Formulation Development
OmniSeq & LabCorp Extend Exclusive Distribution Pact & Complete Follow-On Investment Agreement
OmniSeq and LabCorp recently announced an extension of their exclusive distribution agreement as well as an additional investment by LabCorp. The distribution agreement and LabCorp’s…
ChemioCare Announces Initiation of PETT-Based (Permeation Enhanced Transdermal Technology) Lenalidomide Program
ChemioCare USA Inc. recently announced it is initiating development of a transdermal formulation of lenalidomide, which is currently marketed in an oral form. ChemioCare believes…
Catalent Invests $14 Million at its Softgel Facility
Catalent recently announced that work is underway to expand integrated turnkey softgel capabilities at its facility in Eberbach, Germany. The $14-million expansion, which is scheduled…
Autolus Therapeutics Receives FDA Orphan Drug Designation
Autolus Therapeutics plc recently announced the US FDA has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).
Cambrex Completes New Quality Control Laboratory for Generic API Development in Milan
Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, recently announced that it had opened a new 120m2 quality control (QC) laboratory at its site in Paullo, Milan, Italy.
CureVac Granted Patent Claiming the Combination of mRNA Vaccines With Anti-PD-L1 Antibodies
CureVac AG recently announced it has been granted a patent from the European Patent Office entitled, Combination of Vaccination and Inhibition of the PD-1 Pathway…
Rexahn & BioSense Global Announce Collaboration & License Agreement
Rexahn Pharmaceuticals, Inc. and BioSense Global LLC recently announced a collaboration and license agreement to advance the development and commercialization of RX-3117 for pancreatic cancer…
Kamada Announces FDA Acceptance of Inhaled AAT Program
Kamada Ltd. recently announced receipt of a letter from the US FDA stating the company has satisfactorily addressed the concerns and questions regarding its Inhaled…
Enesi Pharma & BARDA Drive Enter Public-Private Partnership to Develop Solid Dose Vaccine Delivery Technology
Enesi Pharma recently announced it has entered a public-private partnership with the US Biomedical Advanced Research and Development Authority’s (BARDA) DRIVe (Division of Research, Innovation,…
Fibrocell Announces Development & Commercialization Collaboration With Castle Creek Pharmaceuticals
Fibrocell Science, Inc. recently announced the completion of a collaboration agreement with Castle Creek Pharmaceuticals to develop and commercialize Fibrocell’s lead gene therapy candidate, FCX-007,…
Biotechpharma to Expand Process Development & GMP Manufacturing Capacity
Biotechpharma UAB recently announced further expansion of its fermentation capacity to 5,000 L, along with an additional state-of-the-art process development laboratory, investing more than $56…
Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial
Soligenix, Inc. recently announced today it has reached a significant milestone in the Phase 3 clinical study (the “DOM-INNATE” study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC).
Paragon Bioservices to be Acquired for $1.2 Billion
Catalent, Inc. and Paragon Bioservices, Inc. and Catalent Inc. recently announced they have entered into a definitive agreement under which Catalent will acquire Paragon for $1.2 billion.
Sanofi & Alnylam Conclude Research & Option Phase of 2014 Rare Disease Alliance
Sanofi and Alnylam have agreed to conclude the research and option phase of the companies’ 2014 RNAi therapeutics alliance in rare genetic diseases. The material…
Neon Therapeutics Announces Completion of Enrollment in Phase 1b Clinical Trial
Neon Therapeutics, Inc. recently announced the completion of enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 with KEYTRUDA (pembrolizumab) and chemotherapy in patients…
XOMA Acquires Royalty Rights to Five Hematology Candidates
XOMA Corporation recently announced it has agreed to acquire the rights to potential royalty payments and a portion of the potential milestone payments associated with…
Bellerophon Announces Agreement With FDA on Regulatory Approval Pathway for INOpulse
Bellerophon Therapeutics, Inc. recently announced it has reached agreement with the US FDA on the regulatory approval pathway for INOpulse in patients with Pulmonary Hypertension…
SomaLogic Announces New Collaboration With Janssen Research & Development
SomaLogic, Inc. recently announced it has entered into a collaborative agreement with Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson…
BioAtla & BeiGene Form Worldwide Development & Commercialization Collaboration
BioAtla , LLC and BeiGene, Ltd. recently announced the two companies have entered into a global co-development and collaboration agreement for the development, manufacturing, and commercialization of BioAtla’s investigational CAB CTLA-4 antibody (BA3071).
GeneDesign Joins Ajinomoto Bio-Pharma Services & Opens Oligonucleotide API Development Center
Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, recently announced that GeneDesign, Inc. has joined the global organization.
