Formulation Development
Ocugen Announces FDA Clearance of IND Amendment to Initiate Phase 3 Clinical Trial - First Gene Therapy to Enter Phase 3 With a Broad Retinitis Pigmentosa Indication
Ocugen, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) amendment to initiate a Phase 3 clinical trial of OCU400,…
PolTREG Identifies Promising Efficacy Biomarker for Type-1 Diabetes in Patients Treated With its Treg Therapy in Combination With Rituximab
PolTREG S.A. recemtly announced it has published data in International Immunopharmacology, which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset…
Medigene AG Secures European Patent for its iM-TCR Technology
Medigene AG recently announced it has been issued a patent by the European Patent Office protecting its inducible Medigene T cell receptor (iM-TCR) technology, which…
Biora Therapeutics Achieves Positive Interim Results for Clinical Trial of BT-600, Advancing NaviCap Platform Development
Biora Therapeutics, Inc. recently shared additional positive interim results from the single-ascending dose (SAD) clinical trial of BT-600, which is a drug-device combination consisting of…
ProMed Pharma Acquires SpineThera Manufacturing Capabilities & Option to License Intellectual Property
ProMed Pharma LLC and SpineThera, Inc. recently announced ProMed Pharma has acquired SpineThera’s cGMP manufacturing operational assets. ProMed Pharma also obtained an option to….
Oruka Therapeutics & ARCA biopharma Announce Merger Agreement
Merger to create a company focused on advancing Oruka’s portfolio of novel biologics that aim to redefine the standard of care for patients with chronic skin diseases….
Lipella Pharmaceuticals Announces FDA Type C Meeting for LP-10 for Hemorrhagic Cystitis
Lipella Pharmaceuticals Inc. recently announced the US FDA has granted a Type C meeting request to discuss the company’s proposed Phase-2b clinical trial design for…
BioCorRx Pharmaceuticals Awarded New Patent for Novel Compound to Treat Pain, Depression & Schizophrenia
BioCorRx Inc. recently announced its subsidiary BioCorRx Pharmaceuticals Inc., a clinical-stage biopharmaceutical company, has been granted a new patent by the United States Patent and…
OrganaBio Launches On-Demand GMP-Compliant Hematopoietic Stem Cell Source for Advanced Therapy Manufacturing
OrganaBio recently announced the launch of HematoPAC-HSC-CB-GMP, on-demand current good manufacturing practice (cGMP)-compliant CD34+ hematopoietic stem cells (HSCs) ethically derived from fresh human cord blood.…
Bora Pharmaceuticals Completes Acquisition of Upsher-Smith
Bora Pharmaceuticals Co. recently announced it has completed the acquisition of Upsher-Smith Laboratories, Inc., a generics manufacturer and marketer based in….
Ipsen & Sutro Biopharma Announce Exclusive Global Licensing Agreement for an ADC Targeting Solid Tumors
Ipsen and Sutro Biopharma recently announced an exclusive global licensing agreement for STRO-003, an antibody-drug conjugate in the final stages of pre-clinical development, which targets the….
Bespak Confirms Inhaled & Nasal Drug Delivery Business Separation From Recipharm
Spin-out unites three sites to create a leading global CDMO as further significant investments announced at Holmes Chapel site….
Evaxion & Undisclosed Collaborator Announce Encouraging Results for Vaccine Antigens Against Staphylococcus Aureus Infection
Evaxion Biotech A/S recently announced the successful conclusion of a series of large non-rodent animal infection studies, testing antigens from Evaxion’s preclinical EVX-B1 vaccine candidate…
Teva & Abingworth Enter Strategic Development Funding Agreement
Collaboration combines Teva’s expertise in respiratory technology development and Launch Therapeutics’ innovative late-stage drug development model to progress Teva’s Dual-Action Asthma Rescue Inhaler (TEV-‘248) program….
Ocuphire Announces US Commercial Launch of RYZUMVl (Phentolamine Ophthalmic Solution 0.75%) by its Partner Viatris
Ocuphire Pharma, Inc. recently announced the US commercial launch of RYZUMVI (phentolamine ophthalmic solution) by its partner Viatris Inc. (NASDAQ: VTRS). Ocuphire has a global…
Corcept Completes Enrollment in Phase 3 Gradient Trial of Relacorilant in Patients With Adrenal Cushing’s Syndrome
Corcept Therapeutics Incorporated recently announced completion of enrollment in GRADIENT, a Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with Cushing’s…
SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science
Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.
FORMULATION DEVELOPMENT - Solving Tough Solubility Issues With Fewer Compromises & Better Outcomes
Anshul Gupte, PhD, says fortunately, enhanced solubility can be achieved using a variety of approaches. For oral solid dosage forms, well-established approaches include micronization, nanoparticles, amorphous solid dispersions (ASDs), lipid-based formulations, salts, and co-crystals.
THERAPEUTIC FOCUS - Perspectives on Sigma-2 Modulation as a Therapeutic Modality for Slowing Age-Related Degenerative Disease
Anthony Caggiano, MD, PhD, believes there is evidence the sigma-2 receptor acts as a regulator of cellular processes, such as autophagy and protein trafficking, which are impaired in age-related degenerative diseases.
VACCINE DEVELOPMENT - Therapeutic Vaccines Development: At the Edge of a New Revolution
Mario Davinelli, PhD, Narcisa Mesaros, MD, David Morland, and Judith Neville, PhD, say therapeutic vaccines are an exciting area of research that has the potential to revolutionize the way we treat diseases.
