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...
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 , 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....
08:00 , Jan 7, 2013 |  BioCentury  |  Finance

Buyside View XXI: Sunny side up

Stephen Hansen Senior Writer  A strong crop of early PDUFA dates and a sense that FDA is more navigable have given money managers in the U.S. and Europe a positive outlook for 2013, which they...
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 |  BioCentury  |  Finance

3Q Financial Markets Preview: Miles of milestones

A deep line-up of milestones could help retain gains the sector has been holding onto since 1Q12. In particular, investors would love to see further breakthroughs in difficult areas such as Alzheimer's disease and obesity....
07:00 , Jun 18, 2012 |  BioCentury  |  Product Development

Immune springboard

A spate of Phase III data events over the next two years will give a readout on how correctly the lessons learned five years ago about cancer immunotherapies targeting T cell responses have been put...