LONDON – Phase II data on Astrazeneca plc’s AZD-1222 COVID-19 vaccine show it prompts an equivalent immune response in healthy people aged 70, to that seen in people ages 18 to 55, despite the fact the elderly had fewer side effects from vaccination. Read More
Positive top-line data from the pivotal phase III study of AAV5-based etranacogene dezaparvovec by Uniqure NV, shows 54 patients met the primary endpoint in treating severe to moderate hemophilia B. Read More
HONG KONG – Shanghai and New Jersey-based Lianbio has landed a commitment of up to $70 million in non-dilutive capital from a new collaboration with Pfizer Inc., just weeks raising $310 million in an oversubscribed crossover financing round. The collaboration is aimed at developing and commercializing new pharmaceutical products in Greater China. Read More
DUBLIN – Health care investor Syncona Ltd. has founded a new startup, Purespring Therapeutics Ltd., to take gene therapy into the kidney. It is committing £45 million (US$59.6 million) in series A funding, which will support the build-out of the new company and take at least one program into the clinic. Read More
DUBLIN – Synox Therapeutics Ltd., a spin-out from Celleron Therapeutics Ltd., has raised €37 million (US$43.7 million) in a series A round to conduct a pivotal trial of emactuzumab, an antibody its parent company in-licensed from Roche Holding AG in August. Read More
HONG KONG – Final results of Takeda Pharmaceutical Co. Ltd.’s phase III open-label extension study of Takhzyro (lanadelumab) showed that continued treatment with the monoclonal antibody may help with the long-term prevention of hereditary angioedema attacks as well as reducing their frequency. Read More
PERTH, Australia – As the idea of going to Mars starts to look less far-fetched, scientists are beginning to ask practical questions about how space affects the stability of drugs. Read More
If the FDA’s opening meeting Nov. 19 on the reauthorization of BsUFA is anything to go by, interchangeability could be a key part of the next round of U.S. biosimilar user fee negotiations. Read More
The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Alvotech, Aquestive, Asklepios, Day One, Orchard, Seelos, Selecta, Teva, Zymeworks. Read More
