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BioWorld - Wednesday, January 21, 2026
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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Regulatory actions for Aug. 14, 2025

Aug. 14, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biodlink, Creative Medical, Insmed, Kexing, Ocugen, Savara.
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Other news to note for Aug. 14, 2025

Aug. 14, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: Abbvie, Apertura, Emugen, Fate, Galibra, Generation Bio, Lixte, NextRNA, Oric, Santhera.
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In the clinic for Aug. 14, 2025

Aug. 14, 2025
Clinical updates, including data readouts and publications: Biohaven, Cytomx, Immunitybio, Mediwound, Neuronascent, Remegen, Response, Stoke, Vor.
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Financings for Aug. 14, 2025

Aug. 14, 2025
Biopharmas raising money in public or private financings, including: Armata, Compass, Gameto, Genmab, Innoviva, Nasus, Sellas, X4.
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Appointments and advancements for Aug. 14, 2025

Aug. 14, 2025
New hires and promotions in the biopharma industry, including: Altos, ALX Oncology, MC Sciences, Vividion.
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Tablets on conveyor belt

US API stockpile added to onshoring toolbox

Aug. 14, 2025
By Mari Serebrov
No Comments
In his latest effort to incentivize domestic manufacturing of drugs and their key ingredients, U.S. President Donald Trump issued an executive order Aug. 13 to replenish the country’s nearly empty Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), giving a preference to U.S.-produced APIs.
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Mirugen co-founders Keith Martin (L) and Raymond Wong (R)
Newco news

Aussie gene therapy company emerges from stealth

Aug. 14, 2025
By Tamra Sami
No Comments
Aussie gene therapy company Mirugen Pty Ltd. has emerged from stealth mode from the Center for Eye Research Australia in Melbourne, toting a AU$4.5 million (US$2.9 million) seed round that will see it optimize its lead candidate to treat retinitis pigmentosa.
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Hands holding pink paper kidneys

New research solves mystery of sex differences in acute kidney injury

Aug. 14, 2025
By Nuala Moran
No Comments
German researchers have cracked the decades-long mystery of why males are more susceptible to acute kidney injury than females, demonstrating that estrogen has a protective effect in females.
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G2Gbio CEO Lee Hee-yong (center) commemorates the company’s listing on the Korea Exchange

Microsphere injectables biotech G2Gbio debuts with $38M

Aug. 14, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Art concept for drug addiction

Elysium fields SOOPR overdose fix to fill opioid void

Aug. 14, 2025
By Randy Osborne
No Comments
Elysium Therapeutics Inc. aims to tackle the problem of opioid overdose with a longer-lasting rescue agent that gets around the not-much-publicized problem of fentanyl rebound, or re-narcotization, which happens when the standard reverser wears off and the culprit drug stays active in the body, potentially killing the patient.
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