Clinical Trials Licensing Production 
Pharmaceutical Technology
FEBRUARY 17, 2023
In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. This often leaves the task to institutions to ensure that licensed drugs are used in their best formulation.
Drug Patent Watch
DECEMBER 12, 2024
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
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Pharmaceutical Technology
JUNE 30, 2022
In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Room to grow.
Camargo
OCTOBER 15, 2020
Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. What is the FDA’s current thinking on the use of single-arm trials?
Worldwide Clinical Trials
OCTOBER 19, 2022
BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. Psychedelic products are having a renaissance moment. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. billion in 2027.
Pharmaceutical Technology
JULY 28, 2022
Rezafungin for injection received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) earlier, which gives the NDA priority review. According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway.
Pharmaceutical Technology
OCTOBER 4, 2022
Shionogi will waive royalty payments on product sales in all countries under this deal as long as Covid-19 is listed by the World Health Organization as a Public Health Emergency of International Concern. In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint.
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