We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Big name drug distributors and the DEA failed to stem the tide of millions of opioid doses into West Virginia despite plenty of warning signs, a House and Energy Commerce Committee report has found. Read More
Cancer trials that rely on event-free survival and complete response to treatment as surrogate endpoints will be acceptable to FDA reviewers, the agency says in a new final guidance issued Wednesday. Read More
Gottlieb said the agency is “going to be putting many more firms on notice that we’re aware that they’re manufacturing cell and tissue products that are subject to our oversight.” Read More
The PBMs, he said, have acquired new responsibilities and duties such as determining which medications are covered and how much money pharmacies are reimbursed for them. Read More
Baldwin called for detailed data on the price hikes, noting that in the wake of the 2017 tax reform bill, Pfizer received nearly $11 billion in tax benefits, almost all of which went to stock buybacks. Read More
Public Citizen questioned Gottlieb’s claim that the drug could help treat soldiers in battlefield settings, noting that the clinical trials only involved patients who underwent minor surgical procedures. Read More
The administration’s proposal to require disclosure of list prices for drugs could hurt Medicare and Medicaid beneficiaries, PhRMA claimed in a 30-page comment on CMS’ proposed rule. Read More
The Justice Department says a series of whistleblower lawsuits against 10 drugmakers is not worth the government’s time or resources to pursue. Read More
HHS would be authorized to manufacture generic drugs in certain circumstances under proposed bills introduced on Tuesday in the Senate and House. Read More
Regulators are more likely to tolerate uncertainty if sponsors can show that the benefits of a proposed biomarker far outweigh the risks or if they can demonstrate that they’ve got an effective risk mitigation plan in place. Read More