Formulation Development
Ocugen Announces First Patient Dosed in Phase 1/2 Clinical Trial for Gene Therapy Candidate
Ocugen, Inc. recently announced the first patient has been dosed in the Phase 1/2 clinical trial of OCU400, a modifier gene therapy candidate for the treatment of retinitis pigmentosa….
Lonza Joins IPAC-RS, an International Consortium Advancing the Regulatory Science of Inhalation Products
Lonza recently announced its membership in the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Through this consortium, Lonza will collaborate with other industry…
Outlook Therapeutics Submits BLA to FDA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics, Inc. recently announced it has submitted its Biologics License Application (BLA) to the US FDA for ONS-5010, an investigational therapy which, if approved,…
Allergy Therapeutics Selects AGC Biologics to Manufacture Novel Peanut Allergy Vaccine Candidate
AGC Biologics recently announced a new partnership with Allergy Therapeutics, the fully integrated specialty pharmaceutical company specializing in allergy vaccines. The CDMO has manufactured Phase 1…
Cidara Therapeutics Announces Completion of Dosing the First Cohort of Healthy Volunteers in Phase 1 Trial
Cidara Therapeutics, Inc. recently announced the first cohort of healthy volunteers has been dosed in its Phase 1 trial of CD388, a highly potent long-acting…
Silo Pharma Enters Agreement With CRO for Pharmacokinetic Study
Silo Pharma, Inc. recently announced it has entered into an agreement with Frontage Laboratories, a CRO providing integrated, science-driven, product development services throughout the….
Vyant Bio & OrganoTherapeutics Announce Strategic Collaboration
Vyant Bio, Inc. and OrganoTherapeutics recently announced they have entered into a collaboration agreement to work toward accelerating the discovery of drugs for the treatment of….
Qualigen Therapeutics Engages TD2 as Contract Research Organization for Preclinical Development
Qualigen Therapeutics, Inc. recently announced it has appointed the renowned contract research organization (CRO) Translational Drug Development (TD2) to lead the preclinical development of lead…
Mapi Pharma Receives US Patent Covering Methods of Suppressing or Alleviating Primary or Secondary Progressive MS With a Sustained-Release Glatiramer Acetate Depot
Mapi Pharma Ltd. recently announced it has been granted US Patent No. 11,167,003 titled Methods for suppressing or alleviating primary or secondary progressive multiple sclerosis….
Acer Therapeutics Enrolls First Patient in its Phase 2a Clinical Trial for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Menopause
Acer Therapeutics Inc. recently announced the enrollment of the first patient in its Phase 2a randomized, double-blind, placebo-controlled, dose-ranging trial evaluating the efficacy, safety, and…
Rentschler Biopharma & Vetter Unveil Xpert Alliance, a Joint Visualization of their Successful Strategic Collaboration
Rentschler Biopharma and Vetter, two globally operating Contract Development and Manufacturing Organizations (CDMOs), recently announced they are unveiling Xpert Alliance, a joint visualization of their…
eTheRNA Manufacturing Announces New LNP Formulation Development & Production Service
eTheRNA Manufacturing recently introduced a new Lipid Nanoparticle (LNP) formulation development and production service to support the discovery and early preclinical development of RNA-based….
Artizan Biosciences Announces Issuance of New US Patent to Cover Proprietary Discovery Platform
Artizan Biosciences, Inc. recently announced the US Patent and Trademark Office has issued US Patent No. 11,299,790 that broadens the use of the company’s proprietary…
Gb Sciences' Nanoparticle Encapsulation Technology Improves the Efficacy of Terpenes for Use in Chronic Pain Formulations
Gb Sciences, Inc. recently announced its sponsored study investigating the effect of nanoparticle encapsulation of three cannabis-based terpenes on their potential efficacy in pain management was….
Albireo Completes Enrollment in Pivotal Phase 3 ASSERT Study
Albireo Pharma, Inc. recently announced the completion of patient enrollment in the ASSERT study, a Phase 3 pivotal trial of Bylvay (odevixibat) in patients with…
Artelo Expands Collaboration With Trinity College Dublin to Investigate Cellular Biology of Fatty Acid Binding Protein Inhibition in Cancer
Artelo Biosciences, Inc. recently announced it has entered into a second collaboration with Richard K. Porter, PhD, of the School of Biochemistry & Immunology at….
Eagle Pharmaceuticals Agrees to Terms to Acquire Acacia Pharma Group plc
Eagle Pharmaceuticals, Inc. recently announced it has reached agreement on the terms of a transfer of the entire issued and to be issued share capital of Acacia Pharma Group plc to Eagle by way of a scheme of arrangement under….
Ionis & Biogen Announce Topline Phase 1 Study Results
Ionis Pharmaceuticals, Inc. & Biogen, Inc. recently announced topline results from the Phase 1 study of BIIB078 (IONIS-C9Rx), an investigational antisense oligonucleotide (ASO) for people…
European Medicines Agency Commences Review of Novel Gene Therapy Candidate for People With Hemophilia B
CSL Behring recently announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for etranacogene dezaparvovec (EtranaDez) under its accelerated assessment procedure.…
RAPT Therapeutics Announces Biomarker Data from Phase 1b Trial
RAPT Therapeutics, Inc. recently announced biomarker data from the company’s randomized placebo-controlled Phase 1b clinical trial of RPT193 in patients with moderate-to-severe atopic dermatitis (AD)…
