Manufacturing Science Matters in Biosimilar Retinal Biotherapeutics
Rapid growth of biosimilars is reshaping retinal therapeutics, with ranibizumab biosimilars already market leaders and aflibercept biosimilars poised to follow. The two drugs differ fundamentally in manufacturing: ranibizumab is produced in Escherichia coli, requiring complex refolding of inclusion bodies, while aflibercept is expressed in CHO cells, enabling proper folding and glycosylation. These divergent platforms affect yields, cost, and process variability, giving aflibercept biosimilars a manufacturing advantage. Consequently, production efficiency may become as decisive as clinical equivalence for market uptake and patient access.
Additive Manufacturing as a Flexible Option for Bespoke Bioreactors
A recent study highlights additive manufacturing as a flexible alternative for producing bespoke bioreactors used in cell and gene therapy. Unlike traditional injection‑molded single‑use devices, 3D printing allows unlimited shape and size changes without new molds. Although per‑part costs are...
ACG Introduces SuperPod for Drug Protection and Sustainability
At Pharmapack 2026, ACG Packing unveiled SuperPod™, a new cold‑form blister laminate that reduces cavity size by up to 39% and triples the number of blisters per shot. The multi‑layer construction enables deeper draws without compromising the aluminum barrier, cutting material...
Johnson & Johnson Brushes Off MFN Impact, Sees Strong Growth for 2026
Johnson & Johnson downplayed the impact of the new Most‑Favored‑Nation (MFN) pricing clause on its earnings, asserting that existing contracts and a diversified portfolio cushion any downside. The company projected a robust growth trajectory through 2026, driven by its oncology...
Key Protein Can Restore Aging Neural Stem Cells' Ability to Regenerate
Researchers at NUS Medicine identified the transcription factor DMTF1 as a key driver of neural stem‑cell function in the aging brain. Experiments using human‑derived and telomere‑dysfunctional stem cells showed that DMTF1 levels drop with age, and restoring its expression revives...
Tanabe Pill Delays Blood Disorder; enGene Adds up to $100M From Loans
Tanabe Pharma announced that its oral melanocortin‑1 receptor (MC1R) agonist achieved its primary endpoint in a Phase 2 trial for a rare blood disorder, delivering a 60% response rate among patients. The pill offers a non‑injectable option that could reduce transfusion...
IntraBio Says Rare Disease Drug Passes Phase 3, Will Seek FDA Approval
IntraBio announced that its experimental therapy for ataxia‑telangiectasia (A‑T) achieved statistically significant improvement in motor function in a pivotal Phase 3 trial. The study met its primary endpoint and demonstrated a favorable safety profile across a genetically defined patient cohort....
J&J Eyes $100B in Sales Amid Gains for Cancer, Immune Drugs
Johnson & Johnson reported a 9.1% rise in fourth‑quarter sales to $24.6 billion and projected full‑year revenue of $100‑101 billion for 2026, up from $94.2 billion. The company’s growth is driven by strong cancer and immune‑therapy sales, offsetting a steep decline in its...
Quantum-Enabled Proteins Open a New Frontier in Biotechnology
University of Oxford engineers quantum‑enabled proteins, creating magneto‑sensitive fluorescent proteins (MFPs) that respond to magnetic and radio‑frequency fields when illuminated. Published in Nature, the study demonstrates deliberate design of quantum mechanical processes inside biomolecules, moving beyond observation of natural quantum...
Engineered Nanobodies Improve Respiratory Defenses in Preclinical Study
Researchers at MD Anderson and Stanford engineered bispecific nanobodies that anchor viral particles to the respiratory mucus, boosting the airway’s first‑line defense. In preclinical mouse models the nanobodies reduced infection rates for influenza and SARS‑CoV‑2 and cut viral transmission. The...
JPM26: Filling C-Suites, Union Square—And Elevators—With Pink
The Biotech CEO Sisterhood’s pink‑themed gathering at the J.P. Morgan Healthcare Conference drew up to 1,000 participants, underscoring a growing movement to spotlight women executives in biopharma. Since its 2022 launch, the group has expanded to about 350 members and...
STAT+: Novo Strikes Deal for Diabetes Cell Therapies
Novo Nordisk announced a strategic deal to acquire Aspect Biosystems, a 3‑D bioprinting company specializing in cell‑based therapies. The acquisition aims to accelerate Novo's development of encapsulated beta‑cell products for type 1 diabetes, leveraging Aspect's platform to scale manufacturing. Financial terms...
