Pipeline news

• College health insurer Wellfleet teams up with binx health to keep students safe and campuses open in the fight against COVID-19

  27 October 2020

  

  Wellfleet Insurance has teamed up with binx health to offer college clients access to easy at-home/in-dorm sample collection for COVID-19 testing using binx’s enterprise solutions for population health screening.

• FDA Grants EUAs for Wren Labs, P23 Coronavirus Tests, Binx Health At-Home Sample Collection Kit

  26 October 2020 genomeweb

  

  The US Food and Drug Administration on Tuesday reissued Emergency Use Authorizations for SARS-CoV-2 tests developed by Wren Laboratories and P23 Labs to allow their use with new specimen types, and granted EUA to Binx Health's SARS-CoV-2 at-home nasal swab collection kit.

• Atea Pharmaceuticals Announces Strategic Collaboration with Roche to Develop and Distribute AT-527 for Patients with COVID-19

  22 October 2020

  

  Atea Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announces that the company has entered into an agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for the exclusive rights to research, develop and distribute AT-527 as an oral antiviral treatment for COVID-19 in territories outside of the United States. Under the terms of the agreement, Atea will receive an upfront payment of $350 million in cash from Roche with the potential for future milestone payments and royalties.

• Marinus Provides Corporate Update on Phase 3 RAISE Trial in Status Epilepticus (SE)

  24 September 2020

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has satisfied the FDA’s protocol-specific questions for the registrational Phase 3 trial (the RAISE trial) in refractory status epilepticus (RSE), allowing the company to begin enrollment in this clinical trial.

• Atea Pharmaceuticals Appoints Polly Murphy, D.V.M, Ph.D., to the Board of Directors

  14 September 2020

  

  Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of next- generation therapeutics for severe viral infections, today announced the appointment of Polly Murphy, D.V.M., Ph.D., Chief Business Officer of UroGen Pharma, to its Board of Directors. Dr. Murphy is a seasoned pharmaceutical executive with a wide range of experience spanning research and development, strategy and operations.

• Marinus Awarded BARDA Contract to Develop IV Ganaxolone for Treatment of Refractory Status Epilepticus Caused by Nerve Agent Exposure Print

  14 September 2020

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has entered into a five-year development contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of IV ganaxolone for the treatment of refractory status epilepticus (RSE), a life-threatening condition in which a significant number of patients do not respond to first- and second-line anticonvulsant drugs.

• Ganaxolone Achieves Primary Endpoint in Phase 3 Trial for CDKL5 Deficiency Disorder (CDD), a Rare Form of Genetic Epilepsy

  14 September 2020

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced positive top-line results from its registrational Phase 3 clinical trial (Marigold Study) evaluating the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy with refractory seizures.

• Epic Sciences Enters into Collaboration with Q2 Solutions to Expand Liquid Biopsy Capabilities

  14 September 2020

  

  Epic Sciences, Inc. today announced it has entered into a global collaboration with Q2 Solutions®, a leading clinical trial laboratory services organization, to offer Illumina®’s TruSight Oncology 500 liquid biopsy test to Epic’s global biopharmaceutical customers.  The addition of TruSight Oncology 500 to Epic’s portfolio of testing capabilities, brings ctDNA analysis to Epic’s CTC-based platform that enumerates and characterizes circulating tumor cells (CTCs).

• Clearside Biomedical’s Oncology Licensing Partner Doses First Patient in its Phase 2 Study in Patients with Choroidal Melanoma Using SCS Microinjector® for Suprachoroidal Delivery

  11 September 2020

  

  Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its licensing partner, Aura Biosciences, has dosed the first patient in its Phase 2 clinical trial evaluating the safety and efficacy of suprachoroidal administration of AU-011 as a potential first-line treatment for patients with primary choroidal melanoma. Aura is using Clearside’s SCS Microinjector® to deliver AU-011 into the suprachoroidal space (SCS®).

• Clearside Biomedical’s Licensing Partner Doses First Patient in its Phase 2 Gene Therapy Trial Using SCS Microinjector® for Suprachoroidal Delivery

  10 September 2020

  

  Clearside Biomedical , Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its licensing partner, REGENXBIO Inc. (Nasdaq: RGNX), has dosed the first patient in its Phase 2 clinical trial to evaluate the suprachoroidal delivery of RGX-314, an adeno-associated virus (AAV) gene therapy, using Clearside’s SCS Microinjector® for the treatment of wet age-related macular degeneration (wet AMD).