BC Extra | Apr 18, 2019
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FDA draft guidance suggests comparing bispecifics to monospecific antibodies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monospecific products targeting the different antigens could be a requirement for gaining FDA approval, according to draft guidance released Thursday.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...
BC Week In Review | Mar 1, 2019
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...
BC Extra | Feb 25, 2019
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...
BC Week In Review | Oct 11, 2018
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...
BC Week In Review | Jun 8, 2018
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...
BC Extra | Jun 5, 2018
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...
BC Week In Review | May 25, 2018
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...
BC Extra | May 21, 2018
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...
BC Week In Review | Apr 27, 2018
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...
BC Week In Review | Mar 30, 2018
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....
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