With this designation, LG Chem will receive benefits such as exclusive sales rights in the US market for seven years, subsidies and tax cuts for clinical testing costs in the US, and preliminary consulting support related to development
TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.
Leading this effort was Cytel’s principal research scientist and Professor of Health Research Methods at McMaster University in Canada, Dr. Edward Mills
The treatment of chorea associated with HD is within the scope of this Orphan Drug Designation
Nocria’s hand-held device uses gentle, controlled puffs of air in the ears for treating migraine attacks
Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
SIFI is currently evaluating various options for the commercialization of Akantior (polihexanide) globally, including potential out-license agreements outside its core markets
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