Formulation Development
Traws Pharma Doses First Patient With Ratutrelvir in Phase 2 COVID Studies, Expects Results by Year-End 2025
Traws Pharma, Inc. recently announced the dosing of the first subject in a Phase 2 study to evaluate ratutrelvir, a ritonavir-free anti-viral treatment in newly diagnosed…
Ensera Launches as New Brand Identity for SteriPack
SteriPack, a global contract design and manufacturing organization (CDMO) for the pharmaceutical and medical device industries, has announced its trading name change to Ensera, signaling…
Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation
Bicara Therapeutics Inc. recently announced the US FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line…
MannKind Announces FDA Accepts for Review its sBLA for Inhaled Insulin in Children & Adolescents
MannKind Corporation recently announced the US FDA has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children…
Shape Therapeutics Shares Breakthrough Preclinical Data for Non-Invasive Treatment of Parkinson’s Disease Using a Brain Targeted AAV Gene Therapy
Shape Therapeutics recently announced it presented new preclinical data highlighting the therapeutic potential of its lead product (SHP-201), a disease-modifying gene therapy for the treatment…
AviadoBio & UgeneX Therapeutics Announce Exclusive Option-License Agreement to Develop Next Generation Optogenetics Gene Therapy to Restore Vision in Patients With Retinal Disease
AviadoBio Ltd. and UgeneX Therapeutics, today announced an exclusive option and license agreement for the development and commercialization of UGX-202, an investigational, AAV-based gene therapy…
Ligand Partner SQ Innovation Receives FDA Approval for Lasix ONYU, an At-Home Treatment for Edema in Heart Failure Patients
Ligand Pharmaceuticals Incorporated recently announced that its partner SQ Innovation Inc. has received approval from the US FDA for Lasix ONYU (furosemide injection), a novel…
New Preclinical Data From Encoded Therapeutics Demonstrate Therapeutic Potential of its One-time, Non-opioid Gene Therapy Candidate for Chronic Pain
Encoded Therapeutics Inc. recently announced preclinical data demonstrating that its AAV9 microRNA (miRNA) gene therapy candidate achieved robust knockdown of SCN9A (NaV1.7), a key mediator of…
Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
Rein Therapeutics recently announced it has received authorization from the European Medicines Agency (EMA) to initiate the Company’s Phase 2 RENEW clinical trial of its…
Gelteq Announces New Product Development Agreement With Melbourne Health for Novel Bowel Polyp Growth Reduction Compound
Gelteq Limited recently announced it has entered into a Product Development and Profit Share Agreement with Melbourne Health, operator of The Royal Melbourne Hospital and…
Annovis Announces Novel Biomarker Data in Alzheimer’s Patients Supporting Buntanetap’s Potential as a Disease-Modifying Treatment
Annovis Bio, Inc. recently announced new results that demonstrate buntanetap’s ability to attenuate inflammation and improve cellular health in Alzheimer’s patients, suggesting potential disease-modifying effects…
Roquette Boosts Extensive Cyclodextrins Portfolio With Launch of KLEPTOSE® Crysmeb methyl-beta-cyclodextrin for Oral & Parenteral Formulations
Roquette, a global leader in plant-based ingredients and pharmaceutical excipients for the health and nutrition sectors, recently launched of its latest novel pharmaceutical excipient: KLEPTOSE®…
Zenas BioPharma & InnoCare Pharma Announce License Agreement Granting Zenas Rights for Three Autoimmune Product Candidates, Including Orelabrutinib, a BTK Inhibitor in Phase 3 Development for Multiple Sclerosis
Zenas BioPharma, Inc. and InnoCare Pharma Limited recently announced a transformational license agreement granting Zenas global development and commercialization rights to orelabrutinib for Multiple Sclerosis…
Complement Therapeutics Receives FDA IND Clearance to Advance CTx001 Into Opti-GAIN, a Phase I/II Clinical Trial in Geographic Atrophy Secondary to AMD
Complement Therapeutics GmbH (CTx), a biotechnology company developing next-generation therapeutics for complement-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared…
Rigel Announces First Patient Enrolled in the Dose Expansion Phase of its Phase 1b Study of R289 in Patients With Lower-Risk MDS
Rigel Pharmaceuticals, Inc. recently announced the first patient has been enrolled in the dose expansion phase of the ongoing Phase 1b study of R289 in…
Lisata Therapeutics & Catalent Announce Global Antibody-Drug Conjugate License Agreement
Lisata Therapeutics, Inc. and Catalent, Inc. recently announced a global product license agreement that allows Catalent to incorporate Lisata’s certepetide into antibody-drug conjugates (ADCs) developed…
Nutriband Files Provisional Patent Application for Enhanced Transdermal Abuse Deterrent Technology
Nutriband Inc. recently announced that it has filed a provisional patent application with the US Patent and Trademark Office (USPTO) to further strengthen Nutriband’s intellectual…
NurExone Demonstrates Reproducible, Dose-Dependent Vision Recovery in Preclinical Glaucoma Model
NurExone Biologic Inc. recently announced new preclinical results showing that its lead candidate ExoPTEN produces a reproducible, dose-dependent therapeutic effect in an eye model of glaucoma.…
CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm
John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.
SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape
Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.
