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    E.g., 2018-06-25

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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...
5:05 AM, Jun 22, 2018  |  BioCentury | Finance

Regenerating eastward

Having capitalized on the cell therapy expertise and manufacturing incentives of its European home base, Promethera Biosciences S.A. is expanding to Japan to tap the commitment to regenerative medicines among investors, pharmas and regulators. After...
7:56 PM, Jun 21, 2018  |  BC Extra | Financial News

First-day bump for Autolus after pricing $150M IPO

Autolus Therapeutics plc (NASDAQ:AUTL) climbed $8 (47%) to $25 its first day of trading Friday after it raised $150 million via the sale of 8.8 million ADSs at $17 in an upsized IPO. Underwriters are...
6:34 PM, Jun 21, 2018  |  BC Innovations | Targets & Mechanisms

T cell balancing act

Among the improvements to next-generation CAR T cell therapies is the need to optimize the ratios of the different T cell subsets. While CD8+ T cells have grabbed most of the attention, a study from...

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