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62 results
2:45 PM, Sep 21, 2018  |  BC Extra | Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

Jivi damoctocog alfa pegol from Bayer AG (Xetra:BAYN) for hemophilia A and Poteligeo mogamulizumab from Kyowa Hakko Kirin
11:31 AM, Aug 08, 2018  |  BC Extra | Company News

FDA approves Kyowa's Poteligeo for CTCL

FDA approved Poteligeo mogamulizumab-kpkc from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat the two most common forms …
10:45 AM, Jul 31, 2018  |  BC Extra | Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) revealed that it and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) sold a rare …
3:08 PM, Jul 27, 2018  |  BC Extra | Company News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

from Fujifilm Kyowa Kirin Biologics Co. Ltd., a JV between Fujifilm Holdings Corp. (Tokyo:4901) and Kyowa Hakko Kirin
3:47 PM, Apr 24, 2018  |  BC Extra | Company News

Amgen considering risk-based Aimovig pricing

On a conference call to discuss 1Q18 earnings call, Amgen Inc. (NASDAQ:AMGN) EVP of Global Commercial Operation Anthony Hooper said the biopharma is "prepared to talk to payers about risk-based contracts with Aimovig." This quarter, Amgen...
2:16 PM, Apr 24, 2018  |  BC Extra | Company News

Biogen looks to ex-U.S. markets for growth

Biogen Inc. (NASDAQ:BIIB) perceives greater long-term growth opportunities than anticipated in the EU and emerging markets, the company's CEO Michel Vounatsos said on its earnings call Tuesday, while noting that the U.S. market remains its...
12:57 PM, Apr 17, 2018  |  BC Extra | Company News

Ultragenyx gains rare disease approval, voucher

FDA approved Crysvita burosumab-twza (KRN23, UX023) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and partner Kyowa Hakko Kirin Co. Ltd …
3:09 PM, Apr 05, 2018  |  BC Extra | Company News

Samsung Bioepis, AbbVie settle Humira biosimilar dispute

in 2016. In March, the EC approved ABP 501 under two names: Amgevita and Solymbic. Kyowa Hakko Kirin
3:09 PM, Mar 23, 2018  |  BC Extra | Company News

Japan approvals include Hemlibra, Shingrix, Galafold

is under review in the U.S., EU and China to treat HCC. Orkedia evocalcet from Kyowa Hakko Kirin
12:30 PM, Feb 23, 2018  |  BC Extra | Company News

XLH therapy burosumab gains EU approval

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the European Commission granted conditional …

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