Formulation Development
Sublimity Therapeutics Receives IND Clearance
Sublimity Therapeutics recently announced that the company has received FDA clearance to proceed with its Phase 2b clinical trial of the company’s lead drug candidate,…
BioTime Enters Into Exclusive Agreement With Orbit Biomedical
BioTime, Inc. recently announced it has entered into a research and option agreement with Orbit Biomedical Limited. Orbit Biomedical, based in London, UK, and Ambler, PA,…
Lilly Announces Agreement to Acquire Loxo Oncology
Eli Lilly and Company and Loxo Oncology, Inc. recently announced a definitive agreement for Lilly to acquire Loxo Oncology for $235 per share in cash,…
Athenex Announces Completion of Target Enrollment in Phase III Study
Athenex, Inc. recently announced that target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on…
Vital Therapies & Immunic Therapeutics Announce Transaction to Create Leading Company
Vital Therapies, Inc. and Immunic AG recently announced they have entered into a definitive agreement under which Vital Therapies is expected to acquire all of the…
SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
FORMULATION FORUM - Sophisticated Formulation Approaches for Insoluble Drug Candidates
Jim Huang, PhD, discusses how a sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
TRANSLATIONAL PHARMACEUTICS - Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services
Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.
EXTRACTABLES & LEACHABLES - A Practical Approach to Extractables & Leachables
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
TOPICAL DELIVERY - Novel Approaches to Topical Antibiotics Promise Innovation in the Treatment of Acne & Rosacea
Scott Herron, MD, PhD, indicates dermatologists and their patients need a better way to deliver antibiotics effectively without contributing to the resistance problem, and an ideal solution might be a new topical antibiotic formulation.
CLINICAL TRIALS - Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF
Elvin Thalund, MS, and Craig Morgan say the emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.
PCI Pharma Services Announces $20-Million Expansion of Biotech Technologies, Including Advanced Injectable Delivery Forms
Leading global biopharmaceutical services provider PCI Pharma Services (PCI) has announced a momentous investment in support of biologic medicines and advanced injectable delivery forms, totaling more than $20 million.
Catalent Makes Significant Investment to Expand Biologics Capacity & Capabilities
Catalent, Inc. recently announced it has commenced a $200 million capital investment in its Biologics business to expand drug substance manufacturing capacity and drug product fill/finish capacity due to projected growth among existing and future customers.
Bristol-Myers Squibb’s Acquisition of Celgene Could Position Company Amongst Top Five Most Profitable Pharma Giants
Following Bristol-Myers Squibb’s (BMS) announcement that it will acquire Celgene in a cash and stock deal with an equity value of approximately $74 billion, Edit…
Elite Pharmaceuticals & SunGen Pharma File ANDA
Elite Pharmaceuticals, Inc. recently announced it filed an Abbreviated New Drug Application (ANDA) with the US FDA for a generic version of an antibiotic product. This…
Sarepta Therapeutics Enters Strategic Relationship With Aldevron
Sarepta Therapeutics, Inc. and Aldevron recently announced they have entered into a long-term strategic relationship for the supply of plasmid DNA to fulfill Sarepta’s needs…
Acer Therapeutics Announces Exclusive License Agreement With Sanofi
Acer Therapeutics Inc. recently announced it has entered into an exclusive license agreement with Sanofi to acquire worldwide rights to osanetant, a clinical-stage, selective, non-peptide…
Merus Announces Strategic Collaboration With Betta Pharmaceuticals
Merus N.V. recently announced it has agreed to grant Betta Pharmaceuticals Co Ltd an exclusive license to develop and commercialize Merus Biclonics MCLA-129 in China. …
Allena Pharmaceuticals Achieves Alignment With FDA on Phase 3 Program
Allena Pharmaceuticals, Inc. recently announced it has reached alignment with the US FDA on both the design of URIROX-2, its second pivotal Phase 3 trial…
Outlook Therapeutics Closes Third Tranche of $20-Million Private Placement for Clinical Trials
Outlook Therapeutics, Inc. recently announced it closed on the third tranche (of four) of its $20-million private placement of common stock to BioLexis Pte. Limited,…
