The German company is looking to strengthen its cancer immunotherapy portfolio by establishing a dedicated research unit and increasing business development in the field.
Merck KGAA is the latest biopharma increasing its investment in the emerging field of immuno-oncology. The German company’s U.S. subsidiary EMD Serono said June 26 that it is establishing an early research unit and increasing business development initiatives in the field.
Merck’s new “innovation platform” will break out early immuno-oncology R&D – preclinical through proof-of-concept – from the firm’s broader oncology...
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
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.
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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order.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.
