Market News & Trends
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…
Gerresheimer AG & Stevanato Group Announce Collaboration on the Development of an Innovative Ready-to-Use Vial Platform
Gerresheimer AG and Stevanato Group S.p.A. recently announced they have jointly developed a high-end Ready-to-Use (RTU) solution platform with an initial focus on vials, based on Stevanato Group’s….
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…
Good Therapeutics Announces Acquisition of Conditionally Active PD-1-Regulated IL-2 Program by Roche
Good Therapeutics recently announced it has entered into a definitive merger agreement to be acquired by Roche. With this acquisition, Roche will gain….
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….
