15 Companies You’ll See at NIBRT Careers in Biopharma 2026
On Saturday, April 25, the National Institute for Bioprocessing Research and Training (NIBRT) will host its 12th annual Careers in Biopharma event in Dublin’s O’Reilly Hall. The free‑registration fair will feature 15 leading biopharma companies—including AbbVie, Amgen, Eli Lilly, Pfizer and WuXi Biologics—offering networking, lectures and upskilling for students and job‑seekers. Notable announcements include Eli Lilly’s $1 bn investment in its Limerick manufacturing hub and Amgen’s $840 m acquisition of Dark Blue Therapeutics. The gathering underscores Ireland’s role as a European biotech hub and a major talent pipeline for the sector.
Former FDA Staffer Cites Political Pressure Blocking Rare‑disease Drug Approval
Former FDA staffer - “I recently left FDA due to the political pressure I was receiving to withhold my recommendation for approval for a drug that was intended for a rare disease. I was part of a review division that...
Japanese Pharma Companies Turning to CDMOs Earlier in Product Life Cycle
Japanese pharmaceutical firms are engaging contract development and manufacturing organizations (CDMOs) earlier in the product lifecycle, especially for peptide programs. Over the past 12‑24 months, demand for preclinical and early‑clinical peptide services has risen sharply, driven by venture‑backed biotech spinouts...
Lilly’s CAR-T Devotion; CBER’s Next Top Dog?
Eli Lilly announced the acquisition of Kelonia Therapeutics, an in‑vivo CAR‑T biotech, extending its push into next‑generation cell therapies. The deal follows Lilly’s recent milestone of becoming the first drugmaker to hit a $1 trillion market value, underscoring a diversification strategy that...
The Problem with Psychedelic Research
President Trump signed an executive order to speed the approval of psychedelic drugs for veterans with PTSD and depression, marking the first major regulatory push for these treatments. A new review of 24 studies compared psychedelics to open‑label antidepressants and...
Is Pharma Missing the Boat on Diagnostics?
Pharma giants are accelerating investments in diagnostics to support precision‑medicine strategies, highlighted by Roche's $595 million purchase of SAGA Diagnostics and Abbott's $21 billion acquisition of Exact Sciences. Venture capital for diagnostics lagged behind AI, with only $1.7 billion raised last year versus...
KT-621 Gets FDA Fast Track Designation for Eosinophilic Asthma
Kymera Therapeutics received FDA fast‑track designation for its oral STAT6 degrader KT‑621, targeting moderate‑to‑severe eosinophilic asthma and atopic dermatitis. The first‑in‑class molecule works intracellularly, offering a potential oral alternative to injectable biologics that block the IL‑4/IL‑13 pathway. Phase 2b trials are...
This Artificial Retina Doesn't Just Aim to Restore Sight—It Opens a Hidden Channel of Vision
Researchers at Yonsei University and the Institute for Basic Science have unveiled an implantable artificial retina that detects near‑infrared (NIR) light and converts it into electrical pulses to stimulate surviving retinal ganglion cells. The device combines a phototransistor array with...
Sanofi’s Tolebrutinib Gets CHMP Backing for Certain MS Patients Despite FDA Rejection
Sanofi’s BTK inhibitor tolebrutinib received a positive opinion from the European Medicines Agency’s CHMP for treating relapsing forms of multiple sclerosis, despite a complete response letter from the U.S. FDA in December. The CHMP recommendation paves the way for a...
CAR T-Cell Therapy May Prevent Progression of Smoldering Myeloma
A phase‑2 trial of ciltacabtagene autoleucel (cilta‑cel) in 20 high‑risk smoldering multiple myeloma patients achieved a 100% overall response rate, with all participants reaching minimal residual disease negativity within two months and no progression after a median 15.3‑month follow‑up. The...
New Scoring Tool Shows Radiation Can Reprogram Pancreatic Tumor Environment
Researchers at Fox Chase Cancer Center introduced the Harmonic Output of Stromal Traits Factor (HOST‑Factor), a composite scoring system that quantifies the functional state of the pancreatic tumor microenvironment. Using the tool, they showed that pulsed low‑dose‑rate (PLDR) chemoradiation reprograms...
Start Lifestyle Changes With GLP‑1, Not After Stopping
The GLP-1 weight regain studies everyone is citing have a quiet design flaw: in a lot of those trials, patients were put on a rigid reduced-calorie plan while on the drug, then told to keep following that same rigid plan...
