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. Read More
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. Read More
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. Read More
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. Read More
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Boehringer Ingelheim International GmbH signed a €1.058 billion (US$1.26 billion) deal with Simcere Pharmaceutical Group Ltd. to license select rights to SIM-0709, a preclinical TL1A/IL-23p19-directed bispecific antibody targeting inflammatory bowel disease (IBD). Read More
Rolling out guidance to help pharma manufacturers provide direct-to-consumer drugs at lower prices, the U.S. Department of Health and Human Services (HHS) clarified ways to eliminate the middlemen while still abiding by the federal anti-kickback statute. Read More
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. Read More
New hires and promotions in the biopharma industry, including: Cancervax, Cardiff, Clarametyx, Integrated, Ipsen, Kiora, Kivu, Lexeo, Myoventive, Qlaris, Tubulis, Zag. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Baseline, Boehringer, Genenta, Hetero, Insilico, Ixcells, Lisata, Mesoblast, MS Pharma, Qilu, Rosebud, Simcere. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Bioarctic, Eisai, Huahui, Imviva, Intellia, Innovent, Otsuka, Quoin. Read More
