Formulation Development
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…
Agios Announces Publication of Phase 3 ACTIVATE-T Data Demonstrating Benefits of PYRUKYND for Adults With Pyruvate Kinase Deficiency
Agios Pharmaceuticals, Inc. recently announced data from the core period of the pivotal Phase 3 ACTIVATE-T study of PYRUKYND (mitapivat) in adults with pyruvate kinase (PK) deficiency who receive regular….
Kapruvia Approved in Switzerland With Additional Regulatory Decisions Expected in H2 2022
Cara Therapeutics, Inc. and Vifor Fresenius Medical Care Renal Pharma recently announced they have received approval for Kapruvia from the Swiss Agency for Therapeutic Products (Swissmedic). Kapruvia will be the first….
AUM Biosciences Receives FDA Orphan Drug Designation for the Treatment of Solid Tumors With the NTRK Fusion Gene
AUM Biosciences recently announced the US FDA has granted Orphan Drug Designation (ODD) to AUM601, a highly selective, oral small molecule that inhibits not only…
Blue Water Vaccines Announces Exploration of its VLP Platform for Use in Monkeypox Vaccine Candidate
Blue Water Vaccines Inc. recently announced the company plans to explore the potential to develop a novel monkeypox vaccine using its norovirus shell and protrusion…
Ventyx Biosciences Announces Positive Topline Phase 1 Data for its Selective Allosteric TYK2 Inhibitor VTX958
Ventyx Biosciences, Inc. recently announced positive data from the company’s Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial of VTX958, a…
Immunic Receives Notice of Allowance for Composition-of-Matter Patent in the US for Small Molecule Modulator Targeting Restoration of Intestinal Barrier Function & Regeneration of Bowel Epithelium
Immunic, Inc. recently announced it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for patent application 16/646130 titled Compound…
