Avixgen Co. Ltd., a subsidiary of Dx&Vx Co. Ltd., inked a $360 million license agreement with an unidentified U.S.-based biotechnology company, granting the latter rights to its advanced cell penetrating (ACP) peptide drug delivery platform.
It looks like Biogen Inc.’s Nrf2 activator, Skyclarys (omaveloxolone), will maintain its status as the sole therapy approved for treating patients with Friedreich’s ataxia (FA), at least for now. The U.S. FDA asked for another “adequate and well-controlled study” in the complete response letter (CRL) issued to PTC Therapeutics Inc. for 15-lipoxygenase inhibitor vatiquinone. The agency said “substantial evidence of efficacy was not demonstrated.”
“Our mission is to apply our protein-protein interaction (PPI) big data-generation platform to create novel antibody therapeutics,” Proteina Co. Ltd. CEO Yoon Tae-young recently told BioWorld. “We have been working to build a proprietary technology platform for more than 15 years,” Yoon said, “and we take pride in the fact that we made our own technology platform, instead of running a company based on licensed-in technology.”
A U.S. appeals court schooled the FDA as it handed Vanda Pharmaceuticals Inc. a “technical knockout” of sorts in yet another regulatory bout with the agency – this one over the FDA’s refusal to grant the company’s request for a hearing after it had received a complete response letter (CRL) for a jet lag supplemental indication for Hetlioz (tasimelteon).
Adding another name to an impressive roster of partners assembled over the past few years, Skyhawk Therapeutics Inc. inked a neurology-focused deal with Merck KGaA aimed at discovering small-molecule RNA-targeted drugs that could be worth more than $2 billion.
A little-known tissue composed of a cluster of immune cells could offer novel insights into the development of neurological disorders. Meninges' immune system changes with age and neurodegeneration. Are they protecting the brain or fueling disease?
G2Gbio Inc. debuted on the Korea Exchange with a ₩52.2 billion (US$37.7 million) IPO Aug. 14. Nearly half of the funds raised will be used to expand Cheongju-si, South Korea-based G2Gbio’s manufacturing plants and help mass produce sustained-release injectable drug products such as GB-5001, its lead candidate in development as a once-monthly formulation of donepezil (Aricept; Eisai Co. Ltd.) for Alzheimer’s disease.
Quince Therapeutics Inc.’s mid-July completion of enrollment in the pivotal phase III study in ataxia-telangiectasia (A-T) marked an important milestone for the South San Francisco-based firm, which is not the only contender in the space. The study called NEAT – a rough acronym for “Neurological Effects of eDSP on Subjects with A-T” – will evaluate Quince’s lead asset, eDSP, in the neurodegenerative illness.
In the tumor microenvironment, cancer cells activate various signaling pathways to promote their growth. This includes the formation of blood vessels. However, the circulatory system is not the only one attracted to the tumor. Researchers at Sanford Research have uncovered a mechanism to circumvent the immune response that would destroy them.
Vertex Pharmaceuticals Inc.’s bad news from a phase II pain study and separately on the regulatory front caused shares (NASDAQ:VRTX) to close Aug. 5 at $393.83, down $78.44, or 16%. Vertex rolled out top-line results from the phase II dose-ranging study to test the safety and efficacy of its NaV1.8 pain signal inhibitor, VX-993, in tackling acute pain after bunionectomy.
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