JPM26: KalVista’s HAE Win Is a ‘Tale of Two Markets’
KalVista secured FDA approval for its oral on‑demand hereditary angioedema drug Ekterly after a delayed PDUFA review and reported political pressure. The pill is positioned as the only oral option in a market dominated by injectable therapies, targeting the $3.8‑6.5 billion...
#JPM26: Regeneron, Lilly, Summit on Rivals Crowding Into Same Targets
Drug makers Regeneron, Eli Lilly and Summit Therapeutics are converging on identical biological targets, intensifying competition for potential megablockbuster therapies. The firms are pursuing treatments for diseases lacking effective options, hoping to capture large market share. Their pipelines reveal overlapping...
EU Approves Otsuka's Long-Acting HAE Drug Dawnzera
European Commission approved Otsuka’s Dawnzera, a first‑in‑class antisense RNA therapy, for prophylaxis of hereditary angioedema in patients 12 and older. Clinical data showed an 81% attack‑rate reduction with four‑weekly dosing and up to 94% reduction after one year. Otsuka secured...
Roche Raises NC Manufacturing Investment to $2B To Support Obesity Challenge
Roche, through Genentech, is boosting its North Carolina manufacturing commitment from $700 million to roughly $2 billion to expand a 700,000‑square‑foot facility in Holly Springs. The plant, slated to be operational by 2029, will add about 100 jobs, bringing total staffing to over...
GSK Joins Growing PD-1 SubQ Push With Alteogen Alliance Worth up to $285M+
GSK has committed $20 million upfront and up to $265 million in milestones to partner with South Korea’s Alteogen, aiming to create a subcutaneous version of its PD‑1 cancer drug Jemperli. Alteogen will supply its Hybrozyme recombinant hyaluronidase (ALT‑B4) to enable under‑skin...
Hopstem Maps Course to Bring Stem Cell Stroke Therapy to US
Hopstem Biotech received FDA clearance to begin US clinical trials of its iPSC‑derived stroke therapy, hNPC01, under an accelerated development pathway. The company completed a Phase 1 study in China showing sustained motor improvements over 18 months without safety concerns. The...
Think Bioscience Gets $55M to Unearth New Drug Pockets
Think Bioscience, a Boulder‑based biotech, announced a $55 million Series A round that was oversubscribed by investors. The capital will fund its platform that seeks previously hidden binding pockets on proteins and other molecules. By targeting these cryptic sites, the company aims...
ImmunityBio Rises as Route Opens to Broader Anktiva Label
ImmunityBio announced an FDA pathway to refile for Anktiva in papillary‑only NMIBC after an initial rejection. The IL‑15 agonist, already approved for BCG‑refractory CIS, generated $113 million in sales last year. Data from the QUILT‑3.032 trial show a 58.2% 12‑month disease‑free...
Researcher Finds Way to Predict Whirling Disease with Almost No Data
University of Calgary researchers have developed an AI‑driven early‑warning system that can predict whirling disease in trout and salmon using minimal data. By training a hidden Markov model on a single confirmed outbreak and leveraging readily available environmental metrics such...
JPM26 Recap, Novo’s Oral Wegovy Soars as Lilly’s Orforglipron Is Delayed, IPOs Return
At the JPMorgan Healthcare Conference, Novo Nordisk’s oral Wegovy quickly reached roughly 3,100 patients within its first week, underscoring strong demand for oral obesity therapies. Eli Lilly’s competing oral candidate, orforglipron, saw its FDA decision pushed back to April 10, despite...
Call Goes Out for Type 1 Diabetes Screening in UK
Researchers from the University of Birmingham reported that the ELSA feasibility trial screened roughly 17,000 UK children aged three to 13 using a finger‑prick autoantibody test, identifying early‑stage type 1 diabetes before symptoms appear. The study found 75 children with...
Bristol Myers Squibb Announces Collaboration with Microsoft to Advance AI-Driven Early Detection of Lung Cancer
Bristol Myers Squibb has teamed with Microsoft to embed FDA‑cleared AI radiology algorithms into Microsoft’s Precision Imaging Network, aiming to spot lung nodules earlier and streamline radiology workflows. The collaboration leverages a platform already used by more than 80% of...
Going With the Flow: Finding Success in Academic and Biotech Research Cultures
The piece contrasts academic and biotech research cultures, highlighting how each handles uncertainty. Academic labs prioritize deep exploration and iterative validation, treating ambiguous results as opportunities for further inquiry. Biotech startups focus on data that can drive decisions quickly, balancing...
