Citeline, a Norstella company

While ASKA tries to double the number of its stocks to avoid MBO attempts by Dalton, the Asia-focused PE insists on the plan while criticising the move as irresponsible.

Rising Leader Abbas Kazimi's leadership at Nimbus Therapeutics combines immigrant resilience, patient-first partnerships, contrarian strategic bets and a deeply personal mission driving breakthrough drug discovery innovation.

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.

Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Biopharma executives and investors at the BIO convention noted the competition emerging from China with high-quality assets that could make strong additions to their portfolios.