Market News & Trends
IVERIC bio Enters Strategic Manufacturing Relationship With Catalent's Paragon Gene Therapy
IVERIC bio, Inc. and Catalent Biologics recently announced they have entered into an agreement for production and manufacturing of GMP-grade adeno-associated virus (AAV) vector for IVERIC bio’s gene therapy product candidates.
Progenics Pharmaceuticals Doses First Patient in Phase 2 Clinical Study
Progenics Pharmaceuticals, Inc. recently announced that the first patient has been dosed in the company’s Phase 2 clinical study evaluating I-131 1095 radiotherapy in combination…
Innovate Biopharmaceuticals Announces Start of First Phase 3 Clinical Trial
Innovate Biopharmaceuticals, Inc. recently announced the start of the first Phase 3 clinical trial in celiac disease. Innovate expects to provide further updates as screening…
Deciphera Pharmaceuticals and Zai Lab Limited Announce Exclusive License Agreement
Deciphera Pharmaceuticals, Inc. and Zai Lab Ltd. recently announced an exclusive license agreement to advance the development and commercialization of ripretinib in Greater China (mainland…
InflaRx Treats First Patient in Phase 2a Clinical Trial
InflaRx N.V. recently announced the treatment of the first patient in a Phase 2a clinical trial evaluating the company’s lead product candidate, IFX-1, in Pyoderma…
Oncologie Closes $80-Million Financing for Clinical-Stage Pipeline
Oncologie recently announced it has closed an $80M Series B financing. Existing investors, led by Nan Fung Life Sciences and Pivotal BioVentures China, are joined…
CytoDyn & FDA Will Meet to Potentially Finalize Protocol for Pivotal Monotherapy Trial
CytoDyn Inc. recently announced the US FDA has requested an in-person meeting to discuss and potentially finalize the company’s recently submitted protocol for a pivotal…
Ligand Subsidiary Vernalis & PhoreMost Limited Announce Collaboration for Novel Oncology Target
Ligand Pharmaceuticals Incorporated and PhoreMost Limited recently announced the signing of a research collaboration agreement between Ligand’s subsidiary Vernalis and PhoreMost on an undisclosed novel oncology target.
Designing a CMC Strategy for Accelerated Development of Biotherapeutics
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity……..
DRGT Completes a Pivotal Phase I Trial; Results Confirm 6X Faster Attainment of Maximum Plasma Levels
Druggability Technologies Holdings (DRGT) recently announced results from a pharmacokinetic study of their novel formulation of celecoxib (DRGT-46), which achieves faster time to maximum plasma concentration (Tmax) compared to traditional celecoxib capsules.
Insilico Launches Comprehensive Portfolio of Predictive Digital Twins for Cell Culture Process Development
In close alignment with customer needs Insilico Biotechnology AG has developed a modular suite of Digital Twins that cover key steps during bioprocess development.
Biogen Completes Acquisition of Nightstar Therapeutics for Approximately $800 Million
Biogen recently announced it has completed its acquisition of Nightstar Therapeutics, a clinical-stage gene therapy company, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders.
Enable Injections Enters Strategic Partnership With Sanofi
Enable Injections, Inc. recently announced it has entered into a multi-product development agreement with Sanofi S.A.
Aptar Acquires Nanopharm & Gateway Analytical
AptarGroup, Inc. recently announced it has acquired two leading pharmaceutical services companies, Nanopharm Ltd. and Gateway Analytical LLC, for a combined enterprise value of approximately $50 million.
ASLAN Pharmaceuticals Completes Phase 1 Study
ASLAN Pharmaceuticals recently announced the successful completion of its single ascending dose (SAD) study testing the first-in-class therapeutic antibody ASLAN004 in healthy volunteers, and the…
Foamix Announces Publication of Phase 3 FMX101 Study
Foamix Pharmaceuticals Ltd. recently announced the peer review publication of the Phase 3 study FX2017-22 (Study 22) in the Journal of the American Academy of…
Cytel & Axio Join Forces to Create Industry Leader in Analytical Solutions for Drug Development
Cytel Inc. and Axio Research recently announced they have joined forces to create the largest global biometrics organization focused on delivering advanced analytical solutions for…
BioXcel Therapeutics Announces FDA Clearance of IND Application
BioXcel Therapeutics recently announced an update of its immuno-oncology program for BXCL701, an orally available systemic innate-immune activator with dual mechanisms of action. BTI is…
Allena Pharmaceuticals Announces Interim Study Results
Allena Pharmaceuticals, Inc. recently announced interim data from Study 206, its Phase 2 basket clinical trial of reloxaliase, an orally administered, recombinant oxalate-degrading enzyme. Study…
VBI Vaccines Reports Data From Part A of the Ongoing Phase 1/2a Study
VBI Vaccines Inc. recently presented a poster at the American Society of Clinical Oncology (ASCO) Annual Meeting that exhibited expanded clinical data from Part A…
