07:00 , Apr 27, 2015 |  BC Week In Review  |  Clinical News

Lympreva dasiprotimut-T regulatory update

EMA’s CHMP recommended against approval of Lympreva dasiprotimut-T from Biovest to treat follicular non-Hodgkin’s lymphoma (NHL). CHMP said the Phase III trial of Lympreva was inadequately designed and carried out to establish the product’s benefit...
01:14 , Apr 25, 2015 |  BC Extra  |  Company News

CHMP backs Opdivo and Hetlioz, spurns Lympreva

EMA's CHMP issued several recommendations on Friday, backing marketing authorization of candidates from Bristol-Myers Squibb Co. (NYSE:BMY) and Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) while declining to recommend one from Biovest International Inc. (Minneapolis, Minn.). CHMP recommended...
02:03 , Feb 14, 2015 |  BC Extra  |  Company News

Intrexon acquires mucosal therapeutics play ActoGeniX

Synthetic biology company Intrexon Corp. (NYSE:XON) will acquire ActoGeniX N.V. (Zwijnaarde, Belgium) for $60 million. Intrexon will gain ActoGeniX's TopAct platform, an oral delivery technology based on living, non-pathogenic microorganisms, and a pipeline including two...
08:00 , Jan 20, 2014 |  BC Week In Review  |  Clinical News

BiovaxID dasiprotimut-T regulatory update

Biovest said EMA accepted for review an MAA for BiovaxID to treat follicular non-Hodgkin's lymphoma (NHL). BiovaxID is an autologous vaccine containing tumor-specific idiotype proteins from an individual patient's lymphoma cells and conjugated to keyhole...
07:00 , Jul 29, 2013 |  BC Week In Review  |  Company News

Biovest cancer, biomanufacturing news

Biovest emerged from Chapter 11 bankruptcy and completed a restructuring and recapitalization strategy. The company has eliminated about $48.5 million in debt, which has been converted into new shares of Biovest common stock and issued...
07:00 , Jul 1, 2013 |  BC Week In Review  |  Financial News

MDxHealth completes private placement

MDxHealth S.A. (Euronext: MDXH), Liege, Belgium   Business: Diagnostic   Date completed: 6/25/13   Type: Private placement   Raised: €18 million ($23.6 million)   Shares: 8.7 million   Price: €2.06   Shares after offering: 34.3...
07:00 , Mar 18, 2013 |  BC Week In Review  |  Company News

Biovest cancer news

Biovest filed for Chapter 11 bankruptcy in the U.S. Bankruptcy Court for the Middle District of Florida. Biovest is seeking access to up to about $5.6 million in new funding from its senior secured lenders....
07:00 , Aug 20, 2012 |  BC Week In Review  |  Clinical News

BiovaxID regulatory update

Accentia's Biovest International Inc. (OTCQB:BTVI, Tampa Fla.) subsidiary said FDA requested a second Phase III trial to support a BLA submission for BiovaxID as consolidation therapy in follicular non-Hodgkin's lymphoma (NHL). The agency requested the...
07:00 , Jul 23, 2012 |  BC Week In Review  |  Clinical News

BiovaxID regulatory update

Accentia's Biovest International Inc. (OTCQB:BTVI, Tampa Fla.) subsidiary said EMA formally notified the subsidiary that an MAA for BiovaxID to treat follicular non-Hodgkin's lymphoma (NHL) is eligible for review under EMA's centralized procedure. Biovest plans...
07:00 , Jul 2, 2012 |  BC Week In Review  |  Financial News

MDxHealth completes private placement

MDxHealth S.A. (Euronext: MDXH), Liege, Belgium   Business: Diagnostic   Date completed: 6/29/2012   Type: Private placement   Raised: €3 million ($3.7 million)   Shares: 2 million   Price: €1.50   Shares after offering: 25.5...