Formulation Development
Vectura Provides Status Update on Hikma's ANDA for Generic Advair Diskus VR315 (US)
Vectura Group plc, an industry-leading inhalation CDMO, recently confirmed the announcement made by its partner Hikma Pharmaceuticals PLC, which has received a minor complete response letter (CRL) from the US FDA in….
T-knife & Catalent Sign Technology Transfer & Manufacturing Agreement
T-knife GmbH and Catalent recently announced they have signed an agreement to provide technology transfer and CGMP clinical manufacturing of T-knife’s T1367 T-cell receptor (TCR) program…..
Hovione Announces Partnership to Produce Ligand's Captisol; Used in Gilead's Covid-19 Treatment
Hovione recently announced the signing of a partnership agreement with Ligand to significantly ramp up the production output of Captisol, a Ligand product, which is a chemically modified cyclodextrin proven to improve the solubility….
Thomas H. Lee Partners & Frazier Healthcare Partners Acquire Adare
Thomas H. Lee Partners, L.P. and Frazier Healthcare Partners recently announced they have acquired Adare Pharmaceuticals, which will be rebranded Adare Pharma Solutions, a leading specialty contract development….
Metrics Contract Services Begins $10-Million Plant Expansion
Metrics Contract Services recently announced it has commenced construction on the expansion of its novel oral solid dosage manufacturing facility expansion in Greenville, NC. The…
Oculis to Present Significant Corporate & Clinical Development Progress
Oculis S.A., a biopharmaceutical company focused on developing transformative topical ophthalmic treatments to improve the sight and lives of patients, recently announced that Dr. Marcia…
Knopp Biosciences Completes Enrollment in Phase 2 Trial of Oral Dexpramipexole in Eosinophilic Asthma
Knopp Biosciences LLC recently announced the completion of enrollment in a Phase 2 trial of the oral small-molecule dexpramipexole in patients with moderate-to-severe eosinophilic asthma.…
ARCA biopharma Announces Submission of IND Application
ARCA biopharma, Inc. recently announced it has submitted an Investigational New Drug (IND) application with the US FDA under the Coronavirus Treatment Acceleration Program (CTAP) to…
CombiGene & Cobra Biologics Sign Agreement to Secure GMP Production of Plasmids for Production of Gene Therapy
Cobra Biologics and CombiGene AB (publ) (CombiGene) recently announced they have signed agreements covering Good Manufacturing Practice (GMP) production of two essential….
Gain Therapeutics Announces Research Collaboration With Sumitomo Dainippon Pharma
Gain Therapeutics, Inc. recently announced it has entered into a strategic research collaboration agreement with Sumitomo Dainippon Pharma Co., Ltd. for the research and development of….
Novus Announces Acquisition of Anelixis
Novus Therapeutics, Inc. recently announced it has completed the acquisition of Anelixis Therapeutics, Inc., a privately held clinical-stage biotechnology company developing a next-generation….
Vectura Partners With Monash University to Support Development of Inhaled Oxytocin to Prevent Postpartum Haemorrhage
Vectura Group plc recently announced it has signed an agreement with Monash University’s Institute of Pharmaceutical Sciences (MIPS) to develop inhaled oxytocin delivered via a….
Thermo Fisher Scientific Partners With AstraZeneca & the University of Nebraska Medical Center
Thermo Fisher Scientific recently announced new collaborations of the Thermo Fisher Precision Medicine Science Center (PMSC) with AstraZeneca and the University of Nebraska Medical Center as part of its ongoing development of….
Arctoris & Syntekabio Form Drug Discovery Research Partnership
Arctoris has recently signed a Memorandum of Understanding with listed Korean company Syntekabio, Inc. to collaborate on drug discovery efforts. The first project under the…
Orasis Raises $30 Million to Advance Clinical Development Program
Orasis Pharmaceuticals recently announced the closing of a $30-million Series C financing. The financing was co-led by new investor Bluestem Capital and returning investor Visionary…
Imanis Life Sciences Presents a First-in-Class Neutralizing Antibody Test for COVID-19
Imanis Life Sciences, LLC recently announced presentations about the development and validation of IMMUNO-COV, the first scalable, quantitative neutralizing antibody test for COVID-19. The company…
Fortress Biotech Announces Initiation of Phase 3 Studies
Fortress Biotech, Inc. recently announced that Caelum Biosciences, Inc., in collaboration with Alexion Pharmaceuticals, Inc., initiated the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase…
Vaxart Announces FDA Clearance of IND Application for Oral COVID-19 Vaccine
Vaxart, Inc. recently announced the US FDA has completed its review of the company’s Investigational New Drug (IND) application for its Phase 1 clinical trial…
Catalent to be Added to S&P 500 Index
Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer…
Peptilogics Receives FDA Orphan Drug Designation for Novel Peptide Therapy for the Treatment of Prosthetic Joint Infections
Peptilogics recently announced that the US FDA has granted Orphan Drug Designation for PLG0206, the company's first-in-class, broad-spectrum antibiotic peptide, for the treatment of prosthetic…