Eli Lilly has settled a case with patients using insulin, who accused the company and others of artificially inflating prices of the lifesaving drug. Lilly will pay out a total of $13.5 million and will maintain their $35 a month out-of-pocket price cap for four years at minimum. The company, which […]
Canadian Health Officials Tried to Hide Evidence Health Minister Stalled Drug Pricing Reform
Recently released emails show that Health Canada officials tried to hide a letter from Health Minister Jean-Yves Duclos to the Patented Medicines Prices Review Board (PMPRB), Canada’s independent drug pricing agency, asking them to delay drug pricing reform last year. The letter mirrored the pharma […]
US FDA Fast Tracks Antithrombotic from BMS and J&J
Johnson & Johnson and Bristol Meyer’s Squibb’s (BMS’s) antithrombotic milvexian has been fast tracked by the US Food and Drug Administration for three indications, according to the companies. The drug received the designation for the drug for stroke, atrial fibrillation, and acute coronary […]
US FDA Approves Paxlovid for High-Risk Adults
The US Food and Drug Administration (FDA) approved Pfizer’s Paxlovid for patients at high risk of severe COVID-19 this week. The move is based on a randomized clinical trial that found that unvaccinated patients who had not been infected by COVID-19 before were 86% less likely to be hospitalized if […]
India’s NPPA Cuts Off-Patent Drug Ceiling Prices by Half
The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing agency, has announced it will cut the ceiling price of off-patent drugs by half to address profiteering in the pharmaceutical industry. The list of drugs covers much of the country’s National List of Essential Medicines […]
CMS Using Real-World Evidence in Medicare Drug Pricing Negotiations
The US Centers for Medicare and Medicaid Services (CMS) noted in a recent guidance that it will consider real-world data (RWD) and real-world evidence (RWE) as part of its upcoming Medicare drug pricing negotiations. However, the pharma industry is still awaiting clear guidance on the process, which […]
US House Members Call on FDA to Address Chemotherapy Shortages
A bipartisan group of US House representatives is calling on the Food and Drug Administration (FDA) to address ongoing shortages of key chemotherapy drugs. In a letter written by Debbie Dingell (D-MI) and Tim Wahlberg (R-MI), lawmakers highlight the current shortages of cisplatin and carboplatin and […]
FDA’s CDER Looking Towards Quicker Accelerated Approval Withdrawal Approach
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 […]
