M&A activity in the life sciences space proceeded largely as usual in 2022, with most transactions receiving expected levels of agency scrutiny and closing in the normal course despite aggressive rhetoric from new leadership at both agencies. Notably, the government has thus far not applied more novel theories of antitrust…
Investigators interested in rare disease treatment development have the opportunity to approach drug and biologic developers to obtain investigational drug supply for trials in which the investigators, typically at academic institutions, act as sponsor-investigators. Similarly, companies open to extending their product development pipelines can look to investigator-initiated trials as a…
In global observance of Rare Disease Day, Goodwin invites you to join us for a special awareness event on March 1, 2023 in our Boston office or virtually for those attending remotely to spotlight the critical work being done to address over 7,000 rare diseases that impact more than 300…
The 340B Drug Pricing Program is a government program, administered by the Health Resources and Services Administration (HRSA), that allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy certain prescription drugs at a steep discount from drug manufacturers. Drug manufacturers participate in the 340B Program as…
For sponsors utilizing a data monitoring committee in their trial designs to monitor for emerging safety signals, lack of effect, and/or futility of treatment, understanding data monitoring committee conflict of interest limitations is important to ensuring an objective view of the data from a trial. Where we see these conflict…
