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October 11, 2024

Volixibat gains FDA breakthrough therapy designation

Mirum Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its drug candidate, volixibat, for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).

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The drug is under evaluation in Phase IIb studies for both primary sclerosing cholangitis and primary biliary cholangitis. Credit: Louis Reed / Unsplash.
October 9, 2024

PsychoGenics secures NIH contract to identify new pain therapeutics

PsychoGenics has expertise in various scientific methods including behavioral testing, electrophysiology, and translational EEG. Credit: Mathurin NAPOLY / matnapo on Unsplash.
October 8, 2024

Neuvivo files NDA seeking FDA approval for ALS treatment

Clinical studies have shown that NP001 is generally safe and well-tolerated. Credit: National Cancer Institute on Unsplash.

Contracts

August 9, 2024

Bavarian Nordic secures $156.8m US vaccine deal

The vaccine is marketed under various brand names. Credit: Mathurin NAPOLY / matnapo on Unsplash.

Boehringer Ingelheim receives EC conditional marketing approval for spesolimab

Marinus Pharmaceuticals signs collaboration agreement with Tenacia Biotechnology

Harbour BioMed, Moderna partner on immunotherapies development

Deals

Deals July 15, 2024

Merck enhances ophthalmology portfolio with EyeBio acquisition

Pharmaceutical Business Review

Biocon signs licensing and supply deal for diabetes drug in Brazil

Q32 Bio concludes merger deal with Homology Medicines

Zuellig Pharma acquires Cialis and Alimta brands from Lilly

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  4. FDA grants fast track status for Volastra’s VLS-1488 to treat ovarian cancer
  5. FDA grants approval for Fresenius-Formycon’s biosimilar Otulfi

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