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 that will go into effect in 2028. The slate includes 15 drugs and, for the first time, is open to Part B drugs, as well as Part D. Consequently, seven of the 15 drugs are biologics. The impact of negotiations isn’t expected to make much of a difference to the bottom line for most of the 13 companies with a selected drug, as the price set by the CMS will only apply to Medicare. According to Leerink Partners LLC’s David Risinger, Medicare exposure of 14 of the selected drugs will account for only 0% to 3% of the companies’ estimated 2027 worldwide sales. The exception is Gilead Sciences Inc.’s Biktarvy, the first HIV drug to be negotiated. Risinger estimated that Biktarvy’s Medicare exposure would represent about 8% of Gilead’s worldwide revenue next year.

Seamless seals $1.12B gene editing deal with Lilly on hearing loss

Seamless Therapeutics has received big pharma endorsement of its proprietary recombinase gene editing platform by sealing a potential $1.12 billion deal with Eli Lilly and Co. to apply the technology in hearing loss. Dresden, Germany-based Seamless will design and program site-specific recombinases to correct mutations in unspecified genes that are related genetic causes of hearing loss. Lilly will have an exclusive license to the recombinases. “One of the reasons that we’re so excited about this, is that it allows us to take our technology platform into an area we’re not working on,” said Albert Seymour, CEO. “[We] will have our own fully-owned program, but then through partnerships we can utilize [it] in other areas,” he told BioWorld.

Calcimedica sags on halt of Auxora trial in acute kidney injury

Following the recommendation of an independent data monitoring committee, Calcimedica Inc. said it is discontinuing the phase II study testing Auxora in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure. Data from the 150-patient study, dubbed Kourage, had been expected to read out in the first half of this year. Instead, the company said it will follow the voluntary halt with a comprehensive review of unblinded data, with a focus on enrollment criteria, to determine a path forward in AKI. Meanwhile, Calcimedica said it continues to finalize the design for a pivotal trial testing Auxora, a selective small-molecule inhibitor of Orai1-containing calcium release-activated calcium channels, in the separate indication of acute pancreatitis. Shares of Calcimedica (NASDAQ:CALC) were down 76% at noon to $1.22, after trading as low as 82 cents.

Phase I/II Regenxbio gene therapies for MPS I, II placed on clinical hold

Shares of Regenxbio Inc. (NASDAQ:RGNX) were trading at $10.95, down $2.46, or 18%, on word that the U.S. FDA has placed a clinical hold on its gene therapy, RGX-111, for the treatment of mucopolysaccharidosis (MPS) I, also known as Hurler syndrome, 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. The agency did the same with RGX-121, for the treatment of MPS II, also known as Hunter syndrome, because of shared risk between trials. RGX-121 is undergoing a phase II/III experiment called Campsite. Rockville, Md.-based Regenxbio said the neoplasm case was identified during routine brain magnetic resonance imaging of an asymptomatic 5-year-old who had been given intracisternal RGX-111 four years earlier.

Boehringer nabs preclinical IBD bispecific in $1.2B Simcere pact

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). Under the terms announced Jan. 27, Boehringer receives global rights to SIM-0709, excluding greater China, Macao, Hong Kong and Taiwan. The €1.05 billion is inclusive of an up-front payment, as well as development, regulatory and sales milestone payments. Simcere is also eligible to receive royalties on net sales outside the greater China territory.

Study digs into links between age, sex, hormones and asthma

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. Lloyd, who is professor of medicine and vice dean for institutional affairs at Imperial College London, is co-corresponding author of a paper describing some of the underlying molecular mechanisms. In their experiments, which they published in Science Immunology on Jan. 23, 2026, Lloyd and her colleagues link a signaling axis that included interleukin-33 and epidermal growth factor receptor.

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Also in the news

Baseline, Bial, Bioarctic, Boehringer, Cancervax, Cardiff, Clarametyx, Eisai, Epidarex, Genenta, Greenwich, Hetero, Huahui, Imviva, Innovent, Insilico, Integrated, Intellia, Ipsen, Ixcells, Kazia, Kiora, Kivu, Lexeo, Lisata, Mesoblast, MS, Myoventive, Option, Otsuka, Qilu, Qlaris, Quoin, Roche, Rosebud, Savara, Simcere, Skyhawk, Trexbio, Tubulis, Zag