07:00 , Sep 29, 2014 |  BC Week In Review  |  Clinical News

Egranli balugrastim regulatory update

EMA's CHMP recommended approval of Teva's Egranli balugrastim to treat chemotherapy-induced neutropenia. Last year, Teva withdrew a BLA for the long-acting recombinant human G-CSF fused to human albumin, which was under FDA review for neutropenia....
16:18 , Sep 26, 2014 |  BC Extra  |  Company News

CHMP backs Teva's Egranli for neutropenia

EMA's CHMP recommended marketing authorization of Egranli balugrastim from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to prevent chemotherapy-induced neutropenia. Approval will include a pharmacovigilance plan. Last November, Teva withdrew a BLA for the long-acting recombinant human...
08:00 , Jan 6, 2014 |  BioCentury  |  Finance

4Q Stock Wrap-Up: All's well that ends well

Although two segments lost ground in 4Q13, all of biotech's market cap groups finished 2013 in the black. Large caps valued at more than $5 billion led the way in the fourth quarter, tacking on...
08:00 , Nov 25, 2013 |  BC Week In Review  |  Clinical News

Balugrastim regulatory update

Teva said it withdrew a BLA for balugrastim, a long-acting recombinant human G-CSF fused to human albumin that had been under FDA review for neutropenia. The company, which submitted the BLA in December 2012, said...
01:57 , Nov 19, 2013 |  BC Extra  |  Company News

Teva withdraws balugrastim BLA

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said it withdrew a BLA for balugrastim, a long-acting recombinant human G-CSF fused to human albumin that had been under FDA review for neutropenia. The company, which submitted the BLA...
07:00 , Oct 28, 2013 |  BC Week In Review  |  Clinical News

Lonquex lipegfilgrastim regulatory update

Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.) said Teva notified it that the generics company withdrew a BLA from FDA for Lonquex lipegfilgrastim to prevent chemotherapy-induced neutropenia. Amgen said that as a result of the withdrawal...
07:00 , Jul 9, 2012 |  BC Week In Review  |  Clinical News

Balugrastim: Phase II/III data

Data from the Phase III portion of a Phase II/III trial in 256 breast cancer patients receiving myelosuppressive therapy showed that subcutaneous injections of 40 and 50 mg balugrastim were both non-inferior to subcutaneous injections...
07:00 , Jul 9, 2012 |  BC Week In Review  |  Clinical News

Balugrastim: Phase III data

A double-blind Phase III trial in 304 breast cancer patients receiving chemotherapy showed that subcutaneous injections of 40 mg balugrastim was non-inferior to subcutaneous injections of 6 mg Neulasta pegfilgrastim on the primary endpoint of...
07:00 , Apr 19, 2010 |  BioCentury  |  Strategy

Finding cancer flexibility

Generic drug maker Teva Pharmaceutical Industries Ltd. has no internal research capabilities and has for years leveraged its relationships with Israeli academic organizations and startup biotechs to provide it with early stage opportunities as it...
08:00 , Jan 28, 2008 |  BC Week In Review  |  Company News

CoGenesys, Teva deal

Teva will acquire CoGenesys for $400 million in cash. Teva said CoGenesys' technology platforms, including its albumin-fusion technology to develop long-acting biopharmaceuticals, will bolster its position in biosimilars. CoGenesys also has Cardeva, a long-acting B-type...