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Home » Newsletters » BioWorld

BioWorld

Sep. 26, 2023

View Archived Issues
stock prices up

Answered Prader(s): Soleno wins big in phase III; NDA next year

Soleno Therapeutics Inc. (NASDAQ: SLNO) pulled off in a major way its randomized-withdrawal phase III study with DCCR (diazoxide choline) in Prader-Willi syndrome, boosting the shares by $22.37, or 505%, to close Sept. 26 at $26.80. “Our work is not done, but this was a big step,” said CEO Anish Bhatnagar. Read More

With positive phase III data, Ionis looks to approval in rare disease

Positive top-line phase III study results for olezarsen in treating familial chylomicronemia syndrome has Ionis Pharmaceuticals Inc. looking down the road to U.S. FDA approval. It’s the company’s second attempt at getting an approval for treating the rare disorder. Read More
Brain with handshake and cityscape

Acurastem, Takeda strike $580M licensing deal for ALS, neurodegenerative drugs

Acurastem Inc. said on Sept. 25 that it struck an out-licensing deal potentially worth $580 million with Takeda Pharmaceutical Co. Ltd. to develop drugs for amyotrophic lateral sclerosis (ALS) and other PIKfyve gene-targeting therapeutics. Under the terms, Tokyo-headquartered Takeda obtains exclusive worldwide rights to Acurastem’s PIKfyve-targeting therapeutics, including Acurastem’s lead AS-202 asset, an antisense oligonucleotide therapy to treat ALS. Read More

Intercept finds Italian buyer with Alfasigma in $794M M&A

Three months after Intercept Pharmaceuticals Inc. received its second complete response letter for obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis, causing a mass layoff and the decision to drop development for the indication, Bologna, Italy-based Alfasigma SpA agreed to acquire the company for $19 per share in cash, or about $793.8 million. Read More
Pathways illustration

Going forward, regulatory flexibility essential in biosimilar realm

As biosimilar development expands beyond monoclonal antibodies to more complex biologics, the flexibility built into regulatory paths across the world will become more essential. Rather than making wholesale changes to those pathways, regulators need to follow the science in exercising the flexibility they already have, Leah Christl, executive director of global biosimilars regulatory affairs and R&D policy at Amgen Inc., told BioWorld. In doing so, “we do need to look forward to what might be coming down the pipeline,” in addition to looking backwards at what types of biosimilars have already been approved, she said. Read More

Japan’s MHLW approves slew of new drugs, including Eisai/Biogen’s Leqembi for Alzheimer’s

Thanks to a raft of new approvals by Japan’s Ministry of Health, Labor and Welfare (MHLW), patients in Japan will soon have access to Biogen Inc./Eisai Co. Ltd.’s Leqembi (lecanemab), an amyloid-beta binder, for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease. Read More

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Please take a few minutes to fill out this short survey to help us provide you with the best possible source of news. Customer feedback is critical so that we can make BioWorld an even more useful and valuable component of your daily workflow. We want to continue to evolve to serve you. The survey should take less than 5 minutes. You can click through to the question here. Read More

Appointments and advancements for Sept. 26, 2023

New hires and promotions in the biopharma industry, including: Aspect, Lixte, Mesoblast, Nextrna, Omass, Syneos. Read More

Financings for Sept. 26, 2023

Biopharmas raising money in public or private financings, including: Acasti, Acesion, Seabelife, Transcode. Read More

In the clinic for Sept. 26, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4SC, Ascendis, Clene, Escient, Lantern, Nervgen, Novartis, Nykode, Reviva, Zucara. Read More

Other news to note for Sept. 26, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amphista, AN2, Arcturus, Beactica, Biogen, BMS, Byorna, CGA 369, Dyadic, Evotec, Geovax, Liminal, Mediwound, Novo Nordisk, Oncopeptides, Probiogen, Reata, Sohm, Spinogenix, Sygnature, Synfini, Thea, Theradaptive, Theratechnologies, Trethera, Ube, Ultragenyx. Read More

Regulatory actions for Sept. 26, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Alvotech, Appili, Ardelyx, Biogen, Biora, Cara, Coherus, Daewoong, Eisai, Genmab, Nymox, Pfizer, Sanofi, Shuttle, Takeda, Theratechnologies, Tris. Read More

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