Market News & Trends
UAB & Mereo Announce Positive Top-line Results From Phase 1b/2 Trial of Alvelestat in Hospitalized Patients With COVID-19 Respiratory Disease
The University of Alabama at Birmingham (UAB) and Mereo BioPharma Group plc recently announced top-line data from a Phase 1b/2 clinical trial evaluating alvelestat, a…
Allarity Therapeutics Submits NDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma
Allarity Therapeutics, Inc. recently announced the submission of a new drug application (NDA) with the US FDA seeking marketing approval for dovitinib for the third-line…
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….
First US Patients With Persistent Cardiac Arrythmias Treated Using Volta Medical’s Artificial Intelligence-Based Analysis
Volta Medical recently announced the introduction of its leading-edge product, VX1, at three leading US hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital…
Certara Announces FDA Renewal & Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, recently announced the US FDA has renewed and expanded its licenses of Certara’s proprietary biosimulation software,…
Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 in the Treatment of Liver Cancer
Hepion Pharmaceuticals, Inc. recently announced the US FDA has accepted its investigational new drug (IND) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the…
Intra-Cellular Therapies Announces US FDA Approval of CAPLYTA for the Treatment of Bipolar Depression in Adults
Intra-Cellular Therapies, Inc. recently announced the US FDA approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults,…
Viridian Therapeutics Announces First Subject Dosed in Phase 1/2 Clinical Trial of VRDN-001 for Thyroid Eye Disease (TED)
Viridian Therapeutics, Inc. recently announced the first subject was dosed in a Phase 1/2 proof-of-concept clinical trial for VRDN-001, a monoclonal antibody that blocks the…
Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine
Novavax, Inc. recently announced the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax' COVID-19 vaccine (also known as NVX-CoV2373) to…
Editas Medicine Announces FDA Clearance of IND Application for EDIT-301 for the Treatment of Transfusion-Dependent Beta Thalassemia
Editas Medicine, Inc. recently announced the US FDA has cleared the IND for EDIT-301 for the treatment of transfusion-dependent beta thalassemia (TDT), enabling the company…
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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)….