Search Results for: AIT Therapeutics Granted Orphan Drug
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AIT Therapeutics Granted Orphan Drug Designation October 9, 2017
AIT Therapeutics Inc. recently announced the US FDA has granted orphan drug designation to the company for its novel NO...Elevar Therapeutics & Jiangsu Hengrui Pharma Announce Global Commercialization Licensing Agreement October 17, 2023
Elevar Therapeutics, Inc. and Jiangsu Hengrui Pharmaceuticals Co., Ltd. recently announced a global licensing agreement that grants Elevar rights to commercialize and develop Hengrui Pharma’s anti-PD-1 antibody camrelizumab in combination with….
Zevra Therapeutics to Acquire Acer Therapeutics, Expanding its Rare Disease Portfolio & Adding Commercial Product August 31, 2023
Proposed acquisition of Acer for $15M in Zevra stock plus Contingent Value Rights (CVRs) and Zevra’s purchase of Acer’s secured debt in capital efficient structure….
Akari Therapeutics Provides Update on Development of Long-Acting PAS-Nomacopan for Treatment of Geographic Atrophy July 11, 2023
Akari Therapeutics, Plc recently announced updates on the development of long-acting PAS-nomacopan as a potential treatment for geographic atrophy (GA)....Elevar Therapeutics Submits NDA to FDA for Combination of Rivoceranib & Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma May 17, 2023
Elevar Therapeutics, Inc. recently announced it submitted an NDA to the US FDA for its investigational drug rivoceranib, an oral...Fulcrum Therapeutics Enrolls First Patient in Pivotal Global Phase 3 Clinical Trial July 5, 2022
Fulcrum Therapeutics, Inc. recently announced the first patient has been dosed in REACH, a Phase 3 clinical trial designed to...Revive Therapeutics Receives FDA Orphan Drug Designation February 16, 2022
Revive Therapeutics Ltd. recently announced the US FDA has granted Orphan Drug Designation (ODD) for Bucillamine for the prevention of...Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation November 23, 2021
Revive Therapeutics Ltd. recently announced it has filed an application with the US FDA to receive Orphan Drug Designation (ODD) for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver….
Vector Pharma & Oncopeptides FZCO Announce Collaboration to Provide Pepaxti to Patients in the Middle East & North Africa March 27, 2024
Oncopeptides AB and Vector Pharma FZCO recently announced a collaboration to commercialize Oncopeptides’ flagship drug Pepaxti (melphalan flufenamide) in the Middle….
PHARMACEUTICAL GLOBALIZATION - Navigating Opportunities & Obstacles December 4, 2023
Jürgen Hönig says rapid globalization of the pharmaceutical industry has created new complexities as companies navigate different regulations and government policies, but there are many reasons for optimism, including harmonization, collaboration, and convergence.
Jazz Pharmaceuticals & Zymeworks Announce Exclusive License Agreement October 20, 2022
Jazz Pharmaceuticals plc and Zymeworks Inc. recently announced Jazz and Zymeworks’ subsidiary, Zymeworks BC Inc., have entered into an exclusive licensing agreement under which Jazz will acquire….
Liminal BioSciences Announces Resubmission of Biologics License Application September 9, 2020
Liminal BioSciences Inc. recently announced the company, through its US subsidiary Prometic Biotherapeutics Inc., has filed a resubmission of the...Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial April 18, 2019
Soligenix, Inc. recently announced today it has reached a significant milestone in the Phase 3 clinical study (the “DOM-INNATE” study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC).