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Abbott has received European CE Mark approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with peripheral artery disease (PAD) below the knee (BTK)
Esprit…
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The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion…
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Approval was based on P-III (PURPOSE 1 & PURPOSE 2) trials of Yeytuo vs Truvada, where PURPOSE 1 showed 0 infections & 100% risk reduction in 2134 women, while…
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The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference product
In Oct 2024, Bio-Thera & Gedeon Richter entered a…
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PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA.
The…
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BioArctic has entered into an option, collaboration, and license agreement with Novartis to develop a neurodegeneration treatment using BrainTransporter
As per the deal, BioArctic receives $30M upfront and could earn up to…
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MannKind has signed definitive merger agreement to acquire ScPharmaceuticals
Under the merger agreement, MannKind will launch a tender offer to acquire all outstanding scPharmaceuticals shares for $5.35 per share…
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Merz Therapeutics has enrolled the first patients in two global P-III studies, MINT-E (episodic migraine, ~990 pts) and MINT-C (chronic migraine, ~780 pts), evaluating the efficacy and safety of…
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Abbott has secured regulatory approval for its denosumab biosimilar in Thailand, increasing access to advanced treatments for osteoporosis and cancer-related bone loss
Denosumab is a mAb that works by…