BIO Is Expanding Its Work to Defend IP
The Biotechnology Innovation Organization (BIO) is scaling its intellectual‑property advocacy by creating an IP Task Force and a new Economic Growth, Innovation, and Intellectual Property Committee to steer strategy. BIO is actively lobbying on Capitol Hill, filing amicus briefs, and...
Real‑time CGM Cuts HbA1c in Large Type 2 Diabetes Trial
Researchers led by Dr. Emma Wilmot and Dr. Lala Leelarathna reported that real‑time continuous glucose monitoring (CGM) significantly improved glycemic outcomes for 303 adults with type 2 diabetes on basal insulin, outperforming traditional finger‑prick testing. The findings, published in The Lancet...
Cardiometabolic Trials: Using Expertise to Turn Complexity Into Robust Results
Nucleus Network’s Minneapolis site has emerged as a benchmark for early‑phase cardiometabolic trials, leveraging AI‑driven recruitment, rigorous PI oversight, and advanced imaging to deliver decision‑grade data. In the Rivus RIV‑HU6‑203 study the team screened 506 candidates, randomised 80 participants and...
Mabwell Initiates P-III Trial for 9MW2821 in TNBC
Mabwell has launched a Phase III trial of its Nectin‑4‑targeting antibody‑drug conjugate 9MW2821 in patients with locally advanced or metastatic triple‑negative breast cancer (TNBC). The study pits 9MW2821 against the investigator’s choice of chemotherapy in patients who have already received taxane‑based...
FDA Declines to Approve AbbVie's Botox Follow-Up
The FDA sent a complete response letter to AbbVie, rejecting its filing for TrenibotE, a rapid‑acting, shorter‑duration botulinum toxin intended as a follow‑up to Botox. The agency’s concerns focus on manufacturing data rather than safety or efficacy, and AbbVie says...
A Watershed Event.
The FDA approved Regeneron’s gene therapy that restores hearing in children born deaf, with the company pledging free access. At the same time, Anthropic unveiled Mythos, an AI model that autonomously discovers and exploits software vulnerabilities, prompting the U.S. to...
Dasatinib and Quercetin Outperform Navitoclax in a Mouse Model of Intervertebral Disc Degeneration
Researchers compared two senolytic strategies in a mouse model of intervertebral disc degeneration, finding that the dasatinib‑quercetin (DQ) cocktail outperformed navitoclax. In SM/J mice, DQ lowered degeneration grades, reduced senescence markers such as p19ARF, p21, and SASP, and preserved nucleus...
Vistin Pharma ASA Reports Q1 Earnings Dip as European Market Pressures Persist
Vistin Pharma ASA announced first‑quarter earnings of NOK21.49 million, down 0.9% from a year earlier, while revenue fell 2.5% to NOK112.21 million. The results reflect tightening reimbursement environments and competitive pressure across Europe’s pharmaceutical sector.
Lessons Learned in the Current Biotech Funding Environment
MaxCyte CEO Maher Masoud says the recent lumpy biotech funding climate has forced companies to sharpen their focus on lead assets rather than spreading resources across multiple programs. He notes that leaner financing is sufficient to advance cell and gene...
The Long Wait for Rare Disease Treatment Approval: Q&A with Dr. Patricia E. Greenstein
In early 2026 the FDA issued draft guidance that elevates real‑world data (RWD) to a primary evidentiary role in rare and ultra‑rare disease drug approvals. The agency now accepts a single pivotal trial supported by high‑quality RWD, reducing the need...
FDA Clears First Genetic Hearing Loss Gene Therapy
Regeneron became the first company to receive FDA clearance for a gene therapy targeting congenital hearing loss, approving its OTOF‑focused product Otarmeni. The therapy, an AAV‑delivered one‑shot infusion, will be offered free to U.S. patients, a rare move given typical...
CatalYm Doses First Patient in Phase II/III VINCIT Trial
CatalYm has begun dosing the first patient in its Phase II/III VINCIT trial, evaluating the anti‑GDF‑15 antibody visugromab for cancer‑associated cachexia. The double‑blind, placebo‑controlled study plans to enroll about 518 participants with advanced solid tumours such as NSCLC and colorectal cancer....
Nanoengineered Micellar Hydrogel with Controllable Strain‐Dependent Behavior for Brain Slice‐Like Tissue Patch Bioprinting
Researchers have created a nanoengineered chitosan micelle‑crosslinked hydrogel (CDP) that can be tuned to three distinct rheological states for extrusion‑based bioprinting. By balancing dynamic covalent crosslinks with shear‑induced micelle stacking, the CDP‑II formulation tolerates up to 200% strain while maintaining...
