Eli Lilly and the Menarini Group have both gotten the nod from the US Food and Drug Administration (FDA) for their new cancer medications. Lilly’s therapeutic for relapsed or refractory mantle cell lymphoma, called Jaypirca, is only the fourth drug of its kind approved by the agency. It will cost […]
EMA Committee Announces Orphan Drug Application Changes to Improve Access to Rare Eye Disease Medications
Policies regarding orphan drug designations for a group of rare genetic eye diseases called inherited retinal dystrophies are changing, according to the European Medicines Agency (EMA). The changes would target terminology regarding the categories of disorders that are covered under the orphan drug […]
DiaCarta Monkeypox Test Kit Issued Emergency Use Authorization by FDA
Earlier this month, the US Food and Drug Administration (FDA) issued an emergency use authorization for DiaCarta’s QuantiVirusTM MPXV test kit. The kit is a PCR test for monkeypox virus (MPXV) that tests for two separate regions of the MPXV genome to account for the chance of future mutations that […]
FDA – Last Week in Review
Last week, the US Food and Drug Administration (FDA) made key decisions regarding the approval of multiple medications and accepted submissions of a few others. First, the agency approved the use of semaglutide as a first-line diabetes therapy. In addition, it accepted the application for […]
APAC Therapeutic Access and Financing Trends to Watch in 2023
The market access and reimbursement landscape in APAC is set to shift in 2023, according to a new interview with Jeff Weisel, APAC managing director for PRMA Consulting. Weisel notes that global economic forces will play a significant role in payer decision-making in APAC, with inflation and the […]
Indian Pharma Industry Growth May Hit Drug Pricing and Regulatory Overhang Roadblocks
A report covered in Express Pharma predicts that growth in the Indian pharma market may be capped just shy of last year’s numbers. In its prediction, the report notes this may occur in response to pricing negotiations, ongoing supply chain disruptions, inflation, and regulatory pressure. However, […]
FDA Approves Alzheimer’s Treatment by Biogen and Eisai
The US Food and Drug Administration (FDA) has approved Biogen and Eisai’s new Alzheimer’s drug, lecanemab. The drug is the first of its kind because it slowed cognitive decline in patients, a sticking point with the ill-fated Aduhelm that was pulled from the market last year. However, it is unclear […]
Interview with Director of FDA’s CBER, Peter Marks
Ben Comer, Chief Editor of Life Science Leader, spoke with Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last year to discuss the Center’s goals for the coming year. The first priority is working through a backlog of […]
2022 FDA New Drug Approvals Lowest in Six Years
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) gave the nod to 37 new drugs for clinical use last year, a low after the past five years. However, this number was buffered by a slate of approvals by the Center for Biologics Evaluation and Research (CBER), […]
Achieving EU Medical Device Regulation Compliance
Medical device companies must apply a coordinated approach to achieve compliance with the EU Medical Device Regulation (MDR). In a recent Life Science Leader article, learn key strategies for planning for MDR compliance. The first such strategy is the establishment of an effective leadership team […]
