European biotechnology firms engaged in drug discovery and development raised $1.96 billion in equity investment during the first quarter. That tally represents a drop of 67% on the $5.888 billion invested during the same quarter of 2021, when the COVID-19 crisis drove global and European biotechnology investing to unprecedented levels. Read More
After COVID-19 reached a pandemic peak in January due to the omicron variant, infections in the U.S. are now hitting the lowest levels since March of 2020. During the past week, there were 195,963 confirmed SARS-CoV-2 infections in the country, according to Johns Hopkins University data. That is 5.5% fewer infections than the same week two years ago and 56% fewer than last year. Deaths are also down to 5,602 for the week, although there were lower points in the spring and summer months of 2020 and 2021. Read More
The fortunes of Protalix Biotherapeutics Inc. improved dramatically with phase III results from the Fabry disease study called Balance, and a resubmission of the BLA for pegunigalsidase alfa (PRX–102) is planned for the second half of this year. In February, an MAA for PRX-102 was submitted to the EMA. Read More
A patient’s death has prompted the FDA to place a partial clinical hold on Curis Inc.’s phase I/IIa study of emavusertib in leukemia. The patient, who had relapsed or refractory acute myeloid leukemia, experienced several conditions. One of them was rhabdomyolysis, a dose-limiting toxicity of emavusertib. Rhabdomyolysis is a breakdown of muscle fibers in the blood. Read More
Pharmaceutical agents took center stage in Washington on the first full day of the 2022 scientific sessions of the American College of Cardiology, such as an April 2 presentation on the use of the mavacamten for obstructive hypertrophic cardiomyopathy (OHC). Milind Desai of the Cleveland Clinic said 16-week data for this cardiac myosin inhibitor showed well in reducing heart failure class status, but there are data arising from studies in China which suggest that radiofrequency (RF) ablation might also work for these patients. Read More
Gilead Sciences Inc. said it is increasing manufacturing capacity to match an anticipated increase in demand for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), which gained FDA approval for a wider group of lymphoma patients late last week. Read More
Still reeling from the impact COVID-19 has had on its research activities and funding, Cancer Research UK is to launch a new organization combining all its drug discovery expertise in a single team, with a single portfolio, later this month. Read More
Japan’s Ministry of Health, Labour and Welfare finished the first quarter – and Japan’s fiscal year – with a bang, handing out 32 approvals in the month of March. It marked a massive jump from previous months, which saw 13 products approved in February 2022 and 12 in January 2022. A total of nine products were approved in December 2021. Read More
Four biopharma companies are pooling some of their chemical data and making it public for the first time as part of the pioneering stage of a European effort to reduce the need for animal testing in drug development. Read More
New hires and promotions in the biopharma industry, including: Alzamend, Diurnal, Effector, Legend, Nanoscope, Novartis, Oramed, Orum, Rallybio, Reaction Biology, Scorpion, Tessa, Ventus. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Academy of Neurology annual meeting, including: Clene, Emalex, Genentech, H. Lundbeck, Horizon, Mitsubishi, Neurelis, Neurocrine, Neuroderm, TG. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aligos, Alpine, Aqualung, Copernicus, G1, Gridiron, Inmune, Innovation1, Northeastern University, ST. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Finch, Merck & Co., Reata, Valenzabio, Y-mabs. Read More
