Formulation Development
ENA Respiratory Announces FDA IND Clearance for First-in-Class Antiviral Innate Immunomodulator
ENA Respiratory recently announced the US FDA has issued a "safe to proceed" notice for its investigational new drug (IND) application for a Phase 1b…
Coave Therapeutics Showcases its ALIGATER Platform for Generating Conjugated AAV Vectors Exhibiting Superior Performance in Delivering Ocular Gene Therapy Through the Suprachoroidal Route
Coave Therapeutics recently announced preclinical studies on its novel Conjugated AAV (coAAV) gene therapy vectors demonstrate promising results for ocular gene therapy. Engineered coAAV vectors,…
Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical for $2.4 Billion
Deciphera’s kinase inhibitor expertise and established commercialization platform in key markets will reinforce ONO Pharmaceutical’s pipeline and accelerate global reach….
Corcept Completes Enrollment in Phase 4 Trial
Corcept Therapeutics Incorporated recently announced completion of enrollment in CATALYST, a Phase 4 trial examining the prevalence of hypercortisolism (Cushing’s syndrome) in patients with difficult-to-control…
CanSinoBIO CSO Shares Latest Results of Innovative Pneumococcal Vaccine
On April 20, the 2024 National Vaccines and Health Conference organized by the Chinese Preventive Medicine Association (CPMA) and the Chinese Center for Disease Control…
Abzena Launches Next-Generation Immunogenicity Tool for De-Risking the Development of Complex Biologics & Bioconjugates
Abzena recently announced the launch of its enhanced bioassay platform EpiScreen® 2.0, a comprehensive suite of assays that predict and evaluate potential risks of preclinical immunogenicity in protein….
Biolojic Design Announces Nektar Therapeutics Has Exercised its License Option to Develop an AI-Designed Agonistic Antibody Targeting TNFR2 for the Treatment of Autoimmune Diseases
Program is the Product of a Research Collaboration between Biolojic Design and Nektar entered in 2021….
Immutep Announces Positive Preliminary Topline Results From TACTI-003 Cohort B
Immutep Limited recently announced preliminary topline results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase 2b trial evaluating eftilagimod alpha (efti) in combination with MSD’s…
PEP-Therapy & Institut Curie Announce First Patients Dosed in Phase 1b Clinical Trial Evaluating PEP-010 in Ovarian & Pancreatic Cancers
PEP-Therapy and Institut Curie recently announced the dosing of the first patients in a Phase 1b clinical trial evaluating PEP-Therapy’s lead candidate, PEP-010, based on…
Mission Bio's New Translocation Analysis Offers Insights Into Critical Safety Assessment for Gene-Edited Cell Products
Mission Bio recently announced the launch of a new single-cell capability that enhances our understanding of translocations (chromosomal rearrangements) in gene-edited therapies. Measuring predicted translocations along…
XOMA Earns $9-Million Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDA for Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma
XOMA Corporation recently announced it has earned a $9-million milestone related to the US FDA’s approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for…
Barinthus Bio Announces Topline Data From Phase 1b/2 of VTP-200 in Persistent High-Risk Human Papillomavirus Infections
Barinthus Biotherapeutics plc recently announced topline final data from the APOLLO trial (also known as HPV001), a completed randomized, placebo-controlled Phase 1b/2 dose-ranging trial of…
Nykode Therapeutics Initiates Phase 2 Trial of VB10.16 in Second Line HPV16-Positive Cervical Cancer
Nykode Therapeutics ASA recently announced the initiation of the Phase 2 clinical trial VB-C-04. The trial evaluates VB10.16, the company’s off-the-shelf therapeutic cancer vaccine candidate…
Tiziana Life Sciences Announces Study Results From Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients
Tiziana Life Sciences, Ltd. recently announced a study related to its lead candidate, foralumab, was highlighted in Neurology Today, the official news source of the…
Kynos Therapeutics Announces Positive Top-Line Results From First-in-Human Phase I Study of its KMO Inhibitor
Kynos Therapeutics Ltd recently announced the key findings from the first-in-human Phase 1 trial of its lead drug candidate, KNS366. KMO is an enzyme that…
Salubris Biotherapeutics Announces $35 Million in Financing & Provides Pipeline Progress Update
Salubris Biotherapeutics, Inc. recently announced a new capital infusion of $35 million to fund continued research and development of clinical and preclinical programs. SalubrisBio also…
Cellares & Bristol Myers Squibb Announce $380-M Worldwide Capacity Reservation & Supply Agreement
Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the US, EU, and Japan for Bristol Myers Squibb’s use ….
Neurolentech Signs Technology Access Partnership With Kaerus Bioscience
Kaerus Bioscience will access Neurolentech’s NDD Drug Discovery Platform to support development of its preclinical asset pipeline for numerous genetic syndromes….
Nutcracker Therapeutics Demonstrates Positive Data on Anti-Prostate Cancer Therapeutic
Nutcracker Therapeutics, Inc. recently presented two posters at the American Association for Cancer Research (AACR) Annual Meeting in San Diego: one showcasing the latest preclinical data…
Regeneration Biomedical Doses First Patient in a First-in-Human Phase 1 Clinical Trial of Stem Cell Therapy Delivered Directly Into the Brain of Patients With Alzheimer’s Disease
Regeneration Biomedical, Inc. recently announced the first patient has been dosed in an FDA-cleared, first-in-human Phase 1 clinical trial of autologous, Wnt-Activated Adipose-Derived Stem Cells…
