The three US FDA-approved anti-CGRP antibodies for migraine prevention have similar efficacy and matching prices, but Lilly thinks access to Emgality – including through value-based arrangements – along with the biologic's ease of use and headache-free data will differentiate the product.
Eli Lilly & Co. has hit the ground running with a carefully crafted pitch to differentiate its third-to-market CGRP inhibitor Emgality (galcanezumab-gnlm), which the US FDA has now approved in a 120 mg monthly dose for the preventative treatment of migraine in adults.
The company revealed the approval late in the evening of Sept. 27 and immediately began making its pitch to gain...
The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.
The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.
Oral RNA splicing modulator has gone into a Phase II/III trial
Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.
Government policy ramifications and tight financial markets mean it’s time to prepare strategically for a better business development environment, EY suggests.
