Market News & Trends
Metrics Contract Services Appoints Commercial Manufacturing BD Lead
Metrics Contract Services, a full-service contract development and manufacturing organization (CDMO) in novel oral solid dose (OSD) products, has appointed Kim Black-Washington as Senior Business…
Santhera Enters Exclusive License Agreement With Sperogenix for Vamorolone in Rare Diseases in the Greater China Region
Santhera Pharmaceuticals recently announced it has entered into an exclusive license agreement with Sperogenix Therapeutics, a China-based company specializing in orphan diseases. Under this agreement….
Viridian Therapeutics Submits IND Application for VRDN-002 to the US FDA
Viridian Therapeutics, Inc. recently announced the submission of an investigational new drug (IND) application to the US FDA for VRDN-002, a humanized monoclonal antibody that…
FDA Grants Breakthrough Therapy Designation for Cullinan Oncology’s CLN-081 in Patients With Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Cullinan Oncology, Inc. recently announced the US FDA has granted Breakthrough Therapy Designation for CLN-081 for the treatment of patients with locally advanced or metastatic…
TCR² Therapeutics & Arbor Biotechnologies Establish Collaboration to Advance Allogeneic TRuC-T Cell Therapies
TCR2 Therapeutics Inc. and Arbor Biotechnologies recently announced the two companies have entered into a strategic research collaboration and non-exclusive license agreement focused on the…
Biogen Exercises Option With Ionis to Develop & Commercialize Investigational ASO for SMA
Biogen Inc. and Ionis Pharmaceuticals, Inc. recently announced that Biogen exercised its option to obtain from Ionis a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB115/ION306…..
Centogene’s CentoCloud Set to Revolutionize Rare Disease Diagnostics With Decentralized SaaS Platform for Laboratories Around the World
Centogene N.V. recently announced the global release of CentoCloud, a SaaS platform enabling decentralized analysis, interpretation, and reporting of genomic variants linked to rare diseases.…
Vaccinex Reports Phase Ib KEYNOTE B84 Combination Study of Keytruda & Pepinemab in Patients With Advanced, Recurrent, or Metastatic Head & Neck Squamous Cell Carcinoma Passes Planned Interim Safety Analysis
The Phase 2 segment of the study is now expected to begin enrollment and is expected to accelerate patient accrual…..
Assembly Biosciences Outlines Anticipated 2022 Pipeline Development Milestones
Assembly Biosciences, Inc. recently outlined anticipated progress and milestones for its development pipeline in 2022…..
Inotiv, Inc. & Synexa Life Sciences Sign Letter of Intent to Establish Center of Excellence for Biotherapeutics & Biomarkers
Inotiv, Inc. and Synexa Life Sciences recently announced they intend to form a collaboration that will accelerate Inotiv’s development of biomarkers essential to the understanding of safety and efficacy of novel biotherapeutics, enhancing the….
Ovid Therapeutics Expands Epilepsy Franchise With Novel KCC2 Activators
Ovid Therapeutics Inc. recently announced the company has entered into an exclusive license agreement with AstraZeneca for a library of early stage small molecules targeting…
Spero Therapeutics Announces FDA Acceptance & Priority Review of NDA for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis
Spero Therapeutics, Inc. recently announced the US FDA has granted Priority Review designation and confirmed the acceptance for substantive review of the New Drug Application…
Allarity Therapeutics & Oncoheroes Biosciences Sign Agreements to Advance Pediatric Cancer Development of Dovitinib & Stenoparib
Allarity Therapeutics, Inc. and Oncoheroes Biosciences, Inc. recently announced they have entered into licensing agreements under which Oncoheroes will acquire exclusive, global development rights to Allarity’s therapeutic candidates….
US FDA Approves Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children
Immix Biopharma, Inc. recently announced the US FDA has granted Rare Pediatric Disease (RPD) designation for IMX-110 for the treatment of a life-threatening form of…
FDA Approves First Pill to Treat COVID After Pfizer's Oral Medication Reduced Hospitalizations by 88% in Key Study
US health regulators recently authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst…
Atossa Therapeutics Begins Enrollment of Phase 2 Clinical Study of Oral Endoxifen in Sweden
Atossa Therapeutics, Inc. recently announced it has initiated enrollment of its Phase 2 clinical study of oral Z-Endoxifen in Sweden. Participants in the study will…
UAB & Mereo Announce Positive Top-line Results From Phase 1b/2 Trial of Alvelestat in Hospitalized Patients With COVID-19 Respiratory Disease
The University of Alabama at Birmingham (UAB) and Mereo BioPharma Group plc recently announced top-line data from a Phase 1b/2 clinical trial evaluating alvelestat, a…
Cocrystal Pharma’s COVID-19 Oral & Intranasal/Pulmonary Protease Inhibitors Exhibit Powerful In Vitro Potency Against the SARS-CoV-2 Omicron Variant
Cocrystal Pharma, Inc. recently announced in vitro studies demonstrate its oral and intranasal/pulmonary SARS-CoV-2 main protease inhibitors exhibit antiviral potency against the Omicron variant…..
Allarity Therapeutics Submits NDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma
Allarity Therapeutics, Inc. recently announced the submission of a new drug application (NDA) with the US FDA seeking marketing approval for dovitinib for the third-line…
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….
