Formulation Development
Catalent to Purchase Bristol-Myers Squibb Facility
Bristol-Myers Squibb Company and Catalent, Inc. recently announced that Catalent has agreed to purchase Bristol-Myers Squibb’s oral solid, biologics, and sterile product manufacturing and packaging…
Bavarian Nordic Initiates Phase 3 Trial of Vaccine
Bavarian Nordic A/S recently announced the initiation of a pivotal Phase 3 trial of the freeze-dried formulation of MVA-BN smallpox vaccine in 1,110 healthy, vaccinia-naïve…
Aclaris Therapeutics Announces Positive 6-Month Results from Phase 2 Clinical Trial
Aclaris Therapeutics, Inc. recently announced positive results from a Phase 2 open-label clinical trial of ATI-502 (AGA-201), an investigational topical Janus Kinase (JAK) 1/3 inhibitor, in patients with androgenetic alopecia (AGA), a condition commonly known as male/female-pattern baldness.
iBio Announces First Agreement for Fill-Finish Services
iBio, Inc. recently announced the activation of its new cGMP sterile fill-finish services operation via the signing of a supply agreement with a clinical-stage biopharmaceutical company developing breakthrough gene and cell therapies.
Gilead & Nurix Establish Lucrative Strategic Collaboration
Gilead Sciences, Inc. and Nurix Therapeutics, Inc. recently announced a global strategic collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation drugs for patients with cancer and other challenging diseases.
Sanofi & Google to Develop New Healthcare Innovation Lab
Sanofi and Google will establish a new virtual Innovation Lab with the ambition to radically transform how future medicines and health services are delivered by tapping into the power of emerging data technologies.
Genesis Drug Discovery & Development Expands Preclinical Contract Research Portfolio With Acquisition
Genesis Drug Discovery & Development (GD3), the contract research organization (CRO) of Genesis Biotechnology Group (GBG), recently announced that it has expanded its drug development services through…
Akari Therapeutics’ Nomacopan Demonstrates Positive Early Safety & Efficacy
Akari Therapeutics, Plc, a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated,…
Developing Microfluidic Routes to Effective Nanoparticle Drug Delivery Systems
A Dolomite Microfluidics’ set-up is helping researchers in the University of Manchester’s Division of Pharmacy and Optometry to enhance drug delivery. Dr Annalisa Tirella explained:…
Array BioPharma Acquisition Will Accelerate Pfizer’s Position as a Major Player in Colorectal Cancer
Following the news that Pfizer has agreed to acquire Array BioPharma in a deal worth approximately $11.4 billion, Tajekesa Chapman, PhD, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the potential of this buy-out on the treatment of colorectal cancers.
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.
