Argenx Names New CEO; Van Hauwermeiren to Become Chair
Swiss biotech Argenx announced that Dr. Anneliese Klein will assume the chief executive officer role on July 1, 2026, while founder Peter Van Hauwermeiren transitions to board chair. Klein, formerly head of commercial operations at Roche’s antibody division, brings deep market expertise. Van’s move to chair is intended to reinforce governance as Argenx advances its late‑stage pipeline, including the complement‑inhibitor candidate ARGX‑113. The leadership shift follows a 2025 fiscal year that delivered an 18% revenue increase and expanded the company’s global footprint.
2026 Biotech Kickoff — a BioCentury Podcast
The BioCentury podcast kicked off 2026 by evaluating biotech trends across the United States, Europe and Asia. Funding streams are reviving, with venture capital and IPO activity picking up, while innovation in gene‑editing and mRNA remains robust. At the same...
ENA Respiratory: Boosting Prophylactic Immunity with a Pan-Viral Nasal Spray
Australian biotech ENA Respiratory has unveiled a pan‑viral nasal spray that primes the host’s innate immune system to block a broad range of upper‑respiratory viruses. Early‑stage trials reported up to a 70% drop in laboratory‑confirmed infections across influenza, RSV and...
Gene Editing in Indonesia: Can New Biotechnology Solve Old Agricultural Problems?
Indonesia faces mounting food‑security pressures as climate stress and import dependence strain its staple‑centric agriculture. Gene‑editing technologies, touted for precise, non‑transgenic trait improvements, are being positioned to boost rice, cassava and sorghum yields. Yet stakeholder interviews reveal deep skepticism, especially...
Synaptic Potentiation Requires PARP1 Activation: Prevailing Concepts Are Revisited
A recent Mol Psychiatry study reveals that poly‑ADP‑ribose polymerase 1 (PARP1) activation is indispensable for long‑term synaptic potentiation (LTP) and memory formation. The authors demonstrate a DNA‑independent activation pathway where phosphorylated Erk2 binds PARP1, exposing its NAD⁺ site and triggering poly‑ADP‑ribosylation...
Suppressor tRNAs: Giving Genetic Medicines a Broader Reach
Suppressor tRNAs are emerging as a versatile platform to overcome premature stop codons that limit many gene‑editing and RNA‑based therapies. Recent preclinical studies demonstrate that engineered tRNAs can restore full‑length protein production across diverse disease models, from muscular dystrophy to...
China Clears Mepolizumab for COPD
China’s National Medical Products Administration approved GSK’s mepolizumab (Nucala) as an add‑on maintenance therapy for adults with eosinophilic COPD, making it the first monthly biologic for the disease in the country. The decision rests on Phase III MATINEE and METREX trials...
High-Throughput Platform Enables Aptamer Discovery and Kinetic Profiling
Researchers at the Chinese Academy of Sciences unveiled SPARK‑seq, a high‑throughput platform that merges CRISPR perturbations, single‑cell multi‑omics and aptamer sequencing to map aptamer‑target interactions in native cellular contexts. In a proof‑of‑concept study, the system screened over 8,000 single cells,...
Microalgae Could Fuel Hawaiʻi's Renewable Future
Researchers at the University of Hawaiʻi at Mānoa have demonstrated how synthetic biology and CRISPR‑based metabolic engineering can boost microalgae’s production of lipids and terpenoids, key feedstocks for renewable jet fuel, bio‑based chemicals, and pharmaceuticals. The study, published in Plant...
Making Smart Decisions and Investments in Trained Staff Key to 2026 Success
Raj Puri, chief commercial officer of Argonaut Manufacturing, warns that U.S. tariffs will keep pressuring pharma manufacturers in 2026, extending costs and timelines for new or upgraded facilities. He highlights that large capital projects face uncertainty in a volatile geopolitical...
Quick Execution with Operational Integrity
Meri Beckwith, Co‑CEO of Lindus Health, outlines how 2025 trends will shape pharma in 2026. AI moved from experimental to strategic, accelerating trial design, site selection and patient matching. Decentralized trial models combined with real‑world data enable nationwide recruitment and...
FUJIFILM Irvine Scientific Becomes FUJIFILM Biosciences
FUJIFILM Irvine Scientific rebranded as FUJIFILM Biosciences on Jan. 1, 2026, aligning its name with a 55‑year legacy in cell‑culture media and bioprocessing. The change underscores the unit’s shift toward biologics manufacturing and CDMO services. Recent strategic moves include a $3 billion, 10‑year...
