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BioWorld - Sunday, May 18, 2025
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In the clinic for Feb. 22, 2024

Feb. 22, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aleta, Bioxytran, Cardiol, Enlivex, Immunitybio, Kazia, Lutris, Mabwell, Neurosense, Northsea, Polpharma, Realta, Recode, Rejuvenate, Rhythm, Simcere, Viiv.
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Financings for Feb. 22, 2024

Feb. 22, 2024
Biopharmas raising money in public or private financings, including: Agile, Chromocell, Ocular, ORI.
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Appointments and advancements for Feb. 22, 2024

Feb. 22, 2024
New hires and promotions in the biopharma industry, including: Ansa, Astellas, Hansa, Ikena, Inflarx, Kane, Ocular.
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BIO CEO 2024: Prepping for better times

Feb. 21, 2024
By Lee Landenberger
Helping executive and investors prepare for better economic times is a strong theme in the upcoming BIO CEO 2024 conference, which runs Feb. 26 and 27 in New York. The annual conference, sponsored by the Biotechnology Innovation Organization, is designed to present a broad, unbiased view of investment opportunities. Panels of experts are set to discuss hot therapeutic areas and the key business issues facing companies and the industry.
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Bladder cancer illustration

CG Oncology, Engene, and more line runway in bladder cancer

Feb. 21, 2024
By Randy Osborne
The first – and handsomely upsized – IPO of this year by CG Oncology Inc., along with the sizeable financing Feb. 14 by Engene Holdings Inc., proved Wall Street’s interest in non-muscle invasive bladder cancer, where a number of other players also are busy.
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Hand holding gear, dollar sign

Insamo emerges with $12M for membrane-permeable peptide approach

Feb. 21, 2024
By Jennifer Boggs
To understand the focus of startup Insamo Inc., one need look no further than its name, which co-founder and CEO Timothy Craven described as “portmanteau of ‘internally satisfied molecules,’” highlighting its efforts to create orally administered and membrane-permeable cyclic peptides across a range of disease areas.
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Scientists working in Samsung Bioepis lab

Keytruda biosimilars ramp up; Samsung Bioepis starts phase I

Feb. 21, 2024
By Marian (YoonJee) Chu
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
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Hit with warning letter, China company suspends US API production

Feb. 21, 2024
By Mari Serebrov
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
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Regulatory actions for Feb. 21, 2024

Feb. 21, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Therapies, Affamed, Argenx, Astrazeneca, Avidity, Bristol Myers Squibb, Celltrion, Certa, Daiichi Sankyo, Disc Medicine, Genentech, Harmony, Immuneering, Iovance, Jacobio, Kalvista, Mabwell, Matinas, Merck, Monopar, MRM Health, Omnix, Pepgen, Pfizer, Rapt, Servier, Ultimovacs.
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Other news to note for Feb. 21, 2024

Feb. 21, 2024
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bavarian Nordic, Hitgen, Hox, Inveniai, Liquidia, Olatec, Ono Pharmaceuticals, Pharmadrug, Pharmather, Sairiyo, Tevogen, United Therapeutics, Vaccines, Vernalis.
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