Market News & Trends
Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
Valneva SE recently announced it has completed rolling submission of the Biologics License Application (BLA) to the US FDA for its single-shot chikungunya vaccine candidate, VLA1553.…
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
DBV Technologies recently announced that the US FDA has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety,…
KemPharm Announces Initiation of Phase 2 Clinical Trial Investigating KP1077 for the Treatment of Idiopathic Hypersomnia
KemPharm, Inc. recently announced the initiation of a Phase 2 clinical trial evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep…
Achieve Life Sciences Announces Patent Granted by USPTO for New Cytisinicline Formulation
Achieve Life Sciences, Inc. recently announced the United States Patent and Trademark Office (USPTO) has issued US Patent No. 11,459,328 covering the mesylate salt formulation…
BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY III Phase 3 Trial for Acute Treatment of Agitation in Patients With Alzheimer’s Disease
BioXcel Therapeutics, Inc. recently announced the first patient has been dosed in the pivotal Phase 3 TRANQUILITY III trial of BXCL501 (dexmedetomidine) sublingual film, the…
Assembly Biosciences Announces Promising Interim Results from Two Clinical Trials Evaluating Highly Potent Next-Generation Core Inhibitor Candidates
Assembly Biosciences, Inc. recently announced promising interim efficacy, safety and pharmacokinetic (PK) results from two ongoing clinical studies of its investigational next-generation HBV core inhibitors,…
F2G Announces FDA Filing Acceptance of NDA for Olorofim for the Treatment of Invasive Fungal Infections
F2G Inc. recently announced the US FDA has accepted for filing its New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections…
Ocugen Announces Phase 3 Confirmatory Clinical Trial Agreement for NeoCart
Ocugen, Inc. recently announced the US FDA agreed to Ocugen’s proposed control and overall design for the Phase 3 study of NeoCart, a regenerative cell…
Synlogic Announces Achievement of Proof of Concept for SYNB8802 in Enteric Hyperoxaluria Based on Urinary Oxalate Lowering in Phase 1b Study
Synlogic, Inc. recently announced that SYNB8802 has demonstrated proof of concept through clinically significant lowering of urinary oxalate in a Phase 1b study in patients…
Catalent to Expand Its Biologics Analytical Services With New Facility in North Carolina
Catalent recently announced it is to establish a new biologics analytical center of excellence in Durham, within North Carolina’s Research Triangle, to offer comprehensive stand-alone…
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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)….