Formulation Development
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Going Beyond the Science to Become True Partners
Contributor Cindy H. Dubin speaks with leading CDMOs about how they are adapting to bio/pharma client needs, their capabilities in handling complex molecules, and how they are transforming from specialist contractors to true partners.
FORMULATION FORUM - Advances in Drug Delivery by Antibody Drug Conjugates (ADCs)
Shaukat Ali, PhD, and Jim Huang, PhD, focus on two aspects of drug delivery through ADCs. One, where an antibody is conjugated via a ligand with functionalized LNPs carrying cytotoxic drugs; and two, where an antibody is conjugated directly with drug through a linker at the specific site.
AMORPHOUS SOLID DISPERSION SPECIATION - Impact of Polymer Chemistry & Drug Properties
Wesley K. Tatum, PhD, focuses on the use of in vitro techniques for characterizing ASD performance and on how these techniques can be used to help better understand the role of polymer chemistry in ASD performance.
EXECUTIVE INTERVIEW - Lonza: Navigating Today’s Challenges in Drug Solubility & Bioavailability
Adi Kaushal, Director and Technology Head, Bioavailability Enhancement at Lonza, discusses solubility and bioavailability challenges and Lonza’s approach.
EXECUTIVE INTERVIEW - PCI Pharma Services: A Consultative Approach to High Potency Formulation Development
David O’Connell, Director of Scientific Affairs at PCI Pharma Services, explains how important it is to choose the right CDMO partner to accompany you throughout the drug product lifecycle.
THERAPEUTIC FOCUS - The Unmet Need of Agitation in Alzheimer’s Disease
Ram Mukunda, MS, and Evelyn Gutiérrez, and Claudia Grimaldi report on IGC-AD1, the first natural cannabinoid-based investigational drug to be tested in human FDA trials for the treatment of AD, which has shown promising results in treating agitation in Alzheimer’s patients.
Deciphera Pharmaceuticals Announces Oral Presentation of Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients With Tenosynovial Giant Cell Tumor
Deciphera Pharmaceuticals, Inc. recently announced that results from the company’s MOTION pivotal Phase 3 study of vimseltinib in patients with TGCT are being highlighted in…
Denali Therapeutics Announces FDA Has Selected DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo Syndrome Type A) for START Pilot Program Intended to Accelerate Development of Rare Disease Therapies
Denali Therapeutics Inc. recently announced the US FDA has selected DNL126 for participation in the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot…
Ecolab Life Sciences & Repligen Announce Commercial Launch of DurA Cycle Affinity Resin for Large-Scale Biologic Manufacturing
St. Paul, MN, US and Waltham, MA, US – June 3, 2024 – Ecolab today announced that its Purolite resin business, together with Repligen Corporation (NASDAQ:RGEN), a life…
Longeveron Announces Contract Development & Manufacturing Business & First Contract
Longeveron Inc. recently announced the launch of its contract development and manufacturing business at the company’s 15,000-sq-ft state-of-the-art Good Manufacturing Practice (GMP) facility. This facility contains….
Aeterna Zentaris & Ceapro Complete Merger Transaction
Aeterna Zentaris Inc. and Ceapro Inc. recently announce the successful completion and closing of their all-stock merger of equals transaction (the Transaction), which was previously announced by….
uniQure Receives FDA Regenerative Medicine Advanced Therapy Designation for Investigational Gene Therapy in Huntington’s Disease
uniQure N.V. recently announced the US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational gene therapy AMT-130 for the treatment of…
PhoreMost Achieves Second Milestone in Target Discovery Alliance With Boehringer Ingelheim
PhoreMost Ltd., has triggered a second milestone payment in its multi-project target discovery collaboration with Boehringer Ingelheim. This was achieved by identifying and validating novel…
Anocca AB & Shinobi Therapeutics Announce Strategic Partnership to Develop Allogeneic TCR-T Cell Therapies in Oncology
Anocca AB and Shinobi Therapeutics recently announced a strategic partnership to use Shinobi’s proprietary immune evasive iPS-T cell platform with novel candidate TCRs, discovered and…
Nxera Pharma & PrecisionLife Expand Strategic R&D Partnership Into New Therapeutic Area
Nxera Pharma Co. Ltd and PrecisionLife recently announced the expansion of their strategic R&D partnership into auto-immune disorders with the potential to identify new drug…
Elevar Therapeutics Reports Landmark Median Overall Survival of 23.8 Months in First-Line Treatment for Unresectable Hepatocellular Carcinoma
Elevar Therapeutics, Inc. recently announced the landmark overall survival (OS) analysis of camrelizumab and rivoceranib as a first-line treatment for unresectable hepatocellular carcinoma (uHCC) will…
Patient Dosing Commenced in Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients With Obstructive Sleep Apnea
Incannex Healthcare Inc. recently announce patient dosing has commenced in the company’s Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients…
Sanofi Completes Acquisition of Inhibrx, Inc.
Sanofi recently announced the completion of its acquisition of Inhibrx, Inc. The acquisition adds SAR447537 (formerly INBRX-101) to Sanofi’s rare disease pipeline, underscoring the company’s…
Nxera Pharma to Receive $4.6 Million in Milestone Payments Rrom Centessa Pharmaceuticals
Nxera Pharma recently announced it expects to receive $4.6 million in milestone payments from Centessa Pharmaceuticals pursuant to a license agreement regarding Nxera technology used…
Jeito Capital Announces Acquisition by Merck & Co. of its Portfolio Company EyeBio for a Potential Value of $3 Billion
This acquisition reflects the significant clinical progress achieved with Restoret, EyeBio’s novel late-phase candidate for diabetic macular edema, as well as….
