BioCentury | Oct 13, 2017
Clinical News

AcelRx's Dsuvia gets CRL

...from EMA's CHMP. By year end, AcelRx plans to resubmit an NDA for Zalviso sufentanil (ARX-01...
...sufentanil via a pre-programmed handheld device. AcelRx CMO Pamela Palmer told BioCentury the recommendations in Zalviso's...
...Calif. Product: Dsuvia sufentanil sublingual tablet (ARX-04) (formerly Single-Dose Sufentanil NanoTab) Business: Neurology Jennie Walters Dsuvia Sufentanil sublingual tablet Zalviso AcelRx...
BioCentury | Oct 12, 2017
Company News

AcelRx's Dsuvia gets CRL

...from EMA's CHMP. By year end, AcelRx plans to resubmit an NDA for Zalviso sufentanil (ARX-01...
...sufentanil via a pre-programmed handheld device. AcelRx CMO Pamela Palmer told BioCentury the recommendations in Zalviso's...
...the device than the drug. Sufentanil is a synthetic mu opioid receptor (MOR; OPRM1) analgesic. Jennie Walters ARX-01 ARX-04 Dsuvia Zalviso AcelRx...
BioCentury | Oct 6, 2017
Finance

Coasting on catalysts

...Moderate to severe acute pain PDUFA date 10/12/17 AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) / Gruenenthal Group Zalviso...
BioCentury | Jul 8, 2017
Finance

A clinical quarter

...thrombocytopenic purpura (TTP) Ph III HERCULES data 2H17 AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) / Gruenenthal Group Zalviso...
BioCentury | Dec 31, 2016
Finance

Delivering takeouts

...thrombocytopenic purpura (TTP) Submit MAA; Ph III data Early 2017; 2H17 AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Zalviso...
BioCentury | Oct 3, 2016
Clinical News

Zalviso sufentanil: Phase III started

...AcelRx began the open-label, U.S. Phase III IAP312 trial to evaluate 15 ug sublingual Zalviso sufentanil...
...Pharmaceuticals Inc. (NASDAQ:ACRX), Redwood City, Calif. Gruenenthal Group , Aachen, Germany Product: Zalviso sufentanil ( ARX-01...
...patients who experience at least 1 system-generated error based on controller data while using the Zalviso...
BioCentury | Sep 28, 2015
Company News

AcelRx, Gruenenthal, PDL BioPharma deal

...sold to PDL a portion of the royalties and milestone payments related to pain product Zalviso...
...receives from Gruenenthal. In 2013, AcelRx granted Gruenenthal commercialization rights in Europe and Australia to Zalviso...
...that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic. The European Commission approved Zalviso...
BioCentury | Sep 28, 2015
Clinical News

Zalviso sufentanil regulatory update

...The European Commission approved an MAA from Gruenenthal for Zalviso sufentanil sublingual tablets to manage acute...
...postoperative pain in adults. Gruenenthal expects to launch the product next half in Western Europe. Zalviso...
...Pharmaceuticals Inc. (NASDAQ:ACRX), Redwood City, Calif. Gruenenthal Group , Aachen, Germany Product: Zalviso sufentanil ( ARX-01...
BioCentury | Aug 3, 2015
Clinical News

Zalviso sufentanil regulatory update

...EMA’s CHMP recommended approval of Zalviso sufentanil sublingual tablets from Gruenenthal Group (Aachen, Germany) to manage...
...severe postoperative pain in adults. AcelRx said Gruenenthal expects to launch the product next half. Zalviso...
...see BioCentury, Jan. 12). AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX), Redwood City, Calif. Product: Zalviso sufentanil ( ARX-01...
BioCentury | Apr 6, 2015
Finance

Up, up and acquired

...disease psychosis (PDP) to 2H15 AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Delays resubmission of an NDA for Zalviso...
...NASDAQ:ACRX) 36% to ~34 $75.4 2.00 12/31/14 $37.7 AcelRx will focus on FDA approval of Zalviso...
...team and field-based medical personnel, who were hired in preparation for a potential launch of Zalviso...
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