Thursday, 19 April 2018 - 10:24
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Regeneron Pharmaceuticals

Regeneron and Sanofi win legal battle against Amgen over Praluent

Regeneron and its partner Sanofi have won their legal battle against Amgen: indeed, a US appeals court yesterday reversed the former ruling preventing the two companies from marketing Praluent. Sanofi’s shares soon rose 1.8%, while Regeneron’s were up 1.6%. By…

Positive opinion for Sanofi/Regeneron’s dupilumab in atopic dermatitis

CHMP, a Committee part of EMA, issued a positive opinion on the marketing authorization of Sanofi/Regeneron’s dupilumab in Europe, for the treatment of atopic dermatitis. Dupilumab is a human monoclonal antibody, specifically designed to inhibit the IL-4 and IL-13 proteins,…

Sanofi/Regeneron’s Praluent: positive results in diabetes patients

Sanofi and Regeneron Pharmaceuticals announced positive results from two Phase IIIb/IV ODYSSEY-DM clinical trials conducted in patients with diabetes. Praluent (alirocumab), when administered on top of maximally tolerated doses of statins, significantly reduced LDL-C, the primary endpoint of the ODYSSEY…

The incredible growth of biotech industry

The American Society of Clinical Oncology Annual Meeting ended few days ago without producing any sharp rise in shares, except for Loxo Oncology, which presented data causing shares to soar by 40%. The financial community was relieved that no untoward…

CHMP: green light to Sanofi/Regeneron’s Kevzara for rheumatoid arthritis

Sanofi and Regeneron Pharmaceuticals have announced that EMA CHMP has adopted a positive opinion for the marketing authorization of Kevzara (sarilumab), recommending its approval for the treatment of adult patients with moderate-to-severe rheumatoid arthritis. Kevzara is a monoclonal antibody whose…

FDA approves Sanofi – Regeron’s Dupixent (eczemas)

FDA approved Dupixent, the treatment for moderate-to-severe eczemas co-developed by Regeneron Pharmaceuticals and Sanofi. Dupixent, which will be sold at $37,000 per year in the US, is one of the most relevant drugs launched this year. It will be closely…

Praluent patent infringement, Sanofi and Regeneron to appeal

Sanofi and Regeneron Pharmaceuticals announced they will appeal the injunction granted today by the District Court for the District of Delaware, US; preventing the commercialization and manufacturing of Praluent in the US for having infringed two Amgen patents. The two…

Amgen wins patent infringement case against Sanofi/Regeneron (Praluent)

A federal judge rejected the motion related to a patent infringement case between Amgen—which obtained a favorable verdict last March—and Sanofi/Regeneron, Reuters reported. Indeed, in October 2014 Amgen sought to stop sales of Praluent, a drug from the class of…

MAA for Sanofi/Regeneron’s Dupixent accepted in Europe

Sanofi and Regeneron Pharmaceuticals announced that EMA accepted for review the MAA (Marketing Authorization Application) for Dupixent (dupilumab) for the treatment of adult patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent, an investigational product, is a…

FDA, Response Letter for sarilumab

Regeneron Pharmaceuticals and Sanofi today announced that FDA issued a Complete Response Letter (CRL) regarding the BLA for sarilumab, an investigational interleukin-6 receptor antibody for the treatment of moderate-to-severe rheumatoid arthritis. The Response Letter refers to certain issues identified during…

Phase IIb trial for Teva and Regeneron’s fasinumab placed on hold

Regeneron Pharmaceuticals’ and Teva Pharmecuticals’ shares (Wall Street) lost over 1% on Monday after FDA placed on hold the Phase IIb clinical trial enrolling 800 patients (in four dose groups) treated with the painkiller fasinumab, jointly developed by the two…

FDA, priority review for Sanofi/Regeneron’s dupilumab in atopic dermatitis

Sanofi and Regeneron Pharmaceuticals today announced that FDA has accepted for priority review the BLA (Biologics License Application) for dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. The PDUFA (Prescription Drug User Fee Act) should…