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…
Synlogic Achieves Research Milestone in Collaboration With Roche for Development of Novel Synthetic Biotic to Treat Inflammatory Bowel Disease
Synlogic, Inc. recently announced it has received a milestone payment for the achievement of prespecified success criteria under the research collaboration agreement with Roche for….
Hovione Expands Drug Product Offering With New Manufacturing Line Dedicated to Continuous Tableting
Hovione recently announced it has expanded its continuous manufacturing offering and services. A new state-of-the-art continuous manufacturing facility is….
Novo Nordisk to Acquire Forma Therapeutics & Expand Presence in Sickle Cell Disease & Rare Blood Disorders
Novo Nordisk and Forma Therapeutics, Holdings Inc. recently announced they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for….
Qureight Announces World’s First Digital Biomarker for Lung Fibrosis
For the first time, artificial intelligence (AI) using convolutional neural networks has been used to analyse trial data involving the lung disease idiopathic pulmonary fibrosis (IPF). The technology picked up….
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…
Laverock Therapeutics Founded to Develop the Next Generation of Programmable Cell Therapies
Laverock Therapeutics Ltd was founded to develop a unique gene silencing platform for the creation of programmable, allogeneic cell therapies. Having recently completed a….
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…
Aria Pharmaceuticals Advances Pipeline With Six Provisional US Patents Filed Across Three Diseases
Aria Pharmaceuticals recently announced the company has successfully filed a total of six provisional patents with the United States Patent and Trademark Office (USPTO) for lead candidates in its lupus, idiopathic pulmonary fibrosis (IPF), and….
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…
Timber Pharmaceuticals Announces Publication of Results from Phase 2b CONTROL Study of FDA-Designated Breakthrough Therapy
Timber Pharmaceuticals, Inc. recently announced that results from the previously completed Phase 2b CONTROL study that evaluated TMB-001, a topical isotretinoin formulated using the company’s patented IPEG delivery system, in moderate-to-severe congenital ichthyosis (CI) are published….
Imbria Presents Positive Clinical Data for Ninerafaxstat From IMPROVE-DiCE
Imbria Pharmaceuticals, Inc. recently announced positive clinical results from the Phase 2, IMPROVE-DiCE trial demonstrating that ninerafaxstat in patients with T2DM and obesity normalized cardiac…
Esperion Announces Bempedoic Acid Recommended as Oral Non-Statin Therapy for LDL-Cholesterol Lowering
Esperion recently announced bempedoic acid (NEXLETOL) is now recommended as an important oral non-statin therapy for LDL-cholesterol (LDL-C) lowering in the management of atherosclerotic cardiovascular…
Anthos Therapeutics Launches Second Phase 3 Clinical Trial of its Dual-Acting Factor XI Inhibitor
Anthos Therapeutics recently announced the initiation of recruitment for its second Phase 3 clinical trial investigating abelacimab, its novel dual-acting fully human monoclonal antibody targeting…
