With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.” Read More
A new report on the biopharma industry by cybersecurity firm Bluevoyant LLC found that the eight most prominent players in the race for a COVID-19 vaccine faced the highest volume of targeted, malicious cyberattacks, and 77% of the total 20 companies examined had unsecured remote desktop protocol (RDP) ports and email domains lacking basic measures to block hackers. “COVID-19 vaccines are the crown jewels of 2020 – and cyber attackers know it,” the report says. Read More
In a world where the traditional way of conducting business has been disrupted for most of the year, companies for the most part appear to have adapted well to the prevailing environment. BioWorld conducted a short poll to determine readers’ own experiences during these challenging times and how they believed this new normal might reshape their approach to doing business going forward. Read More
HONG KONG – Taiho Pharmaceutical Co. Ltd. has signed an exclusive license agreement with Lung Therapeutics Inc., picking up the Japanese rights to Lung Tx’s LTI-01, a recombinant human single-chain urokinase plasminogen activator for loculated pleural effusion (LPE). Read More
Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: SEC: electronic signatures OK; FDA releases more PSGs; HHS sees AI, NLP as regulatory clean-up service providers; MHRA gives ups and downs of reclassifying drugs; TGA: Diabetes risks greater than NDMA risks. Read More
BioWorld looks at translational medicine, including: Equine encephalitis’ entry elucidated; Slowing cholera down protects survivors of infection. Read More
Biopharmas raising money in public or private financings, including: 4D Molecular, Beyondspring, Briacell, Elevation, Emergex, Evommune, Five Prime, Gan & Lee, Hemogenyx, Keros, Kodiak, Oblique, Oncternal, Oric, Pharvaris, Population Health Investment, Qiming, Scopus, Umoja, Xiaomi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Biogen, Bioventus, Cellectis, Cormedix, Janssen, Nanobiotix, Omeros, Pfizer, PTC, Samsung, Sanofi, Vivet. Read More