TAC to the Future. Plus: GSK’s Rapt Deal, Codifying MFN — a BioCentury Podcast
Next‑generation targeting chimeras (TACs) are moving from research labs to early clinical programs, signaling a new wave of induced‑proximity therapeutics beyond PROTACs. GSK’s $2.2 billion acquisition of Rapt Therapeutics adds a China‑origin allergy platform to its pipeline, highlighting strategic biotech buyouts....
Microglia Activity in the Brain Drives Infantile Amnesia in Young Mice
Scientists at Trinity College Dublin discovered that microglial activity in the brain drives infantile amnesia in young mice. By pharmacologically suppressing microglia during a critical post‑natal window, the researchers observed heightened memory retention of a fearful task. Suppressed microglia led...
4Q25 Wrap: Megacaps Surge in 4Q as All Boats Rise for the Year
In the fourth quarter of 2025, biotech megacap companies—those valued at $10 billion or more—delivered a median stock price increase of 10%, adding $138.4 billion in market value. Over the full year, these megacaps posted the strongest performance, with a median gain...
New AI Tool Removes Bottleneck in Animal Movement Analysis
Researchers at the University of St Andrews have released PoseR, an AI plug‑in that automatically reads animal movement from video and generates human‑readable behavior descriptions. The tool leverages graph neural networks to model animal shapes, dramatically reducing the time required for...
Engineered Mucus-Tethering Bispecific Nanobodies Enhance Mucosal Immunity Against Respiratory Pathogens
Researchers engineered bispecific nanobodies that tether to airway mucus, creating a localized barrier against respiratory viruses. In mouse models, the mucus‑anchored nanobodies dramatically lowered H1N1 influenza titers in nasal passages, trachea and lungs. In a hamster cohousing experiment, a single...
Reducing Environmental Impact: Carbon Pricing and VAT Reform
A new Nature Food study by Plinke, Sureth and Kalkuhl shows that applying carbon pricing or reforming value‑added tax (VAT) on food could markedly lower Europe’s food‑related greenhouse‑gas emissions. Quantitative analysis predicts higher prices on carbon‑intensive items will curb demand...
Congress Advances PRV Reauthorization, NIH Funding, Multi-Cancer Detection Coverage
Congress is moving a bipartisan spending package that would reauthorize pediatric priority review vouchers, safeguard NIH funding, and extend Medicare coverage to multi‑cancer early‑detection tests. The House Appropriations Committee released a bill to fund the government through September and avoid...
Datwyler Collabs with Stevanato and LTS to Advance Home-Based Biologics
Datwyler, LTS Device Technologies, and Stevanato Group announced a strategic partnership to create an integrated platform for self‑administered large‑volume subcutaneous biologics. The solution combines Stevanato’s EZ‑fill® 10‑20 mL cartridges, Datwyler’s NeoFlex™ spray‑coated plungers, and LTS’s Sorrel wearable injector, targeting doses up...
Nasal Passage Cell Response to Common Cold Virus Determines Sickness Severity
Yale researchers used an air‑liquid interface organoid of human nasal epithelium to show that a rapid interferon (IFN) response limits rhinovirus infection to less than 2% of cells, while blocking IFN triggers widespread viral replication. The study also identified a...
Detecting Drought Stress in Trees From the Air
Researchers at Switzerland’s WSL used drone‑borne multispectral cameras to map drought stress across seven native tree species during the hot summer of 2023. By measuring photoprotective pigment signals and canopy greenness, they identified species‑specific responses, such as rapid oak recovery...
Tracer Reveals How Environmental DNA Moves Through Lakes and Rivers
A Cornell‑Granada team created a synthetic DNA tracer to map environmental DNA (eDNA) transport in freshwater. They released 1 µg of the tracer in Cayuga Lake, tracked its dispersion for 33 hours, and built a hydrodynamic model that predicts eDNA source locations....
Proteasomes: A Novel Approach to Target the Immune System
Proteolysis‑targeting chimeras (PROTACs) are leveraging the ubiquitin‑proteasome system to degrade disease‑causing proteins, opening treatment avenues for previously undruggable targets such as aggressive childhood cancers and resistant triple‑negative breast cancer. Major pharmaceutical companies—including Amgen, BMS, J&J, AbbVie, AstraZeneca and Novartis—have advanced...
