LONDON – A veteran of the European vaccines industry has brought together three companies in three countries, in what is described as an ultra-fast-track COVID-19 vaccine development program. From a standing start less than three months ago, the three biotechs, Reithera Srl in Rome, Leukocare AG in Munich, Germany, and Univercells SA in Brussels, Belgium, have advanced to GMP manufacturing, with first-in-human studies due to start in June. Read More
With accelerated approval in hand for Trodelvy (sacituzumab govitecan-hziy) to treat metastatic triple-negative breast cancer (mTNBC), Immunomedics Inc. is looking ahead to data related to the next indication for the antibody-drug conjugate (ADC) – urothelial tumors – “in the near future,” Chairman Behzad Aghazadeh told investors during a conference call. Read More
With completion of a $120 million series B financing, Affinivax Inc. said it's poised to advance several new vaccine candidates for hospital-associated infections into the clinic even as its partner, Astellas Pharma Inc., carries its lead pneumococcal vaccine candidate, ASP-3772, through an upcoming phase III program. Read More
Privately held Swanbio Therapeutics Inc., of Bala Cynwyd, Pa., completed a $52 million expanded series A financing designed to boost the company’s R&D of adeno-associated virus (AAV)-based gene therapies to treat adrenomyeloneuropathy (AMN) and other rare, monogenic neurological diseases. Read More
By analyzing the antibody response of a survivor of Marburg virus infection, researchers at the University of Texas Medical Branch and Vanderbilt University Medical Center have gained new insights into the function of non-neutralizing antibodies in fighting infections. Read More
HONG KONG – Not even the 9,500 kilometers between Cambridge, U.K., and Tokyo, or the ongoing COVID-19 pandemic, could prevent Japan’s Astellas Pharma Inc. from completing its acquisition of Cambridge-based Nanna Therapeutics Ltd. in a £12 million (US$14.78 million) deal. Read More
Shares of Gilead Sciences Inc. were dented April 23 after reports surfaced that its antiviral drug, remdesivir, failed to improve the condition of patients with COVID-19. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adocia, Aivita, Amryt, Astrazeneca, Baudax, Cel-Sci, Incyte, Leap, Obseva, Sanofi, Surface, Theravance, United Therapeutics, Windmil. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amidebio, Caladrius, CNS Pharma, Cstone, Immuneoncia, Immunomedics, Merck and Co., Rafael, Revive, Samsung Biologics, Vitalis. Read More
