Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX™, the company’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B.
Biogen Idec Inc. today reported third quarter 2013 total revenues of $1.8 billion, an increase...
Isis Earns $10 Million Milestone Payment from Biogen Idec for Advancement of ISIS-DMPK Rx to Treat Myotonic DystrophyOctober 16, 2013 8:04 am | News | Comments
Isis Pharmaceuticals, Inc. announced today that it has earned a $10 million milestone payment...
Biogen Idec has been added to the prestigious Dow Jones Sustainability World Index becoming the first and only U.S. based biotech sector firm to make the list. The company was also named to the Dow Jones Sustainability Index (DJSI) North America for the fourth consecutive year, one of only three biotech companies included.
Shares of Isis Pharmaceuticals advanced yesterday after the company reported positive results from a study of a drug designed to treat spinal muscular atrophy, a rare genetic disorder. Isis said most of the children who received the largest doses of its drug ISIS-SMN continued to show improvements in muscle function up to 14 months after treatment.
Amicus Therapeutics, a biopharmaceutical company developing therapies for rare and orphan diseases, has entered a collaboration with Biogen Idec to discover, develop and commercialize novel small molecules for the treatment of Parkinson's disease.
Biogen Idec and Isis Pharmaceuticals, Inc. today announced that the companies have entered into a broad, multi-year collaboration to leverage antisense technology to advance the treatment of neurological diseases. The agreement combines Biogen Idec's expertise in neurology with Isis' leadership in antisense technology to develop novel therapies to treat neurological disorders.
Biogen Idec today announced that Spyros Artavanis-Tsakonas, Ph.D., has been named the company’s Chief Scientific Officer (CSO). Dr. Artavanis-Tsakonas had served as interim CSO while on sabbatical from Harvard Medical School. He will now continue in this role in a permanent capacity, and will also lead the company’s research strategy, capabilities and discovery platforms.
Biogen Idec has submitted a new injectable multiple sclerosis drug to the Food and Drug Administration for U.S. market approval. The drug, called Plegridy, is intended to treat patients with relapsing forms of multiple sclerosis, a disease of the immune system in which the body attacks the brain and spinal cord.
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the marketing approval of ELOCTATE™ (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A.
Biogen Idec has completed its purchase of Elan Corporation’s interest in TYSABRI ® (natalizumab) and has gained full strategic, commercial and decision-making rights to TYSABRI. The transaction was originally announced on February 6, 2013.
The U.S. Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to control multiple sclerosis in adults with hard-to-treat forms of the disease.The twice-a-day capsules, called Tecfidera, offer a new option for multiple sclerosis, a debilitating disease in which the body attacks its own nervous system.
Biogen Idec today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 8,399,514, which offers additional protection for TECFIDERA™ (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The patent, which will expire in 2028, covers the dosing regimen of daily administration of 480 mg of TECFIDERA.
Biogen Idec announced today that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A.
Biogen Idec, Forest and Bayer Among Top Sponsors Rated by Investigative Sites in New CenterWatch SurveyMarch 4, 2013 7:59 am | News | Comments
More than 2,000 global investigative sites rate the best biopharmaceutical companies to work for in a new survey conducted by CenterWatch, a provider of global clinical trials information. The survey results were released today in the March issue of The CenterWatch Monthly newsletter.
FDA Accepts Biogen Idec’s Biologics License Application for First Long-Lasting Factor IX Therapy for Hemophilia BMarch 4, 2013 7:50 am | News | Comments
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline.
Biogen Idec to Acquire Full Rights and Control of TYSABRI® from Elan for Upfront Cash and Contingent PaymentsFebruary 6, 2013 7:58 am | News | Comments
Biogen Idec Inc. today announced the company has agreed to purchase Elan’s interest in TYSABRI (natalizumab) and upon closing will gain full strategic, commercial and decision-making rights to TYSABRI. Upon the closing of the transaction, the previous collaboration agreement between the companies, whereby worldwide TYSABRI profits were split 50/50, will be terminated along with the agreement’s change of control provisions.
Biogen Idec Inc. has announced full year and fourth quarter 2012 results.
Biogen Idec said a potential multiple sclerosis treatment designed to last longer between injections fared well in late-stage research, and the drug developer plans to submit it to U.S. and European regulators for possible approval this year.
Biogen Idec and Elan Submit Applications for First-Line Use of TYSABRI in anti-JCV Antibody Negative Patients with MSJanuary 17, 2013 3:25 am | News | Comments
Biogen Idec and Elan Corporation have submitted applications to the FDA and European Medicines Agency (EMA) requesting updates to the TYSABRI ® (natalizumab) labels.
WESTON, Mass. (AP) — Biogen Idec is halting the development of an experimental treatment for Lou Gehrig's disease after a late-stage study.
Biogen Idec announced today that it has created a new research consortium in collaboration with several leading academic research centers that will leverage a range of scientific techniques and disciplines to identify new approaches to treating amyotrophic lateral sclerosis (ALS).
Biogen Idec and Eisai Inc. today announced a strategic alliance that will bolster the manufacturing capabilities of both companies’ Research Triangle Park (RTP)-based facilities.
Biogen Idec and Isis Pharmaceuticals Announce Collaboration For Antisense Programs to Treat Neurological DisordersDecember 11, 2012 3:21 am | News | Comments
Biogen Idec and Isis Pharmaceuticals, Inc. have entered into a global collaboration agreement under which the companies will discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders.
Biogen Idec has dedicated a new facility in Research Triangle Park (RTP), consolidating its 300-person Patient Services operation with the existing RTP campus
Shares of Biogen Idec Inc. continued to slump Friday after the company said the Food and Drug Administration has delayed a decision on its multiple sclerosis pill BG-12.
WASHINGTON (AP) — Biogen Idec has received U.S. approval for an easier-to-use injection device for its multiple sclerosis drug Avonex.
Samsung Biologics and Biogen Idec announced today that the companies have established their joint venture, Samsung Bioepis Co., Ltd., to develop, manufacture and market biosimilars in keeping with their agreement announced in December.
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