Advancing Pharmaceutical Quality Through Integrated Digital Systems and Collaborative Scientific Innovation
Saharsh Davuluri of Neuland Labs outlines a digital overhaul of API manufacturing, leveraging AI tools such as Merck’s Synthia and automated parallel synthesizers to design scalable processes. He envisions a fully paperless plant where electronic batch records feed directly into...
Multi-Compendial Compliance for Pharmaceutical Excipients–Part 2: A Detailed Assessment for Specification Equivalence
The article presents a technical assessment of compendial tests across the European Pharmacopoeia, USP‑NF, and Japanese Pharmacopoeia to establish specification equivalence for pharmaceutical excipients. It recommends standardizing on the Ph. Eur. method for most tests, applying the tightest acceptance criteria, and...
Nearly Every Corn Seed Planted in Colorado Is Covered in Insecticide: Lawmakers May Restrict the Chemical
Nearly every corn seed planted in Colorado is coated with a neonicotinoid insecticide, a practice that protects seedlings but also introduces the chemical into plants, soil and water. Environmental groups are drafting legislation that would ban such coatings unless farmers...
Machine Learning Drives Drug Repurposing for Neuroblastoma
Researchers at Lund University used machine learning to repurpose existing drugs for high‑risk neuroblastoma. They identified a synergistic combination of a statin and a phenothiazine that markedly slowed tumor growth in mouse models. Laboratory trials showed reduced tumor cholesterol, increased...
RO4938581, a GABAA-Α5 Negative Allosteric Modulator Rescued Behavioral and EEG Phenotypes of a Mouse Model of Dup15q Syndrome
The study shows that mice carrying the 15q duplication exhibit ~1.5‑fold elevation of GABA A‑α5 receptors in cortex, hippocampus and striatum, leading to heightened inhibitory synaptic activity and a characteristic increase in beta‑band EEG power. Chronic oral administration of the selective...
A Better Way to Detect Off-Target Genome Changes From Base Editors
St. Jude Children’s Research Hospital unveiled CHANGE‑seq‑BE, a new assay that sensitively maps off‑target activity of CRISPR base editors while using only a fraction of sequencing resources. The method, published in Nature Biotechnology, demonstrated 95.4 % on‑target specificity in an FDA‑emergency case...
Epigenetic Mechanisms Affected by Stress During Adolescence and the Increased Risk for Depression Later in Life: A Systematic Review
This systematic review examined how stressful life events during adolescence reshape epigenetic landscapes and elevate depression risk later in life. By screening 30 preclinical and clinical studies, the authors identified consistent DNA methylation and micro‑RNA changes—particularly affecting the BDNF pathway—in...
Harmeier Returns to Lead Roche Venture Fund
Roche has announced that Dr. Harmeier is returning to head its Roche Venture Fund, the pharma giant’s dedicated early‑stage investment arm. Harmeier previously led the fund from 2015 to 2020 before moving to a senior role within Roche’s corporate development...
Insilico’s Big Gain After Hong Kong Listing: Finance Report
Insilico Medicine saw its stock surge after debuting on the Hong Kong Stock Exchange, climbing roughly 45% on the first trading day. The secondary offering raised about $1.2 billion, pushing the company’s market capitalization past the $10 billion mark. The strong demand...
Best of BioCentury 2025
BioCentury released its "Best of BioCentury 2025" collection, curating the year’s most consequential biotech stories from its editorial team. The anthology spotlights breakthroughs in gene‑editing, AI‑driven drug discovery, and evolving regulatory frameworks. By distilling these seminal moments, BioCentury reinforces its mission...
Advocates Regroup After Sanders Blocks Pediatric PRV Reauthorization
Senator Bernie Sanders halted a Senate vote to reauthorize the rare pediatric disease priority review voucher (PRV) program, demanding unrelated multi‑billion‑dollar spending measures be adopted first. Although he expressed support for the PRV incentive, Sanders made clear his conditions would...
Industry Outlook 2026: Success Through Top Talent, AI Utilization, and Sustainability
Ardena US managing director Ian Bilodeau says AI is reshaping pharma by linking fragmented data and speeding product decisions. He also emphasizes that attracting and developing top talent requires challenging, impact‑focused work environments. Sustainability, highlighted by Ardena’s EcoVadis certification, is...
The Evolution of Data-First Regulatory Operations
Remco Munnik of Arcana Life Sciences says European regulators are cementing a data‑first approach, with the EMA’s electronic product database and digital submission forms becoming standard. The pharma sector is eager to embed AI for document automation and quality oversight,...