Is Stem Cell Therapy About to Transform Medicine and Reverse Ageing?
Stem cell therapy is re‑emerging as a credible route to tissue regeneration and age‑reversal after a decade of failed anti‑ageing bets. Researchers are now demonstrating partial cellular reprogramming that restores youthful function without erasing cell identity. Early‑stage human trials from...
Case Study: Data Sharing Through DECIPHER Supports Rare Disease Research and Clinical Care
The European Genomics Initiative’s DECIPHER platform now hosts data from the University of Bristol’s GenROC study, which has collected clinical and parent‑reported information on nearly 550 children with rare neurodevelopmental disorders. DECIPHER already contains genetic and phenotypic records for more...
Diagonal Therapeutics’ Innovative Clustering Antibodies for Vascular Diseases
Diagonal Therapeutics is advancing a pioneering platform of clustering antibodies designed to restore vascular receptor signaling, targeting the root cause of genetic vasculopathies. Its lead candidate, DIAG723, has earned FDA Orphan Drug Designation for hereditary hemorrhagic telangiectasia (HHT) and shows...
Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026
Johnson & Johnson presented Phase III Vivacity‑MG3 data on its anti‑IgG antibody, Imaavy (nipocalimab), in generalized myasthenia gravis (gMG). In the 24‑week post‑hoc analysis, patients receiving Imaavy plus standard of care were about four times more likely to achieve sustained...
Regeneron Reports the US FDA Accelerated Approval of Otarmeni (Lunsotogene Parvec-Cwha) in Genetic Hearing Loss
Regeneron’s Otarmeni (lunsotogene parvec‑cwha) received FDA accelerated approval for treating severe to profound sensorineural hearing loss caused by biallelic OTOF gene variants. The therapy, provided free of charge in the U.S., was evaluated in a Phase I/II CHORD trial of...
What Defines Equipment Readiness in Pharmaceutical Production
Equipment readiness is a critical pillar for pharmaceutical manufacturers, ensuring each batch meets strict quality and safety standards. Core elements include regular calibration, thorough sanitization, preventive maintenance, and meticulous documentation. Operator training and real‑time monitoring further safeguard compliance with regulatory...
India’s Praj Industries Opens AI-Enabled Precision Fermentation Lab, Signs Government MoU
Indian biotech firm Praj Industries has opened an AI‑enabled Advanced Precision Fermentation Lab at its Pune R&D centre, Praj Matrix. The facility focuses on large‑scale precision fermentation to boost efficiency, cut carbon emissions and reduce scale‑up risk for pharma, food,...
Opinion: Prasad’s FDA Exit Good for Rare Diseases but New CBER Head Must Repair Eroded Trust
Vinay Prasad’s exit from the FDA’s Center for Biologics Evaluation and Research (CBER) follows a Senate hearing that highlighted inconsistent approval pathways for rare‑disease therapies. Industry sponsors and patient advocates complained that the agency reversed previously negotiated trial designs, leaving patients...
'Sterility Failures' Prompt FDA to Threaten Radiopharmaceutical Producer with Disciplinary Action
The FDA issued a warning letter to the University of California San Francisco Radiopharmaceutical Facility after sterility testing uncovered Bacillus contamination in a PET‑imaging agent batch. The agency found the facility’s explanation—that the bacteria entered the test tube during analysis—insufficient...
Weizmann Study Finds Genes Explain Up to 50% of Lifespan Variation
Researchers at the Weizmann Institute of Science, led by Ben Shenhar, published a study showing that genetics may account for roughly 50% of human lifespan variation, double previous estimates. The finding challenges the long‑standing view that lifestyle dominates longevity and...
FGF21 Shows Dual Action: Reduces Drinking, Shields Liver
The study validated FGF21-a liver-derived hormone currently in clinical trials for fatty liver disease “as a dual-action therapeutic that both curbs harmful drinking behaviors and protects against alcohol-related liver injury https://t.co/VdPZvQQ9qp
Results May Vary, But Reporting Shouldn’t: FDA Sends a Not-So-Gentle Reminder on ClinicalTrials.gov Compliance
On March 30, 2026, the FDA emailed more than 2,200 sponsors and investigators linked to over 3,000 clinical trials that have not posted required results on ClinicalTrials.gov or failed quality‑control review. The agency reminded that results must be posted within...
