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12:18 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Apricus get CRL for ED candidate Vitaros

Apricus Biosciences Inc. (NASDAQ:APRI) said it received a complete response letter to a resubmitted NDA for Vitaros alprostadil to treat erectile dysfunction. The company said FDA cited CMC and safety concerns specific to the 2.5%...
12:17 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA panel to review volanesorsen from Akcea, Ionis

Akcea Therapeutics Inc. (NASDAQ:AKCA) said FDA's Division of Metabolism and Endocrinology Products will hold an advisory committee meeting to review an NDA for volanesorsen (IONIS-APOCIIIRx) to treat familial chylomicronemia syndrome (FCS), a rare lipid disorder...
12:17 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Preclinical Results

Synlogic reports preclinical data for STING agonist-producing candidate in melanoma

Synlogic Inc. (NASDAQ:SYBX) reported preclinical data from mouse models of melanoma showing that intratumoral SYN-STING significantly reduced tumor growth compared with saline controls (p<0.05). SYN-STING also significantly increased total T cell numbers and activated effector...
12:16 PM, Feb 23, 2018  |  BC Week In Review | Company News  |  Sales & Marketing

Novo launches Ozempic and Fiasp in U.S.

Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) launched in the U.S. Ozempic semaglutide (NN9535) to treat Type II diabetes in adults and Fiasp rapid-acting insulin (NN1218) analog to improve glycemic control in adults with Type I and...
12:16 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Icon Bioscience's Dexycu

Icon Bioscience Inc. (Sunnyvale, Calif.) said FDA approved an NDA for Dexycu dexamethasone intraocular suspension to treat inflammation associated with cataract surgery. Dexycu is a sustained-release formulation of dexamethasone delivered using Verisome technology. The company did...
7:26 AM, Feb 23, 2018  |  BC Week In Review | Financial News  |  Proposed Offerings

Taiwan Liposome planning NASDAQ listing

Drug delivery company Taiwan Liposome Co. Ltd. (TPEx:4152) proposed to raise up to $50 million on Feb. 17 through the sale of ADSs in a NASDAQ listing underwritten by Cantor Fitzgerald, CLSA, H.C. Wainwright, Janney...
7:25 AM, Feb 23, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Amicus raises $300M in bumped-up follow-on

Amicus Therapeutics Inc. (NASDAQ:FOLD) raised $300 million on Feb. 15 through the sale of 19.4 million shares at $15.50 in an upsized follow-on underwritten by J.P. Morgan, Goldman Sachs, Cowen, Leerink and BofA Merrill Lynch....
7:25 AM, Feb 23, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Celularity unveils size of series A

Celularity Inc. (Warren, N.J.) revealed on Feb. 15 that it has raised more than $250 million in series A funding and assets from Celgene Corp. (NASDAQ:CELG), three other biotechs and private investors. The cell therapy,...
7:25 AM, Feb 23, 2018  |  BC Week In Review | Company News  |  Deals

Ipsen seeks to invest in early stage innovation with Arix

Life sciences investment firm Arix Bioscience plc (LSE:ARIX) partnered with Ipsen Group (Euronext:IPN; Pink:IPSEY) to create new companies focused on developing and commercializing "innovative therapies" in undisclosed indications. Arix declined to disclose further details about...
7:25 AM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Celgene's Otezla meets in Phase III for Behcet's disease

Celgene Corp. (NASDAQ:CELG) reported data from the Phase III RELIEF trial in 207 active Behcet's disease patients with oral ulcers showing that twice-daily oral 30 mg Otezla apremilast (CC-10004) met the primary endpoint of reducing...

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