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Home » Newsletters » BioWorld

BioWorld

Sep. 21, 2023

View Archived Issues
Kidney, pills, bottle

Filspari trips in IgAN phase III; data good enough to Protect against FDA withdrawal?

Travere Therapeutics Inc.’s narrow phase III miss in the study called Protect with the approved endothelin and angiotensin II receptor antagonist Filspari (sparsentan) in IgA nephropathy (IgAN) had Wall Street speculating about the fate of the compound, which is available for the indication by way of accelerated approval in the U.S., having been given the nod in February. Read More

Chinabio 2023: Cansino, Gracell, Immuneonco’s C-suites offer IPO insights in China, US

Raising capital has always been a challenge for small to medium biotech firms worldwide, but the economic whiplash and the wider downturn across international markets post-pandemic have pushed Chinese biotechs to make-it-or-break-it scenarios for crossing the IPO threshold, speakers at the Chinabio Partnering Forum 2023 said in Shanghai. Read More
Medici drug delivery system

ITCA-650 beaten down by safety issues at EMDAC hearing

Safety concerns overrode benefit when the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously, 19-0, Sept. 21 that the potential risks of Intarcia Therapeutics’ ITCA-650 outweighed the compliance and A1C-lowering benefits the twice-yearly implantable exenatide-device combination product could provide for adults with type 2 diabetes. Read More

Inventiva licenses NASH candidate for Japan, South Korea development

Inventiva SA is getting $10 million up front and the possibility of $231 in clinical, regulatory and commercial milestones by exclusively licensing its nonalcoholic steatohepatitis (NASH) candidate, lanifibranor, to Hepalys Pharma Inc. to sell in Japan and South Korea, two massive markets for the indication. Read More
Handshake_global2.png

Everest licenses Asian rights to Kezar’s autoimmune drug zetomipzomib

Everest Medicines Ltd. is in-licensing Kezar Life Sciences Inc.’s phase II autoimmune disease candidate, zetomipzomib in a deal worth $132 million for greater China, South Korea and southeast Asia rights. Kezar’s lead molecule zetomipzomib (KZR-616) is a first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Read More

Appointments and advancements for Sept. 21, 2023

New hires and promotions in the biopharma industry, including: Acadia, Atreca, Bluejay, Coave, Faron, Maxion, Ocugen, Stoke. Read More

Financings for Sept. 21, 2023

Biopharmas raising money in public or private financings, including: Akari, Innocan, Lynk, Osteal, Seelos, Seraxis, Verimmune. Read More

In the clinic for Sept. 21, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affamed, Alzecure, Asieris, Humanetics, Immpact, Peptilogics, Photocure, Protara, Regulus, Relmada, Seelos, Syndevrx, Vir. Read More

Other news to note for Sept. 21, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Addex, Akari, Astellas, Biocurate, CCM Biosciences, Celexor, Cyclo, Debiopharm, Hillhurst, Inmagene, Liminal, Nykode, Paratek, Replay, Sarcomatrix, Strykagen, Syena, Takeda, Transcend. Read More

Regulatory actions for Sept. 21, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, Atara, Everest, Genflow, Hepagene, Menarini, Merck, Spybiotech, Stemline, Takeda. Read More

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