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BioWorld - Wednesday, April 22, 2026
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Venatorx raises $42M to move phase I antibiotic program into pivotal trials

July 26, 2017
By Cormac Sheridan
DUBLIN – Antibiotics developer Venatorx Pharmaceuticals Inc. raised $42 million in a series B round that will fund a registration trial of its lead program, VNRX-5133, which it has penciled in for the first half of next year.
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Neuralstem rocked on phase II miss of NSI-189 in MDD, but presses on

July 26, 2017
By Marie Powers
"This is an exciting opportunity for us," Rich Daly, chairman and CEO of Neuralstem Inc., said about top-line phase II data of NSI-189 to treat major depressive disorder (MDD). Those aren't necessarily words that might follow a miss on the primary efficacy endpoint – a statistically significant reduction in depression symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS) – which sent the company's shares (NASDAQ:CUR) tumbling as much as 60 percent Tuesday before closing at $2.81 for a loss of $2.77, or 49.6 percent.
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Kezar in the ignition: Fuel immunoproteasome effort with $50M series B round

July 26, 2017
By Randy Osborne
The scientific campaign for a better version of Velcade (bortezomib, Takeda Oncology Co.) for multiple myeloma (MM) that began at Proteolix Inc. survived two mergers and ultimately failed, but led to the formation of Kezar Life Sciences Inc., with a promising approach, not to cancer but to autoimmune disorders.
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Biogen sails to strong 2nd quarter on winds of SMA drug sales

July 26, 2017
By Michael Fitzhugh
Strong sales of Biogen Inc.'s pricey spinal muscular atrophy drug, Spinraza (nusinersen), helped the company cruise past consensus estimates and hit record second-quarter sales on Tuesday.
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Prevention beyond vaccines is changing HIV field

July 26, 2017
By Anette Breindl
PARIS – A bird in the hand is worth two in the bush. And in that spirit, the newest research on a wide variety of prevention strategies other than vaccination are being presented at the meeting of the International AIDS Society (IAS) this week, despite the conviction that a vaccine will ultimately be necessary to end the HIV pandemic.
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In the clinic

July 26, 2017
Neon Therapeutics Inc., of Cambridge, Mass., and Apexigen Inc., of San Carlos, Calif., plan to test Neon's NEO-PV-01, a neoantigen vaccine based on DNA mutations from patients' individual tumors, in combination with Apexigen's CD40 agonist antibody, APX-005M, in a phase Ib trial in patients with metastatic melanoma.
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Other news to note

July 26, 2017
Bristol-Myers Squibb Co., of Princeton, N.J., said the FDA accepted its supplemental BLAs to update dosing of PD-1 inhibitor Opdivo (nivolumab) to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications.
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Appointments and advancements

July 26, 2017
Nabriva Therapeutics plc, of Dublin, named Francesco Maria Lavino chief commercial officer. He will be based out of the company's U.S. headquarters in King of Prussia, Pa.
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Financings

July 26, 2017
Gemphire Therapeutics Inc., of Livonia, Mich., entered a loan and security agreement with Silicon Valley Bank for a term loan of up to $15 million, subject to funding in up to three tranches.
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Regulatory front

July 25, 2017
The FDA issued guidance Monday on dealing with informed consent in clinical trials that involve no more than minimal risk to subjects, in keeping with a provision in the 21st Century Cures Act.
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