The FDA has issued a complete response letter (CRL) regarding the new drug application for CCP-07 (Vernalis/Tris Pharma), an extended-release cough-and-cold medication. A CRL is issued when the FDA has completed its review of a new drug application and questions remain that preclude the application’s approval at that time.
Valeant Pharmaceuticals International has announced that, following the approval of its Patient Access and Pricing Committee (PAPC), it has decided to list brodalumab injection (Siliq) at $3,500 per month, which the company says is the lowest price for an injectable biologic psoriasis treatment currently on the market.
As House Republicans try to reach agreement on a bill to overhaul the Patient Protection and Affordable Care Act (PPACA), they may be ready to let states make the ultimate decision about whether to keep a key consumer provision in the act that conservatives say is raising insurance costs, according to a report from Kaiser Health News (KHN).
In February 2017, members of the NEJM Catalyst Insights Council––a group of executives, clinical leaders, and clinicians at organizations directly involved in health care delivery––were asked to predict the Trump administration’s impact on health care in America.
Lessons abound in the story about Glybera, a gene therapy developed by the Dutch biotech company UniQure to treat a very rare disease, but one stands out: Good luck getting insurers to cover a treatment that costs $1 million for a one-time dose and that helps only a miniscule number of patients.
Insurers are struggling to make decisions about their 2018 exchange offerings amid mixed signals from the Trump administration and congressional Republicans about the future of the Patient Protection and Affordable Care Act (PPACA), according to an article in the Wall Street Journal.
During a question-and-answer session in London, House Speaker Paul Ryan (R-Wisconsin) announced that Republicans are busy putting together a second attempt at dismantling the Patient Protection and Affordable Care Act (PPACA), according to The Hill.
And they can pull them right back out again, changing their minds in the coming months and not participate in the ACA exchanges, according to the Wall Street Journal. It’s a struggle for health insurance officials, making this decision about should they stay or should they go.
A new study conducted in the U.S. and Romania has shown that, within two years after experiencing a myocardial infarction (MI), nearly one in five patients stop taking life-saving statins, and nearly two in five end up taking the drugs in lower doses or less often than they should, according to a Reuters report.
Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, has allotted only five hours, or half a day, to the breast cancer drug neratinib (Puma Biotechnology) at an advisory committee meeting scheduled for May 24, according to a report posted on the financial news website The Street.