As ASCO approaches, Novartis tries to highlight its oncology offerings, despite a very early immuno-oncology pipeline.
Like some of the other companies that are behind in the immuno-oncology space, Novartis AG is relying on combination treatments to get it back in the game and is hoping that its strength in gene therapies will give it an advantage. The Swiss pharma knows it can't recover in the near-term, but is planning to be on top in five years.
Novartis has long been a leader and innovator in the oncology space, a story best told by its blockbuster leukemia...
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
