Astrazeneca plc said it has received about $486 million from the U.S. government to support the development and supply of a long-acting antibody combination under evaluation for the prevention and treatment of COVID-19. Phase III trials of the candidate, AZD-7442, are slated to begin later this month, the company told BioWorld. One trial will enroll more than 6,000 adults for the prevention of COVID-19 with additional trials set to enroll about 4,000 adults for the treatment of the infection, the Cambridge, U.K.-based company said. Read More
LONDON – Facing down the pandemic, U.K. biopharma had a record summer, raising just over £1 billion (US$1.3 billion) from June to August. That was up from £585 million in the second quarter of 2020, and brings the amount raised in the first nine months to £1.9 billion, putting 2020 on target to beat the 2018 record, when the annual total was £2.2 billion. Read More
DUBLIN – Priothera Ltd. closed a €30 million (US$35.4 million) series A round to shepherd an oral sphingosine 1 phosphate (S1P) receptor agonist through clinical development in patients with acute myeloid leukemia (AML) who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Read More
New York-based Avenue Therapeutics Inc. took receipt from the FDA of a surprise complete response letter (CRL) – characterized by Wainwright analyst Joseph Pantginis as “bizarre” – with regard to the NDA for intravenous (I.V.) tramadol in acute pain. Read More
In a world where the traditional way of conducting business has been disrupted for about eight months and counting, no one would have faulted the biopharmaceutical sector if its operations had been placed in a slow-down mode until the COVID-19 pandemic “all clear” had been sounded. Yet, despite the restrictions faced, companies have adapted quickly to the prevailing environment. Read More
LONDON – The first confirmed case of COVID-19 reinfection in the U.S. has been reported, with a patient testing positive for two distinct SARS-CoV-2 strains within 48 days, while testing negative in between contracting the two infections. Read More
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altimmune, Antengene, Auravax, Bausch, Cstone, Curon, Eyenovia, Hitgen, Innocan, Ligand, Novabay, Pfizer, Rhizen, Wuxi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Avenue, Astrazeneca, Celltrion, Gannex, Immunomedics, Oncopeptides, Oxular. Read More
