The U.S. FDA’s green light April 17 for Abbvie Inc. to expand the label of Qulipta (atogepant) – the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine, with language that includes prevention of such headaches chronically in adults – provided a welcome addition to the arsenal, but sufferers are still waiting for an improved remedy. Vaxxinity Inc. just might have it. And with a vaccine, no less.
Shin Nippon Biomedical Laboratories Ltd. (SNBL) agreed to acquire Satsuma Pharmaceuticals Inc.as part of a deal worth as much as $220 million that includes rights to the STS-101 migraine drug. Shin Nippon will pay 91 cents in cash per share, as well as a non-tradeable contingent value right worth up to $5.77 per share based on the potential sale, license, or other grant of rights of Satsuma’s migraine drug STS-101.
After issuing three prior complete response letters, the U.S. FDA finally granted approval via the 505(b)(2) NDA pathway to Intelgenx Corp.’s Rizafilm Versafilm to treat acute migraine.
Just three months after raising $12.9 million, Remedee Labs SAS reported it has signed a partnership with pharmaceutical group Upsa SAS to ramp commercialization of its smart bracelet for chronic pain. “We are going to rapidly deploy our non-invasive chronic pain relief technology throughout France and Europe,” David Crouzier, co-founder and CEO of Remedee Labs, told BioWorld.
Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist nasal spray approved by the U.S. FDA for acute treatment of migraine with or without aura in adults. The product is slated to launch this summer. Meanwhile, Wall Street has questions about New York-based Pfizer’s performance in the migraine space.
Theranica Bio-Electronics Ltd. broadened its U.S. FDA clearances for the Nerivio prescription wearable to include migraine prevention in individuals with or without aura. The remote electrical neuromodulation (REN) device offers an alternative to the significant population of migraine patients who do not respond to or cannot tolerate prescription drugs that treat the condition.
Remedee Labs SA raised $13.25 million to accelerate the commercial deployment of its mini endorphin stimulator for chronic pain. This is the company’s third funding round after initial fundraising of $11.66 million.
Cerecin Inc. has successfully closed the first tranche of a series IIB financing with investors from South Korea, with SK Securities Co. Ltd. and KNT Investment LLC leading the round.
Cerecin Inc. has successfully closed the first tranche of a series IIB financing with investors from South Korea, with SK Securities Co. Ltd. and KNT Investment LLC leading the round. Proceeds from the financing, of undisclosed value, will help the company advance clinical studies of its CER-0001 (tricaprilin) in migraine and infantile spasm.
Pfizer Inc. is taking over Biohaven Pharmaceutical Holding Co. Ltd. for $11.6 billion to bring aboard Nurtec ODT (rimegepant), the calcitonin gene-related peptide (CGRP) receptor antagonist first approved in February 2020 for acute migraine in adults with or without aura.
