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Fresenius Kabi
News

The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…
March 27, 2025

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Alvotech and Dr. Reddy's
News

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva) 

Shots:  The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product  As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. …
March 18, 2025

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Amgen
News

Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

Shots: The EC has approved Blincyto monotherapy as a part of consolidation therapy to treat 1L philadelphia chromosome-negative CD19+ B-ALL adults based on P-III (E1910) trial Blincyto + CT showed improved OS with 4.5yrs. median follow up vs CT alone, whereas 5-yrs. mFU demonstrated 82.4% vs 62.5% OS in 112 pts The trial was led by…
January 30, 2025

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Amgen
News

Amgen Receives the US FDA Approval for Lumakras + Vectibix to Treat Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer (mCRC)

Shots: The FDA has approved Lumakras + Vectibix combination to treat metastatic KRAS G12C-mCRC in adults diagnosed via FDA approved test, receiving fluoropyrimidine-, oxaliplatin- & irinotecan-based CT The approval was based on P-III (CodeBreaK 300) Trial assessing Lumakras (960mg/240mg, QD) + Vectibix vs investigator’s choice of SoC (n=54; trifluridine/tipiracil or regorafenib) in patients …
January 20, 2025

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Amgen
News

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

Shots: The MHRA has granted conditional marketing authorization to Imdylltra for treating adults with ES-SCLC, whose disease progressed post prior 2 lines of treatment. Further evaluation is underway This authorization was supported by P-II (DeLLphi-301) study assessing Imdylltra (10mg, Q2W) in ES-SCLC patients (N=99). It showed ORR of 41% & mDoR of 9.7mos. …
January 6, 2025

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Viewpoints_Dr. Robert Fogel_Janet Franklin_Dr. Dave Singh
VIEWPOINTS

ATS 2024: Robert Fogel, Janet Franklin, and Dave Singh from AstraZeneca & Amgen in Conversation with PharmaShots

Shots:  Recently AstraZeneca and Amgen presented the results in late-breaking session from the COURSE trial, a proof-of-concept study evaluating tezepelumab in COPD  The PoC study was carried out in people with moderately to very severe COPD with a broad range of eosinophil levels  Today, at PharmaShots we have Robert Fogel from AstraZeneca, Janet Franklin from…
October 8, 2024

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Viewpoints_Maria Belvisi_Dr. Sarah Doffman_Dr. Janet Franklin
VIEWPOINTS

ATS 2024: Maria Belvisi, Sarah Doffman, and Janet Franklin from AstraZeneca & Amgen in a Stimulating Conversation with PharmaShots

Shots:  Jointly developed by AstraZeneca & Amgen, AZD8630/AMG targets Thymic stromal lymphopoietin (TSLP), an epithelial cytokine involved in Chronic Inflammatory Disorders  Recently, AstraZeneca and Amgen released the P-I data evaluating AZD8630/AMG104 on three doses vs. placebo for 28 days. The data demonstrated linear PK at all three doses  Today, at PharmaShots we have Prof. Maria…
October 7, 2024

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Immunology Top 20 2024
TOP 20

Top 20 Immunology Companies of 2024

Shots: Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodies In 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…
July 25, 2024

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