00:24 , Jun 21, 2019 |  BC Extra  |  Company News

June 20 Company Quick Takes: Priority Review for Alexion, Melinta therapies; plus Alimera, Denovo and more

Priority Review for Alexion's Ultomiris sBLA  FDA accepted and granted Priority Review to an sBLA from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) for Ultomiris ravulizumab-cwvz to block complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome....
22:45 , Apr 7, 2017 |  BioCentury  |  Finance

To market, to market

Investors are hoping that a slew of approvals and data readouts can maintain biotech’s momentum on the heels of several high-profile successes that came just before or after 1Q’s end. Chief among those was Vertex...
00:53 , Dec 31, 2016 |  BioCentury  |  Finance

Delivering takeouts

  BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are...
07:00 , Oct 10, 2016 |  BC Week In Review  |  Clinical News

Medidur fluocinolone acetonide intravitreal implant: Completed Phase III enrollment

pSivida completed enrollment of 150 patients in a double-blind, sham-controlled, Indian Phase III trial evaluating 0.18 mg intravitreal Medidur. The product uses the same micro-insert and corticosteroid as Iluvien fluocinolone acetonide intravitreal implant to treat...
07:00 , Aug 22, 2016 |  BC Week In Review  |  Clinical News

Medidur fluocinolone acetonide intravitreal implant: Additional Phase III data

Additional data from a double-blind, international Phase III trial in 129 patients with recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis showed that 0.18 mg intravitreal Medidur led...
07:00 , Aug 15, 2016 |  BC Week In Review  |  Company News

pSivida ophthalmic news

In July, pSivida said it plans to consolidate all R&D to its facility in Watertown. Subject to an employee consultation process required by U.K. law, pSivida plans to close its research facility in Malvern, U.K....
08:00 , Jan 4, 2016 |  BC Week In Review  |  Clinical News

Medidur fluocinolone acetonide intravitreal implant: Phase III data

Top-line data from a double-blind, international Phase III trial in 129 patients with recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis showed that 0.18 mg intravitreal Medidur met...
01:51 , Dec 23, 2015 |  BC Extra  |  Clinical News

pSivida rises on Phase III uveitis data

pSivida Corp. (NASDAQ:PSDV; ASX:PVA) gained $0.79 (21%) to $4.49 on NASDAQ on Tuesday after its Medidur fluocinolone acetonide intravitreal implant met the primary endpoint in a Phase III study to treat chronic, non-infectious posterior uveitis....
07:00 , Apr 6, 2015 |  BC Week In Review  |  Clinical News

Iluvien fluocinolone acetonide intravitreal implant: Completed Phase III enrollment

pSivida completed enrollment of 120 patients in a double-blind, sham-controlled, international Phase III trial evaluating 0.18 mg intravitreal Iluvien. The trial targeted 120 patients with recurrent non-infectious uveitis affecting the posterior segment of the eye...
08:00 , Feb 9, 2015 |  BC Week In Review  |  Clinical News

Iluvien fluocinolone acetonide intravitreal implant regulatory update

Finland and Luxembourg approved Iluvien fluocinolone acetonide intravitreal implant from Alimera to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The injectable insert that delivers fluocinolone acetonide...