Bridgebio Pharma Inc. subsidiary QED Therapeutics Inc., seeded in 2018 with $65 million and a license to Novartis AG's infigratinib, said the first patients have been dosed with the drug in two separate cancer trials.
Anti-drug antibodies noted in the phase Ib portion of the PREVAIL study in lupus drew queries for Oldwick, N.J.-based Provention Bio Inc. during a conference call related to earnings, but analysts seemed more interested in the company’s later-stage push in type 1 diabetes (T1D).
In a second phase III trial for treating progressive forms of multiple sclerosis (MS), designed to confirm the successful first trial, Medday Pharmaceuticals SA’s investigational MD-1003 failed to hit its primary and secondary endpoints.
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe.
With a phase IIb readout coming in the third quarter of 2020, Cambridge, Mass.-based Fulcrum Therapeutics Inc. might be set up for a win in facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder for which there’s no treatment.
Kala Pharmaceuticals Inc. plans to use its positive phase III data in dry eye disease (DED) with KPI-121 (loteprednol etabonate ophthalmic suspension 0.25%) as the basis for the resubmission of its NDA in the second quarter of 2020.
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.
In a setback for Astrazeneca plc's plans to tackle previously untreated cases of advanced bladder cancer, neither its immune checkpoint inhibitor, Imfinzi (durvalumab), nor a pairing of it with the investigational drug tremelimumab beat standard-of-care (SOC) chemotherapy in improving overall survival (OS) during a phase III trial evaluating the treatments as first-line (1L) care for patients with advanced disease.
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.
An experimental gene editing therapy for an inherited form of blindness has become the first in vivo CRISPR medicine to be administered to patients, according to Editas Medicine Inc. and its partner, Allergan plc, which licensed the candidate in 2018.
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