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Death puts Cellectis cell therapy tests on hold

French cell therapy specialist Cellectis, which is developing a gene-modified cancer treatment, was forced to suspend testing following a patient death.

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Novartis names new CEO for 2018

Novartis CEO Joe Jimenez will step down on Feb. 1, 2018, and hand over the top leadership role of the Swiss company to drug development chief Vas Narasimhan.

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Profit on $475,000 Novartis cancer drug could be a while coming

Novartis’s new gene-modifying cancer therapy’s $475,000-per-patient sticker price has drawn fire from advocate groups calling for cheaper drugs, but analysts said the Swiss drugmaker could initially struggle to break even.

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Novartis gene therapy for leukemia wins U.S. approval

Novartis’ anticipated leukemia treatment Kymriah is the first gene therapy to receive U.S. marketing clearance.

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FDA approves rare blood cancer drug

The U.S. Food and Drug Administration approved Pfizer Inc.’s rare blood cancer drug Besponsa with a boxed warning.

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Vitamin C May Encourage Blood Cancer Stem Cells to Die

Vitamin C may “tell” faulty stem cells in the bone marrow to mature and die normally, instead of multiplying to cause blood cancers. This is the finding of a study led by researchers from Perlmutter Cancer Center at NYU Langone Health, and published online August 17, 2017, in the journal Cell.

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Eight PDUFA Dates to Watch in August 2017

The biotech industry did OK in July 2017. The NYSE ARCA Biotech Index and the iShares NASDAQ Biotechnology Index (ETF) grew about 1.9 percent and 2.9 percent, respectively last month. There have been 26 new molecular entity approvals so far this year. With that figure in mind, here are eight companies looking at PDUFA dates in August 2017.

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FDA Panel Unanimously Endorses Novartis’ CAR-T Leukemia Drug

A U.S. Food and Drug Administration advisory panel unanimously recommended approval of Novartis AG’s CAR-T therapeutic, CTL019 (tisagenlecleucel), for B-cell acute lymphoblastic leukemia.

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FDA panel to focus on safety of Novartis gene therapy drug

The U.S. Food and Drug Administration will ask a panel of advisors to focus on the safety of Novartis AG’s experimental gene therapy drug when it meets to review the product.

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Pfizer’s Besponsa Approved in EU

The European Commission approved Besponsa as monotherapy for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

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