BioCentury | Mar 9, 2019
Regulation

Gottlieb’s exit interview

...abuse potential (see “Turning the Tide” ). Gottlieb thinks the public conversation over approval of Dsuvia...
...opioids based on characteristics that differentiate them from marketed drugs (see “Gottlieb Justifies Approval of Dsuvia...
BioCentury | Jan 12, 2019
Finance

We all fall down

...episodes in Parkinson's disease patients treated with carbidopa-levodopa AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) FDA approves Dsuvia sufentanil sublingual tablet...
BioCentury | Nov 9, 2018
Clinical News

FDA approves AcelRx, Coherus, Pfizer Products, rebuffs Trevena's Olinvo

...the indication. AcelRx gained $0.65 (16%) to $4.80 Nov. 2 when FDA approved Dsuvia sufentanil sublingual tablet (ARX-04...
...Calif. Pfizer Inc. (NYSE:PFE), New York, N.Y. Trevena Inc. (NASDAQ:TRVN), Chesterbrook, Pa. Product: Dsuvia sufentanil sublingual tablet (ARX-04...
...sufentanil sublingual tablet (ARX-04), Udenyca pegfilgrastim-cbqv, Lorbrena lorlatinib, Olinvo oliceridine (TRV130) Business: Neurology, hematology, cancer Sandi Wong Biosimilar of pegfilgrastim Dsuvia Olinvo...
BioCentury | Nov 2, 2018
Company News

FDA approves AcelRx, Coherus, Pfizer products, rebuffs Trevena's Olinvo

...for the indication. AcelRx gained $0.65 (16%) to $4.80 Friday when FDA approved Dsuvia sufentanil sublingual tablet (ARX-04...
...in circumstances when patients cannot swallow or tolerate an IV (see "Gottlieb Justifies Approval of Dsuvia"...
...against recommending approval of Olinvo (see "Trevena Goes for MOR than Morphine" ). Sandi Wong Biosimilar of pegfilgrastim Dsuvia Olinvo...
BioCentury | Nov 2, 2018
Company News

Gottlieb justifies approval of Dsuvia, a new opioid

...a new opioid analgesic, Commissioner Scott Gottlieb Friday explained the agency’s decision to approve Dsuvia sufentanil sublingual tablet...
...Analgesic Drug Products Advisory Committee voted 10-3 on Oct. 19 that the benefit-risk profile of Dsuvia...
...Raeford Brown told ABC television and other media that he opposed approval because he believes Dsuvia...
BioCentury | Oct 19, 2018
Clinical News

FDA panel votes in favor of AcelRx's pain candidate

...and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil sublingual tablet (ARX-04...
...modified the use directions. It also conducted an additional human factors validation study (see "AcelRx's Dsuvia...
...NASDAQ:ACRX), Redwood City, Calif. Product: Dsuvia sufentanil sublingual tablet (ARX-04) Business: Neurology Elizabeth S. Eaton Dsuvia, Dzuveo, Sufentanil sublingual tablet (ARX-04, single-dose sufentanil nanotab) AcelRx...
BioCentury | Oct 12, 2018
Company News

FDA panel votes in favor of AcelRx's pain candidate

...and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil sublingual tablet (ARX-04...
...modified the use directions. It also conducted an additional human factors validation study (see "AcelRx's Dsuvia...
...market hours, added $0.88 (22%) to $4.86 in after-hours trading. Elizabeth S. Eaton Dsuvia, Dzuveo, Sufentanil sublingual tablet (ARX-04, single-dose sufentanil nanotab) AcelRx...
BioCentury | Oct 6, 2018
Finance

Seeking validation

...NYSE:ABBV) Upadacitinib (ABT-494) Rheumatoid arthritis Submit reg apps worldwide 4Q18 AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Dsuvia sufentanil sublingual tablet...
BioCentury | Sep 13, 2018
Clinical News

Advisory committee meeting Oct. 12 to discuss NDA for Acelrx's Dsuvia

...meet Oct. 12 to discuss an NDA from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) for Dsuvia sufentanil sublingual tablet (ARX-04...
...PDUFA date. In October 2017, AcelRx received a complete response letter for Dsuvia (see “AcelRx’s Dsuvia...
...NASDAQ:ACRX), Redwood City, Calif. Product: Dsuvia sufentanil sublingual tablet (ARX-04) Business: Neurology Jaime De Leon Dsuvia, Dzuveo, Sufentanil sublingual tablet (ARX-04, single-dose sufentanil nanotab) AcelRx...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

...Luspatercept (ACE-536) Beta-thalassemia Top-line Ph III BELIEVE data Mid-2018 AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Dsuvia sufentanil sublingual tablet (ARX-04...
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