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“Having timely, accurate information about what drugs are being actively marketed helps provide transparency around circumstances where generic competition is lacking,” Gottlieb said. Read More
Scilex noted that numerous over-the-counter lidocaine patches that do not conform to the FDA’s 1983 tentative final monograph are being marketed. Read More
Sen. Bernie Sanders (I-Vt.) took aim at Florida-based drug developer Catalyst Pharmaceutical over what he called the “staggering” list price for Firdapse (amifampridine), a treatment for a rare neuromuscular disease that the company plans to launch in the first quarter of 2019. Read More
A California judge ruled in Boehringer Ingelheim’s favor in another court case involving its blockbuster blood thinner Pradaxa (dabigatran) and allegations of fraud and failure to warn about the drug’s risks. Read More
HHS Secretary Alex Azar on Monday plugged the Trump administration’s efforts to bring some daylight to prescription drug rebates through proposed “transparent and upfront discounts” that go directly to the patients. Read More
Any amendments must be submitted electronically even if the original submission was submitted prior to implementation of the electronic submission requirements, the agency said. Read More
The group called for an update to the “outmoded” Part D requirement that plans cover two drugs per class, claiming that the requirement has created an incentive for drugmakers to drive up Part D costs. Read More
Approximately 65,000 residents of the state live with chronic hepatitis C virus, and about 30,000 are covered by state-purchased health care insurance. Read More
While the FDA shot down Keryx Biopharmaceuticals’ request for five-year new chemical entity (NCE) exclusivity for its Auryxia (ferric citrate) oral tablets, it OK’d the drugmaker’s petition for three-year exclusivity. Read More
PhRMA said it “strongly opposes” the proposed changes to the protected-classes policy, claiming it would be unlikely to result in significant savings and would be inconsistent with Medicare Part D’s non-discrimination protections. Read More
Spread pricing has previously been targeted by states such as Ohio, which forced PBMs contracted by its Medicaid program to scrap spread pricing models. Read More