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October 31, 2024

Shanghai Henlius Biotech, Organon announce FDA acceptance of BLA for HLX14

Shanghai Henlius Biotech (Henlius) and Organon have announced the US Food and Drug Administration (FDA) acceptance of the biologic license application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).

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The BLA filing is supported by data from a series of head-to-head studies for HLX14, which include comparative quality analytical studies and two clinical trials. Credit: Louis Reed on Unsplash.
October 29, 2024

Kivu Bioscience secures $92m in Series A funding for ADC development

The funds will be channelled towards advancing Kivu’s multiple oncology programmes into clinical trials. Credit: JOSHUA COLEMAN on Unsplash.
October 28, 2024

FDA grants IND clearance for RiboX’s RXRG001

Xerostomia and hyposalivation are complications seen in patients undergoing radiation treatment for head and neck cancer. Credit: Myriam Zilles 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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