Formulation Development
Catalent Biologics Completes $30-Million Project for Biopharmaceutical Development & Drug Product Manufacturing in Limoges, France
Catalent recently announced the completion of a $30-million project at its facility in Limoges, France, to transform the site into a European center of excellence…
Innoforce & Hibiscus BioVentures Announce Strategic Partnership to Enable Development of Advanced Therapies
Innoforce and Hibiscus BioVentures recently announced they have formed a strategic partnership to leverage the combined resources of both organizations to advance new Advanced Therapy Medicinal Products (ATMPs) and biologic medicines in order to….
Viatris Announces Receipt of First FDA Approval for Generic Version of Symbicort Inhalation Aerosol in Partnership With Kindeva
Viatris Inc. and Kindeva Drug Delivery L.P. recently announced Mylan Pharmaceuticals Inc., a Viatris subsidiary, has received approval from the US FDA for its Abbreviated New Drug…
KemPharm Earns $1.975 Million From Corium Following FDA Approval of Donepezil Transdermal System
KemPharm, Inc. recently announced it has earned a $1.975 million fee from Corium, Inc. following the approval of Corium’s product ADLARITY (donepezil transdermal system) by…
Qualigen Therapeutics Extends Research Agreement on RAS Program
Qualigen Therapeutics, Inc. recently announced the mutual extension of a research agreement with University of Louisville Research Foundation (ULRF). The revised agreement expands the company’s…
Biogen & Eisai Amend Collaboration Agreements on Alzheimer's Disease Treatments
Biogen Inc. and Eisai Co., Ltd. recently announced the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the US as ADUHELM (aducanumab-avwa)…..
BioMed X Institute & Merck KGaA Start Second Research Project in Immunology
BioMed X recently announced the start of its new research project Regulatory T Cell Dysfunction in Autoimmunity and Inflammaging (TDA) in collaboration with Merck KGaA, Darmstadt,…
OncoArendi Therapeutics Announces License Option Agreement With University of Michigan
OncoArendi Therapeutics S.A. recently announced it has entered into an option-to-license agreement with Innovation Partnerships at the University of Michigan (U-M) to develop novel small…
NeuBase Therapeutics Presents New Preclinical Data for its Myotonic Dystrophy Type 1 Program Demonstrating Splice Rescue, Nuclear Aggregate Resolution & Myotonia Reversal
NeuBase Therapeutics, Inc. recently announced new preclinical data for its lead development candidate, NT-0231.F, to treat myotonic dystrophy type 1 (DM1). ….
Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis
Phathom Pharmaceuticals, Inc. recently announced it has submitted a new drug application (NDA) to the US FDA for the use of vonoprazan as a treatment…
Oxford Biomedica Broadens its Viral Vector Capabilities With the Launch of Oxford Biomedica Solutions
Oxford Biomedica plc recently announced it has completed its deal with Homology Medicines Inc. to establish Oxford Biomedica Solutions LLC, a new US-based full scope,…
Synthetic Biologics Completes Acquisition of VCN Biosciences
Synthetic Biologics, Inc. recently announced it has completed the acquisition of VCN Biosciences, S.L. (VCN) following the satisfaction of all closing conditions…..
Vetter’s Extraordinary Performance Sweeps the Board at the 2022 CMO Leadership Awards
Vetter recently announced it has won the 2022 CMO Leadership Awards in all six core categories – quality, expertise, compatibility, capabilities, reliability and service…..
Cocrystal Pharma Initiates Enrollment in Phase 1 Influenza A Study
Cocrystal Pharma, Inc. recently announced dosing of the first subjects in a Phase 1 clinical trial of healthy adults evaluating its novel, broad-spectrum, orally administered…
Pharmazz Announces FDA Clearance of an IND Application for Phase 2 Clinical Trial
Pharmazz recently announced US FDA clearance of an Investigational New Drug (IND) application for a Phase 2 clinical trial of centhaquine as an adjuvant to…
Evonik Launches New Technology to Improve Solubility of Oral Small Molecules
Evonik recently announced it now offers EUDRATEC SoluFlow, a new microparticle technology to enhance solubility of active pharmaceutical ingredients in oral drug products…..
Denali Therapeutics Announces Initiation of Phase 1/2 Clinical Trial
Denali Therapeutics Inc. recently announced dosing has begun in a Phase 1/2 clinical trial of DNL593 (PTV:PGRN) for the potential treatment of frontotemporal dementia (FTD)…
Vibalogics Completes Major Milestone in $50-Million Facility Expansion
Vibalogics has recently announced the completion of its expansion project at its GMP facility in Cuxhaven, Germany. The new building features biosafety level (BSL) 2…
Novartis, Voyager Therapeutics Reach License Option Agreement
Novartis recently announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three….
BioNTech & Regeneron Expand Strategic Collaboration
BioNTech SE recently announced the expansion of its strategic collaboration with Regeneron to advance the company’s FixVac candidate BNT116 in combination with Libtayo (cemiplimab), a PD-1 inhibitor….