Market News & Trends
Lonza Expands HPAPI Multipurpose Suite for Payload-Linker Manufacturing in Visp (CH)
Lonza recently announced the completion of the expansion of its Highly Potent API (HPAPI) multipurpose suite in Visp (CH). The expansion adds development and manufacturing…
Oxford Biomedica Solutions Signs Agreement With New Partner to Deliver the Full Solution for Its AAV Programs
Oxford Biomedica Solutions LLC recently announced it has signed an agreement with an undisclosed US-based private biotechnology company. The agreement will provide The Full Solution…
Vaxxinity Announces First Subjects Dosed in Phase 1 Clinical Trial of UB-313 for Preventive Treatment of Migraine
Vaxxinity, Inc. recently announced the first subjects have been dosed in a Phase 1 clinical trial of UB-313, a vaccine targeting calcitonin gene-related peptide (CGRP),…
Bryn Pharma Announces Completion of its Pivotal Study Comparing UTULY Epinephrine Intranasal Spray Versus 0.3-mg Epinephrine Autoinjector for the Treatment of Anaphylaxis
Bryn Pharma LLC recently announced the completion of its pivotal study of UTULY (epinephrine nasal spray). The primary objective of the study was to evaluate whether…
Nuvectis Pharma Announces Positive Data for NXP800 in a Preclinical Model of ARID1a-Mutated Gastric Carcinoma
Nuvectis Pharma, Inc. recently announced positive data for NXP800 in a preclinical xenograft model of ARID1a-mutated gastric carcinoma. “Following the strong preclinical proof of concept…
Revolo Biotherapeutics Completes Enrollment in Phase 2 Trial
Revolo Biotherapeutics recently announced it has completed enrollment and has fully randomized all patients in a Phase 2a proof of concept clinical study investigating its…
Chiesi Global Rare Diseases Announces FDA Acceptance of BLA Filing for the Proposed Treatment of Alpha-Mannosidosis
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., recently announced the US FDA has accepted the Biologics License Application (BLA) and granted…
Ocuphire Pharma Announces Last Patient Completes Final Visit in ZETA-1 Phase 2b 24-Week Trial
Ocuphire Pharma, Inc. recently announced the last patient of the 103 enrolled subjects since April 2021 has completed their 24-week study visit in the Phase…
Pace Life Sciences Acquires Biopharma Global, Expanding FDA Regulatory Affairs Strategy & Consulting Capabilities to the Biotechnology & Pharmaceutical Markets
Pace Life Sciences, LLC recently announced it has acquired Biopharma Global (Biopharma). Biopharma specializes in full-service regulatory support for orphan products to treat rare diseases…
Tarsus Submits New Drug Application to the FDA for TP-03 for the Treatment of Demodex Blepharitis
Tarsus Pharmaceuticals, Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the…
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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)….