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172682 items
10:58 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA places hold on upcoming Phase I for point-of-care CAR Ts

FDA placed a clinical hold on an upcoming Phase I trial sponsored by Ziopharm Oncology Inc. (NASDAQ:ZIOP), which would be the first for its third-generation, point-of-care CAR T cells that require two days for manufacturing....
10:57 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Medivir delays remetinostat Phase III

Medivir AB (SSE:MVIR B) lost SEK4.60 (12%) to SEK34.05 on June 18 after announcing it will delay to 2019 the start of a Phase III trial of remetinostat in early stage cutaneous T-cell lymphoma (CTCL)....
10:57 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

BMS first to cross finish line in China PD-1 approval race

The State Drug Administration approved Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY), marking China’s first approval of an immuno-oncology agent, according to the pharma. The anti-PD-1 mAb is indicated to treat locally advanced or metastatic...
10:57 AM, Jun 22, 2018  |  BC Week In Review | Company News  |  Sales & Marketing

Vertex gets reimbursement deal for Orkambi in Sweden

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said June 18 it agreed to a long-term access agreement for cystic fibrosis drug Orkambi lumacaftor/ivacaftor with Swedish authorities. Beginning July 1, Orkambi will be reimbursed in Sweden at an undisclosed...
10:57 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA panel to review Paratek antibiotic

FDA's Antimicrobial Drugs Advisory Committee scheduled an Aug. 8 meeting to discuss two NDAs for omadacycline from Paratek Pharmaceuticals Inc. (NASDAQ:PRTK). The agency is reviewing oral and IV versions of the amniomethylcycline antibiotic to treat community-acquired...
10:56 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

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 questions...
10:56 AM, Jun 22, 2018  |  BC Week In Review | Company News  |  Sales & Marketing

NICE recommends Roche's Ocrevus for relapse-remitting multiple sclerosis

The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Ocrevus ocrelizumab from Roche (SIX:ROG; OTCQX:RHHBY) to treat relapse-remitting multiple sclerosis. In January, the European Commission approved the second-generation humanized mAb against CD20...
8:35 AM, Jun 22, 2018  |  BC Week In Review | Company News  |  Deals

BridgeBio launches mitochondrial-focused subsidiary

BridgeBio Pharma LLC (Palo Alto, Calif.) launched Fortify Therapeutics Inc. June 18 with $20 million and an exclusive license to compounds from NeuroVive Pharmaceutical AB (SSE:NVP; OTCQX:NEVPF) to treat Leber’s hereditary optic neuropathy. Fortify will develop...
8:34 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Daiichi's AML candidate leads to median OS of 6.2 months

Daiichi Sankyo Co. Ltd. (Tokyo:4568) reported additional data from the Phase III QuANTUM-R trial to treat relapsed or refractory acute myelogenous leukemia (AML) showing that oral quizartinib led to median overall survival (OS), the primary...
8:33 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Global Blood's voxelotor shows lower response rate in 24-week sickle cell readout

Global Blood Therapeutics Inc. (NASDAQ:GBT) reported updated Phase IIa data in sickle cell disease patients showing that voxelotor (formerly GBT440) led to a lower hemoglobin response rate than previously reported data had shown. At the European...

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