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Approvals

'Potential Blockbuster' Dupixent Set For EU Eczema OK

While Dupixent looks set for use in Europe for treating moderate-to-severe atopic dermatitis, analysts believe the biologic has a great future in other indications and could eventually become a blockbuster.

Approvals Biologics Commercial
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Approvals

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J&J's Symtuza Will Debut In Europe On Cramped HIV Market

Johnson & Johnson's combination HIV therapy Symtuza has secured a greenlight in Europe, marking its first approval worldwide – but will the big pharma be able to catch up with successful HIV opponents from AbbVie and Gilead?

Infectious Diseases Approvals

Merck KGaA/Pfizer's Bavencio Set To Enter Europe's Crowded I-O Market

The highly-competitive PD-1 field in Europe is very likely to have a new player as Bavencio gets a CHMP recommendation for Merkel cell carcinoma, but the success of Merck KGaA and Pfizer's checkpoint inhibitor will be gauged on how it competes with the competition already on the market in wider, more valuable indications.

Cancer ImmunoOncology

Pipeline Watch: Phase III Starts For Itacitinib And AXS-05

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Roche's Tecentriq Gets The Double At The EU CHMP

Roche's checkpoint inhibitor Tecentriq clears the EU approval hurdle in locally advanced or metastatic urothelial carcinoma and locally advanced or metastatic non-small cell lung cancer.

Approvals Policy & Regulation

Merck's Lantus Copy Lusduna Poised For US Market Pending Litigation

The Merck and Samsung Bioepis formulation of Sanofi's insulin glargine was tentatively approved by FDA, a designation that permits the drug to enter the market pending the resolution of ongoing patent litigation.

Biosimilars Approvals

Uphill Climb For Gedeon Richter's Cariprazine After Delayed EU OK

Gedeon Richter has finally had its antipsychotic cariprazine approved in the EU for treating schizophrenia - but its delay to market could dampen demand for the drug unless it can differentiate itself from rivals.

Approvals Business Strategies
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