Belite Bio Files NDA for Tinlarebant After 35.7% Lesion Reduction in Phase 3 Trial
Belite Bio began a rolling New Drug Application for tinlarebant on April 21, 2026, after its Phase 3 DRAGON trial demonstrated a 35.7% reduction in retinal lesion growth for Stargardt disease patients. The filing could accelerate approval for the first...
OZMOSI Teams with Planview to Deploy AI‑Driven Portfolio Planning for Pharma R&D
OZMOSI announced a strategic partnership with Planview, integrating its machine‑readable clinical intelligence into Planview’s AI‑driven portfolio management platform. The deal gives pharmaceutical teams access to data from more than 800,000 trials, 35,000 drugs and 4,000 diseases, promising faster, data‑backed R&D...
Cumberland Pharma’s $100 Million Sale to Apotex Affiliate Sends Stock 44% Higher
Cumberland Pharmaceuticals Inc. agreed to sell its branded U.S. drug portfolio to an affiliate of Apotex for $100 million, prompting a 44% surge in its Nasdaq‑listed shares. The deal highlights ongoing consolidation in the specialty pharma market and raises questions about...
Houston Friday Night: Comedy, Immunization Partnership Celebrate Vaccines
Friday night in HoustonTX I will be there along with The Immunization Partnership and COMEDY INJECTION, VACCINES: 9th Wonder of the World https://t.co/GPSrrB3poV https://t.co/THhFN31ebn
Study Finds Rapamycin May Undermine Exercise Benefits
Researchers at the Lifespan Research Institute reported that rapamycin, a leading longevity drug, may blunt the physiological gains from regular exercise. The finding challenges the common biohacker practice of pairing rapamycin with fitness regimens and highlights a potential trade‑off between...
Hims & Hers Gains 7% on FDA Peptide Review, Faces Amazon Competition
Hims & Hers Health surged more than 7% when the FDA scheduled a July 23‑24 meeting to review several peptide drugs, giving investors a new growth narrative. The rally was later tempered as Amazon launched a competing GLP‑1 weight‑loss service,...
Spinogenix Starts CLARITY Phase 2b/3 Trial of SPG601 for Fragile X Syndrome
Spinogenix, a clinical‑stage biopharma, has launched the CLARITY trial – a two‑part Phase 2b/3 study of its oral BK‑channel modulator SPG601 in male patients with Fragile X Syndrome. The initial arm will enroll up to 48 adult males, followed by...
Tempus Teams with USC to Scale AI‑Driven Precision Oncology for 1.5 Million Patients
Tempus AI, Inc. and the Keck School of Medicine of USC announced a multi‑year collaboration that will embed Tempus’ AI platform into more than 1.5 million yearly patient visits across USC’s cancer centers. The deal covers molecular testing, trial matching, care‑gap...
RFK Jr.’s FDA Shake‑up Sparks Biotech Uncertainty
Health Secretary Robert F. Kennedy Jr.’s overhaul of the FDA, marked by rapid leadership turnover, layoffs and recent rejections of experimental cancer therapies, has left biotech firms uneasy. The turmoil coincides with a plunge in venture capital to its lowest level in two...
Blood-Derived microRNA Signatures Associated with Hippocampal Structure and Atrophy Rate: Findings From the Rhineland Study
Researchers analyzed blood‑derived microRNA profiles from over 2,000 participants in the Rhineland Study to uncover associations with hippocampal structure and its longitudinal atrophy. Cross‑sectional analysis identified a set of miRNAs—including miR‑199a‑3p/199b‑3p, miR‑155‑5p, miR‑146a‑5p and miR‑505‑5p—linked to larger left hippocampal volume,...
New Bioreactor Turns Stem Cells Into an Immune-Cell Factory, Producing 40 Million Human Macrophages per Week
Researchers at Hannover Medical School have unveiled a medium‑scale bioreactor that converts induced pluripotent stem cells into human macrophages at commercial‑grade volumes. The system can harvest up to 40 million immune cells per bioreactor each week for up to ten weeks,...
Cell Therapy Phase I Activity Accelerates on China Surge
BioCentury’s website now features a detailed Privacy Preference Center that categorizes cookies into strictly necessary, functional, marketing, advertising, and analytics groups. Users can toggle consent for each category, though disabling essential cookies may impair login and navigation. The policy clarifies...
Meta-Analysis Flawed by Mixing Disparate Anti‑amyloid Agents
A harsh critique of the recent @cochranecollab meta-analysis of the anti-amyloid drugs for Alzheimer's disease https://t.co/EU4JMOVWkV 'These results and their overarching conclusion that “successful removal of amyloid from the brain does not seem to be associated with clinically meaningful effects in...