DUBLIN – Hansa Biopharma AB is nearing a key milestone in its evolution, as a regulatory decision on its first marketing authorization application (MAA) looms. The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to deliver an opinion during the second quarter on its application for imlifidase in supporting kidney transplants in sensitized patients.
HONG KONG – U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. has teamed up with Mount Sinai Health System, New York City's largest academic medical system, to develop novel biotherapies in oncology and immunology. The two parties will also be using Harbour’s H2L2 Harbour Mice platform to develop a monoclonal antibody (MAb) against the coronavirus that has turned into a global epidemic.
During its Feb. 27, 2020, conference call on the previous year’s fourth-quarter results – though not in a related press release – Nektar Therapeutics Inc. let news drop that the prospective breast cancer (BC) therapy Onzeald (etirinotecan pegol) for patients with brain metastases had failed in top-line phase III outcomes.
New York-based Kadmon Holdings Inc.’s recent oral late-breaker session on KD-025 in chronic graft-vs.-host disease (cGVHD) at the Transplantation & Cellular Therapy (TCT) meeting – along with data that rolled out from two studies testing competitor Jakafi (ruxolitinib) from Incyte Corp. – signaled potential advantages in the former’s candidate, already highly regarded.
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, on Feb. 21 launched a pre-revenue listing on Shanghai’s STAR market, a Nasdaq-style tech board, to reap $241 million at a valuation of almost $2 billion. Its share price soared more than 83% during its first trading day.
New York-based Hoth Therapeutics Inc. said preliminary preclinical data on a topical nanoparticle formulation of the endocannabinoid anandamide it licensed from Zylö Therapeutics Inc. represents "a positive step toward underlining the transformative potential" of the early stage therapy for the skin disease cutaneous lupus erythematous.
Filgotinib (GLPG-0634) has the potential to be a blockbuster drug, according to Cortellis Drugs to Watch analysis, but it may take a few approvals in various indications to reach the coveted mark of $1 billion in annual sales.
At 26 years old, Karen Jury stood before a class of elementary students as her right arm tingled before falling completely numb. That led to a conversation with her doctor. Years of migraine headaches and a recurring sensation of shock waves throughout her body, simply from the turn of her head, resulted in a scheduled spinal tap and an MRI. She received a diagnosis of Arnold-Chiari malformation, a structural defect in the base of the skull and cerebellum.
No matter how effective it is, a drug is worthless if the people who need it can’t afford it. That’s been almost an anthem for patients and policy wonks testifying before U.S. Congress on drug prices.
New analysis from Clarivate Analytics' Cortellis Forecast Team predicts 11 medicines set to enter the market in 2020 will reach more than $1 billion in sales by 2024.
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