00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
01:36 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

FDA needs more information to approve manufacturing changes to ADMA's Bivigam

ADMA Biologics Inc. (NASDAQ:ADMA) said FDA has issued a complete response letter to a prior approval supplement (PAS) reporting CMC changes to an approved BLA for Bivigam. The company dropped $1.92 (46%) to $2.29 on...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
08:00 , Feb 8, 2016 |  BC Week In Review  |  Company News

Biotest, Kedrion deal

Biotest granted Kedrion exclusive rights to commercialize Bivigam in the U.S. The polyspecific IV immune globulin is marketed in the U.S. to treat primary humoral immunodeficiency. The companies declined to provide financial terms. Biotest AG...
07:00 , Oct 9, 2014 |  BC Innovations  |  Cover Story

Invigorating IVIG

  Although IVIG has been a mainstay in autoimmune disease therapy for decades, there is still high variability in both safety and potency among different batches because the antibodies are sourced from pooled human blood....
08:00 , Feb 11, 2013 |  BC Week In Review  |  Company News

Biotest sales and marketing update

Biotest's Biotest Pharmaceuticals Corp. subsidiary launched IV Bivigam 10% human immune globulin in U.S. to treat primary immune deficiency disorders. The wholesale acquisition cost of the polyspecific IV immune globulin is $1,199.60 for a 100...
08:00 , Jan 7, 2013 |  BC Week In Review  |  Clinical News

Bivigam 10% human immune globulin regulatory update

On Dec. 20, Biotest said FDA approved a BLA from Biotest's Biotest Pharmaceuticals Corp. subsidiary for IV Bivigam 10% human immune globulin to treat primary immune deficiency disorders. The company plans to launch the polyspecific...
07:00 , Jul 18, 2011 |  BioCentury  |  Strategy

mAbs are icing on the cake

Biotest AG has returned to its roots in plasma proteins. After selling off its tools and diagnostics businesses, the company is looking to grow by increasing its plasma protein product offerings and expanding its global...
07:00 , Sep 1, 2003 |  BC Week In Review  |  Clinical News

Gamunex immune globulin intravenous regulatory update

The FDA approved for marketing BAYG's Gamunex for patients with compromised immune systems. Gamunex, which was approved in Canada in August, will be available in Canada early next year and in the U.S. this fall....
07:00 , Aug 25, 2003 |  BC Week In Review  |  Clinical News

Gamunex immune globulin intravenous regulatory update

Canada approved for marketing BAYG's Gamunex 10% intravenous human immune globulin ( IGIV ) to treat idiopathic thrombocytopenic purpura, primary immune deficiencies, allogeneic bone marrow transplantation and pediatric HIV infection. According to BAYG, Gamunex is...