The FDA granted accelerated approval for Verastem Oncology's Copiktra, or duvelisib, as a treatment for adult patients with small lymphocytic lymphoma or relapsed/refractory follicular lymphoma or chronic lymphocytic leukemia following two or more lines of therapy.
An analysis from The Associated Press found that drugmakers implemented more drug price hikes than cuts from January through July despite the Trump administration's campaign to lower drug prices. There were 4,412 price hikes and 46 cuts during the period, but there were fewer increases than in previous years and the median increase was smaller than in 2017, though the median price cut was also smaller than in prior years.
House and Senate lawmakers finalized a major opioid legislative package late Monday, and it won't include a technical change to Medicare Part D's "doughnut hole" language pushed by pharmaceutical firms. The final package includes a measure by Sen. Rob Portman, R-Ohio, that would temporarily lift restrictions on use of Medicaid funds for inpatient addiction treatment.
Gilead Sciences said it will launch generic versions of its blockbuster hepatitis C drugs Epclusa and Harvoni in January through a new subsidiary called Asegua Therapeutics. The authorized generics will cost $24,000 per treatment course, well below the launch prices of Harvoni and Epclusa, which were $94,500 and $74,760, respectively.
Under the leadership of President and CEO Mark Merritt, the Pharmaceutical Care Management Association has educated lawmakers about the pharmaceutical industry and how pharmacy benefit managers work. "Our strength is coming up with serious policy solutions that show how to reduce drug costs for consumers," Merritt said.
Pharmaceutical Research and Manufacturers of America pushed to add a provision to bills meant to curb opioid misuse that would reverse a law requiring drugmakers to offer a 70% discount to Medicare Part D subscribers in the coverage gap.
A final guidance document and a draft guidance document will streamline the FDA review process for generic, branded and biologic drugs and aim to help sponsors submit high-quality applications to avoid multiple review cycles, FDA Commissioner Scott Gottlieb says.
Makers of brand-name drugs have continued to raise prices far more often than they have lowered them, despite promises from the industry and the Trump administration. From January through July there were 96 price increases for each price cut, including 395 price increases and 24 decreases in June and July alone.
Roche Holding will begin marketing FoundationOne Liquid, a blood test from Foundation Medicine that can analyze the presence of 70 common gene mutations in a patient's blood sample from circulating tumor DNA that comes from solid tumors. The new assay also has features that can pinpoint which patients have a higher chance of benefiting from cancer immunotherapy.
Eight percent of 1,040 health plans received a top rating of 4.5 or 5 in the National Committee for Quality Assurance's health plan quality ratings report. Massachusetts, Rhode Island and Maine had the highest percentage of plans rated at 4.5 or 5.
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