07:00 , Jun 3, 2013 |  BC Week In Review  |  Clinical News

Somatropin Biopartners regulatory update

EMA's CHMP recommended approval of once-weekly Somatropin Biopartners to treat growth hormone deficiency (GHD) in pediatric and adult patients. Somatropin Biopartners is a sustained-release formulation of somatropin, a recombinant human growth hormone. The company expects...
07:00 , Sep 24, 2012 |  BC Week In Review  |  Company News

Bioton, Medipolis deal

CMO Medipolis granted Bioton rights to a biosimilar insulin analog manufacturing technology. Medipolis said the deal is worth €5.3 million ($6.9 million). The companies declined to disclose details. Bioton S.A. (Warsaw:BIO), Warsaw, Poland   Medipolis...
07:00 , Aug 27, 2012 |  BC Week In Review  |  Clinical News

Valtropin somatropin regulatory update

EMA said that in May it withdrew marketing authorization for human growth deficiency drug Valtropin somatropin. According to the agency, Bioton's BioPartners GmbH unit voluntarily withdrew marketing authorization for the drug last October for commercial...
08:00 , Feb 6, 2012 |  BC Week In Review  |  Company News

Bioton, Actavis deal

Bioton and Actavis formed a JV to develop and register insulins, including analog insulins. Bioton will be responsible for development and manufacturing, while Actavis will have an exclusive license to commercialize the products in the...
07:00 , Oct 10, 2011 |  BC Week In Review  |  Clinical News

LB03002: Phase III data

An open-label, international Phase III trial in 167 previously untreated children with GHD showed that expected height velocity growth rates were maintained during the second year of treatment in patients treated with once-weekly 0.5 mg/kg...
00:18 , Dec 11, 2010 |  BC Extra  |  Company News

EMA reviewing somatropin safety

The European Medicines Agency will review the safety of products containing somatropin human growth hormone after a long-term epidemiological study suggested an increased risk of mortality with somatropin therapy compared to the general population. EMA...
07:00 , Jul 5, 2010 |  BioCentury  |  Finance

2H10 milestones

2H10 milestones Selected products with Phase III or regulatory milestones expected in 2H10 Company Product Indication Event Milestone Actelion Ltd. (SIX:ATLN) Pivlaz clazosentan Prevent the occurrence of cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH) Ph...
07:00 , Apr 19, 2010 |  BC Week In Review  |  Clinical News

Ribavirin Biopartners 200 mg tablets regulatory update

The EC approved an MAA from Bioton's Biopartners GmbH unit for Ribavirin Biopartners 200 mg tablets to treat chronic hepatitis C virus (HCV) infection in combination with peginterferon alfa-2b or interferon alfa-2b. Merck & Co....
07:00 , Jun 15, 2009 |  BC Week In Review  |  Clinical News

SR-rhGH: Phase III data

A double-blind, European and U.S. Phase III trial in 152 adults with GHD showed that subcutaneous LB03002 met the primary endpoint of significantly reducing mean fat mass from baseline compared with placebo at 6 months....
01:15 , Jun 12, 2009 |  BC Extra  |  Clinical News

LB03002 meets growth hormone deficiency endpoint

Bioton S.A. (Warsaw, Poland) and LG Life Sciences Ltd. (KSE:068870) said a double-blind, European and U.S. Phase III trial in 152 adults with growth hormone deficiency showed that subcutaneous LB03002 met the primary endpoint of...