Market News & Trends
Petros Pharmaceuticals Receives Positive Response from FDA Following Recent Demonstration of Technology Component in Pursuit of OTC Status for STENDRA
Petros Pharmaceuticals, Inc. recently announces it has received positive feedback from the US FDA following the FDA’s informal review of Petros’ technology component for self-selection…
Alvotech & Teva Announce FDA Approval of Biosimilar to Stelara
Alvotech and Teva Pharmaceuticals recently announced the US FDA has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment…
CordenPharma & GENEPEP Celebrate Strong Collaboration Leveraging Peptide Drug Substance Discovery & Clinical Development Expertise
CordenPharma and GENEPEP have recently celebrated 1 year of their fruitful partnership signed in 2023, which supports biotech companies with the development, discovery, and manufacturing…
Evaxion Announces Phase 2 Clinical Trial Update: First Patient Completed Dosing With Personalized Cancer Vaccine
Significant Phase 2 clinical trial progress obtained with first patient finalizing EVX-01 vaccine dosing….
Atossa Therapeutics & Quantum Leap Healthcare Announce Clinical Trial to Evaluate (Z)-Endoxifen in Combination With Abemaciclib in Women With ER+/HER2- Breast Cancer
Atossa Therapeutics, Inc. and Quantum Leap Healthcare Collaborative recently announced the initiation of a new study to evaluate Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib…
Voyager Therapeutics Announces Selection of Development Candidate for GBA1 Program in Collaboration With Neurocrine Biosciences, Triggering Milestone Payment
Voyager Therapeutics, Inc. recently announced the joint steering committee with its collaborator Neurocrine Biosciences has selected a lead development candidate in the GBA1 gene therapy program for the potential treatment of Parkinson’s disease….
Kincell Bio & Imugene Announce Strategic Manufacturing & Process Development Partnership
Kincell Bio to acquire Imugene’s North Carolina manufacturing facility for up to $6M USD in upfront and milestone-driven payments over 3 years….
Cullinan Therapeutics Announces Strategic Expansion Into Autoimmune Diseases & $280-Million Private Placement
CLN-978 clinical development to focus exclusively on autoimmune diseases, pursuing systemic lupus erythematosus as a first indication….
SAB Biotherapeutics Provides SAB-142 Trial Update
SAB Biotherapeutics, Inc. recently announced its Chief Medical Officer, Dr. Alexandra Kropotova, MD, MBA, disclosed SAB has completed dosing the third cohort for SAB-142 with…
GRI Bio Expands Intellectual Property Protection for Proprietary Natural Killer T Cell Modulators With Issuance of Patent
GRI Bio, Inc. recently announced the Korean Intellectual Property Office (KIPO) has issued a Notice of Patent Grant for Patent Application No. 10-2017-7018579 titled Prevention…
Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis
Organovo Holdings, Inc. recently released the complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR314…
Cresset Creates New Vice President Role to Lead its Artificial Intelligence Strategy
Cresset an innovative provider of solutions for CADD, DMTA efficiency, and contract research, has expanded its senior leadership team with the appointment of Cambridge Scientist…
BC Platforms & NTT Group Announce Official Opening Ceremony for Exclusive Collaboration & Launch of Japanese Precision Medicine Platform
BC Platforms (BCP) recently announces an exclusive collaboration with NTT Life Science Corporation, a company in the medical field of the NTT Group, to accelerate data-driven….
Naobios & Sumagen Sign Exclusive Partnership to Develop HIV Vaccine
Naobios will manage process development and initiate launch of cGMP manufacturing for Phase 2 clinical trials….
New Drug Delivery System Developed by Hebrew University Researchers Simultaneously Delivers Diverse Therapeutic Agents in a Single Carrier
A new drug delivery system that overcomes previous limitations in delivering diverse therapeutic compounds in a single carrier has been developed by Hebrew University of…
Ocular Therapeutix Executive Chairman Becomes President & CEO
Ocular Therapeutix, Inc. recently announced Executive Chairman, Pravin U. Dugel, MD, is assuming the roles of President and Chief Executive Officer (CEO), and that Antony…
Neurona Therapeutics Presents Positive Clinical Update From Cell Therapy Trial in Adults With Drug-Resistant Focal Epilepsy
Neurona Therapeutics presented updated preliminary data from its ongoing open-label Phase 1/2 clinical trial of NRTX-1001 in adults with drug-resistant, unilateral mesial temporal lobe epilepsy…
AviadoBio Announces First Patient Treated in Clinical Trial Evaluating AVB-101 for Frontotemporal Dementia With GRN Mutations
AviadoBio recently announced the first patient has been treated in the Phase 1/2 ASPIRE-FTD trial evaluating AviadoBio’s investigational gene therapy, AVB-101, in people with frontotemporal…
NovelMed Receives FDA Orphan Drug Designation for Treating Paroxysmal Nocturnal Hemoglobinuria; Seeks Partnership
NovelMed recently announced the US FDA has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment….
Asahi Kasei Bioprocess & Axolabs Announce Strategic Partnership to Accelerate Oligonucleotide Therapeutics Development
Asahi Kasei Bioprocess (AKB), part of the Asahi Kasei Group, and Axolabs have recently announced a strategic partnership in the burgeoning field of oligonucleotide….