Market News & Trends
Catalent Biologics Completes Madison Facility Expansion to Double Clinical & Commercial Drug Substance Capacity
Catalent recently announced it has completed the expansion of two new suites at its biologics drug substance development and manufacturing facility in Madison, WI, and…
Akouos Receives Orphan Drug & Rare Pediatric Disease Designations
Akouos, Inc. recently announced the US FDA has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for AK-OTOF, a gene therapy…
AEON Biopharma Doses First Patient in Phase 2 Trial of ABP-450 for the Treatment of Cervical Dystonia
AEON Biopharma, Inc. recently announced the initiation of patient dosing in a Phase 2 study of ABP-450 for the treatment of cervical dystonia. The company…
Yumanity Therapeutics Announces Study Demonstrating In Vivo Efficacy of YTX-7739 in a Glioblastoma Multiforme (GBM) Mouse Model
Yumanity Therapeutics recently announced results of a study that demonstrate in vivo efficacy, including increased median overall survival, of YTX-7739 in a mouse model for…
AzurRx BioPharma Initiates Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections
AzurRx BioPharma, Inc. recently announced it has initiated its Phase 2 RESERVOIR clinical trial of a proprietary oral formulation of micronized niclosamide (FW-1022) for the…
uniQure Announces Completion of Enrollment in First Cohort of Phase 1/2 Clinical Trial of AMT-130 for the Treatment of Huntington’s Disease
uniQure recently announced the completion of patient enrollment in the first dose cohort of a randomized, double-blinded, Phase 1/2 clinical trial of AMT-130 for the…
AIM ImmunoTech Posts New Developments in Intranasal COVID-19 Treatment Clinical Study
AIM ImmunoTech Inc. recently announced it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of AIM’s drug Ampligen…
New England Journal of Medicine Publishes Results of the PULSAR Phase 2 Trial of Sotatercept in Patients With Pulmonary Arterial Hypertension
Acceleron Pharma Inc. recently announced the New England Journal of Medicine has published results of the PULSAR Phase 2 trial of sotatercept in patients with pulmonary…
TCR² Therapeutics Establishes Commercial-Scale Cell Therapy Manufacturing Facility
TCR2 Therapeutics Inc. recently announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. for an existing 85,000-sq-ft cell therapy…
Provectus Biopharmaceuticals Receives Notice of Allowance for Adult Solid Tumor Cancer Combination Therapy Patent
Provectus recently announced the United States Patent and Trademark Office (USPTO) has allowed US patent (USP) application 16/678,133, which covers the use of intralesional (aka…
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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)….