Dipanshu Dixit
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Alkem Laboratories has launched Pertuza 420mg/14mL, a Perjeta biosimilar, across India for treating HER2-positive breast cancer
In a P-III trial, Pertuza showed equivalent efficacy, safety, and immunogenicity to the reference product
Pertuzumab is a HER2/neu receptor antagonist that was approved for HER2-positive breast cancer
Ref: Alkem Laboratories | Image: Alkem Laboratories | Press Release
Related News:- CuraTeQ Biologics Reports…
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Biogen has entered into a definitive agreement to acquire Alcyone Therapeutics, building on its partnership to advance ThecaFlex DRx
As per the deal, Biogen will acquire Alcyone Therapeutics for $85M upfront + potential milestone payments tied to the development & approval of ThecaFlex DRx with nusinersen & other products. The deal gives Biogen full…
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CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported positive P-III results for its denosumab biosimilar targeting postmenopausal osteoporosis, as an alternative to Prolia
The study involved 446 postmenopausal women across 40 sites in EU met all EPs, showing no significant differences between the biosimilar and Prolia
The trial confirmed the biosimilar's efficacy in improving…
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The EC and Swissmedic have approved Ekterly to treat acute HAE attacks in pts (age≥12) across EEA states. Launch is expected in Germany in Q4’25 and in Switzerland in H2’26
Ekterly’s approval by the EC and Swissmedic was based on the P-III (KONFIDENT) trial. Published in NEJM (May 2024), results showed significantly faster symptom…
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The US FDA has received accelerated approval from the US FDA for Forzinity (elamipretide HCl)] to improve muscle strength in pts with Barth syndrome (Wt.≥30 kg or 66 lbs)
Approval was based on efficacy and safety data from the TAZPOWER trial, which showed improved knee muscle strength
Forzinity is a mitochondrial cardiolipin binder. It…