darzalex

Showing 12 posts of 27 posts found.

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Potential blockbuster AZ immunotherapy secures FDA approval

May 2, 2017
Manufacturing and Production, Sales and Marketing AstraZeneca, bladder cancer, darzalex

The FDA has granted accelerated approval to AstraZeneca’s (AZ) immunotherapy therapy Imfinzi (durvalumab) for the treatment of locally advanced or …

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Janssen scores EU approval for blood cancer drug Darzalex

May 2, 2017
Manufacturing and Production, Sales and Marketing Europe, European Commission, Janssen, darzalex

Janssen has announced that its CD38-directed monoclonal antibody Darzalex (daratumumab) has expanded its indication with a thumbs-up from the European …

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EMA recommends expanded indication for Janssen multiple myeloma drug

February 27, 2017
Manufacturing and Production, Research and Development, Sales and Marketing Janssen, darzalex

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its positive opinion for the use of …

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SMC rejects Janssen’s multiple myeloma treatment Darzalex

January 17, 2017
Manufacturing and Production, Sales and Marketing Janssen, SMC, darzalex

The Scottish Medicines Consortium (SMC) has decided not to recommend Janssen’s Darzalex (daratumumab) for routine use by NHS Scotland as …

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J&J and Genmab’s drug races to second line treatment approval

November 22, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Genmab, Janssen, Johnson & Johnson, darzalex, multiple myeloma

Janssen, a part of Johnson & Johnson, and Genmab have announced that their multiple myeloma drug Darzalex (daratumumab) has been …

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Darzalex receives breakthrough designation in multiple myeloma from FDA

July 26, 2016
Manufacturing and Production, Research and Development FDA, Genmab, Janssen, darzalex, multiple myeloma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Darzalex (daratumumab) in combination with standard of …

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Genmab receives milestone payment for first Darzalex sale in Europe

May 31, 2016
Manufacturing and Production, Sales and Marketing EU, FDA, Janssen, commercial, commercialised, daratumumab, darzalex, genman, multiple myeloma, sale, sales

Genmab (NASDAQ: GEN) has announced that the company is set to receive a milestone payment of $30 million from its …

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Darzalex meets endpoint in late-stage multiple myeloma trial

May 19, 2016
Research and Development Genmab, Janssen, daratumumab, darzalex, dexamethasone, lenalidomide, phase 3, phase III, trial

Genmab has announced that positive results from a Phase III trial evaluating Darzalex (daratumumab), which is being developed in partnership …

legal

Janssen and Genmab sued for patent infringement in US

April 5, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Genmab, Janssen, darzalex, morphosys, patent infringement

German biotech company, Morphosys, is suing Janssen and Genmab for alleged patent infringement in their oncology drug, Darzalex (daratumumab).

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Two CHMP nods for Janssen

April 4, 2016
Research and Development, Sales and Marketing Xeplion, darzalex, multiple myeloma

The European Commission’s scientific committee has recommended Janssen’s Darzalex (daratumumab) for multiple myeloma and Trevicta (paliperidone palmitate) for maintenance treatment …

genmab

Genmab Darzalex success triggers second milestone payment

March 10, 2016
Research and Development, Sales and Marketing Genmab, Janssen, daratumumab, darzalex, follicular lymphoma

Genmab says it has reached a $5 million milestone in its daratumumab collaboration with Janssen as a result of success …

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Strong cancer trial data for Janssen at ASH 2015

December 8, 2015
Research and Development Cancer, Janssen, darzalex, imbruvica, oncology

Janssen presented new cancer trial data at the 57th Annual American Society of Haematology (ASH) meeting Orlando, Florida – with …

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