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Biocon Biologics Enters into a Collaboration Agreement with Sandoz for the Commercialization of Ogivri (biosimilar, trastuzumab) and Abevmy (biosimilar, bevacizumab) to Treat Cancer 
Shots:   Under the terms of the agreement, Sandoz received the exclusive right to commercialize and distribute Ogivri, the biosimilar version of Herceptin & Abevmy, the biosimilar version of Avastin, across Australia for the treatment of various cancer indications   Additionally, Sandoz AG will be held responsible to distribute Biocon’s biosimilar versions of trastuzumab and bevacizumab across Australia…
February 9, 2024
Rani Therapeutics Reports the Results for RT-111 Capsules Containing CT-P43 (biosimilar, ustekinumab) in P-I Trial for the Treatment of Various Indications
Shots:   The P-I clinical trial evaluates the safety & efficacy of RT-111 in delivering CT-P43 (biosimilar, ustekinumab) in patients with moderate to severe plaque psoriasis, active psoriatic arthritis & IBD  As per the results, RT-111 delivered CT-P43 in a dose proportional manner with high bioavailability & depicted a higher Cmax & shorter Tmax vs ustekinumab…
February 3, 2024
Astellas
Astellas Receives the EMA’s Validation on Type II Variation Application for Padcev (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) to Treat Advance Bladder Cancer
Shots The application was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study were OS & PFS whereas the 2EPs were ORR, DoR & safety The results depicted that the study met its…
January 29, 2024
Takeda
Takeda Reports EC’s Approval of Hyqvia as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Shots Takeda’s Hyqvia has been approved as maintenance therapy for treating chronic inflammatory demyelinating polyneuropathy (CIDP) on stable IVIG therapy valid throughout the EU plus Iceland, Liechtenstein, Norway & Northern Ireland The approval is based on the results from the P-III (ADVANCE-CIDP 1) study assessing Hyqvia’s safety and efficacy as a maintenance therapy to…
January 29, 2024
Evive’s Ryzeneuta (efembalenograstim alfa) Receives the CHMP’s Positive Opinion for the Treatment of Neutropenia and Febrile Neutropenia
Shots: The CHMP has granted a positive opinion to Ryzeneuta (20mg, IV) based on its safety and efficacy evaluation results as compared to PBO The recommendation was made by CHMP for EC’s approval as medicinal product for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with…
January 26, 2024
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