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NEWS

The US FDA Grants Fast Track Designation to BridgeBio Oncology Therapeutics’ BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer

Shots: The US FDA has granted FTD to BBO-8520 for the treatment of metastatic NSCLC with KRAS^G12C mutations in adults BBO-8520 showed significant tumor inhibition in preclinical models, post resistance to sotorasib.  In addition, BBO-8520 is being assessed in a P-I (ONKORAS-101) trial in KRAS^G12C NSCLC patients either receiving KRAS^G12C inhibitors or no targeted…
January 14, 2025

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NEWS

Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine in P-I Trial to Treat 1L Acute Myeloid Leukemia (AML)

Shots: The first patient was dosed with iadademstat (ORY-1001) + venetoclax + azacitidine combination to treat AML naïve patients (n=45) under the P-I trial to evaluate the safety, tolerability, preliminary efficacy & optimal dose. Trial will be managed & funded by NCI under CRADA In addition, the combination is being evaluated to treat 1L…
January 14, 2025

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NEWS

Neurocrine’s Crenessity (Crinecerfont) Secures the US FDA’s Approval to Treat Adults and Pediatrics with Congenital Adrenal Hyperplasia (CAH)

Shots: The US FDA’s approval of Crenessity as an adjunctive treatment to glucocorticoid replacement to treat CAH was based on a global P-III (CAHtalyst Pediatric: n=103, age: 4-17yrs. & Adult: n=182, age: 18-58yrs.) trials. It has also received PRV on approval Pediatric study achieved its 1 & 2EP, depicting ~4x greater reductions in androstenedione…
January 14, 2025

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NEWS

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots:     The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway  Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain  Sipavibart was discovered…
January 9, 2025

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Fresenius Kabi
NEWS

Fresenius Kabi Canada Receives Health Canada NOC for Otulfi (Biosimilar, Stelara)

Shots: Following the NOC approval of Tyenne (tocilizumab) & Idacio (adalimumab), Fresenius Kabi Canada has received Health Canada NOC for Otulfi (ustekinumab), a biosimilar to Stelara for Crohn's disease, ulcerative colitis, plaque psoriasis, and active psoriatic arthritis NOC approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent…
January 8, 2025

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Key Biosimilars Events of December 2024
INSIGHTS+

Key Biosimilars Events of December 2024

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…
January 7, 2025

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NEWS

GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)

Shots: GlycoNex has reported a licensing agreement to develop SPD8, a biosimilar version of Amgen’s Prolia and Xgeva (denosumab) The licensee will secure rights for the development, regulatory activities & commercialization of SPD8 in the designated regions. The deal includes development and commercial milestones, supporting GlycoNex's global business operations SPD8 is under P-III…
January 7, 2025

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