Government Funding Bill Features PBM Reforms, Voucher Reauthorization
The U.S. House will vote on a bipartisan continuing resolution to keep the federal government operating beyond Jan. 30, bundling sweeping pharmacy‑benefit‑manager (PBM) reforms and a reauthorization of the children's health voucher program. The PBM provisions aim to increase pricing transparency,...
EU Parliament Adopts Stricter Drug Stockpiling Rules Under Critical Medicines Act
The European Parliament approved amendments to the Critical Medicines Act, introducing stricter drug‑stockpiling requirements and new financial incentives for manufacturers. The legislation mandates a minimum safety‑stock level—roughly 5 % of a product’s annual EU consumption—and tighter reporting on supply‑chain data. Companies...
Valneva Withdraws Chikungunya Vaccine From US
Valneva announced the withdrawal of its chikungunya vaccine from the United States, removing the product from the market and suspending a post‑marketing study. The decision follows internal safety assessments and regulatory feedback. The company has not provided detailed efficacy data,...
Virtual Staining Advances: AI Uses Cell Context to Improve Imaging Accuracy
Researchers at Ben‑Gurion University have introduced a contextual AI system that translates label‑free microscope images into virtual fluorescent stains, dramatically improving accuracy. By feeding the model metadata such as cell shape, neighborhood, and colony position, the AI can correctly label...
PH‐Responsive Psoralen Delivery System for Infected Bone Defects: Spatiotemporal Photothermal Disinfection Coupled with Osteogenesis and Osteoclast Regulation
Researchers introduced a pH‑responsive nanoplatform—PSO/ZIF‑8@PDA (PZP) nanoparticles—that couples photothermal activity with controlled psoralen release. The system degrades rapidly in acidic, infection‑laden bone tissue, delivering antibacterial action first, then promoting osteogenesis as the environment normalizes. In vitro studies identified an optimal...
West Launches New Prefillable Syringe System that Streamlines Biologic Delivery
West Pharmaceutical Services introduced the Synchrony S1 prefillable syringe system at Pharmapack 2026, targeting biologics and combination products. The platform offers 1 ml and 2.25 ml staked‑needle options as well as Luer‑lock configurations, paired with NovaPure and FluroTec barrier‑film plungers. By delivering a single‑source,...
Aspect Biosystems and Novo Nordisk – Enter New Phase of Partnership to Develop Curative Medicines for Diabetes
Novo Nordisk and Aspect Biosystems have entered a new partnership phase to develop curative cellular medicines for diabetes. Aspect will acquire Novo Nordisk's stem‑cell‑derived islet and hypoimmune technologies and lead development, manufacturing, and commercialization, while Novo Nordisk retains rights to...
Clinician Groups Ask Court to Overturn CDC's Childhood Vaccine Overhaul
Leading physician organizations have filed a federal lawsuit seeking to overturn the CDC’s recent overhaul of the U.S. childhood vaccine schedule. The groups contend the new recommendations are reckless and lack adequate safety evidence. The legal challenge targets the addition...
Inovalon Launches Clinical Trial Eligibility Screener to Accelerate Trial Recruitment
Inovalon introduced a Clinical Trial Eligibility Screener, an API that evaluates patient eligibility in real time using longitudinal primary source data. The service applies natural language processing to parse free‑text inclusion and exclusion criteria, delivering pass, fail or inconclusive results...
Exploring Postoperative Feeding Challenges in Neonatal Surgery
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J&J Bets on Isomorphic for AI-Powered Drug Hunt
Johnson & Johnson’s Janssen Biotech unit has entered a cross‑modality, multi‑target research collaboration with Isomorphic Labs, the Alphabet‑backed AI drug‑discovery start‑up. The partnership combines Isomorphic’s planet‑scale computing and AI‑driven design engine with J&J’s experimental and development capabilities, covering both small‑molecule...
The Shift From Containment to Protection: Packaging Trends Impacting Pharma
In 2025 pharmaceutical packaging moved from simple containment to active protection, with functional materials that mitigate moisture, oxygen and impurity risks. Companies are embedding safety features such as child resistance directly into paperboard, while sustainability mandates drive mono‑material, recyclable designs....
Key Mitochondrial Genes Linked to Necrotizing Enterocolitis
A multi‑center genomic study has pinpointed five mitochondrial genes that significantly increase the risk of necrotizing enterocolitis (NEC) in preterm infants. Researchers analyzed DNA from over 1,200 neonates and correlated gene expression patterns with clinical outcomes, revealing a clear mitochondrial...
