Pfizer Inc. CEO Albert Bourla has been talking for the past few weeks about creating a vaccine to control the omicron variant. Now the company, with partner Biontech SE, has initiated a clinical study of its new candidate by testing it in healthy adults. Bourla has said the company can adapt its vaccine to new variants in under three months and could have one ready to go in March if necessary.
The amount of clinical data reported in January so far is currently 30% below the amount reported during the same month last year, which was the slowest month of 2021.
The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aculys, Aqualung, Boehringer Ingelheim, Cytoimmune, Evotec, G1, Gilead, Immix, Inmune, Monte Rosa, Neurelis, Opiant, Regenerx, Siga, Spago, Yeda.
Supply chain issues overshadowed Royal Phillips NV fourth-quarter 2021 results, as the Dutch conglomerate reported sales of $5.5 billion (€4.9 billion), a 10% organic year-on-year decline. Philips management said sales were impacted by several headwinds, including supply chain challenges and postponement of equipment installations in hospitals related to COVID-19. The recall of the Respironics device also caused a double-digit decline in the sleep & respiratory business.
Once again, the U.S. FDA giveth and it taketh away. Just a few days after expanding its approval for Gilead Sciences Inc.’s Veklury (remdesivir) to provide access to more people infected with COVID-19, the FDA essentially shut down the use of two monoclonal antibody (mAb) treatments Jan. 24 that had been authorized to treat mild-to-moderate COVID-19 infections – Regeneron Inc.’s Regen-Cov (Ronapreve in Europe), an antibody cocktail of casirivimab and imdevimab, and Eli Lilly and Co.’s bamlanivimab and etesevimab that are administered together.
LONDON – A pledge to “bottle” improvements made in setting up and running clinical trials during the pandemic has materialized in the formation of Protas Ltd., a nonprofit promising to stage large-scale phase III clinical trials in common diseases for less than one tenth the current cost. Protas will design and run randomized phase III studies of new and repurposed drugs in conditions including depression, dementia, heart, lung and respiratory conditions, arthritis and cancer.