Double Cone Tumble Blender Provides Homogeneity in Heavy-Duty Applications
Charles Ross & Son introduced the DCB-5 Double Cone Tumble Blender, a five‑cubic‑foot unit designed for high‑density powder processing. The machine combines a stainless‑steel jacket, a 2 HP intensifier bar, and an integrated vacuum system to deliver repeatable homogeneity and simultaneous...
A Zero-Shot Learning Framework for Maize Cob Phenotyping
Scientists have unveiled a zero‑shot learning framework that phenotypes maize cob geometry without any model retraining. The system combines text‑guided object detection, lightweight segmentation, and calibrated trait extraction, delivering 98‑100% detection accuracy and over 0.95 correlation for trait estimates. It...
From AI to Smart Factories: How Pharma Is Preparing for 2026
Manish Garg of Hikma Pharmaceuticals highlighted how AI, personalized medicine, and smart manufacturing reshaped pharma in 2025 and set the agenda for 2026. AI accelerated drug discovery and clinical design, while niche, high‑value therapies gained prominence. Companies are regionalizing supply...
New Technique Lights up Where Drugs Go in the Body, Cell by Cell
Researchers at Scripps have unveiled vCATCH, a whole‑body imaging platform that lights up covalent drugs at single‑cell resolution in mice. By attaching a tiny chemical handle to drugs and using highly selective click‑chemistry, the method tags each bound molecule with...
HITL and HOTL: An Air Traffic Control Analogy for Agentic AI
ArisGlobal’s senior VP Jason Bryant argues that both human‑in‑the‑loop (HITL) and human‑on‑the‑loop (HOTL) remain essential for deploying agentic AI in pharma. He uses an air‑traffic‑control analogy, portraying AI agents as aircraft and the orchestration layer as air‑traffic management. Bryant stresses...
Legends Lost: Baltimore, Rutter Among Biotech’s Greats to Depart in 2025
The biotech community mourned the loss of several iconic figures in 2025, including Nobel laureate David Baltimore and industry pioneer Rutter. Their careers spanned groundbreaking scientific discoveries, the founding of biotech firms, and the cultivation of global research ecosystems. The...
Industry Outlook 2026: The Impact of Novel Therapies
In 2025 the pharmaceutical sector saw a surge of novel therapies, notably next‑generation biologics such as bispecifics, fusion proteins, multi‑specifics, and a wave of antibody‑drug conjugates (ADCs). A breakthrough sub‑category, antibody‑oligo conjugates (AOCs), gained traction for muscular dystrophy, highlighted by...
Sanofi Adds HBV Vaccine, Shingles Candidate via Dynavax Takeout: Deals Report
Sanofi has agreed to acquire two vaccine assets from Dynavax, including an approved hepatitis B vaccine and a late‑stage shingles candidate. The transaction, announced in late December 2025, adds to Sanofi’s existing vaccine portfolio and broadens its reach in both...
Right Blood Pressure Drug Can Reduce Healthcare Costs
Researchers analyzed over 340,000 Swedish hypertension patients and found that initiating treatment with angiotensin‑receptor blockers (ARBs) leads to markedly higher long‑term medication persistence. After five years, 80 % of ARB starters remained adherent, versus 65 % for calcium‑channel blockers, the next best...
AI-Driven Breeding Strategy Aims to Boost Orphan Crops for Food Security
A team led by Prof. Xu Cao at the Chinese Academy of Sciences has proposed an AI‑empowered breeding framework, dubbed DSAP, to accelerate the domestication of orphan crops such as fonio, tef, and cowpea. The strategy integrates de novo genome editing,...
BioCentury’s 2025-26 Picks and Predictions. Plus: BioMarin and More Biotech ICYMI — a BioCentury Podcast
BioCentury’s year‑end podcast highlights 2025 as a turning point for biotech, with revived market sentiment, robust M&A activity and a more assertive FDA under new leadership. Analysts spotlight the $4.8 billion acquisition of Amicus Therapeutics by BioMarin as a marquee deal,...
2025 Was an Inflection Point. Will 2026 Show the Impact?
2025 emerged as a turning point for biotech, marked by a surge in follow‑on financings that lifted market sentiment. Mid‑year, capital markets revived, driven by stronger late‑stage pipeline data and the appointment of new leaders at the FDA and NIH....
Bone Disease Readout Sinks Mereo, Ultragenyx Shares: Clinical Roundup
Mereo BioPharma and Ultragenyx reported disappointing readouts from their bone disease programs, triggering sharp declines in both stocks. Mereo’s trial failed to meet its primary endpoint, while Ultragenyx showed only modest efficacy signals. The market reaction erased roughly 15% of...
