Pharmaceuticals, Biotechnology and Life Sciences
Daiichi Sankyo’s test of HER3 antibody drug conjugate U3-1402 data suggest that targeting HER3 with may be an effective treatment strategy irrespective of mechanism of resistance identified in the setting of EGFR TKI resistance, where new precision treatments are needed, said Helena Yu, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center, and a trial investigator.
@Boehringer has the first FDA-approved therapy to slow the rate of decline in pulmonary function for systemic sclerosis-associated interstitial lung disease
Allergan and Molecular Partners’s Abicipar pegol DARPin therapy was accepted by FDA in the USA, and the European Medicines Agency (EMA) has validated a Marketing Authorisation Application (MAA), for patients with neovascular (wet) age-related macular degeneration (nAMD).
BioPharmX posted net loss for the second quarter ended July 31, 2019 was $2.6 million, or $0.22 per share, compared with a net loss of $4.4 million, or $0.58 per share, during the prior fiscal year’s second quarter.
Amplyx was granted the FDA’s Fast Track designations for two of its lead antifungal candidate intravenous (IV) and oral formulations, fosmanogepix (APX001), for seven indications, the company said Monday ina press release.
BerGenBio will have two presentations to highlight its Phase II clinical trial with bemcentinib and Merck’s anti-PD-1 therapy Keytruda in patients with advanced non-small cell lung cancer (NSCLC), which showed promising clinical activity overall.
Eli Lilly’s test of oral selpercatinib monotherapy for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC) saw a 68 percent objective response rate (ORR), and also showed that safety analysis of all 531 patients enrolled to LIBRETTO-001, selpercatinib was well-tolerated, with only 9 patients (1.7%) discontinuing therapy due to treatment-related toxicity.
The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC), said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.
Selvita has dosed the first patient in its Phase 1b study of CDK8 inhibitor, SEL120, which is being initially investigated in the treatment of patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS).
Mereo BioPharma will present the 6-month interim data from the open label arm of the its Phase 2b dose-ranging clinical study of setrusumab (BPS-804) in adults with Type I, III or IV osteogenesis imperfecta (OI) at the upcoming American Society for Bone and Mineral Research (ASBMR) 2019 Annual Meeting to be held from September 20-23 in Orlando, FL.