20:44 , Apr 18, 2019 |  BC Extra  |  Clinical News

FDA draft guidance suggests comparing bispecifics to monospecific antibodies

Demonstrated efficacy of a bispecific antibody against monospecific products targeting the different antigens could be a requirement for gaining FDA approval, according to draft guidance released Thursday. The guidance describes non-clinical and clinical recommendations for...
20:03 , Mar 1, 2019 |  BC Week In Review  |  Company News

Spark gives Roche beachhead in gene therapy

Roche (SIX:ROG; OTCQX:RHHBY) will acquire Spark Therapeutics Inc. (NASDAQ:ONCE) for $4.8 billion in a deal that marks the Swiss pharma's first major move into gene therapy. The deal announced early Feb. 25 was the first...
07:11 , Feb 25, 2019 |  BC Extra  |  Company News

Spark gives Roche beachhead in gene therapy

Roche (SIX:ROG; OTCQX:RHHBY) will acquire Spark Therapeutics Inc. (NASDAQ:ONCE) for $4.8 billion in a deal that marks the Swiss pharma's first major move into gene therapy. The deal announced early Monday was the first major...
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...
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...
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....