34 documents

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17:30 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 on Oct. 10 that a resubmitted BLA from Celltrion Inc. (KRX:068270) supports approval of CT-P10, its biosimilar of Rituxan/MabThera rituximab. The panel backed the biosimilar's approval as a...
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22:09 , Oct 10, 2018 |  BC Extra  |  Company News

FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 Wednesday that a resubmitted BLA from Celltrion Inc. (KRX:068270) supports approval of CT-P10, its biosimilar of Rituxan/MabThera rituximab. The panel backed the biosimilar's approval as a monotherapy to...
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18:10 , Aug 31, 2018 |  BC Week In Review  |  Financial News

Biosimilars company Mabpharm sets sights on Hong Kong IPO

Mabpharm Ltd. (Taizhou, China) proposed Aug. 22 to list on the Hong Kong Exchanges and Clearing Ltd. (HKEX) in an IPO underwritten by CICC. Mabpharm is the second biotechnology company this week to file to...
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22:52 , Aug 22, 2018 |  BC Extra  |  Financial News

Biosimilars company Mabpharm sets sights on Hong Kong IPO

Mabpharm Ltd. (Taizhou, China) proposed Wednesday to list on the Hong Kong Exchanges and Clearing Ltd. (HKEX) in an IPO underwritten by CICC. Mabpharm is the second biotechnology company this week to file to list...
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17:51 , Aug 3, 2018 |  BC Week In Review  |  Company News

Celltrion wins another biosimilar infliximab lawsuit

A federal judge ruled July 30 that biosimilar Inflectra infliximab-dyyb from Celltrion Inc. (KOSDAQ:068270) does not infringe a patent from Johnson & Johnson (NYSE:JNJ) covering autoimmune drug Remicade infliximab. The decision follows a previous Celltrion...
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22:04 , Aug 1, 2018 |  BC Extra  |  Company News

Celltrion wins another biosimilar infliximab lawsuit

A federal judge ruled Monday that biosimilar Inflectra infliximab-dyyb from Celltrion Inc. (KOSDAQ:068270) does not infringe a patent from Johnson & Johnson (NYSE:JNJ) covering autoimmune drug Remicade infliximab. The decision follows a previous Celltrion victory...
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21:26 , Jul 27, 2018 |  BioCentury  |  Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
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15:39 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Amgen's biosimilar non-inferior to Remicade in Phase III for RA

Amgen Inc. (NASDAQ:AMGN) said 3 mg/kg ABP 710, a biosimilar of Remicade infliximab, was non-inferior to Remicade on the primary endpoint of the proportion of patients with a 20% improvement in American College of Rheumatology...
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23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
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18:50 , Feb 9, 2018 |  BC Week In Review  |  Clinical News

FDA warns Celltrion of GMP violations at Inflectra facility

FDA issued a warning letter to Celltrion Inc. (KOSDAQ:068270) on Jan. 26 identifying "significant violations" of GMP regulations regarding production of Inflectra biosimilar infliximab-dyyb (CT-P13) at its manufacturing facility in Incheon, South Korea. According to...
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