Formulation Development
Cue Biopharma Doses First Patient in Clinical Trial
Cue Biopharma, Inc. recently announced it dosed the first patient in a Phase 1 clinical trial of CUE-101 at Washington University, Alvin J. Siteman Cancer Center, St. Louis, Missouri for the treatment of….
Cabaletta Bio Receives IND Clearance From FDA to Initiate First Clinical Trial
Cabaletta Bio, Inc. recently announced it has received clearance of its IND application from the US FDA to initiate a first-in-human clinical trial of…..
Ocugen & CanSinoBIO Enter Strategic Co-Development & Manufacturing Partnership
Ocugen, Inc. has recently entered into a strategic partnership with CanSino Biologics on Ocugen’s gene therapy pipeline product candidates for inherited retinal diseases, which are…
Novel Silica Delivery System Enters Final Preclinical Development Stage
N4 Pharma Plc recently announced results from the company’s latest research study into its novel silica nanoparticle for cancer treatments and vaccines, Nuvec. The work,…
AGTC & Otonomy Announce Strategic Collaboration to Develop & Commercialize Gene Therapy
Applied Genetic Technologies Corporation and Otonomy, Inc. recently announced they have entered into a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to…
MODIFIED RELEASE - Alternative Strategies for Development of Modified-Release Dosage Forms
Andy Lewis, PhD, discusses a range of available formulation technologies, the challenges in MR formulation development, and the use of a design-space approach with on-demand manufacturing.
COMBINATION PRODUCT DEVELOPMENT - New Horizons in Development to Meet Emerging Demands
Ed Trappler and John A. Merhige, MEM, believe it is no longer sufficient to put a product in a vial, and the future of healthcare products places increasing demands on the industry to provide innovations for delivering combination products.
CHARACTERIZATION CORNER - A New Weapon in Formulation Development
Matt McGann explains how Microfluidic Modulation Spectroscopy is the final addition in the biophysical characterization scientist’s toolkit.
MICROFLUIDIC ENCAPSULATION - Controlling Drug Delivery With PLGA
Richard Gray, MA, discusses the use of polymer microparticles for pharmaceutical applications, including specific examples of polylactic-co-glycolic acid (PLGA) encapsulation.
ON-BODY DELIVERY SYSTEMS - Analysis & Simulation of Injection Volume Accuracy
Christian Riva, MS, presents a case study proving it is possible to have a realistic prediction of the injection volume accuracy of a drug delivery system, even in an early stage of product development, when only a high-level product architecture is available.
EXECUTIVE INTERVIEW - Cambrex: Providing Big Value in the Small Molecule Outsourcing Market
Simon Edwards, President, CDMO Sales & Marketing at Cambrex, discusses the biggest trends in the small molecule outsourcing market.
DATA ANALYTICS - Leveraging Cloud-Based Data & Analytics to Optimize Pharmaceutical Manufacturing
Benzi Mathew explains how recognition is increasing about the powerful impact data and analytics can have on optimizing the manufacturing process and ensuring demand is met every time, all the time.
Entera Bio Reports Positive Results from a Phase 2 PK/PD Study of Oral PTH
Entera Bio Ltd. recently announced the presentation of positive results from its pharmacokinetic (PK) and pharmacodynamic (PD) study in patients with hypoparathyroidism treated with its…
Dance Biopharm Presents Phase 2 Clinical Data Highlighting Rapid Effects of Inhaled Human Insulin
Dance Biopharm Holdings, Inc., recently presented data from its Phase 2 clinical study of Dance 501, a novel gentle mist formulation of human insulin administered with its….
Immutep to Receive Milestone Payment From GSK
Immutep Limited recently announced it will receive a milestone payment from GSK of $5.02 million related to the first patient being dosed in…..
Atlas Nanotech Announces Successful Development of First-Ever OTC Nanotechnology Vitamin A
Costas Inc. DBA Atlas Nanotech adds another unique nanotechnology medical product to its portfolio. Recently, CEO Dr. Julio Riestra announced the completion of development of…
Mustang Bio Announces Phase 1 Clinical Trial
Mustang Bio, Inc. recently announced that City of Hope, a world-renowned independent cancer research and treatment center, has opened and is beginning to treat its…
Novo Nordisk & Emisphere Announce Development Update
Novo Nordisk recently announced the Federal Food and Drug Administration (FDA) has approved Rybelsus, a semaglutide tablet, for the treatment of adults with type 2…
Minerva Neurosciences & Catalent Enter Commercial Supply Agreement
Minerva Neurosciences, Inc. and Catalent recently announced they have entered into a long-term commercial supply agreement for Roluperidone (MIN-101), an investigational compound under development by…
Aptevo Therapeutics Introduces New Adaptir Bispecific Antibody Candidate
Aptevo Therapeutics Inc. recently introduced a new immuno-oncology candidate, APVO603, built on Aptevo’s proprietary ADAPTIR bispecific antibody platform. Jane Gross, PhD, Chief Scientific Officer for…