German researchers have cracked the decades-long mystery of why males are more susceptible to acute kidney injury than females, demonstrating that estrogen has a protective effect in females.
Eli Lilly and Co. has fallen into line with U.S. President Donald Trump’s May 12 executive order on most-favored nation pricing, announcing it will put up drug prices in Europe in order to make them lower in the U.S. In a statement on Aug. 14, the company said it supports the Trump administration’s objective of more fairly sharing costs of “breakthrough medical research” across developed countries.
In a regulatory round-up, the U.K. Medicines and Healthcare Products Regulatory Agency opened a survey regarding in-house device manufacturing, the EU Notified Bodies staffed up last year and the Singapore Health Sciences Authority and the Hong Kong Department of Health agreed to share information.
German researchers have cracked the decades-long mystery of why males are more susceptible to acute kidney injury than females, demonstrating that estrogen has a protective effect in females.
The increasing recognition of its importance in national security, economic growth and health has seen biotech emerging as the latest frontier in geopolitical competition, with implications for companies ranging from startups to multinationals – and for global investment in the sector.
The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions.
The issues facing the EU’s Medical Device Regulation and the In Vitro Diagnostic Regulation are the stuff of legend, but the EU’s notified body group, TEAM NB, has proposed a mechanism to deal with some of the administrative problems.
The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions.
Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP). In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, a disease that has yet to see a cure, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels.
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