NOVARTIS

Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination

Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination

Published 23/10/2017

Novartis on Monday said the U.S. Food and Drug Administration has granted breakthrough therapy status to the combination of Tafinlar and Mekinist to treat patients with BRAF V600-positive stage III melanoma following surgery. [more…]

Novartis posts a win, Roche a flop in skin cancer trials

Novartis posts a win, Roche a flop in skin cancer trials

Published 10/09/2017

Swiss drugmaker Novartis notched a trial win for its drug cocktail against skin cancer on Monday, while a rival treatment from Roche with slipping sales failed in a separate study with a similar patient group. [more…]

Novartis names drugs chief as CEO to deliver return to growth

Novartis names drugs chief as CEO to deliver return to growth

Published 04/09/2017

Novartis (NOVN.S) CEO Joe Jimenez will step down on Feb. 1 and hand over to drug development chief Vas Narasimhan to decide the fate of $50 billion in assets and make good on a pledge to return the Swiss company to sales growth. [more…]

Novartis hopeful for novel heart drug, despite `modest` benefit

Novartis hopeful for novel heart drug, despite `modest` benefit

Published 27/08/2017

Novartis will seek regulatory approval this year for a new kind of anti-inflammatory heart drug, though some experts fear fatal infection risks and a high price may overshadow the medicine's limited benefits. [more…]

Novartis wins European approval for biosimilar version of Roche`s MabThera

Novartis wins European approval for biosimilar version of Roche`s MabThera

Published 19/06/2017

Swiss drugmaker Novartis on Monday said it had won European approval for its biosimilar version of Roche's blockbuster Rituxan as the crosstown rivals go head-to-head on a drug to treat blood cancers and immunological diseases.

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South Korea to fine Novartis unit over unfair drug promotions

South Korea to fine Novartis unit over unfair drug promotions

Published 08/06/2017

FILE PHOTO: The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland, January 25, 2017. REUTERS/Arnd Wiegmann/File Photo

South Korea's antitrust regulator said it would fine Novartis' local unit 500 million won ($444,089) for alleged unfair promotions, in another setback for the Swiss drugmaker that was fined earlier this year over kickbacks to doctors.

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Novartis says U.S. regulator grants speedy review of CAR-T cell therapy

Novartis says U.S. regulator grants speedy review of CAR-T cell therapy

Published 30/03/2017

FILE PHOTO: The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland, January 25, 2017. REUTERS/Arnd Wiegmann/File Photo

Novartis AG on Wednesday said the U.S. Food and Drug Administration (FDA) has agreed to accelerate its review of the Swiss drugmaker's CTL019 therapy for young patients with B-cell acute lymphoblastic leukemia.

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Novartis wins CHMP nod for drug combo against some lung cancers

Novartis wins CHMP nod for drug combo against some lung cancers

Published 24/02/2017

The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland January 25, 2017. REUTERS/Arnd Wiegmann

Swiss drugmaker Novartis's drugs Tafinlar and Mekinist edged closer to approval in Europe to be used together against a type of lung cancer after a key committee on Friday published a recommendation to expand the combination's indications.

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Novartis cancer drug Zykadia gets FDA priority review

Novartis cancer drug Zykadia gets FDA priority review

Published 23/02/2017

The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland January 25, 2017. REUTERS/Arnd Wiegmann

The U.S. Food and Drug Administration (FDA) has granted priority review to Novartis drug Zykadia as a first-line treatment for some lung cancer patients, the Swiss drugmaker said on Thursday.

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Novartis eye drug franchise takes hit with failed Fovista studies

Novartis eye drug franchise takes hit with failed Fovista studies

Published 12/12/2016

The logo of Swiss drugmaker Novartis is seen at its headquarters in Basel, Switzerland October 22, 2013. REUTERS/Arnd Wiegmann/File Photo

Swiss drugmaker Novartis's bid to bolster its eye drug portfolio suffered a setback on Monday when it announced combining Lucentis with Fovista in patients with neovascular age-related macular degeneration (nAMD) did not produce better outcomes than treatment with Lucentis alone.

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