With the PDUFA date fast approaching for Regenxbio Inc.’s gene therapy RGX-121, the U.S. FDA placed the drug on clinical hold along with another, RGX-111, after preliminary analysis of a single case of neoplasm (specifically, an intraventricular central nervous system tumor) in a participant treated in the phase I/II study with the latter treatment.
Heeding the recommendation of an independent data monitoring committee, Calcimedica Inc. said it is discontinuing the phase II study testing calcium release-activated calcium channel inhibitor Auxora in patients with acute kidney injury with associated acute hypoxemic respiratory failure.
Seamless Therapeutics has received big pharma endorsement of its proprietary recombinase gene editing platform, sealing a potential $1.12 billion deal with Eli Lilly and Co. to apply the technology in hearing loss.
The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.
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The prevalence of asthma differs between men and women, and furthermore, the difference changes over the lifespan. “Asthma is more common in boys than girls, but more common in women than men,” Clare Lloyd told BioWorld. Females are particularly susceptible to asthma during developmental periods of hormonal changes, also known as puberty, pregnancy and menopause.
Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Jan. 23 to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biogen, Cogent, Eisai, GSK, Mannkind, Merz.
Biopharma happenings, including deals and partnerships, and other news in brief: Arcutis, Bluejay, BNC Korea, Eclipse, Hanchorbio, Indivior, Kowa, Leios, Mirum, Terrain, Wuxi.
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