Formulation Development
Catalent Invests $40 Million to Increase Patient-Centric Dose Form Manufacturing Capabilities
Catalent recently announced it is investing up to $40 million at its manufacturing facility in Winchester, KY. The investment will see the installation of new…
Emisphere Provides Development Update on Novo Nordisk Drug Using its Eligen SNAC Carrier Technology
Novo Nordisk recently announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for oral semaglutide, a glucagon-like peptide-1 (GLP-1) analogue in a tablet taken once-daily, for the treatment of adults with type 2 diabetes.
Oculos & Optceutics Partner to Bring Expanded Services to Ophthalmic Innovators
Oculos and Optceutics recently announced they are entering into a co-promotion arrangement to provide broader services for clients spanning from early research through product approval.
Caris Life Sciences Acquires Pharmatech
Caris Life Sciences recently announced it has acquired Pharmatech, Inc., a pioneer of the original Just-In-Time research system with the largest research-ready oncology network.
DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
European Commission Approves Treatment of Moderate-to-Severe Plaque Psoriasis
AbbVie, a research-based global biopharmaceutical company, recently announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
TOPICAL DEVELOPMENT - Fast Tracking Your Way to Success
Marc Brown, PhD, Jon Lenn, PhD, and Jeremy Drummond, PhD, believe it is essential the lead (and potentially a back-up formulation depending on any risk factors identified) has been optimized and characterized to demonstrate it will maintain its quality and performance as well as provide the best chance of measurable success in the clinical setting.
CHECKPOINT INHIBITORS - Novel Targets & Global Markets
Laurie L. Sullivan and Cheryl L. Barton, PhD, say as manufacturers expand the clinical utility and healthcare professionals become more familiar with their efficacy and safety profiles, the checkpoint inhibitor market will continue to expand, becoming the cornerstone of many cancer treatment regimens.
DRUG DEVELOPMENT - Softgel Technology for Fast-Tracked Development Programs
Jeff Browne, PhD, and Ronak Savla, PharmD, PhD, believe given the accelerated timelines associated with expedited programs, lipid-based drug formulations, encapsulated in softgel capsules, provide an attractive option for addressing the challenges facing formulators.
FORMULATION FORUM - Formulation Development From Preclinical to First-In-Human
Jim Huang, PhD, says when a compound enters preclinical development for a GLP tox study from the drug discovery stage, formulators have innovative options on how to develop a tox and clinical formulation that ensures the success of IND and first dose in human.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2018
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, offers a short overview of drug delivery and formulation transactions and includes some of the numbers that color the trends of 2018 along with some thoughts on notable transactions and technologies.
Adynxx Announces Merger Agreement With Alliqua BioMedical
Adynxx, Inc. recently provided a business and clinical development update. Adynxx entered into a merger agreement with Alliqua Biomedical, Inc. that will result in Adynxx…
ExCellThera’s Lead Technology Receives FDA Regenerative Medicine Advanced Therapy Designation
ExCellThera Inc. recently announced the US FDA has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic…
Vyome Therapeutics Begins Dosing in Phase 2 Trial of Bactericidal Antibiotic Topical Gel
Vyome Therapeutics Inc. recently announced it has dosed the first patient in its Phase 2 trial of the company’s lead clinical candidate, VB-1953, for the…
OmniSeq & LabCorp Extend Exclusive Distribution Pact & Complete Follow-On Investment Agreement
OmniSeq and LabCorp recently announced an extension of their exclusive distribution agreement as well as an additional investment by LabCorp. The distribution agreement and LabCorp’s…
ChemioCare Announces Initiation of PETT-Based (Permeation Enhanced Transdermal Technology) Lenalidomide Program
ChemioCare USA Inc. recently announced it is initiating development of a transdermal formulation of lenalidomide, which is currently marketed in an oral form. ChemioCare believes…
Catalent Invests $14 Million at its Softgel Facility
Catalent recently announced that work is underway to expand integrated turnkey softgel capabilities at its facility in Eberbach, Germany. The $14-million expansion, which is scheduled…
Autolus Therapeutics Receives FDA Orphan Drug Designation
Autolus Therapeutics plc recently announced the US FDA has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).
Cambrex Completes New Quality Control Laboratory for Generic API Development in Milan
Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, recently announced that it had opened a new 120m2 quality control (QC) laboratory at its site in Paullo, Milan, Italy.
CureVac Granted Patent Claiming the Combination of mRNA Vaccines With Anti-PD-L1 Antibodies
CureVac AG recently announced it has been granted a patent from the European Patent Office entitled, Combination of Vaccination and Inhibition of the PD-1 Pathway…
