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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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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

JCR Pharmaceuticals and Modalis Progress into the Next Phase of Joint Research Agreement to Develop Gene Therapy

Shots:JCR Pharmaceuticals & Modalis have reported successful validation of initial PoC to develop gene therapy targeting CNS disease and will advance to the next phase under a new joint agreement The new agreement aims at conducting preclinical studies for gene therapy using JCR's BBB-crossing J-Brain Cargo tech and for gene therapy payload using Modalis' CRISPR-GNDM…
January 6, 2025

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INSIGHTS+

Most Viewed Articles of 2024 

2024, remained a busy year for PharmaShots. To keep our readers up to date on the developments in the healthcare sector, PharmaShots worked steadfastly to deliver real-time and real-world updates. Here’s a synopsis of our key reports and most-read news of the year.    Top 20 Medical Device Companies of 2024  Shots:   Bringing innovation and technology to healthcare, the…
January 2, 2025

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NEWS

Corcept Therapeutics Reports NDA Submission of Relacorilant to the US FDA for Treating Hypercortisolism

Shots:Corcept has submitted NDA of relacorilant to the US FDA for the treatment of endogenous hypercortisolism (Cushing’s syndrome) Submission was based on pivotal GRACE study, confirmatory P-III (GRADIENT) & long-term extension trials plus P-II hypercortisolism trial. Relacorilant showed improved symptoms without adrenal insufficiency, hypokalemia, QT prolongation, or progesterone receptor-related AEs (endometrial thickening or…
January 1, 2025

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xbrane
NEWS

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate 

Shots: Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024 The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…
December 31, 2024

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Johnson& Johnson
NEWS

Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC 

Shots:     The EC has approved Rybrevant + Lazcluze as a 1L treatment of advanced NSCLC harboring EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations. The EC’s decision of lazertinib for the corresponding combination regimen is pending (was granted CHMP’s recommendation last month) Approval was based on P-III (MARIPOSA) trial assessing Rybrevant +…
December 30, 2024

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BMS
NEWS

BMS’ Opdivo Qvantig SC Injection Secures the US FDA’s Approval for Solid Tumor Opdivo Indications 

Shots:   The US FDA has approved Opdivo Qvantig (nivolumab & hyaluronidase-nvhy) SC injection for previously approved solid tumor Opdivo indications, incl. as monotx., maintenance therapy after Opdivo-Yervoy combination & with CT or cabozantinib Approval was based on P-III (CheckMate-67T) study assessing Opdivo Qvantig (nivolumab: 1,200mg & hyaluronidase: 20,000 units, SC, Q4W; n=248) vs Opdivo (3mg/kg,…
December 27, 2024

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