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Home » Newsletters » BioWorld

BioWorld

Sep. 28, 2023

View Archived Issues
Stem-cells2.png

Adcom leaves Brainstorm looking at options

Brainstorm Cell Therapeutics Inc. said it’s exploring all its options in the wake of a Sept. 27 U.S. FDA advisory committee vote, in which the committee overwhelmingly disagreed with the company that the data it presented supported the effectiveness of Nurown (debamestrocel) for the treatment of mild to moderate amyotrophic lateral sclerosis. Read More

Bionomics stock charges ahead with positive PTSD data

Positive top-line data from the phase IIb study of BNC-210 to treat post-traumatic stress disorder (PTSD) supercharged Bionomics Ltd.’s stock. Shares (NASDAQ:BNOX) closed trading a dramatic 243.8% higher at $3.37 each on Sept. 28. The oral, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor stumbled last December in a phase II trial for treating social anxiety disorder but now has regained momentum. Read More
Illustration of antibodies binding to human cell receptors

Immunovant to raise $450M on ‘potent’ falls in IgG levels with MAb in phase I

Immunovant Inc. is seeking a $450 million windfall on the back of the “best-in-class potential” of its early stage monoclonal antibody for IgG-mediated autoimmune diseases, IMVT-1402, which a phase I readout demonstrated could supersede the firm’s lead, batoclimab. Read More
Samsung Biologics Bio Campus II

Samsung, Celltrion set record targets as S. Korea banks on Bio Economy 2.0

As South Korea increases its stakes on the “bioeconomy” as its next growth engine and as its “second semiconductor industry,” leading domestic biologic and biosimilar drug producers such as Samsung Biologics Co. Ltd. and Celltrion Inc. are setting record production targets to become forerunners in the global playing field. Read More
Mosaic illustration of a mouse

Genetic editing of individual cells points to late targets for developmental disorders

A new gene editing method uses the CRISPR technique to modify the cells of an organ in vivo, creating a mosaic used to identify the effects of each altered gene. Scientists from the Swiss Federal Institute of Technology (ETH) in Zürich developed this technology called AAV-Perturb-seq, based on adeno-associated virus (AAV) to target, edit and analyze single-cell genetic perturbations. Read More

Fabre-Kramer’s NME Exxua approved in US for MDD

It has been a long time coming, but Fabre-Kramer Pharmaceuticals Inc. finally received U.S. FDA approval for its major depressive disorder candidate, Exxua (gepirone hydrochloride extended-release tablets). The approval comes three months after the June 23 PDUFA date (as a result of amendments filed by the company in April and May), but 24 years after the original NDA was filed in 1999. Read More

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Appointments and advancements for Sept. 28, 2023

New hires and promotions in the biopharma industry, including: Anheart, Oncoc4, Sibylla, Spexis. Read More

Financings for Sept. 28, 2023

Biopharmas raising money in public or private financings, including: Adlai, Deka, Evozyne, Geneos, Soleno. Read More

In the clinic for Sept. 28, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adcentrx, Adverum, Alligator, Alto, Biosenic, Candel, Cantex, Cardiff, Gracell, Kallyope, Remegen, Sensei, Small, Smart Immune, Unity, VBI. Read More

Other news to note for Sept. 28, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Biocity, Gigagen, Gritstone, Hitgen, Merck, Quris-AI, Scynexis. Read More

Regulatory actions for Sept. 28, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4SC, ABM, Ideaya, Ocuphire, Remegen, Shionogi, Ultragenyx, Viatris. Read More

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