The US Food and Drug Omnibus Reform Act (FDORA) empowered the Center for Drug Evaluation and Research (CDER) with the ability to expedite the withdrawal of drugs that were granted accelerated approval if confirmatory trials are not successful. The new process, which has yet to be rolled out, will be […]
Biden Admin Proposes CMS Rule to Make Drug Manufacturing Costs Transparent
The Biden administration and the Centers for Medicare and Medicaid Services (CMS) have put forward a new rule intended to bolster drug price transparency by highlighting drug manufacturing and transportation costs. This would be performed via a variety of tools, including a drug price verification […]
Indian Pharma Group Petitions NPPA to Establish Prospective Batch Pricing
When India’s National Pharmaceutical Pricing Authority (NPPA) sets ceiling prices for drugs, pharma companies can be fined if even one pharmacist charges higher. As a result, the Indian Drug Manufacturer’s Association (IDMA), should put in place prospective price batching that would apply the new […]
Only Some US Prescription Drug Prices are 10X Higher than Other Countries
A common talking point in US drug pricing discussions is that US residents pay 10 times as much for prescription medicines than people in other nations. While this is true for many drugs, the picture is more complex. Making such an analysis is complicated by the comparator nations, the drugs […]
NICE Recommends Expanding Approval for AstraZeneca’s Heart Failure Med
The UK’s National Institute for Health and Care Excellence (NICE) has recommended that Astrazeneca’s heart failure med Forixga (dapagliflozin) should have its indication expanded to adults regardless of the degree of their left ventricular ejection fraction (LVEF). The drug was previously indicated […]
FTC Requests Information from Group Purchasers in PBM Probe
During its ongoing probe into the pharmacy benefit manager (PBM) industry, the US Federal Trade Commission (FTC) requested information regarding two group purchasing organizations, which negotiate discounts for PBMs. The two companies included Zinc Health and Ascent Health Services, adding to the […]
Exploring Insulin Pricing Practices and Their Effects on Patients
Shortly after the passage of the US Inflation Reduction Act, which capped the price of insulin for some patients, three major drugmakers pledged to drop list prices for their insulin products. In a new IQVIA article, learn more about the role of insulin in diabetes management, the underlying forces […]
US Court of Appeals Considering Limiting Access to Mifepristone
Comments from Republican-appointed federal judges on the US Court of Appeals for the Fifth Circuit reveal their openness to restricting access to mifepristone, a key component for medication abortions. The judges and the plaintiffs, a group of conservative care providers, noted that the drug is more […]
Max Foundation and BeiGene to provide Free Brukinsa to 29 LMICs
The Max Foundation, a Seattle-based organization dedicated to health equity, is collaborating with the biotech BioGene to provide Brukinsa to patients with chronic lymphocytic leukemia (CLL) in 29 lower- and middle-income countries (LMICs). The program will last for 3 years and will also provide […]
India’s NPPA Announces New Price Caps for Similar Drugs Sold by Same Drugmaker
India’s National Pharmaceutical Pricing Authority (NPPA) has rolled out a new policy capping prices on similar drugs sold by the same pharma company to the price of the least expensive version. The agency made the move based on the Drug Price Control Order, which it used previously to make medical […]
