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Articles by Dan Marino
1980’lerin Miami Hurricanes’i Tarihe Geçti
Amerikan kolej futbolunun 150 yılı aşkın tarihinde pek çok dominant takım vardı, ancak 1980’lerde Miami Hurricanes, spora damga vuran en etkileyici ekiplerden biri oldu. Sahanın dışına taşan özgüvenleriyle rakiplerini sürekli rahatsız eden takım, gol sonrası saha ortasında dans etmesi ve parlak turuncu formalarıyla dikkat çekiyordu. Bu tarz, John U. Bacon’a göre kolej futbolunu adeta bir tiyatroya dönüştürdü ve Kanaryalar, kolej futbolunun kötü çocukları olarak anıldı.
Vetter Starts Construction of a New Production Site in Germany
Vetter, a leading Contract Development and Manufacturing Organization (CDMO), is celebrating the start of construction on its new site in Saarlouis with a traditional groundbreaking ceremony today. During the first construction phase, the company will build a state-of-the-art facility for the commercial production of injectable drugs on the 95-acre industrial site.
Zenas BioPharma Announces First Subject Dosed in Phase 1 Clinical Trial of ZB021, a Novel, Potentially Best-in-Class Oral IL-17AA/AF Inhibitor
Zenas BioPharma, Inc. recently announced that the first subject has been dosed in the Phase 1 trial of ZB021, a novel potentially best-in-class oral IL-17AA/AF inhibitor. “Dosing the first subject in our Phase 1 trial of ZB021 marks an important milestone for Zenas as we rapidly advance our earlier-stage pipeline and broaden our presence in autoimmune and inflammatory diseases,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas.
Enterprise Therapeutics Achieves Primary Efficacy Outcome in Phase 2 Clinical Trial for Cystic Fibrosis With Novel Inhaled ENaC Blocker ETD001
Enterprise Therapeutics Ltd (Enterprise), a biopharmaceutical company dedicated to the discovery and development of novel therapies to improve the lives of people with respiratory diseases, today announced that its Phase 2 trial for ETD001, the Company’s lead candidate for treatment of cystic fibrosis (CF), achieved its primary efficacy outcome.
ENA Respiratory Successfully Completes First Part of Phase II Study of INNA-051 Nasal Spray Designed to Protect Against Symptomatic Viral Respiratory Infections
ENA Respiratory, a clinical-stage pharmaceutical company developing antiviral host defence enhancers to minimize the impact of symptomatic viral respiratory infections, today announces the successful completion of Part A of its Phase IIa community study of INNA-051, and progression to Part B.
Cereno Scientific Enters Collaboration with PHA Europe & Global to Advance Patient-centered Drug Development in Pulmonary Hypertension
Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced a collaboration with the patient organization PHA Europe & Global. The partnership aims to strengthen patient-centric drug development, increase disease awareness, and improve outcomes for individuals living with pulmonary arterial hypertension (PAH) and related pulmonary hypertension conditions.
Hongene Demonstrates Advanced Oligonucleotide CDMO Capabilities Through Support of SiranBio’s Dual-Target siRNA Program
Hongene Biotech Corporation recently announced its support of SiranBio’s SA1211 program, a dual-target siRNA candidate for chronic hepatitis B, underscoring Hongene’s ability to deliver end-to-end development and manufacturing solutions for structurally complex oligonucleotide therapeutics.
Ecolab Life Sciences Opens Bioprocessing Applications Lab in Korea to Support Downstream Process Development Across Asia
Ecolab Life Sciences is expanding the bioprocessing business with the launch of a new Bioprocessing Applications Lab (BPAL) in Dongtan, Korea, giving biopharmaceutical manufacturers across Asia better local access to downstream process development support. Strategically located to serve customers throughout the region, the site is Ecolab’s first bioprocessing facility in Asia and joins an established applications network in the United States and the United Kingdom.
Achieve Life Sciences Announces Operational Progress Including Completion of Technology Transfer to Adare Pharma Solutions
Achieve Life Sciences, Inc.recently announced significant operational progress including the transfer of cytisinicline manufacturing to U.S.-based Adare Pharma Solutions (Adare). Achieve has now completed the analytical method transfer to Adare’s manufacturing facility in Vandalia, Ohio. Completion of these activities ensures that all testing procedures are fully qualified at the site, maintaining the highest standards of quality control and regulatory compliance.
