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Home » Newsletters » BioWorld

BioWorld

Oct. 22, 2024

View Archived Issues
Multiple sclerosis, neurons concept art.

Interim analysis allows Immunic to stick with phase III MS studies

It’s a go for the two phase III Ensure studies of Immunic Inc.’s lead asset in treating relapsing multiple sclerosis. An unblinded data monitoring committee’s interim futility analysis concluded that the placebo-controlled, pivotal studies using vidofludimus calcium may continue as planned, with the program expected by the company to be completed in 2026. Read More

FDA issues CRL: Inspection woes hold up Camurus’ acromegaly drug

Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO. Read More
Brain and encephalography

Cureverse, Angelini ink $360M deal for oral Alzheimer’s drug

Cureverse Inc. and Angelini Pharma SpA signed a potential $360 million deal for CV-01, an oral small-molecule candidate for Alzheimer’s disease and neurological disorders like epilepsy. As a novel candidate, CV-01 suppresses neuroinflammatory reactions through the Kelch-like ECH-associated protein 1 and nuclear factor erythroid 2-related factor signaling pathway. Read More
Mounjaro pen

NICE backs Mounjaro for obesity but UK’s NHS urges phased rollout

For once, the U.K.’s health technology assessment body, the National Institute of Health and Care Excellence (NICE), has no reservations about the cost effectiveness of a new drug and is recommending Eli Lilly and Co.’s obesity therapy, Mounjaro (tirzepatide), for use in the National Health Service (NHS). Read More
Man sitting on bed holding head

Can Nrx combination unlock NMDA’s oomph in akathisia?

Targeting NMDA in mental health has chalked wins but not universally, as shown by Sage Therapeutics Inc.’s failure of the placebo-controlled phase II Lightwave study testing dalzanemdor in Alzheimer's disease, which missed the primary outcome measure, another bit of bad luck from the company that was disclosed Oct. 8. Read More

BioWorld Insider podcast: A quantum leap into the future of drug development

In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Read More

Appointments and advancements for Oct. 22, 2024

New hires and promotions in the biopharma industry, including: Heparegenix, Inmed, Novo Nordisk. Read More

Financings for Oct. 22, 2024

Biopharmas raising money in public or private financings, including: Bioaffinity, Capricor, Daré, Inhibikase. Read More

In the clinic for Oct. 22, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Cerevance, Foresee, Galderma, Genentech, Gilead, Karolinska, Merck, Mitsubishi Tanabe, Novo Nordisk, Nurix, Regeneron, Regenxbio, Roche. Read More

Other news to note for Oct. 22, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Kintara, Quantum, Tuhura, Xbrane. Read More

Regulatory actions for Oct. 22, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Amneal, Astrazeneca, Beigene, Biomea Fusion, Elevar, Everest, Ionis, Lindis, Papillon. Read More

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