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Launches

Formycon Snatches First Brazilian Approval For Lucentis Biosimilar

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.

Merck & Co.’s RSV Antibody Approved In US In Time To Compete With Blockbuster Beyfortus

The US FDA approved Merck’s Enflonsia (clesrovimab) to prevent RSV in newborns and infants on the same day Sanofi assured that it would ship Beyfortus in time for the 2025-2026 RSV season.

Formycon And Fresenius Launch Partnered Stelara Rival In Canada

Several years after the initial signing of their agreement, Formycon and Fresenius Kabi announced the launch of their Stelara biosimilar Otulfi in Canada, adding another key market to their list.

Sandoz Leads Charge With First US Denosumab Launch

Competition to Amgen’s Prolia and Xgeva denosumab brands has hit the US market, with Sandoz taking the lead by launching its interchangeable Jubbonti and Wyost biosimilars.

After Dasatinib Apotex Debuts US Tasigna Competition

Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.

Zydus To Continue Mirabegron Sales

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list.

Zydus To Continue Mirabegron Sales, Looks To World-First Dual Shigella-Typhoid Vaccine

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list

First Blood-Based Test Cleared For Alzheimer’s Boosts Anti-Amyloid Drugs

The US FDA approval of Fujirebio’s Lumipulse should boost access to medicines like Eisai’s Leqembi and Lilly’s Kisunla; the firms are praising patients’ access to earlier diagnoses.

Eisai Forecasts 73% Leqembi Sales Rise In FY25 As Demand Expands

Eisai spent most of its FY24 earnings call discussing plans for growing sales of Biogen-partnered Alzheimer’s drug Leqembi from JPY44.3bn ($304.1m) to JPY76.5bn ($525.1m) in FY25.

Sarepta Slammed By Double Blow: Elevidys Sales Miss, Prasad’s CBER Appointment

Sarepta’s stock price was battered after Vinay Prasad was appointed to lead the US FDA’s CBER, then the company’s shares were bruised when Q1 Elevidys sales came in below consensus.

Vertex Sinks On Below-Consensus Revenue, Limited Sales From New Launches

Vertex is in need of diversification, but in addition to its lower-than-expected Q1 revenue, sales of the company’s newest CF drug Alyftrek and pain medicine Journavx disappointed.

NewAmsterdam’s Davidson On Reviving “Failed” Drug Class To Fill Cardiovascular Treatment Gap

After a string of high-profile failures by big pharma, Michael Davidson is positioning his company's CETP inhibitor as the next breakthrough in cardiovascular medicine. The body of data to support this position is growing.