Drugs

Dr. Reddy’s, XenoPort Agreement on Psoriasis Therapy

Dr. Reddy’s Laboratories and XenoPort have entered into a license agreement that grants Dr. Reddy’s exclusive U.S. rights for developing and commercializing XenoPort’s clinical-stage oral new chemical entity XP23829 for treating moderate-to-severe chronic plaque psoriasis. The therapy is also being considered for treating patients with relapsing forms of multiple sclerosis.

Under the terms of the agreement, XenoPort will receive a $47.5 million up-front payment and an additional $2.5 million for transfer of certain clinical trial materials to Dr. Reddy’s. XenoPort will also be eligible to receive up to $190 million if certain regulatory milestones are met and up to $250 million upon the achievement of certain commercial milestones.

XP23829 is considered a novel fumaric acid ester, according to the companies. Fumaric acid esters possess a “unique anti-inflammatory mechanism of action and have been used to treat psoriasis in Germany for over 20 years,” they say.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome