Market News & Trends
Ajinomoto Bio-Pharma Services Successfully Develops Highly Functional Ancestral RNA Ligase
Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, recently announced the development of a new enzyme for double strand oligonucleotide formation with high….
Amydis Announces Enrollment of Cerebral Amyloid Angiopathy Participants in Phase 1/2a Retinal Tracer Trial
Amydis Inc. recently announced initiation of enrollment of patients with cerebral amyloid angiopathy (CAA), an age-associated disease in which a protein called amyloid beta (Aβ)…
uniQure Announces the European Commission Approval of the First Gene Therapy for Adults With Hemophilia B
uniQure N.V. recently announced its partner, global biotechnology leader CSL, has received conditional marketing authorization (CMA) from the European Commission for HEMGENIX (etranacogene dezaparvovec), the first…
Processa Pharmaceuticals Announces Prioritization on Development of Next-Generation Chemotherapies
Processa Pharmaceuticals, Inc. reiterates the strategic prioritization of its pipeline of proprietary oncology drugs, defined as Next-Generation Chemotherapies (NGCs). Previous studies with these….
Icosavax Granted FDA Fast Track Designation for RSV & hMPV Vaccine Candidate
Icosavax, Inc. recently announced the US FDA has granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) VLP…
Kadimastem Submits IND Application for its Phase 2a Clinical Trial With AstroRx for the Treatment of ALS
Kadimastem Ltd recently has submitted an Investigational New Drug (IND) application to the US FDA for an approval for a multi-site Phase 2a clinical trial to test its lead neurological….
Ocuphire Announces APX3330 Phase 2 Data Presentations at Retina Meetings
Ocuphire Pharma, Inc. recently announced two presentations featuring efficacy and safety results from the company’s recently completed ZETA-1 Phase 2 trial of oral APX3330 in…
Frontera Therapeutics Doses First Patient in a Trial of Gene Therapy for the Treatment of X-Linked Retinitis Pigmentosa
Frontera Therapeutics recently announced it has dosed the first patient in a clinical trial of its gene therapy product, FT-002. FT-002 is being studied for…
Cytovation Announces First Patient Dosed in Phase 2a Study Investigating CyPep-1 Monotherapy in Advanced Melanoma Refractory to Checkpoint Inhibitors
Cytovation ASA recently announced the first patient has been dosed in its Phase 2a study investigating CyPep-1 monotherapy in patients with advanced melanoma refractory to…
First Subject Dosed in Small Pharma’s First-in-Human Phase 1 Clinical Trial
Phase 1 study will compare two routes of SPL028 administration; intravenous and intramuscular….
VYNE Therapeutics Announces Positive Results from Phase 1a Single & Multiple Ascending Dose Trial for Investigational Novel BET Inhibitor
VYNE Therapeutics Inc. recently announced positive results from the Phase 1a portion of its Phase 1a/b clinical trial evaluating its novel BET inhibitor, VYN201, for vitiligo…..
Akari Therapeutics Announces Preclinical Development Progress Toward Potential IND on Long-Acting PAS-Nomacopan for Geographic Atrophy
Akari Therapeutics, Plc recently announced updates on progress in the pre-clinical development program for long-acting PAS-nomacopan as a potential treatment for geographic atrophy (GA) secondary…
Nexcella Enters US GMP Manufacturing Agreement to Expand Ongoing Phase 1b/2 Clinical Trial
Nexcella, Inc. recently announced it has entered into a manufacturing agreement with a well-known United States Good Manufacturing Practice (GMP) cell therapy manufacturer that will…
BioXcel Therapeutics Announces Positive Full Data from Phase 2 Trial of BXCL701 in Rare, Aggressive Form of Prostate Cancer
BioXcel Therapeutics, Inc. recently announced full data from its Phase 2a trial of BXCL701, the company’s investigational, oral innate immune activator, in combination with….
Purple Biotech Announces First Patient Dosed in Open Label, Randomized Part of CM24 Phase 2 Clinical Trial
Purple Biotech Ltd. recently announced the first patient has been dosed in the randomized part of the open label Phase 2 clinical trial evaluating CM24…
Vaxart Doses First Subject in the Phase 2 Clinical Trial of its Bivalent Norovirus Candidate
Vaxart, Inc. recently announced it has dosed the first subject in the Phase 2 clinical trial of its oral tablet bivalent norovirus candidate. The dose-ranging…
Neurona Therapeutics Announces FDA Clearance of Expanded Inclusion Criteria for Phase 1/2 Clinical Trial of Regenerative Cell Therapy in Patients With Dominant Hemisphere Drug-Resistant Focal Epilepsy
Neurona Therapeutics recently announced the US FDA has cleared an amendment to Neurona’s ongoing Phase 1/2 clinical trial of NRTX-1001 in people with drug-resistant mesial…
Catalent Appoints New Senior VP, General Counsel, Chief Compliance Officer & Secretary
[caption id="attachment_137301" align="alignleft" width="146"] Joseph A. Ferraro[/caption] Catalent, Inc. recently announced the appointment of Joseph A. Ferraro as Senior Vice President, General Counsel, Chief Compliance…
Lonza to Expand Early Development Services Offering Into North America
Lonza recently announced it will expand its Early Development Services (EDS) offering into North America with a new laboratory in Cambridge, MA. The 17,000-sq-ft facility…
Acumen Pharmaceuticals Completes Enrollment in Phase 1 Trial of First Monoclonal Antibody Developed to Selectively Target Toxic Aβ Oligomers in Patients With Early Alzheimer’s Disease
Acumen Pharmaceuticals, Inc. recently announced the completion of enrollment in its Phase 1 INTERCEPT-AD trial of ACU193 in patients with early Alzheimer’s disease…..