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September 29, 2023

Merck gains FDA priority review for sotatercept BLA

The US Food and Drug Administration (FDA) has accepted Merck’s (MSD) biologics license application (BLA) of sotatercept to treat pulmonary arterial hypertension [PAH (WHO Group 1)], for priority review.

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Merck filed BLA for sotatercept based on findings from the Phase III STELLAR clinical trial in pulmonary arterial hypertension patients. Credit: Yale Rosen from USA / commons.wikimedia.org.
September 28, 2023

IDEAYA receives fast track designation for breast cancer therapy

IDE161 is intended to treat adult patients with advanced or metastatic hormone receptor-positive (HR+), Her2- breast cancer with germline or somatic BRCA 1/2 mutations. Credit: National Cancer Institute on Unsplash.
September 27, 2023

Saptalis Pharmaceuticals receives FDA approval for metronidazole oral suspension

Metronidazole is prescribed to more than 10 million people in the US, as a frontline oral treatment to help treat parasitic and anaerobic bacterial infections. Credit: HeungSoon from Pixabay.

Contracts

December 14, 2022

Boehringer Ingelheim receives EC conditional marketing approval for spesolimab

Micrograph of psoriasis vulgaris. Credit: Jenny Giang, Marc A. J. Seelen, Martijn B. A. van Doorn, Robert Rissmann,Errol P. Prens and Jeffrey Damman/ commons.wikimedia.org.

Marinus Pharmaceuticals signs collaboration agreement with Tenacia Biotechnology

Harbour BioMed, Moderna partner on immunotherapies development

Kite, Refuge sign license deal for gene expression platform for blood cancers

Deals

Deals August 15, 2023

Eli Lilly and Company completes acquisition of Versanis Bio

Pharmaceutical Business Review

GSK acquires pharma firm Bellus Health for $2bn

EdgeCap Partners buys majority stake in Comac Medical

Chiesi Farmaceutici acquires biopharmaceutical firm Amryt Pharma

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RWS at RAPS Convergence 2023 – 3-5 October in Montreal, Canada
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Tosoh at the BioProcess International Conference ‒ 19-21 September in Boston, MA
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Unique Solutions, Endless Possibilities: Meet with Procaps Group During CPHI Barcelona 2023
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