23:06 , Oct 11, 2018 |  BC Week In Review  |  Clinical News

FDA approves Roche's Hemlibra for hemophilia without inhibitors

FDA approved an sBLA for Hemlibra emicizumab-kxwh from Roche (SIX:ROG; OTCQX:RHHBY) to reduce the frequency of bleeding episodes in adults and children with hemophilia A without Factor VIII inhibitors. The company said it is now...
16:48 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

Hemlibra gets priority review

Roche (SIX:ROG; OTCQX:RHHBY) said FDA accepted and granted Priority Review to its sBLA for Hemlibra emicizumab-kxwh to treat hemophilia A in adults and children without Factor VIII inhibitors. Its PDUFA date is Oct. 4. FDA is...
13:54 , Jun 5, 2018 |  BC Extra  |  Company News

Priority Review for Hemlibra in new hemophilia A indication

Roche (SIX:ROG; OTCQX:RHHBY) said FDA accepted and granted Priority Review to its sBLA for Hemlibra emicizumab-kxwh to treat hemophilia A in adults and children without Factor VIII inhibitors. Its PDUFA date is Oct. 4. FDA is...
15:30 , May 25, 2018 |  BC Week In Review  |  Clinical News

Genentech reports Phase III data for Hemlibra without inhibitors

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) reported full data from the Phase III HAVEN 3 trial of Hemlibra emicizumab-kxwh as prophylaxis in hemophilia A patients without Factor VIII inhibitors. Data were presented at...
22:30 , May 21, 2018 |  BC Extra  |  Clinical News

Genentech reports Phase III data for Hemlibra without inhibitors

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) reported full data from the Phase III HAVEN 3 trial of Hemlibra emicizumab-kxwh as prophylaxis in hemophilia A patients without Factor VIII inhibitors. Data were presented at...
19:40 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

Hemlibra patient develops neutralizing anti-drug antibodies

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) disclosed that a hemophilia A patient who was receiving Hemlibra emicizumab-kxwh in the Phase III HAVEN 2 trial developed neutralizing anti-drug antibodies to Hemlibra that resulted in...
15:38 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Japan approvals include Hemlibra, Shingrix Galafold

Japan approved a basket of drugs including hemophilia drug Hemlibra emicizumab from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), shingles vaccine Shingrix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Fabry's disease drug Galafold migalastat from Amicus Therapeutics Inc....
15:37 , Mar 30, 2018 |  BC Week In Review  |  Company News

Genentech discloses deaths in patients treated with Hemlibra

The Hemophilia Federation of America said on March 27 that it was notified by the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) that a total of five deaths have occurred in patients receiving hemophilia drug...
23:29 , Mar 27, 2018 |  BC Extra  |  Company News

Genentech discloses deaths in patients treated with Hemlibra

The Hemophilia Federation of America said on Tuesday that it was notified by the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) that a total of five deaths have occurred in patients receiving hemophilia drug Hemlibra...
22:09 , Mar 23, 2018 |  BC Extra  |  Company News

Japan approvals include Hemlibra, Shingrix, Galafold

Japan approved a basket of drugs including hemophilia drug Hemlibra emicizumab from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), shingles vaccine Shingrix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Fabry's disease drug Galafold migalastat from Amicus Therapeutics Inc....