Formulation Development
Revolo Biotherapeutics Completes Enrollment in Phase 2 Trial
Revolo Biotherapeutics recently announced it has completed enrollment and has fully randomized all patients in a Phase 2a proof of concept clinical study investigating its…
Chiesi Global Rare Diseases Announces FDA Acceptance of BLA Filing for the Proposed Treatment of Alpha-Mannosidosis
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., recently announced the US FDA has accepted the Biologics License Application (BLA) and granted…
WHITEPAPER - Launching a Drug-Device Combination: 5 Key Factors to Focus On
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
Ocuphire Pharma Announces Last Patient Completes Final Visit in ZETA-1 Phase 2b 24-Week Trial
Ocuphire Pharma, Inc. recently announced the last patient of the 103 enrolled subjects since April 2021 has completed their 24-week study visit in the Phase…
Pace Life Sciences Acquires Biopharma Global, Expanding FDA Regulatory Affairs Strategy & Consulting Capabilities to the Biotechnology & Pharmaceutical Markets
Pace Life Sciences, LLC recently announced it has acquired Biopharma Global (Biopharma). Biopharma specializes in full-service regulatory support for orphan products to treat rare diseases…
Tarsus Submits New Drug Application to the FDA for TP-03 for the Treatment of Demodex Blepharitis
Tarsus Pharmaceuticals, Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the…
Good Therapeutics Announces Acquisition of Conditionally Active PD-1-Regulated IL-2 Program by Roche
Good Therapeutics recently announced it has entered into a definitive merger agreement to be acquired by Roche. With this acquisition, Roche will gain….
Mannkind Successfully Completes Phase 1 Study of Inhaled Clofazimine
MannKind Corporation recently announced it has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101) and is planning discussions with the US…
Avalo Advances BTLA Agonist Fusion Protein to IND-Enabling Stage
Avalo Therapeutics, Inc. recently announced its human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein, AVTX-008, has now entered IND-enabling studies, with a target…
Tenaya Therapeutics Announces FDA Clearance of IND & Initiation of Phase 1 Safety Study for an HDAC6 Inhibitor for Heart Failure With Preserved Ejection Fraction
Tenaya Therapeutics, Inc. recently announced clearance of its Investigational New Drug (IND) application to begin clinical testing of TN-301 by the US FDA. TN-301 is…
Synlogic Achieves Research Milestone in Collaboration With Roche for Development of Novel Synthetic Biotic to Treat Inflammatory Bowel Disease
Synlogic, Inc. recently announced it has received a milestone payment for the achievement of prespecified success criteria under the research collaboration agreement with Roche for….
Hovione Expands Drug Product Offering With New Manufacturing Line Dedicated to Continuous Tableting
Hovione recently announced it has expanded its continuous manufacturing offering and services. A new state-of-the-art continuous manufacturing facility is….
Novo Nordisk to Acquire Forma Therapeutics & Expand Presence in Sickle Cell Disease & Rare Blood Disorders
Novo Nordisk and Forma Therapeutics, Holdings Inc. recently announced they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for….
Qureight Announces World’s First Digital Biomarker for Lung Fibrosis
For the first time, artificial intelligence (AI) using convolutional neural networks has been used to analyse trial data involving the lung disease idiopathic pulmonary fibrosis (IPF). The technology picked up….
Vaxart Announces Positive Top-line Phase 2 Clinical Study Data Demonstrating Safety & Immunogenicity of Its Wuhan S-Only COVID-19 Pill Vaccine Candidate
Vaxart, Inc. recently reported positive top-line data from the first part of a planned two-part Phase 2 study of its Wuhan S-only oral pill COVID-19…
SOLUBILITY ENHANCEMENT - How Microparticles are Opening Doors to New Solutions for Oral Drug Delivery
Jessica Mueller-Albers, PhD, Yiming Ma, PhD, Alexander Bernhardt, PhD, and Michael Damm review the use of microparticles for solubility enhancement of oral small molecules and how this approach can address the challenges in pharmaceutical formulations.
GENERATIVE AI TECHNOLOGY - Generative Machine Learning Can Construct Smooth Chemical Search Spaces for Efficient Drug Discovery
Jason Rolfe, PhD, and Ali Saberali, PhD, and Mehran Khodabandeh, MSc, explain how Generative ML promises to efficiently optimize more accurate estimates of binding affinity and other pharmacological properties over the entirety of drug-like chemical space.
GENE THERAPY - Developing Affordable Point of Care CAR-T Therapies: Expanding Efficacy & Impact
Rimas Orentas, PhD, and Boro Dropulić, PhD, MBA, believe the future belongs to those who will be able to innovate rapidly, maintain regulatory confidence, and drive down costs to make CAR-T cell and other engineered cell therapies available to all who would benefit.
EXECUTIVE INTERVIEW - Emergent CDMO: A Molecule-to-Market Partner for Complex Biologics
Bill Hartzel, Senior Vice President and Head of CDMO Business, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.
DRUG DEVELOPMENT STRATEGIES - Marrying Target Product Profile, Regulatory & Partnering Strategies for Long-Term Product Success
Chris Rojewski believes given the costs, time, and risks associated with contemporary drug development, it’s time this fundamental aspect of successful development be brought as close to the program as possible — the CDMO tasked with executing drug strategy in the first place.
