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New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis

New interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that Biogen’s investigational treatment diroximel fumarate was generally well tolerated in people with relapsing MS.

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Novartis data at AAN show Gilenya is only disease-modifying therapy with proven superiority versus glatiramer acetate in RRMS

Novartis announced the full data of the ASSESS study, which evaluated the efficacy of oral, once-daily Gilenya (fingolimod) at 0.5mg and 0.25mg versus once-daily subcutaneous injections of glatiramer acetate 20mg in reducing disease activity over 12 months in patients with relapsing remitting multiple sclerosis (RRMS).

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Teva migraine drug helps to contain profit fall

Teva Pharmaceutical Industries posted a slightly smaller than expected drop in first-quarter 2019 profit and forecast a sharp rise in 2020 revenue from the company’s new migraine drug Ajovy.

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FDA Green-Lights EMD Serono’s Mavenclad

EMD Serono, a unit of Merck KGaA, announced that the U.S. FDA approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis and active secondary progressive disease.

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Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

Celgene Corporation announced that the company submitted a New Drug Application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).

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U.S. appeals court upholds ruling that canceled Teva Copaxone patents

A U.S. appeals court upheld a ruling that canceled patents owned by Teva Pharmaceutical Industries Ltd. on the blockbuster multiple sclerosis drug Copaxone.

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Roche and Novartis Strengthen Their Presence in the MS Market

Roche company Genentech has released data from a long-term clinical trial of Ocrevus (ocrelizumab) in multiple sclerosis. The U.S. FDA and the European Medicines Agency accepted Novartis’ marketing applications for siponimod (BAF312) to treat secondary-progressive multiple sclerosis in adults.

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Novartis’ Siponimod accepted for FDA review

The U.S. FDA accepted Novartis’ New Drug Application for the investigational oral, once-daily siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis in adults.

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U.S. appeals court invalidates Acorda patents on MS drug

A U.S. appeals court invalidated Acorda Therapeutics Inc. patents covering the multiple sclerosis drug Ampyra, opening the door to generic competition for the company’s flagship product.

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Roche faces UK pricing row over multiple sclerosis drug Ocrevus

Roche faces a fresh row over drug pricing in Britain, following a decision by the body responsible for medicine use within the state health service not to approve the company’s drug Ocrevus for treating a highly disabling form of multiple sclerosis (MS).

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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