FDA looks to expedite drug approvals; New EMA leader wants to increase scrutiny;

> The FDA is considering whether consumers should be able to get drugs for high blood pressure, cholesterol, migraines and asthma without a prescription. It also intends to expand its accelerated approval program based on relaxed standards for effectiveness. Story

> Guido Rasi, new leader of the European Medicines Agency, says he intends to increase scrutiny of new drugs in an effort to improve safety, the medical benefit, as well as the cost of drugs for the EU. Item

> Eight of the largest drug manufacturers--including GlaxoSmithKline ($GSK), Novartis ($NVS) and Pfizer ($PFE)--have been sued by a consumer group that alleges that the use of coupons to reduce copayments drives up health costs and is illegal. Story

> A distributor of Johnson & Johnson ($JNJ) hip implants dropped an attempt at getting legal sanctions against a law firm it said solicited clients from confidential patient information that was accidentally given to it in discovery. Article

> Florida's crackdown on pill mills is showing results as the number of pain clinics has dropped nearly 40%. News

> The Centers for Medicare and Medicaid Services is proposing new rules it believes would make it more difficult for Medicare patients to get their hands on too many pain pills. However, the AMA is opposing the idea as it would give too much leverage over doctor's decisions, the association says. Item


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.