Market News & Trends
Catalent Expands Singapore Clinical Supply Facility for Increased Temperature-Controlled Capabilities
Catalent recently announced a $2.2-million expansion to its clinical supply facility in Singapore. The investment will increase the site’s footprint by nearly 20% to 31,000…
Mannkind Successfully Completes Phase 1 Study of Inhaled Clofazimine
MannKind Corporation recently announced it has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101) and is planning discussions with the US…
Avalo Advances BTLA Agonist Fusion Protein to IND-Enabling Stage
Avalo Therapeutics, Inc. recently announced its human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein, AVTX-008, has now entered IND-enabling studies, with a target…
Tenaya Therapeutics Announces FDA Clearance of IND & Initiation of Phase 1 Safety Study for an HDAC6 Inhibitor for Heart Failure With Preserved Ejection Fraction
Tenaya Therapeutics, Inc. recently announced clearance of its Investigational New Drug (IND) application to begin clinical testing of TN-301 by the US FDA. TN-301 is…
Vaxart Announces Positive Top-line Phase 2 Clinical Study Data Demonstrating Safety & Immunogenicity of Its Wuhan S-Only COVID-19 Pill Vaccine Candidate
Vaxart, Inc. recently reported positive top-line data from the first part of a planned two-part Phase 2 study of its Wuhan S-only oral pill COVID-19…
Hepion Pharmaceuticals Announces Initiation of Phase 2b ASCEND-NASH Trial
Hepion Pharmaceuticals, Inc. recently announced it has screened the first subject in the ASCEND-NASH clinical trial. The trial is being conducted at up to 121…
Denali Therapeutics Announces New Interim Data from Phase 1/2 Study of DNL310 in MPS II (Hunter Syndrome)
Denali Therapeutics Inc. recently announced new interim results from a Phase 1/2 trial of DNL310 (ETV:IDS) in MPS II (Hunter syndrome). DNL310 is an investigational,…
FDA Grants Fast Track Designation for Longeveron’s Treatment for Hypoplastic Left Heart Syndrome in Infants
Longeveron Inc. recently announced the US FDA has granted Fast Track Designation to Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare…
Immutep Granted Japanese Patent for Eftilagimod Alpha, a Soluble Lag-3 Protein, in Combination With a PD-1 Pathway Inhibitor
Immutep Limited recently announced the grant of a new patent (No. 7116547) titled Combined Preparations for the Treatment of Cancer or Infection by the Japanese…
Outlook Therapeutics Re-Submits BLA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics, Inc. recently announced it has re-submitted its Biologics License Application (BLA) to the US FDA for ONS-5010, an investigational ophthalmic therapy which, if…
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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)….