Formulation Development
First Patient Dosed in Phase 1 Clinical Trial Evaluating Neoepitopes Formulated in IMV’s DPX Delivery Platform
IMV Inc. recently announced that the first patient has been treated in the Phase 1 trial evaluating neoepitopes formulated in the company’s proprietary DPX delivery…
AMAG Pharmaceuticals Completes Acquisition of Perosphere
AMAG Pharmaceuticals, Inc. recently announced it has completed the previously announced acquisition of Perosphere Pharmaceuticals Inc., a private biopharmaceutical company. Through this acquisition, AMAG adds…
Zafgen Announces Positive Results for Phase 2 Clinical Trial
Zafgen, Inc. recently announced positive data for the second cohort of its Phase 2 clinical trial of ZGN-1061, designed to evaluate efficacy and safety in…
MilliporeSigma & Roche Renew Global Distribution Agreement
MilliporeSigma and Roche recently announced they have agreed to renew their current distribution agreement for the Biochemical Reagents and Kapa Biosystems product portfolios, as well as select qPCR & Nucleic Acid Purification products.
Bavarian Nordic Announces Exercise of $44-Million Option by BARDA
Bavarian Nordic A/S recently announced the US Biomedical Advanced Research and Development Authority (BARDA) have exercised another option under the ongoing contract for freeze-dried MVA-BN smallpox vaccine.
Lonza & Takeda Partner in Development & Manufacture of Cancer Treatment
Lonza recently announced another major milestone in its multiproduct partnership with Takeda.
Immutep Enters Into Clinical Trial Collaboration, Service, and Supply Agreement
Immutep Limited recently announce it has entered into a clinical trial collaboration agreement, a supply agreement, and a service agreement with CYTLIMIC Inc. for its…
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.
