Formulation Development
Pieris Pharmaceuticals Announces Dosing of First Patient in Phase I Combination Trial
Pieris Pharmaceuticals, Inc. recently announced it has dosed the first patient in the company’s Phase 1 combination clinical trial of PRS-343, its lead proprietary immuno-oncology…
MilliporeSigma Launches Next-Generation Process Technologies for Intensified Drug Production
MilliporeSigma recently launched three new products to help biomanufacturers navigate the evolving biopharma landscape with increased speed, greater flexibility, and enhanced quality. These next-generation process…
Aucta Pharmaceuticals Signs Commercial Manufacturing Agreement With Catalent
Catalent Pharma Solutions recently announced a commercial supply agreement for Aucta Pharmaceuticals, Inc.’s (Aucta) vigabatrin. The agreement follows a successful development program to formulate vigabatrin…
Biothera Pharmaceuticals Announces Immuno-Oncology Clinical Trial Collaboration With AstraZeneca
Biothera Pharmaceuticals, Inc. recently announced a clinical collaboration with AstraZeneca to evaluate whether the combination of Biothera’s Imprime PGG and AstraZeneca’s durvalumab (IMFINZI) can decrease tumor volume in patients with primary untreated locally advanced head and neck cancer prior to surgical resection.
Metrion Biosciences & AMRI Collaborate to Offer Ion Channel Drug Discovery Services
Metrion Biosciences Limited and AMRI recently announced they have signed a new collaboration agreement. The alliance will promote Metrion’s electrophysiology and ion channel screening expertise to global pharmaceutical and biotechnology clients.
CURE Pharmaceutical Expands Distribution of CUREfilm Technology With First Licensing Agreement
CURE Pharmaceutical recently announced it entered into a multi-year licensing agreement for the first time with a leading international cannabis company.
Reata Announces Receipt of $30-Million Milestone Payment
Reata Pharmaceuticals, Inc. recently announced it has received a $30-million milestone payment from its licensee, Kyowa Hakko Kirin Co., Ltd. following the initiation of AYAME, a Phase 3 clinical trial to assess the efficacy and safety of bardoxolone methyl (bardoxolone) for the treatment of diabetic kidney disease in Japan.
Emisphere’s Proprietary Eligen Technology Supports Novo Nordisk’s Oral Semaglutide
Novo Nordisk A/S recently announced the headline results from PIONEER 5, a Phase 3a trial with oral semaglutide in adults with type 2 diabetes and…
Ajinomoto Althea Celebrates 20 Years in San Diego & Opening of New Facility
Ajinomoto Althea, Inc., a leading contract development and manufacturing organization, celebrated its 20th year in operation, making it one of the true anchors of the…
UPM Pharmaceuticals Appoints New Director of Analytical Development
UPM Pharmaceuticals, a Contract Development and Manufacturing Organization (CDMO) focused on oral solid and semi-solid drug dosage forms, has appointed Dr. Chi-Chang Wung to the…
Adverum Biotechnologies Announces IND Active for ADVM-022, a Novel Gene Therapy
Adverum Biotechnologies, Inc. recently announced its Investigational New Drug (IND) application is active for the planned multi-center, open-label, Phase 1, dose-escalation study of ADVM-022, a…
SunGen Pharma Establishes Injectable Division, Forms Manufacturing Relationship
SunGen Pharma recently announced it has entered into a Manufacturing Agreement with Grand River Aseptic Manufacturing (GRAM) to manufacture generic injectable pharmaceutical products.
Cynata’s Stem Cell Therapy Meets All Safety & Efficacy Endpoints in Trial
Australian stem cell and regenerative medicine company Cynata Therapeutics Limited recently announced that CYP-001, its lead Cymerus mesenchymal stem cell (MSC) product candidate, met all clinical endpoints in a Phase 1 trial for the treatment of steroid-resistant acute graft-versus-host disease (GvHD).
Emergent BioSolutions to Acquire ADAPT Pharma
ADAPT Pharma recently announced it has entered into a definitive agreement to be acquired by Emergent BioSolutions. Adapt is solely focused on helping address the opioid overdose and addiction crisis.
CONTROLLED RELEASE - Informed Selection of Modified-Release Technologies Provides Simpler Oral Dose Regimens
Ronak Savla, PhD, reviews some of the physicochemical and biopharmaceutical characteristics of drugs and how they influence creation of a controlled drug delivery formulation.
DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development
Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.
LIPID-BASED DELIVERY - Advanced Lipid-Based Drug Delivery Systems: Solid Lipid Nanoparticles & Nanostructured Lipid Carriers
John K. Tillotson, RPh, PhD, believes increased research and development of these drug delivery platforms will continue to advance therapeutic efficacy and safety for emerging difficult-to-deliver actives.
HIGH-RESOLUTION MASS SPECTROMETRY - A Map to Biologics
William Boomershine, PhD, explains how high-resolution mass spectrometry is a key component to the characterization of novel biologics and biosimilars.
DRUG DELIVERY - Targeted Delivery of Submicron Particle Cancer Chemotherapy: Helping Shift the Immunotherapy Paradigm
Marc A. Iacobucci says that with much attention and research investment into IOT, NanOlogy is shaping a new paradigm for cancer treatment by attempting to improve the safety and effectiveness of tried and true CT through local delivery.
Novan Announces Promising Clinical Results With SB414
Novan, Inc. recently announced an update on the SB414 nitric oxide-releasing cream product candidate and its application to two therapeutic indications: atopic dermatitis and psoriasis.…
