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The Pulse of the Pharmaceutical Industry

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Another Win For Darzalex as FDA Approves Combination Treatment For Multiple Myeloma

Using the Real Time Oncology Review pilot program, the U.S. Food and Drug Administration approved Janssen and Genmab’s Darzalex (daratumumab) in combination with lenalidomide and dexamethasone as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant.

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U.S. court rejects Alvogen’s patent challenge for Celgene’s cancer drug

The U.S. patent office rejected a filing by Alvogen Pine Brook for a review challenging patents on Celgene’s blockbuster myeloma drug Revlimid.

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FDA Advisory Panel Recommends Waiting for More Data Before Approving Karyopharm’s Selinexor

Shares of Karyopharm Therapeutics crashed again after an advisory panel from the U.S. Food and Drug Administration recommended delaying potential approval of the company’s experimental multiple myeloma treatment until additional data is available from an ongoing Phase III study.

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GlaxoSmithKline to look for early-stage assets: CEO

GlaxoSmithKline Plc will actively look to buy early-stage assets and partner with companies, the drugmaker’s chief executive officer said.

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Takeda Drives Immuno-Oncology Portfolio With Three Cell Therapy Collaborations

Takeda Pharmaceutical started 2019 with a spate of cell therapy collaborations designed to advance the company’s novel immuno-oncology portfolio. The three collaborations will accelerate the discovery of next-generation cancer immunotherapies.

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Bristol-Myers to buy Celgene for $74 billion

Bristol-Myers Squibb Co. will buy Celgene Corp. for about $74 billion, creating one of the largest pharmaceutical companies and combining two significant cancer medicine businesses.

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GSK buying cancer firm Tesaro for $5.1 billion

GlaxoSmithKline agreed to buy U.S. cancer specialist Tesaro for $5.1 billion, a costly investment to rebuild the pharma business by new Chief Executive Emma Walmsley that unnerved investors.

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Darzalex Dazzles in Multiple Myeloma Late-Stage Trial

Denmark-based Genmab released top-line data from the Phase III MAIA clinical trial of Darzalex (daratumumab), a drug licensed to Johnson & Johnson’s Janssen.

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Rare manufacturing glitch raises concern over CAR-T therapies: study

A single leukemia cell inadvertently got mixed in with a batch of a patient’s immune cells that were being manufactured into a CAR-T cell therapy and it acquired resistance to the treatment with deadly results, University of Pennsylvania researchers reported.

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Molecular Templates, Takeda Strike MM Deal

Shares of Molecular Templates were up more than 52 percent after announcing a deal with Takeda that could be worth up to $632 million to develop CD38-targeted engineered toxin bodies.

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


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