Immunomedics Inc. gained accelerated FDA clearance for Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior therapies. It’s the first antibody-drug conjugate (ADC) given the go-ahead specifically in relapsed/refractory TNBC and the first anti-Trop-2 ADC bound for the market. Trodelvy, which was granted breakthrough therapy designation and priority review, moved along faster thanks to the objective response rate (ORR) and duration of response (DoR) turned up by Morris Plains, N.J.-based Immunomedics in a single-arm, multicenter phase II study. Continued approval may be contingent on verifying clinical benefit in the confirmatory phase III experiment called Ascent, recently halted by the independent data safety monitoring committee due to compelling evidence of efficacy across multiple endpoints. Read More
Biogen Inc. handily beat earnings expectations in its first-quarter 2020 earnings report to investors but leavened the good news by adding that it now plans to submit its BLA for beta-amyloid-targeting aducanumab for treating Alzheimer’s disease in the third quarter of 2020. Read More
Supernus Pharmaceuticals Inc. has struck an agreement with privately held Navitor Pharmaceuticals Inc. to run a joint phase II program for Navitor's mTORC1 activator, NV-5138, in treatment-resistant depression (TRD). Read More
The acceptance by the FDA of Prevail Therapeutics Inc.’s IND for the one-time, fast-tracked gene therapy PR-006 provided hope for 50,000 to 60,000 people in the U.S beset by frontotemporal dementia with the GRN mutation (FTD-GRN), and the New York-based company is moving ahead with a phase I/II experiment called Proclaim. Read More
BEIJING – Nanobody startup Sysvax Inc., with its R&D center in Beijing and manufacturing facilities in Zhongshan, is developing a recombinant protein vaccine and a nanobody therapeutic for COVID-19, while trying to extend the half-life of potential COVID-19 treatments with its expertise in this smallest possible antibody format. Read More
Recent seizures of fake medical products being marketed in the COVID-19 pandemic underscore the need to curb the growing international trade in counterfeit drugs that’s putting hundreds of thousands of lives at risk, the Organisation for Economic Cooperation and Development (OECD) warned this week. Read More
New hires and promotions in the biopharma industry, including: Agile, Biosig, Clearside, Emergent, Imago, Moleculin, Morphosys, Rocket, Silverback, Therapeuticsmd, Trovagene. Read More
Biopharmas raising money in public or private financings, including: Actinium, Arcturus, Calithera, Cyclacel, Forx, Myosana, Migvax, Realta Life Sciences, VBI. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Algernon, Biontech, Clarity, Janssen, Mallinckrodt, Novartis, Pfizer, Vitro. Read More
