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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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The US FDA has approved the Altaviva device, an implantable tibial neuromodulation therapy to treat urge urinary incontinence
Altaviva device is placed under the skin above the fascia & near the ankle in a minimally invasive, sedation & imaging-free procedure to restore bladder–brain communication & improve bladder control by delivering electrical impulses to the tibial…
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The CHMP has recommended Nipocalimab as an add-on therapy to treat anti-AChR Ab+ & anti-MuSK Ab+ gMG pts (≥12yrs.)
Opinion was based on the P-III (Vivacity-MG3) trial assessing nipocalimab (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC vs PBO + SoC in gMG pts (N=199; 153 were Ab +ve), which showed improved MG-ADL score…
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The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product
Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab
In 2022, Henlius…
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Avant Technologies and Austrianova signed a joint venture and licensing agreement to form Klothonova, a 50/50 Nevada-based Joint Venture focused on developing cell-based therapies using encapsulated Klotho-producing cells
Under the terms of the agreement, Klothonova will leverage Austrianova’s proprietary cell-encapsulation technology to develop and commercialize therapies for Alzheimer’s disease, heart disease, cancer, kidney disease,…
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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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Intellia Therapeutics completed enrollment in the global P-III (HAELO) study evaluating lonvo-z for treating HAE, finishing within 9mos. since the first patient was dosed in Jan 2025, with nearly half of the participants enrolled from the US
The study P-III (HAELO) study will evaluate the efficacy and safety of lonvo-z in ≥60 adults and…
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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 CHMP has recommended Kefdensis and Zvogra, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders
Kefdensis (biosimilar to Prolia) received CHMP approval for treating osteoporosis in high-risk postmenopausal women and men with an increased risk of fractures. Zvogra (biosimilar to Xgeva) received CHMP approval for preventing skeletal events…
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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…

