LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said. Read More
A new randomized controlled trial (RCT) of COVID-19 convalescent plasma (CCP) treatment for moderately ill COVID-19 patients run at 39 Indian hospitals found no association between CCP therapy and reduced mortality or progression to severe disease. Read More
CAJICA, Colombia – Latin American countries are rushing to sign deals to gain access to SARS-CoV-2 vaccines, with Brazil, the largest in the region, right in the race. Already, the country has the third most COVID-19 cases globally, behind only India and the U.S. Read More
The positive interim 24-week liver biopsy results from Arrowhead Pharmaceuticals Inc.’s open-label phase II of its RNAi-based liver-targeted therapeutic, ARO-AAT, came as a surprise to the developers. Read More
DUBLIN – Versant Ventures, the founding investor of Crispr Therapeutics AG, is teaming up with one of the academic founders of that company, Stanford University’s Matt Porteus, to start a new gene editing firm, Graphite Bio Inc., which is focused on targeted integration of DNA to achieve a therapeutic benefit. Read More
DUBLIN – Adrenomed AG reported its anti-adrenomedullin antibody, adrecizumab, attained an absolute reduction of 9% in mortality as compared with placebo at both 14 and 28 days (D28) after treatment in a phase II trial in a large subgroup of patients with septic shock. Read More
A Sept. 16 Senate hearing revisited the Trump administration’s response to the COVID-19 pandemic, and the CDC took the opportunity to post a vaccine distribution plan. CDC director Robert Redfield advised the committee, however, that sufficient quantities of vaccine to cover everyone in the U.S. might not be available until the third quarter of 2021, adding that now is the time to stand up a distribution network for a vaccine that will require cold-chain storage. Read More
Given the minimal accountability written into the 340B prescription drug discount program, a few biopharma companies recently began taking oversight into their own hands by demanding data claims or refusing to extend the mandated discounts to contract pharmacies. Read More
New hires and promotions in the biopharma industry, including: Acasti, Acceleron, Adicet, Asklepios, Century, Compass, Dicerna, Forendo, Forma, Immunome, Moderna, Pneumagen, Rain, Revitope, Vedanta, Volastra, Voyager. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adrenomed, Aim Immunotech, Algernon, Arcutis, Arena, Arrowhead, Aveo, Eli Lilly, Exicure, Galera, Genelux, Heron, Horizon, Immune-Onc, Knopp, Menarini, Ryvu, Springworks, Verastem, Verona. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AVM, Cura, Mateon, Mediwound, Orphazyme. Read More
