Sen. Leahy's reintroduced CREATES Act allows generic sponsors to sue innovators who fail to provide sufficient quantities of REMS covered products, but seems to give wide latitude to courts; bill reflects Congress' broader focus on generic drugs to address drug pricing issue.
A bipartisan group of lawmakers is hoping that reintroduced legislation will stop innovator drug companies from blocking access for generic sponsors to products subject to Risk Evaluation and Mitigation Strategies (REMS) "without a legitimate business justification."
The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S.974) – sponsored by Sen. Pat Leahy, D-Vt., and...
Doctors are increasingly falling victim to financial scams due to their high incomes, busy schedules, and trust in professional networks. Recognizing the tactics scammers use and the reasons behind physicians’ susceptibility is essential for protecting medical professionals.
Senate HELP Committee chair Sanders trying to broker a deal between Novo Nordisk and the major pharmacy benefit managers that will lead to lower list prices.
Alternatives to the top pharmacy benefits managers argue health plan-PBM integration is leading to anti-competitive tactics that make it impossible for some employers to switch PBMs.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Pharmacy benefit manager sues Federal Trade Commission claiming chair Khan has orchestrated a campaign against PBMs that is not based in fact.
Alternatives to the top pharmacy benefits managers argue health plan-PBM integration is leading to anti-competitive tactics that make it impossible for some employers to switch PBMs.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
