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The US FDA has received an NDA for tavapadon (QD, PO) for Parkinson’s disease (PD), supported by P-III (TEMPO-1 & 2) trials in early PD & P-III (TEMPO-3) evaluating…
Day 1 Breakdown
The #PCG2025 Symposium commenced on an inspiring note, setting the stage for two days of insightful discussions, collaborations, and knowledge exchange.
Opening Session
Dr. Ratnesh Jain, Founder…
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Genmab has entered into a transaction agreement to acquire Merus, incl. its lead asset petosemtamab, expanding its late-stage pipeline & accelerating Genmab’s shift to a wholly owned model
As per…
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The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences
Additionally, Amneal expects to incur a $22.5M R&D milestone charge…
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The US FDA has approved label expansion to Evkeeza (evinacumab-dgnb) as an adj. to diet, exercise & other lipid-lowering therapies for the treatment of children (1 to <5yrs.) with…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A and Biosimilars. Check out our full report below:
Roche Reports P-III (evERA Breast Cancer)…
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Intellia has reported P-I trial data assessing nexiguran ziclumeran (nex-z) in ATTRv-PN; results were presented at the International ATTR Amyloidosis Meeting 2025 & published in The NEJM
Single dose of nex-z…
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The US FDA has granted 510(k) clearance to Quantra Hemostasis System with QStat Cartridge, expanding its use in peripartum obstetric procedures to help manage postpartum hemorrhage
Quantra is a…
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Evaxion has granted Merck the rights to EVX-B3, a preclinical vaccine candidate under their Sep 2024 option & license agreement
As per the deal, Merck will assume full responsibility…