Author name: Leonardo Arias

What will Boston Pharmaceuticals CEO Sophie Kornowski do now that the company is selling off its pipeline and winding down operations? Whatever it is, data will take her there.

The proclamation would push back implementation of the EPA’s rule on the carcinogenic gas for two years as the Trump administration reconsiders several emissions standards.

The company reported revenue of $37.2 million in the first quarter, up 39% year over year, but said it has faced challenges in achieving higher rates of adoption in the past.

Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as director of the Center for Drug Evaluation and Research will be his first government position.

The biotech is planning to expand antisense oligonucleotide capabilities and infrastructure on campuses that already produce drugs such as the ALS therapy Qalsody.

Companies have improved their recovery processes and user controls but still lag in risk preparedness, according to the report.

The path to market for Roche’s astegolimab became more uncertain after the investigational antibody failed to significantly lower disease exacerbation rates versus placebo in patients with chronic obstructive pulmonary disease.

The lawsuit argues the rule would drive up the number of uninsured and saddle states with increased healthcare expenses.

Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for DLBCL in a U.S. population, according to the FDA.

Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according to the FDA’s outside experts.