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 artificial intelligence (AI) platform developed by Naperville, Ill.-based Physiq Inc. gave researchers a mean of 10.4 days warning of an impending heart failure exacerbation that would require hospitalization or an emergency department visit, according to a study published in Circulation – Heart Failure.
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.
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19. China now has six clinical trials investigating the drug, originally developed for influenza and also tested against Ebola virus disease.
PERTH, Australia – Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab).
Strongly favorable six-month data disclosed on Jan. 9 by Applied Genetic Technologies Corp. (AGTC) from its ongoing phase I/II program with an adeno-associated virus (AAV) gene therapy for X-linked retinitis pigmentosa (XLRP) did more than provide a whopping stock boost.
With new phase III multiple myeloma (MM) data in hand from Newton, Mass.-based Karyopharm Therapeutics Inc.’s Xpovio (selinexor), Wall Street began speculating about what the results might mean in the marketplace.
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