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Without strong economic incentives, the current antibiotic development pipeline won’t keep pace with burgeoning rates of antibiotic resistance, according to a new study by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More
In an analysis that seeks to help frame the discussion at the upcoming Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, the FDA says that a law enacted in 2017 has increased the number of planned studies to test drugs for pediatric cancers compared to earlier regulatory laws. Read More
Patients with two copies of the Alzheimer’s high-risk gene apolipoprotein e4 (APOE4) are more likely to develop the biological characteristics that define Alzheimer’s disease, a finding that could have important implications in drug design and clinical trials. Read More
The overall quality of data and risk of potential bias in them should be top of the mind for European sponsors who want to employ real-word data (RWD) in non-interventional studies (NIS), according to a reflection paper released by the European Medicines Agency. Read More
The FDA’s CDER has released 2023 Annual Reports for its Offices of New Drugs (OND) and Translational Sciences (OTS), highlighting activities that span dozens of drug approvals and guidances from developing AI-enabled software prototypes to identify adverse drug events. Read More
Most of the new oncology indications approved under Real Time Oncology Review (RTOR) relied on surrogate endpoints that were never confirmed as clinically effective in postmarketing trials, according to a research letter published in JAMA Network Open. Read More
Investigators found that the FDA OK’d nearly 80 percent of these non-supported surrogate markers as appropriate endpoints for a traditional approval. Read More
Almost 60 percent of surrogate markers supporting FDA approvals for nononcologic drugs for chronic diseases aren’t backed up by meta-analyses showing a strong association between the marker and relevant clinical endpoints, a new JAMA Network study says. Read More
Two pharmaceutical giants based in Japan — Takeda and Astellas — have signed a master agreement along with Sumitomo Mitsui Banking Corporation to establish a joint venture company dedicated to the incubation of early drug discovery programs in Japan. Read More