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Janssen Biotech Inc.

Division of Johnson & Johnson
www.janssenbiotech.com

Latest From Janssen Biotech Inc.

US Biosimilar Sponsors Seek Off-The-Record Discussions

Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.

Biosimilars Intellectual Property

Biosimilar Sponsors Want Off-The-Record Labeling Discussions With US FDA

Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions written record; negotiations for BsUFA III may be opportunity to create such a process.

Biosimilars Intellectual Property

EU Approvals: J&J's Darzalex Steps Ahead With New Indication

The European Commission has approved Johnson & Johnson’s/Genmab’s CD38-targeted MAb, daratumumab, and Merck & Co’s checkpoint inhibitor, pembrolizumab, in two first-line additional indications, in multiple myeloma and head and neck cancer, respectively.

 

 

ImmunoOncology Approvals

Deal Watch: Allergan Keeps After Hair Loss With Exicure Deal

Allergan has tried to go after alopecia in the past; Exicure brings a new spherical nucleic acid (SNA) technology. In other recent deals, AstraZeneca sells Seroquel, Losec rights to Germany’s Cheplapharm.

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