18 documents

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20:43 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Dec. 14, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The...
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23:22 , Dec 14, 2018 |  BC Extra  |  Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
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18:09 , Jun 1, 2018 |  BC Week In Review  |  Financial News

JHL raises $106M in bond deal

Biosimilars company JHL Biotech Inc. (Zhubei, Taiwan) raised $106 million on May 15 in convertible bonds led by new investor VMS Investment Group, according to JHL CFO Ellis Chu. Also participating were new investor Ruihua...
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16:45 , May 30, 2018 |  BC Extra  |  Financial News

JHL raises $106M in bond deal

Biosimilars company JHL Biotech Inc. (Zhubei, Taiwan) raised $106 million in convertible bonds led by new investor VMS Investment Group, according to JHL CFO Ellis Chu. Also participating were Ruihua Investment, existing investor Milestone Capital...
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19:36 , Jan 19, 2018 |  BC Week In Review  |  Clinical News

EC approves Amgen's biosimilar Avastin

Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) said the European Commission approved Mvasi (ABP 215), a biosimilar of Avastin bevacizumab. The approval includes all cancer types on Avastin's EU label -- non-small cell lung cancer...
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03:33 , Nov 17, 2017 |  BC Week In Review  |  Clinical News

CHMP recommends Amgen's Avastin biosimilar ABP 215

EMA's CHMP recommended approval of ABP 215 from Amgen Inc. (NASDAQ:AMGN), a biosimilar of Avastin bevacizumab, for all cancer types on Avastin's EU label: non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and colorectal,...
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21:09 , Sep 15, 2017 |  BC Week In Review  |  Clinical News

FDA approves first biosimilar for cancer

FDA approved a BLA from Amgen Inc. (NASDAQ:AMGN) for Mvasi bevacizumab-awwb (ABP 215), a biosimilar of cancer drug Avastin bevacizumab. FDA said Mvasi is the first biosimilar approved in the U.S. to treat cancer. Mvasi...
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18:04 , Sep 1, 2017 |  BC Week In Review  |  Clinical News

FDA approves Chemo's Chagas treatment

FDA granted accelerated approval to benznidazole from the Chemo Research S.L. unit of Chemo Group (Barcelona, Spain) to treat Chagas disease caused by Trypanosoma cruzi in children ages 2-12. FDA said the nitroimidazole antimicrobial is...
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00:04 , Aug 30, 2017 |  BC Extra  |  Company News

FDA approves first Chagas treatment

FDA granted accelerated approval to benznidazole from the Chemo Research S.L. unit of Chemo Group (Madrid, Spain) to treat Chagas disease in children ages two to 12 years. FDA said the oral small molecule antiprotozoal...
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19:31 , Jul 14, 2017 |  BC Week In Review  |  Clinical News

FDA panel backs approval of Amgen's Avastin biosimilar

FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 17-0 in favor of approving ABP 215 from Amgen Inc. (NASDAQ:AMGN). The product is a biosimilar of Avastin bevacizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHBBY)....
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