LONDON – Pharmaceutical companies and academic researchers working on COVID-19 vaccines are being targeted by Russian state-sponsored hackers, according to the U.K. National Cyber Security Centre (NCSC). The U.K. view is endorsed by the U.S. National Security Agency and Canada’s Communications Security Establishment, and the three agencies have issued a joint statement advising companies how to protect against these attacks. Read More
Courtesy of a $50 million series A, Adagio Therapeutics Inc. will join a raft of other companies attempting to end the COVID-19 pandemic with antibodies. Read More
Robust financial markets continue to fuel the industry despite gloom over the COVID-19 pandemic, with Relay Therapeutics Inc. pricing its upsized, 20 million-share IPO at $20 per unit to reap $400 million. Read More
In its first fully virtual markup session, the House Energy and Commerce Committee Wednesday set aside politics to approve a bill that would make the U.S. Strategic National Stockpile (SNS) a better emergency resource – at least for the next few years. Read More
With an Aug. 22 PDUFA date set, Tricida Inc. said it received an FDA notification regarding the NDA for veverimer (TRC-101) for treating metabolic acidosis in chronic kidney disease (CKD) patients, noting that it had identified deficiencies precluding discussion of labeling and postmarketing requirements/commitments. Read More
HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year. "We expect the trial to start in U.S. in the [middle of] next year. We will then expand the trial to China afterwards as planned," Joan Shen, CEO of I-Mab, told BioWorld.Read More
New hires and promotions in the biopharma industry, including: Arkuda, Hansa, Innate, Iveric, Kintai, Maat, Personalis, Ribon, Scholar Rock, Sernova, Sun, Vor, Zikani.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, Bayer, Kiniksa, Mallinckrodt, MC2, Merck, Redhill, Tetra, Tracon and Tricida.
