Formulation Development
Denali Therapeutics Announces New Interim Data from Phase 1/2 Study of DNL310 in MPS II (Hunter Syndrome)
Denali Therapeutics Inc. recently announced new interim results from a Phase 1/2 trial of DNL310 (ETV:IDS) in MPS II (Hunter syndrome). DNL310 is an investigational,…
FDA Grants Fast Track Designation for Longeveron’s Treatment for Hypoplastic Left Heart Syndrome in Infants
Longeveron Inc. recently announced the US FDA has granted Fast Track Designation to Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare…
WHITEPAPER - Key Considerations in Oral Delivery of Peptides – Factors to Consider While Evaluating Oral Administration
Peptide therapeutics are a hot topic in pharmaceutical R&D. While most peptides are administered parenterally, oral delivery of peptide therapeutics offers several advantages. Enteris BioPharma’s…
Aria Pharmaceuticals Advances Pipeline With Six Provisional US Patents Filed Across Three Diseases
Aria Pharmaceuticals recently announced the company has successfully filed a total of six provisional patents with the United States Patent and Trademark Office (USPTO) for lead candidates in its lupus, idiopathic pulmonary fibrosis (IPF), and….
Immutep Granted Japanese Patent for Eftilagimod Alpha, a Soluble Lag-3 Protein, in Combination With a PD-1 Pathway Inhibitor
Immutep Limited recently announced the grant of a new patent (No. 7116547) titled Combined Preparations for the Treatment of Cancer or Infection by the Japanese…
Outlook Therapeutics Re-Submits BLA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics, Inc. recently announced it has re-submitted its Biologics License Application (BLA) to the US FDA for ONS-5010, an investigational ophthalmic therapy which, if…
Timber Pharmaceuticals Announces Publication of Results from Phase 2b CONTROL Study of FDA-Designated Breakthrough Therapy
Timber Pharmaceuticals, Inc. recently announced that results from the previously completed Phase 2b CONTROL study that evaluated TMB-001, a topical isotretinoin formulated using the company’s patented IPEG delivery system, in moderate-to-severe congenital ichthyosis (CI) are published….
Imbria Presents Positive Clinical Data for Ninerafaxstat From IMPROVE-DiCE
Imbria Pharmaceuticals, Inc. recently announced positive clinical results from the Phase 2, IMPROVE-DiCE trial demonstrating that ninerafaxstat in patients with T2DM and obesity normalized cardiac…
Esperion Announces Bempedoic Acid Recommended as Oral Non-Statin Therapy for LDL-Cholesterol Lowering
Esperion recently announced bempedoic acid (NEXLETOL) is now recommended as an important oral non-statin therapy for LDL-cholesterol (LDL-C) lowering in the management of atherosclerotic cardiovascular…
Anthos Therapeutics Launches Second Phase 3 Clinical Trial of its Dual-Acting Factor XI Inhibitor
Anthos Therapeutics recently announced the initiation of recruitment for its second Phase 3 clinical trial investigating abelacimab, its novel dual-acting fully human monoclonal antibody targeting…
MindMed Announces First Patient Dosed in Phase 2b Trial of MM-120 in General Anxiety Disorder
Mind Medicine (MindMed) Inc. recently announced first patient dosing in its Phase 2b dose-optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD),…
Daré Bioscience Announces Global Licensing Rights to Novel Antimicrobial Glycerol Monolaurate for Vaginal Health
Daré Bioscience, Inc. recently announced it has entered into a license agreement with Hennepin Life Sciences LLC under which Daré acquired the exclusive global rights…
Ranok Therapeutics Announces Initiation of Patient Dosing in a Phase 1/2 Clinical Trial of First-in-Class BRD4-Targeting CHAMP Protein Degrader
Ranok Therapeutics recently announced the initiation of patient dosing in the US for a Phase 1/2 study of RNK05047. The trial, entitled CHAMP-1, will evaluate the safety, tolerability, pharmacokinetics, and….
2022 Analytical Testing eBook – Service Providers Offer Innovation
Learn more about the technologies from Alcami, Associates of Cape Cod, Stevanato Group, and West in this exclusive 2022 Drug Development & Delivery Analytical Testing e-book.
Zerion Pharma & Hovione Extend Partnership to Cover Use of Dispersome Technology Platform in Nutraceuticals
Hovione and Zerion Pharma A/S (Zerion) recently announced an extension of their collaboration on Zerion’s Dispersome technology into the nutraceutical/dietary….
Oculis Announces Phase 2 Data Showing Topical Eye Drops Anti-TNFα Agent Licaminlimab Relieves Persistent Ocular Discomfort in Severe Dry Eye Disease
Oculis S.A. recently announced results of the double blinded, multicenter and placebo controlled Phase 2 clinical trial assessing the effect of topical licaminlimab (OCS-02) on global ocular discomfort in patients with severe….
Immatics Announces First Cancer Patient Treated With Second-Generation ACTengine TCR-T Candidate
Immatics N.V. recently announced the treatment of the first patient in its Phase 1b expansion cohort C (NCT03686124) evaluating IMA203CD8, the company’s second-generation TCR-T monotherapy…
Belite Bio Initiates Pivotal Phase 3 Clinical Trial of LBS-008 in Stargardt Disease in the US
Belite Bio, Inc. recently announced it has commenced enrollment for the US Phase 3 clinical trial of LBS-008 in patients with Stargardt Disease (STGD1), a…
Lonza Strengthens Micronization Portfolio With the Introduction of X-Ray Powder Diffraction Capability
Lonza has expanded the range of particle engineering services offered by its Monteggio (CH) site through the introduction of X-ray powder diffraction (XRPD). This rapid analytical technique provides additional….
Cue Biopharma Doses First Patient in Phase 1 Study of CUE-102 for Wilms’ Tumor 1 (WT1) - Expressing Cancers
Cue Biopharma, Inc. recently announced it has dosed the first patient in a Phase 1 dose escalation study evaluating CUE-102, its second clinical drug candidate…
