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NEWS

Pfizer
Pfizer’s Emblaveo (aztreonam-avibactam) Receives Positive CHMP Opinion for the Treatment of Patients with Multidrug-Resistant Infections 
Shots:  Pfizer’s Emblaveo has received a positive CHMP opinion for the treatment of patients with cIAI, HAP (incl. VAP), and cUTI (incl. Pyelonephritis).   The MAA was supported by results from the P-III study comprising the REVISIT and ASSEMBLE studies evaluating the efficacy, safety, and tolerability of Emblaveo in treating serious bacterial infections due to Gram-negative…
March 22, 2024
Dr. Reddy’s Laboratories Expects the Launch of Versavo (biosimilar, bevacizumab) for the Treatment of Several Cancer Indications Across the UK
Shots:  The company has developed Versavo as a biosimilar of Avastin, approved for the treatment of various cancer indications incl. metastatic colorectal cancer, advanced non-squamous NSCLC, recurrent glioblastoma, mRCC, advanced cervical cancer, ovarian cancer & metastatic breast cancer  Based on the clinical evaluation, Versavo is expected to be approved and launched across the UK as…
March 19, 2024
BeiGene
The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma 
Shots:  BeiGene’s Tevimbra has received the US FDA’s approval as a monotx. to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy (CT) excl. PD-(L)1 inhibitor. The US availability is anticipated in H2’24  The approval was supported by the P-III (RATIONALE 302) study assessing the safety & efficacy of Tevimbra vs…
March 14, 2024
Celltrion
Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair) 
Shots:  Celltrion has reported BLA submission for CT-P39, biosimilar version of Xolair (omalizumab), to the US FDA for all indications as of the reference product incl. asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) & CSU  The submission was supported by the data, showing comparable efficacy & safety, from P-III study…
March 10, 2024
Fresenius Kabi
Fresenius Kabi Reports the US FDA’s Approval for Tyenne (Biosimilar, tocilizumab-aazg) as a Treatment of Immunological and Oncological Indications 
Shots:  The US FDA approved Fresenius’ Tyenne (tocilizumab-aazg) developed as a biosimilar version of Actemra (tocilizumab)   According to the patent settlement agreement signed between Fresenius Kabi and Genentech for Tyenne, Fresenius has the license to market its tocilizumab products across the US as per the undisclosed licensing dates   Tyenne functions as an Interleukin-6 (IL-6) receptor…
March 7, 2024
Sandoz
Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab)
Shots:  Sandoz has received the US FDA’s approval for Wyost & Jubbonti (denosumab-bbdz), biosimilars of Xgeva & Prolia (denosumab), based on the clinical studies demonstrating their similarity with the reference drugs  The company’s Jubbonti Risk Evaluation & Mitigation Strategy (REMS) program has also been approved to educate HCPs & patients about the severe hypocalcemia risk…
March 5, 2024
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