BioSpace News Archive

Sesen Bio and Qilu Pharmaceutical Announce Approval of IND Application in China for Vicineum ™ IND approval triggers $3 million milestone payment to Sesen Bio Product market application expected to be submitted to the National Medical Product s Administration in 2022 with potential approval in 2023

Impact of new SARS-CoV-2 variants supports specification of select strains for anticipated case-driven interim analysis in pivotal Phase 2b/3 study Progress in Phase 2a trial in older adults in Peru and Panama enables addition of secondary vaccine efficacy endpoint CureVac reaffirms intention to apply for formal market authorization in Q2 2021

Relief to potentially pay Acer up to $36 million and royalties in exchange for net profit share and territory rights ACER-001 pre-NDA meeting with U.S. FDA scheduled in Q2 2021

Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical stage biotechnology company with a continuous delivery platform of approved drugs in novel indications, announced today that it has completed a Type B pre-Investigational New Drug (“pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding Starton’s proposed clinical studies for STAR-LLD in the treatment of chronic lymphocytic leukemia (CLL).

VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases in both humans and animals, today announced that Scott Powell, EVP of Investor Relations and Chief Financial Officer of Volition America Inc., will present live at LifeSciencesInvestorForum.com on March 25 th .

Company invites individual and institutional investors, as well as advisors and analysts, to attend real-time, interactive presentations on LifeSciencesInvestorForum.com

VistaGen Therapeutics, Inc . (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, announced today that data highlighting the proposed mechanism of action (MOA) of its Phase 3 investigational drug candidate, PH94B nasal spray,

Expanding existing COVID-19 vaccine research collaboration which began in July 2020. Medytox and Dyadic to co-develop C1 enabled COVID-19 vaccines and/or boosters which will immunize people against two or more of the current and future COVID-19 variants (e.g., tetravalent or quadrivalent COVID-19 vaccines) Exclusive license for Republic of Korea and multiple Southeast Asian countries

-Closed Merger with Tenzing Acquisition Corp and publicly listed on NASDAQ Capital Market - -Plans to initiate a pivotal Phase 3 trial in schizophrenia in mid-2021, assuming fundraising goals achieved-

Sirtex Medical (“Sirtex”) , a leading manufacturer of targeted liver cancer therapies, announced full FDA approval of the DOORwaY 90 Study, a trial evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres ® Y-90 resin microspheres in patients with unresectable hepatocellular carcinoma