Formulation Development
Incendia Therapeutics Enrolls First Patient in Phase 1c Clinical Trial of a Novel DDR1 Inhibitor
Incendia Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), recently announced the first patient…
Belite Bio Announces First Patient Dosed in Phase 2/3 Trial of Tinlarebant for the Treatment of Stargardt Disease
Belite Bio, Inc recently announced that the first patient has been dosed at the Tokyo Medical Center in the Phase 2/3 portion of its DRAGON…
Incannex Healthcare Announces Strategic Financing for up to $60 Million
Incannex Healthcare Inc. recently announced it has entered into an agreement to issue up to $10 million in secured convertible notes to Arena Investors, LP…
Tanvex Appoints Biopharma Industry Veteran as New CEO
Tanvex BioPharma, Inc., the biosimilar-focused biopharmaceutical company and CDMO, recently announced its Board of Directors has appointed Stephen Lam as the company's Chief Executive Officer,…
Cartesian Therapeutics Receives FDA Rare Pediatric Disease Designation for Descartes-08 for the Treatment of Juvenile Dermatomyositis
Cartesian Therapeutics, Inc. recently announced the US FDA has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). Descartes-08, Cartesian’s…
Hongene Biotech Corporation & ReciBioPharm Establish a Gene Editing Development Partnership
Hongene Biotech Corporation and ReciBioPharm have announced a strategic collaboration that will enhance gene editing drug manufacturing capabilities. Hongene, renowned for its expertise in the…
GRIN Therapeutics Announces Positive Topline Data from Honeycomb Trial of Radiprodil in GRIN-Related Neurodevelopmental Disorder
GRIN Therapeutics, Inc. recently reported topline results from the its ongoing two-part global Phase 1b open-label trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of…
Protara Therapeutics Announces Completion of First Cohort in Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients With Lymphatic Malformations
Protara Therapeutics, Inc. recently announced completion of the first cohort of the Phase 2 STARBORN-1 trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment…
Serán More Than Doubles Clinical Manufacturing Capacity in Bend, OR
Serán BioScience, LLC, the science-driven drug development partner, recently announced it has completed an expansion to increase the number of process manufacturing suites at its…
ENA Respiratory Announces Extension of US Department of Defense Funding for Novel Prophylactic Antiviral
ENA Respiratory has been awarded an additional $3.13 million contract from the U.S. Department of Defense (DOD). The new funding extends the $8.18 million already…
SPECIAL FEATURE - Injection Devices: From Pens & Autoinjectors to Pills, Sprays & Capsules, Injections Become More Efficient
Contributor Cindy H. Dubin reports on innovative and promising injection technologies that are ever more user friendly, versatile, precise, and life-saving.
FORMULATION DEVELOPMENT - Solubility-Enhancing Technologies in Pharmaceutical Development, a Mini-Review
Timothy Pas, PhD, and Vincent Levet, PhD, believe different solubility-enhancing technologies can be used by developers, and with different advantages and drawbacks, linked to payload, manufacturability, tolerability, and physical and chemical stability, effectively navigating solubility-enhancing solutions is multifaceted.
DRUG DELIVERY - Viewing Lipid Nanoparticle Delivery Technology Through the Lens of a CRDMO
Lu Tian, PhD, says the complexity of LNP formulations demands diverse and integrated capabilities for development – incorporating lipids, oligonucleotides, small molecules, and sometimes antibodies or ligands, and thus it requires a cohesive approach.
SILICON-STABILIZED HYBRID LNPS - Next-Generation Delivery of RNA Therapeutics
Suzanne Saffie-Siebert, PhD, Michael Welsh, PhD, Nissim Torabi-Pour, PhD, and Flavia M. Sutera, PhD, review current shortcomings, as well as some accompanying manufacturing challenges, and will show how they can be addressed by SiSaf’s silicon-stabilized hybrid LNPs.
EXECUTIVE INTERVIEW - Coya Therapeutics: Unlocking the Power of Tregs to Combat Inflammation & Fight Neurodegenerative Diseases
Dr. Howard Berman, Founder and CEO of Coya Therapeutics, discusses how the company is leveraging Tregs, its investigational products and the conditions targeted, Coya’s significant partnership with Dr. Reddy’s Laboratories, and his goals throughout the next 5 years.
Voyager Enters License for Next-Generation Capsid, Bringing Partnered Portfolio of TRACER-Enabled Gene Therapies to 14
Voyager Therapeutics, Inc. recently announced Novartis AG has agreed to license a novel capsid generated from Voyager’s TRACER capsid discovery platform for use in a…
Shuttle Pharma Announces Issuance of US Patent for Selective Histone Deacetylase Inhibitors for the Treatment of Human Disease
Shuttle Pharmaceuticals recently announced the issuance of US Patent No. 12,077,515, titled Selective Histone Deacetylase Inhibitors for the Treatment of Human Disease. This patent was…
Rigel Announces First Patient Enrolled in Phase 1b/2 Trial of REZLIDHIA (olutasidenib) in mIDH1 AML
Rigel Pharmaceuticals, Inc.recently announced the first patient has been enrolled in a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with REZLIDHIA…
Sonoma Biotherapeutics Receives $45-Million Milestone Payment From Regeneron
Sonoma Biotherapeutics, Inc. recently announced it has received a $45-million milestone payment from Regeneron Pharmaceuticals, Inc., under the terms of its active collaboration to discover,…
Recipharm Introduces ReciPredict to Revolutionize Drug Product Development & Manufacturing
Recipharm recently announced the launch of ReciPredict, a cutting-edge platform for Quality by Design (QbD), designed to transform the landscape of drug product development, tech…
