Market News & Trends
Immunic, Inc. Reports Positive Top-line Data From Phase 2 EMPhASIS Trial
Immunic, Inc. recently announced positive top-line data from its phase 2 EMPhASIS trial of lead asset, IMU-838, the company’s selective oral DHODH inhibitor, in patients…
FDA Approves Two Emergency INDs for COVID-19 Outpatient Therapy
Organicell Regenerative Medicine, Inc. recently announced the US FDA approved two outpatient Emergency Investigational New Drug Applications (eINDs) for treating mild-to-moderate respiratory distress due to…
Corbus Pharmaceuticals Completes Enrollment in Phase 3 Study
Corbus Pharmaceuticals Holdings, Inc. recently announced the completion of subject enrollment in DETERMINE, a Phase 3 study assessing the efficacy and safety of lenabasum for…
Rafael Pharmaceuticals Achieves Target Enrollment of 500 Patients in Pivotal Phase 3 Trial
Rafael Pharmaceuticals, Inc. recently announced it has reached its target enrollment of 500 patients in its pivotal Phase 3 clinical trial for metastatic pancreatic cancer…
Catalent Gene Therapy Facility Receives FDA Approval as an Additional Manufacturing Site for AveXis' Gene Therapy
Catalent recently announced that it was approved by the US FDA to produce commercial drug substance intermediate for AveXis’ spinal muscular atrophy (SMA) gene therapy…
BioAegis Therapeutics Initiates Phase 2 Clinical Trial of its Inflammation Regulator for COVID-19 Treatment
BioAegis Therapeutics Inc. recently announced it enrolled its first patient in its Phase 2 study of hospitalized patients with severe COVID-19 pneumonia. This study assesses…
Emerald Health Pharmaceuticals Begins Enrollment in Phase 2a Study
Emerald Health Pharmaceuticals Inc. has recently begun enrollment and has dosed its first patients with diffuse cutaneous systemic sclerosis (dcSSc) in its Phase 2a clinical…
Daré Bioscience Announces Initiation of Phase 1 Clinical Trial of Novel Intravaginal Ring Designed to Deliver Non-oral, Bio-identical Hormone Therapy
Daré Bioscience, Inc. recently announced the initiation of a Phase 1 clinical trial of DARE-HRT1, designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over…
LGM Pharma Acquires Pharmaceutical Development & Manufacturing Unit of Nexgen Pharma
LGM Pharma recently announced it has acquired the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. The combination brings together LGM…
Oculis Announces Successful End-of-Phase 2 Meeting With the FDA
Oculis S.A. recently announced it has successfully completed an End-of-Phase 2 meeting with the US FDA for OCS-01 in two indications: for the treatment of…
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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)….