Top of the morning to you, and a fine one it is. Although quite chilly so far, the clear, blue skies and warm sunshine are a heartening elixir for a busy day ahead. To cope, we are brewing fresh cups of stimulation. Our choice today is chocolate raspberry. As always you are invited to join us. Meanwhile, here are a few items of interest to get you started on your own journey, which we hope will be informative and exciting. Keep in touch, everyone …
Eli Lilly’s next-generation obesity drug led to what appears to be the most weight loss seen so far in a late-stage trial, but rates of side effects were high and many participants discontinued the treatment, including people who felt they were losing too much weight, STAT writes. In a 68-week Phase 3 study of patients with obesity and knee osteoarthritis, those who took the highest dose and stayed on the drug, called retatrutide, lost 28.7% of their weight. When analyzing all treated participants, including those who discontinued, the efficacy was 23.7%. Among the cohorts of treated patients, discontinuation rates due to adverse events ranged from 12% to 18%, compared with 4% in the placebo group. among patients with the highest BMIs — those above 35 — discontinuation rates were still high, ranging from 9% to 12%, compared with 5% in the placebo arm.
European Union Council and Parliament negotiators have reached a provisional “pharma package” deal to modernize medicine rules, speed patient access, and bolster competitiveness, Reuters tells us. The agreement grants companies launching new medicines eight years of data protection for trial results and one year of market protection. Innovative products meeting specific criteria may extend this by a year. To shore up supply security, the text retains Article 56a, empowering countries to mandate that manufacturers supply sufficient quantities to meet patient needs. The package clarifies an exemption permitting generic and biosimilar makers to complete studies, filings and tender bids before patents expire, ensuring immediate market entry. Negotiators approved a transferable exclusivity voucher to spur priority antibiotic development. This grants developers an extra year of market protection for a product of their choice.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
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