissioner’s Priority Program
The FDA granted accelerated approval to Boehringer Ingelheim’s oral HER2 kinase inhibitor Hernexeos six weeks after the company filed its application, marking the second approval under the new Commissioner’s National Priority Voucher (CNPV) program. The decision expands Hernexeos use to...
Promatix EGFR×EphA2 Bispecific ADC Exerts Antitumor Activity
Today’s brief highlights four pre‑clinical advances: Paratus Sciences unveiled PS‑1001, a pan‑inflammasome blocker targeting IL‑1β and IL‑18 for hidradenitis suppurativa; researchers identified the SCAN circuit as a core pathway disrupted in Parkinson’s disease; RX‑10616 demonstrated enhanced radiotherapy response in head‑and‑neck...
Prospect Therapeutics Identifies New JAK1 and TYK2 Inhibitors
Prospect Therapeutics announced the identification of a new series of small‑molecule inhibitors targeting Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2). The lead compounds demonstrate nanomolar potency and selectivity in biochemical assays and effectively suppress cytokine signaling in cellular...
How PBM Reforms Could Push Drugmakers Into the Pricing Spotlight
The Consolidated Appropriations Act of 2026 bans pharmacy benefit managers (PBMs) from receiving compensation tied to drug list prices and mandates 100% rebate pass‑through to plan sponsors by August 2028. The law also allocates roughly $190 million to the Centers for...