BioCentury | Jun 2, 2020
Finance

Hillhouse-backed $160M series B round to drive Genor’s first candidate to the market

Genor plans to establish a commercial team and take its first checkpoint inhibitor to market for a new indication after raising a $160 million series B round led by existing investor Hillhouse Capital. New investors...
BioCentury | Dec 7, 2019
Product Development

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...
BC Extra | Nov 26, 2019
Company News

Nov. 26 Company Quick Takes: Kyowa, Ardelyx expand partnership; plus ICER, Celltrion, Asahi-Veloxis and Merck

Kyowa, Ardelyx expand collaboration with new targets and $20M investment  Under an expanded partnership, Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) will pay Ardelyx Inc. (NASDAQ:ARDX) $10 million in research support over the next two years...
BC Extra | Jul 19, 2019
Company News

July 19 Company Quick Takes: First biosimilars of Avastin, Herceptin launched; plus Gilenya, Celltrion-Nan Fung and Celgene

Amgen, Allergan launch pair of biosimilars  Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) launched Mvasi bevacizumab-awwb and Kanjinti trastuzumab-anns in the U.S.; they are the first biosimilars of Avastin bevacizumab and Herceptin trastuzumab available in...
BC Extra | Jun 28, 2019
Company News

CHMP knocks Evenity for osteoporosis, backs Giapreza for hypotension

EMA's CHMP issued a basket of opinions Friday, including a negative opinion for Amgen's osteoporosis drug Evenity, and a recommendation for La Jolla's hypotension therapy Giapreza. The agency recommended against approval of Evenity romosozumab-aqqg from...
BC Week In Review | Oct 12, 2018
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...
BC Extra | Oct 10, 2018
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...
BC Week In Review | Aug 3, 2018
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...
BC Extra | Aug 1, 2018
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...
BioCentury | Jul 27, 2018
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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