Full Autonomy Is a ‘No-Go Zone’: Setting Parameters for Agentic AI in Pharma
ArisGlobal senior VP Jason Bryant explains that full autonomy for AI agents is off‑limits in pharmacovigilance, citing ethical and legal concerns. Instead, he advocates bounded autonomy managed by an orchestrator that can hand control to humans when needed. The discussion...
The Natural Human Protein Drug May Halt Neuron Death in Alzheimer's Disease
University of Colorado researchers found that the FDA‑approved drug sargramostim, a synthetic GM‑CSF protein, reduced the blood biomarker UCH‑L1 of neuronal death by 40% in Alzheimer’s patients, bringing levels down to those seen in early life. The study also documented...
Structural Covariance, Regional Topology, and Volumetric Aspects of Amygdala Subnuclei in Posttraumatic Stress Disorder Using Ultra-High Field Imaging
Using ultra‑high‑field 7 T MRI, researchers examined amygdala subnuclei volumes, network topology, and structural covariance in 73 PTSD patients, 78 trauma‑exposed controls, and 59 non‑trauma controls. Whole‑amygdala size was unchanged, but the lateral nucleus showed opposite volume shifts: larger left lateral...
Navigating Digitalization, QRM Maturity, and Global Compliance Convergence Into 2026
Henrik Johanning of Epista Life Sciences outlines the European regulatory and manufacturing roadmap for 2026, emphasizing the operationalisation of modern quality risk management (QRM) and the need for tangible upgrades to meet EU GMP Annex 1 requirements. He highlights rising digital...
The Top 10 PharmTech Videos of 2025
The PharmTech roundup reviews the ten most‑watched videos of 2025, revealing a industry pivot toward complex modalities such as AAV‑based gene therapies, high‑concentration biologics, and radiopharmaceuticals. Across the series, manufacturers stress the "CGT 2.0" model—flexible, automated, data‑driven production—to overcome scale‑up bottlenecks....
Researchers Develop Graphene Oxide Hybrid Electrodes for Real-Time Dopamine Monitoring
Researchers at SKKU, HKUST and Jeonbuk University unveiled SIDNEY, a graphene‑oxide‑wrapped hybrid electrode that enables real‑time, label‑free dopamine detection in living neurons and brain organoids. The nanostructured platform combines gold nanopillars with a thin graphene‑oxide coating, achieving a detection limit...
When Biotech Makes Christmas Miracles Happen — Second Edition
The article revisits three recent biotech breakthroughs that felt like miracles: base‑edited CAR‑T cells (BE‑CAR7) delivering remission for relapsed T‑ALL, ex vivo gene‑corrected skin grafts curing severe junctional epidermolysis bullosa, and prenatal enzyme replacement therapy mitigating infantile Pompe disease. Each case...
The Gut Bacteria that Put the Brakes on Weight Gain in Mice
University of Utah researchers identified the gut bacterium Turicibacter as a potent modulator of metabolic health, showing it markedly reduces weight gain, blood sugar, and blood lipids in mice fed a high‑fat diet. The microbe’s effect stems from a suite...
Groundbreaking Discovery Turns Household Plastic Recycling Into Anti-Cancer Medication
University of St Andrews researchers have demonstrated a ruthenium‑catalysed semi‑hydrogenation that depolymerises household PET waste into ethyl‑4‑hydroxymethyl benzoate (EHMB). EHMB is a versatile intermediate for high‑value drugs such as the cancer therapy Imatinib, as well as tranexamic acid and the...
A DIY, Fly-Powered Food Waste Recycling System
University of California‑Riverside researchers have engineered a DIY black‑soldier fly bioreactor that converts on‑site food waste into high‑protein larvae and nutrient‑dense frass. The system uses off‑the‑shelf materials, operates under a single caretaker, and yields roughly one pound of larvae per...
Accelerated Cancer Drug Approvals Deliver Limited Survival Gains at High Cost
A BMJ Medicine study examined Medicare’s use of FDA accelerated‑approval cancer drugs from 2012‑2020. Of the 178,000 beneficiaries treated, only 45% received drugs that later proved to extend survival, adding an estimated 76,000 life‑years. The three most beneficial drugs accounted...
New Microfluidics Technology Enables Highly Uniform DNA Condensate Formation
Researchers at Chuo University introduced a vibration‑induced local vortex (VILV) platform that creates highly uniform DNA condensate droplets using a low‑cost piezoelectric vibrator. The system replaces traditional microfluidic pumps with stable micro‑vortex arrays generated on a simple micropillar device, enabling...