Skip to content Skip to footer
Subscribe Now
NEWS

Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Shots: The EC has approved Amvuttra (vutrisiran) to treat ATTR-CM adults  as an additional indication, based on the global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts The study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved outcomes of mortality, CV events & functional capacity with 6min. walk…
June 10, 2025

Read more

NEWS

Formycon Receives the ANVISA Approval for Ranivisio (Biosimilar, Lucentis) Across Brazil

Shots: Brazil’s ANVISA has approved marketing authorization for Formycon’s Ranivisio (ranibizumab), a biosimilar to Lucentis; launch is anticipated in Q4’25 Formycon & Biomm have partnered to commercialize Ranivisio in Latin America, with approvals already granted in Peru, El Salvador, Honduras, and the Dominican Republic. Additional launches across Central and South America are planned through early…
June 6, 2025

Read more

Biosimilar (May 2025)
INSIGHTS+

Key Biosimilars Events of May 2025 

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   Fresenius Kabi Secured the CHMP’s Positive Opinion for Bomyntra & Conexxence. Our…
June 3, 2025

Read more

Atherosclerosis
INSIGHTS+

Disease of the Month – Atherosclerosis 

Shots:  Characterized by the thickening or hardening of arteries due to plaque buildup, atherosclerosis leads to complications like heart attack or stroke  PharmaShots' Disease of the Month report aims to familiarize the general population with conditions impacting communities worldwide. The report outlines disease characteristics, types, symptoms, diagnosis, treatments, epidemiology, market size, clinical trial analysis, patient…
May 28, 2025

Read more

Fresenius Kabi
NEWS

Fresenius kabi Secures the CHMP’s Positive Opinion for Bomyntra & Conexxence (Biosimilar, Prolia and Xgeva)

Shots:  The CHMP has recommended a positive opinion for the marketing authorization of Bomyntra and Conexxence, biosimilars of Bayer’s Xgeva and Prolia (denosumab). EC approval is anticipated in Q3’25  The MAA submissions were based on comprehensive analytical similarity assessments and two comparative clinical studies: one on PK, PD, and immunogenicity in healthy volunteers, and another assessing efficacy, PD,…
May 27, 2025

Read more

NEWS

mAbxience and Abiogen Pharma Enter into a Strategic Licensing Agreement for Biosimilar across Italy

Shots:  mAbxience, majority-owned by Fresenius Kabi and partially by Insud Pharma, has partnered with Abiogen Pharma in a strategic licensing agreement to develop & commercialize a biosimilar in Italy  As per the agreement, mAbxience will hold marketing authorization, while Abiogen Pharma handles commercialization and marketing in Italy  This collaboration leverages mAbxience’s biosimilar development expertise and…
May 26, 2025

Read more

Load more