News Breaks |
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| March 4, 2013 |
| 07:31 EDT |  | BIIB | FDA accepts Biogen's BLA for recombinant factor rFIXFc
Biogen Idec announced that the U.S. Food and Drug Administration has accepted the company’s Biologics License Application, or BLA, for the marketing approval of recombinant factor IX Fc fusion protein, or rFIXFc, for the treatment of hemophilia B and granted the company a standard review timeline. Recombinant FIXFc is the first product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for hemophilia B. The regulatory submission was based on results from B-LONG, the largest registrational phase 3 clinical study in hemophilia B to date. The study showed that rFIXFc provides long-lasting protection from bleeding with fewer injections than are required with the current standard of care. The company’s BLA submission for rFVIIIFc for use in patients with hemophilia A is on track for filing during the first half of 2013. |
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News For BIIB From The Last 14 Days Check below for free stories on BIIB the last two weeks. |
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| May 23, 2013 |
| 08:04 EDT | | BIIB | Biogen appoints Spyros Artavanis-Tsakonas as Chief Scientific Officer
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| May 21, 2013 |
| 07:24 EDT |  | BIIB | Global Health Care to host a conference
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| 05:44 EDT | | BIIB | Biogen submits application to FDA for approval of Plegridy in RMS
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| May 20, 2013 |
| 15:57 EDT |  | BIIB | Biogen IMS numbers should not be adjusted down at ISI Group
ISI Group confirmed with Biogen that Tecfidera is not captured by IMS and numbers should not be adjusted downward to reflect free drugs dispensed. |
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| 07:39 EDT | | BIIB | Biogen weekly MS drug scripts up 26.5%, says Citigroup
Citigroup says weekly scripts for Biogen's multiple sclerosis drug Tecfidera were up 26.5% to 1,621. Citi says the launch of Tecfidera is on track to beat Q2 estimates by a wide margin and it keeps a Buy rating on shares of Biogen. |
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| May 16, 2013 |
| 07:29 EDT | | BIIB | Leerink to host a bus tour
Boston Biopharma Bus Tour travels throughout Boston on May 16-17. |
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| May 14, 2013 |
| 15:09 EDT | | BIIB | Biogen has a conference call hosted by JPMorgan
JPMorgan Analysts Meacham and Kasimov host a conference call with CEO George Scangos and CFO Paul Clancy on May 17 at 10 am. |
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| May 13, 2013 |
| 11:12 EDT | | BIIB | Biogen MS drug scripts grew 38% week-over-week, says Leerink
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| 07:34 EDT | | BIIB | Biogen says FDA accepts BLA for Eloctate
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| May 10, 2013 |
| 08:00 EDT | | BIIB | Biogen should be bought on weakness before Q2 Tecfidera data, says Stifel
Stifel recommends buying Biogen on any weakness before the company reports Q2 Tecfidera sales data. The firm thinks that any continued strength in Tecfidera prescription data will cause analysts to revise their estimates higher, and it keeps a Buy rating on the shares. |
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| May 9, 2013 |
| 16:59 EDT | | BIIB | Isis Pharmaceuticals earns $3.5M from Biogen
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