Argo Biopharma Announces First Subject Dosed in Phase I Study of siRNA Therapeutic BW-50218
Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage biotechnology company committed to developing next-generation siRNA therapies, today announced the first subject has been dosed in its Phase I clinical trial evaluating BW-50218, in Australia. BW-50218 is an siRNA therapeutic agent targeting the transthyretin protein (TTR). “We are pleased to have dosed the first subject in our Phase 1 trial of BW-50218.
Intellia Therapeutics Reports Positive Phase 3 Results in Hereditary Angioedema, Marking a Global First for In Vivo Gene Editing
Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today announced positive topline results from the global Phase 3 HAELO clinical trial of lonvo-z (formerly known as NTLA-2002) in hereditary angioedema (HAE).
Evonik Strengthens Biotechnology Capabilities for Drug Substance Manufacturing With New Investment in Slovakia
Evonik is investing around EUR 80 million to expand its biotechnology capabilities at its Fermas site in Slovenská Ľupča, Slovakia. The investment will add state-of-the-art downstream fermentation technology to support the contract manufacturing services of the group’s drug substance business. The expansion will create approximately 50 new jobs at the site.
Alcami to Acquire Contract Packaging Organization Tjoapack
Alcami Corporation recently announced it has entered into a definitive agreement to acquire Tjoapack, a leading global contract packaging organization with facilities in the United States and The Netherlands. Tjoapack has been a trusted supplier of contract primary and secondary packaging solutions for more than 35 years. Their packaging and labeling services include oral solid dose (blister and bottles), sterile injectables (vials, pre-filled syringes and auto-injectors) and kitting.
MilliporeSigma Launches First Bio-Based Solvent Portfolio for High-Performance Liquid Chromatography
MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, recently announced the launch of the first bio-based solvent portfolio specifically for high-performance liquid chromatography (HPLC).
ProImmune Collaborates With The University of Texas Medical Branch to Advance Infectious Disease Research
ProImmune, Ltd.recently announced a collaboration with The University of Texas Medical Branch (UTMB) Galveston National Laboratory (GNL), a high-containment, infectious disease research facility, to develop innovative tools for studying high-consequence emerging and endemic infectious diseases.
Symbiosis Expands Commercial Capabilities With Addition of New Stability Chamber
Symbiosis Pharmaceutical Services has expanded its Quality Control (QC) laboratory with the installation of a new 30°C stability chamber. This addition enables Symbiosis to replicate all four ICH-defined climatic zones, enhancing the company’s stability testing capabilities and supporting global commercial drug product supply.
Vetter Strengthens its Global Clinical Manufacturing Network With Strategic Site Enhancements
Vetter recently announced significant progress in the continued expansion of its global clinical manufacturing network. With the ongoing scale-up of its Vetter Development Service offering, the company is taking important steps to provide necessary capacity, advanced technologies, and specialized expertise in response to rising demand for in-human trial material.
ANI Pharmaceuticals Announces Publication of NEW DAY Clinical Trial Results in Ophthalmology
ANI Pharmaceuticals, Inc. recently announced publication of the results from the NEW DAY clinical trial involving ILUVIEN (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in appropriate patients with diabetic macular edema in Ophthalmology, the journal of the American Academy of Ophthalmology. The company previously announced results from the NEW DAY trial in July 2025.
FORE Biotherapeutics Receives Breakthrough Therapy Designation for Plixorafenib
FORE Biotherapeutics, a registration-stage company dedicated to developing targeted therapies to treat patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG). Fore Bio believes this is the first BTD granted to a targeted therapy for HGG.
Amprion Grows Global Footprint With Australian Partnership & Expanded Research Collaborations
Amprion recently announced a series of strategic milestones that underscore the company’s accelerating growth, expanding international footprint, and continued commitment to advancing earlier and more accurate diagnosis of neurodegenerative diseases. Amprion will continue to work with The Michael J Fox Foundation for Parkinson’s Research (MJFF) on multiple research initiatives in 2026.
PRISM ALS: New Stem Cell Models Could Transform Research Into Treatments for MND/ALS
A new global initiative launched today aims to close a critical gap in ALS/MND drug discovery – current cell models used for testing treatments do not currently reflect the diverse nature of the disease – that affects both researchers developing therapies and the people urgently waiting for them.
