Government

Shares of Cambridge, Mass.-based Spero Therapeutics are climbing this morning after the company announced it secured up to $54 million from the government to support its development of SPR944 as a potential treatment against drug-resistant infections.
Novartis and Michael Cohen, attorney to President Donald Trump, had a much deeper relationship than has been previously disclosed and was selling access to the White House, a new report issued by Senate Democrats alleges.
President Trump was able to declare a small victory in the arena of drug pricing earlier this week when Pfizer opted to delay its second price-hike of the year. Other companies though have not followed suit and have gone through with price increases for their drugs.
FDA
The U.S. Drug Enforcement Agency is in the midst of readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.
FDA
On June 11, 2018, FDA Commissioner Scott Gottlieb released a complementary framework for gene therapies, noting that in the last 12 months the agency has approved three different gene therapy products. “This reflects the rapid advancements in this field,” Gottlieb stated.
The scope of the U.S. Food and Drug Administration’s mission could become much narrower if a proposed restructuring of the federal government comes to fruition.
The first company has provided a potential out-of-pocket price for patients who seek access through the recently passed federal Right-to-Try legislation and it’s not cheap.
Food and Drug Administration chief Scott Gottlieb is making a pitch to change the reimbursement model for antimicrobial drugs that target multidrug-resistant infections.
The ink is barely dry on the recently-passed “Right to Try Act,” and the law’s author, Sen. Ron Johnson (R-Wis.) and U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb are butting heads.
Two months after a setback in the U.S. House of Representatives, Congress has authorized “right to try” legislation.
PRESS RELEASES