Market News & Trends
Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial
Avadel Pharmaceuticals plc recently announced positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly…
Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Injection
Amphastar Pharmaceuticals, Inc. recently announced the US FDA has granted approval of its Abbreviated New Drug Application (ANDA) for Epinephrine Injection, USP 30 mg/30 mL…
Orchard Therapeutics Announces First Patient Dosed with OTL-201 Gene Therapy
Orchard Therapeutics recently announced that the first patient has been dosed in an open-label, proof-of-concept investigational study of OTL-201, an ex vivo autologous hematopoietic stem cell…
Harpoon Therapeutics Doses First Patient with HPN217, a BCMA Targeting TriTAC, for Multiple Myeloma
Harpoon Therapeutics, Inc. recently announced the first patient has been dosed with HPN217 in a Phase 1/2 clinical trial focused on relapsed, refractory multiple myeloma…
BioAegis Demonstrates Gelsolin Therapy Can Quell the COVID-19 Cytokine Storm & Promote Tissue Repair
BioAegis Therapeutics Inc. has highlighted recently published gene expression data in animal studies in which recombinant human plasma gelsolin (rhu-pGSN) significantly increased survival in pneumonia…
Santhera & Cold Spring Harbor Laboratory to Investigate Lonodelestat in COVID-19-Related ARDS
Santhera Pharmaceuticals recently announced it has entered into a collaboration agreement with Cold Spring Harbor Laboratory (CSHL) to investigate the potential of lonodelestat (POL6014), a…
Catalyst Biosciences Completes Phase 2b Trial of Subcutaneous Factor IX Dalcinonacog Alfa (DalcA)
Catalyst Biosciences, Inc. recently announced completion of dosing and the 30-day follow-up period for its Phase 2b trial of SQ dalcinonacog alfa (DalcA). “We are…
INmune Bio Announces Initiation of Clinical Program to Determine if Company’s Platform May Prevent Complications of Cytokine Storm Caused by COVID-19
INmune Bio, Inc. recently announced the initiation of a therapeutic program to treat patients with pulmonary complications from COVID-19 infection with its dominant-negative TNF inhibitor…
Vaxart Announces Positive Preclinical Data for its Oral COVID-19 Vaccine Program
Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, recently announced it has obtained positive…
Ascendia Joins the Fight Against COVID-19; Developing Formulations
Ascendia Pharmaceuticals, a specialty CDMO company engaged in the design, formulation, optimization, and manufacture of poorly soluble molecules for various dosage forms with patent-protected technology…
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Molex Expands European Manufacturing Footprint & Capabilities With State-of-the-Art Campus in Poland
Molex recently announced a major expansion of its global manufacturing footprint with the opening of a new campus in Katowice, Poland. The facility’s initial 23,000-square-meter manufacturing space will….
Kala Pharmaceuticals Completes Sale of EYSUVIS & INVELTYS to Alcon Inc
Kala Pharmaceuticals, Inc. recently announced it has completed the sale of its commercial portfolio and related intellectual property assets to Alcon Inc., a transaction that was….
Insightful Science Acquires Protein Metrics to Expand its R&D Solution to Include Proteomics
Insightful Science recently announced it has completed the transaction to acquire Protein Metrics, Inc. to expand the company’s R&D value chain to widen the biopharmaceutical protein analysis arena….
Acer Therapeutics & Relief Therapeutics Announce NDA Submission for ACER-001 for Treatment of Urea Cycle Disorders
Acer Therapeutics Inc. Relief Therapeutics recently announced the submission of a New Drug Application (NDA) to the US FDA for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs)….