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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
Almost 60 percent of the FDA’s staff will be retained to handle core agency activities if the federal government shuts down at midnight Friday, according to an existing contingency plan for fiscal 2019 — which HHS may update this week. Read More
Two different interests groups have asked a federal judge in Washington, D.C., for a chance to make their case against CVS’ proposed $69 billion acquisition of Aetna. Read More