BioCentury | Jan 17, 2019
Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
BC Week In Review | Jun 22, 2018
Clinical News

Valeant receives complete response letter for psoriasis candidate

The Ortho Dermatologics unit of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said it received a complete response letter from FDA to an NDA for Duobrii (IDP-118) to treat plaque psoriasis. According to Valeant, FDA had...
BC Extra | Jun 18, 2018
Company News

Valeant slides on psoriasis delay

Ortho Dermatologics said it received a complete response letter from FDA to an NDA for Duobrii (IDP-118) to treat plaque psoriasis. Ortho parent Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) slid $3.32 (12%) to $23.54 on...
BC Week In Review | Feb 16, 2018
Clinical News

FDA reviewing Valeant's psoriasis candidate Jemdel

The Ortho Dermatologics unit of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said FDA accepted for review an NDA for Jemdel (IDP-122) to treat plaque psoriasis. Its PDUFA date is Oct. 5. Jemdel is a lotion...
BC Week In Review | Nov 3, 2017
Clinical News

FDA reviewing Valeant psoriasis candidate IDP-118

The Ortho Dermatologics unit of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said FDA accepted for review an NDA for IDP-118 to treat plaque psoriasis. Its PDUFA date is June 18, 2018. IDP-118 is a topical...
BC Extra | Nov 2, 2017
Company News

FDA reviewing Valeant's psoriasis candidate

The Ortho Dermatologics unit of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said FDA accepted for review an NDA for IDP-118 to treat plaque psoriasis. Its PDUFA date is June 18, 2018. IDP-118 is a topical...
BC Week In Review | Jan 20, 2017
Clinical News

IDP-118: Ph III data

Top-line data from a double-blind, U.S. Phase III trial in 215 patients with moderate to severe plaque psoriasis showed that topical IDP-118 met the primary endpoint of a greater proportion of patients with a ≥2-point...
BC Week In Review | Jan 20, 2017
Clinical News

IDP-118: Ph III data

Top-line data from a double-blind, U.S. Phase III trial in 203 patients with moderate to severe plaque psoriasis showed that topical IDP-118 met the primary endpoint of a greater proportion of patients with a ≥2-point...
BC Extra | Sep 14, 2016
Top Story

Allergan acquiring Vitae

Allergan plc (NYSE:AGN) is acquiring Vitae Pharmaceuticals Inc. (NASDAQ:VTAE) for $21 per share in cash, or about $639 million. The price is a 159% premium to Vitae's close of $8.10 on Tuesday, before the deal...
BC Innovations | Oct 17, 2013
Distillery Therapeutics

Indication: Cancer

This week in therapeutics Indication Target/marker/pathway Summary Licensing status Publication and contact information Cancer Breast cancer Retinoic acid receptor responder (tazarotene induced) 1 (RARRES1; TIG1); AXL receptor tyrosine kinase (AXL; UFO) In vitro and mouse...
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