Vetter Recognized as 2026 CDMO Leadership Awards Winner
Vetter receives recognition as CDMO of the year in the category “Finished Dose” of the 2026 CDMO Leadership Awards. The award honors the company for exhibiting valued characteristics as a reliable and experienced partner, reaffirming its commitment to offering quality and technical know-how to its customers.
Optibrium Introduces Graphical Interface for QuanSA to Enhance Ligand-Based Affinity Predictions
Optibrium recently announced a new QuanSA plugin for PyMOL, providing an intuitive Graphical User Interface (GUI) for its ligand-based binding affinity prediction method, part of the Company’s BioPharmics 3D molecular modelling platform. The new interface facilitates chemists’ access to accurate affinity predictions that guide the design of potent compounds, and reduces the synthesis and testing burden in lead optimisation.
Quotient Therapeutics Announces Collaboration With Merck to Discover Novel Drug Targets in Inflammatory Bowel Disease Using Somatic Genomics Platform Technology
Quotient Therapeutics, a company pioneering somatic genomics to inform breakthrough medicines, today announced that it has entered a multi-year research collaboration agreement with Merck, known as MSD outside the US and Canada, to discover novel drug targets in inflammatory bowel disease (IBD) using Quotient’s somatic genomics platform technology. Somatic genetic mutations naturally accumulate over a lifetime, resulting in trillions of different genomes within an individual.
iXCells Biotechnologies Joins International Collaboration to Evaluate Chemotherapeutic Toxicity in Human Organoids
iXCells Biotechnologies recently announced it has entered an international collaboration with Rosebud Biosciences, Kantify, and Incite to evaluate off-target chemotherapeutic toxicities in patient-specific organoids. Building on iXCells’ recent partnership with Rosebud1 and funded by Incite, the project will initially focus on predicting toxicity in heart, liver, and kidney tissue models, to develop personalized, multi-organ toxicity profiles for novel chemotherapies.
Clariant Expands Pharmaceutical-Grade PEG Manufacturing Into North America With Texas facility
Clariant is expanding its Clear Lake site to include excipient GMP-compliant manufacturing of pharmaceutical-grade polyethylene glycol (PEG) excipients, significantly improving their availability and reliability for North American customers, with extended reach to Latin America.
Basecamp Research Launches Trillion Gene Atlas to Scale AI-Designed Therapeutics
Basecamp Research recently announced the launch of the Trillion Gene Atlas, a landmark scientific initiative to generate and model biological data at the trillion-gene scale. Launched in collaboration with Anthropic, Ultima Genomics and PacBio, and powered by NVIDIA AI infrastructure, the Trillion Gene Atlas aims to expand known evolutionary genetic diversity 100-fold by collecting genomic data from more than 100 million species across thousands of sites worldwide.
Neuland to Open Commercial Peptide Facility as part of Planned Phased Expansion
Neuland Laboratories will open its new commercial peptide facility in the summer of 2026 at its 17-acre Bonthapally manufacturing campus, with further capacity expansions planned as client demand increases. The first of four planned modules is expected to be operational by the summer of this year, adding commercial-scale capabilities to Neuland’s existing clinical stage S-Block facilities. Module one has secured firm commitments of approximately $30 million.
Centauri Therapeutics Granted FDA QIDP Status for CTX-187 Treatment of Gram-Negative Bacterial Infections
Centauri Therapeutics Limited recently announced the its lead clinical candidate in the ABX-01 program, CTX-187, has received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA). Currently in pre-clinical development ahead of first in-human trials, CTX-187 provides a novel immunotherapeutic approach to treat Gram-negative bacterial infections and expand therapeutic options for clinically vulnerable patients.
LabVantage Solutions Introduces LabVantage CORTEX, Advancing its LIMS Platform for AI-Driven Laboratory Operations
LabVantage Solutions, Inc. recently announced the launch of LabVantage CORTEX, a next-generation artificial intelligence (AI), analytics, and automation platform. The launch represents a strategic evolution of the company’s laboratory informatics portfolio, integrating advanced AI and smarter automation into the core LabVantage LIMS experience to help laboratories operate with greater accuracy, efficiency, and confidence.
Codexis Signs Agreement to Manufacture 50 g siRNA Using its ECO Synthesis Manufacturing Platform
Codexis, Inc. recently announced it has entered into an agreement with an innovator pharmaceutical company to manufacture 50 grams of small interfering RNA (siRNA) using its proprietary ECO Synthesis manufacturing platform to support preclinical development of a therapeutic candidate targeting a cardiovascular indication. Under the terms of the agreement, Codexis will produce siRNA material to support its partner’s preclinical program.
FUJIFILM Biotechnologies Unveils ShunzymeX Precision Purification Technology
FUJIFILM Biotechnologies recently unveiled ShunzymeX precision purification technology, which simplifies downstream processing for complex biologics. The technology will be presented this week at the Festival of Biologics conference in San Diego.
NorthSea Therapeutics Announces Achievement of Key Regulatory Milestones for Orziloben
NorthSea Therapeutics B.V. recently announced the US FDA and the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) have granted Orphan Drug Designations (ODD) to orziloben (NST-6179) for the treatment of intestinal failure associated liver disease (IFALD). Orziloben was also previously granted rare pediatric disease designation by the FDA. “We are pleased that orziloben has received ODD from both agencies.
Quotient Sciences Extends Commercial Manufacturing Partnership for Ultra-Rare Disease Treatment
Quotient Sciences recently announced an extended commercial supply partnership with Ipsen, a global biopharmaceutical company, to manufacture a treatment for Fibrodysplasia Ossificans Progressiva (FOP), an ultra-rare disease affecting fewer than 1,000 people worldwide.
Neurizon Initiates Dosing of NUZ-001 in HEALEY ALS Platform Trial
Neurizon Therapeutics Limited recently announced the first participant has been dosed in Regimen I of the HEALEY ALS Platform Trial evaluating Neurizon’s lead candidate, NUZ-001, for the treatment of amyotrophic lateral sclerosis (ALS). The HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) is a multicentre, double-blind, placebo-controlled adaptive Phase 2/3 clinical trial conducted by the Sean M.
MGS Acquires European-Based Medical Injection Molder Knudsen Plast A/S
MGS recently announced the acquisition of Knudsen Plast A/S, a premier Denmark-based injection molder with more than 40 years of dedicated healthcare manufacturing experience. With operations in both Denmark and Slovakia, the acquisition of Knudsen Plast A/S enhances MGS’ ability to support customer needs across Europe with expanded cleanroom capacity, deep injection molding expertise and greater proximity to fast-growing regional supply chains.
AC Immune Initiates Phase 1 Clinical Trial of NLRP3 Inhibitor
AC Immune SA recently announced that the first participant has been dosed in a Phase 1 clinical trial of ACI-19764, an orally administered small molecule inhibitor of the NLRP3 inflammasome.
SGS Receives Regulatory Approval to Restart Human ¹⁴C ADME Trials
SGS recently announced it has received formal approval from the Belgian Federal Agency for Nuclear Control (FANC) to resume human ADME (Adsorption, Distribution, Metabolism and Excretion) studies using ¹⁴C-radiolabeled investigational products. The approval enables SGS to reintroduce ¹⁴C human ADME studies at its clinical pharmacology unit in Antwerp, reinstating a highly specialized capability within its European early phase clinical research portfolio.
Korsana Biosciences Emerges From Stealth With $175 Millon in Funding to Advance Potential Best-in-Class Therapeutics for Neurodegenerative Diseases
Korsana Biosciences, Inc. recently announced its emergence from stealth, with backing from a leading syndicate of healthcare investors. The Company was founded in 2024 with a $25 million seed investment from Fairmount and Venrock Healthcare Capital Partners.
Axol Bioscience Acquires Ophthalmology Business From Newcells Biotech
Axol Bioscience Ltd. recently announced it has acquired the ophthalmology business of Newcells Biotech, a leading drug discovery partner specializing in the development of in vitro models and bespoke assay services.
Annovis Secures DSMB Approval to Advance Pivotal Phase 3 Trial of Buntanetap in Alzheimer’s Disease
Annovis Bio, Inc. recently announced an independent Data and Safety Monitoring Board (DSMB) has issued a positive recommendation regarding the safety of buntanetap at 6 months, supporting the continuation of the ongoing pivotal Phase 3 AD clinical trial without modification. The DSMB is responsible for periodically reviewing accumulated safety data and providing independent recommendations on the conduct and progression of the study.
