Jyong Biotech Ltd. continues to work on two clinical-stage drugs in urinary tract indications after filing for an IPO that could raise as much as $40 million. The New Taipei City, Taiwan-based Jyong, founded in 2002, has filed an NDA for lead compound MCS-2 to treat benign prostatic hyperplasia with lower urinary tract symptoms. At the phase II stage is a prospect dubbed PCP for “prostate cancer prevention. In the works preclinically is a drug known as IC that is designed to treat Interstitial cystitis/bladder pain syndrome.

US FDA approvals up 20% year-over-year, average 14 a month in 2023

Drug approvals by the U.S. FDA increased 20.48% compared to the first seven months of 2022, even with July approvals slightly down to 13 from the previous six months’ average of 14.5 per month. Worldwide approvals from January to July are down 13.8% from the same period last year.

Celltrion, Celltrion Healthcare merger kicks off, rolling three-into-one ‘big pharma’

South Korea’s Celltrion Inc. is rolling out a tweaked plan to merge its three affiliates – electing for a two-way merger followed by consolidation with the final branch – in its latest efforts to rise through the ranks and emerge as a “true” big pharma. “Our group started as a contract manufacturing organization [CMO] and entered the biosimilar industry,” Celltrion Group Chairman Seo Jungjin said at an impromptu online press conference on Aug. 17. “Now, we are ready to take off as an innovator.”

Gene therapy shows early promise for treating severe alcohol addiction

Research in rhesus monkeys has shown a gene therapy that enhanced activity in dopamine producing neurons in the brain was effective at stopping excessive alcohol consumption in previously addicted animals.

Imagion explores global partnerships to expand molecular MRI footprint for early cancer detection

Imagion Biosystems Ltd. signed a flurry of deals recently to expand its pioneering molecular magnetic resonance imaging platform, Magsense, beyond Australia and into additional indications to detect cancer earlier. The company’s lead program has demonstrated its technology embodied in the Magsense HER2 imaging agent (MSH2IA) is safe and well-tolerated in patients with diagnosed HER2-positive breast cancer.

BioWorld Insider Podcast – The struggle is real: The first half of 2023 was an uphill climb

Guests Karen Carey, BioWorld’s managing editor, and Mike Ward, Clarivate’s global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit.

Also in the news

10xbio, Abbvie, Athersys, Bloom Science, Bristol Myers Squibb, Cantabio, Imbria, Immunic, Inhibikase, Innovent, Ipsen, Medipacific, Minghui, Mitsubishi Tanabe, Neurophth, Nexcella, Nextpoint, Nuvectis, Processa, Qualigen, Regeneron, Response, Reviva, TFC, TFF