SynGenSys Introduces Liver.SET Synthetic Promoter Library for Liver-Specific Gene Expression for In Vivo Gene Therapies
SynGenSys recently announced the launch of its Liver.SET library of liver-specific synthetic promoters. Developed using SyngenSys’ proprietary informatics and computational design platform, the Liver.SET library comprises a range of compact, patentable synthetic promoters for liver-targeted gene expression for in vivo gene therapies.
Quanterix Announces FDA 510(k) Submission for a Multi-Analyte Algorithmic Blood Test for Alzheimer’s Disease Detection
Quanterix Corporation recently announced it has submitted a 510(k) premarket notification to the US FDA for a multi-analyte algorithmic blood test for Alzheimer’s disease (AD). This submission represents a significant milestone in the Company’s mission to provide superior, non-invasive, high-performance diagnostic tools to aid in the evaluation of patients with cognitive symptoms for possible AD.
Cellares to Expand Automated Manufacturing to Gene-Edited Stem Cell Therapies
Cellares recently announced a collaboration with the Stanford Center for Definitive and Curative Medicine (CDCM) and Stanford Innovative Medicines Accelerator (IMA) to automate manufacturing and release testing for gene-edited hematopoietic stem cell (HSC) therapies, expanding the application of Cellares’ automation platforms beyond T cell therapies into a new cell modality.
Piramal Pharma Solutions Introduces Tablet-in-Capsule Capabilities
Piramal Pharma Solutions recently announce the successful development, scale-up, and commercialization of a tablet-in-capsule drug delivery system at its drug product facilities in Pithampur and Ahmedabad, India. With expanded tablet-in-capsule capabilities now in its toolkit, Piramal can offer partners and patients more flexible and customizable dosing options for critical oral drug therapies, including modified release drug delivery.
Ardena Completes Divestment of its Södertälje Drug Substance Site in Sweden to Nanologica
Ardena recently announced it has completed the divestment of its drug substance (API) site in Södertälje, Sweden, to Nanologica AB. The business will operate as a wholly owned subsidiary within the Nanologica Group and will revert to its original name, Syntagon AB. The Södertälje facility is a well-established drug substance (API) CDMO with more than 45 employees and a strong track record in small molecule active pharmaceutical ingredients.
Vetter Pharma to Build New Manufacturing Site in Germany
Vetter Pharma has confirmed its plans to build a state-of-the-art production facility in the Saarland region of southwest Germany. This strategic investment marks a significant milestone in the company’s long-term global growth strategy. Construction is scheduled to begin in the second quarter of 2026. Initially, approximately €480 million have been allocated for the first construction phase of the new commercial production plant. Operations are expected to commence in 2031.
Vortex Biotech Opens New State-of-the-Art Laboratory at Manchester Science Park
Vortex Biotech Holdings Limited has announced the opening of its advanced laboratory facilities at Manchester Science Park. The new site significantly enhances the company’s R&D and commercial delivery capacity and strengthens its position as a leader in liquid biopsy technologies for precision oncology. The laboratories are designed to GLP-ready specifications, allowing future expansion into clinical trial support and commercial product and services development.
Nanexa Announces Breakthrough Preclinical Data Demonstrating Exceptional Pharmacokinetic Profile for Monthly Semaglutide Formulation
Nanexa AB recently announced exceptional preclinical results for its long-acting semaglutide formulation developed using the company’s proprietary PharmaShell drug delivery platform. PharmaShell encases active pharmaceutical ingredients at the atomic level in a highly protective, extremely thin film coating (approximately 30 nm thick) of slow-dissolving non-toxic inorganic oxides.
Levicept Announces FDA Acceptance of IND Application for LEVI-04, a Potentially Disease-Modifying Treatment for Osteoarthritis
Levicept Ltd recently announced the US FDA has accepted its Investigational New Drug (IND) application for LEVI-04. This enables the initiation of further clinical development as a potentially disease-modifying treatment for osteoarthritis. Levicept has completed a successful 518-participant Phase II study of LEVI-04 in patients with pain and disability due to OA of the knee (ClinicalTrials.gov ID: NCT05618782).
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