biogen inc ISIN: US09062X1037

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biogen inc ISIN: US09062X1037

Berichtdoor alles kan beter » 17 Okt 2018 08:55

About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.
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Re: biogen inc ISIN: US09062X1037

Berichtdoor alles kan beter » 17 Okt 2018 08:56

IMRALDITM (adalimumab), a biosimilar referencing HUMIRA® i, is the third anti-TNF biosimilar developed by Samsung Bioepis to be commercialized by Biogen across Europe, following BENEPALITM (etanercept) and FLIXABITM (infliximab)
Biogen and Samsung Bioepis were the first in Europe to receive approvals for biosimilars referencing the three most prescribed anti-TNF medicines in Europe.
Biogen (BIIB) and Samsung Bioepis Co., Ltd. today announced the European launch of IMRALDI™ (adalimumab), a biosimilar referencing HUMIRA®. Starting today, IMRALDI™ will begin launching in major markets across Europe.
The launch of IMRALDI™ marks a significant milestone for Biogen and Samsung Bioepis, as the adalimumab product is the third anti-TNF biosimilar developed by Samsung Bioepis to be commercialized by Biogen across Europe. BENEPALI™ (etanercept) and FLIXABI™ (infliximab) were approved in 2016, and have approximately 100,000 patients currently under treatment with more than 6 million doses administered across 25 and 14 countries, respectively.ii
“We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market,” said Ian Henshaw, Head of Biogen’s Biosimilars Unit.
“The launch of IMRALDI marks what we believe to be a landmark moment for Biogen and Samsung Bioepis and for European healthcare systems. We hope IMRALDI will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market,” said Sang-Jin Pak, Chief Operating Officer, Samsung Bioepis. “In just six years, Samsung Bioepis has successfully developed the industry’s leading portfolio of anti-TNF biosimilars with a strong pipeline of further biosimilar candidates currently under development.”
“We are proud of our collaboration with Biogen, which brings together the development expertise of Samsung Bioepis with the commercial excellence of Biogen for the benefit of patients across Europe.”
The European Commission (EC) approved IMRALDI™ in August 2017 for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.iii
The EC approval was based on data derived from a randomized, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either SB5 or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the SB5 group versus 72.2% in the ADL group. The safety profile of SB5 was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transitioned to SB5, and 254 patients receiving SB5 continued to receive SB5. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.iv v
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Re: biogen inc ISIN: US09062X1037

Berichtdoor alles kan beter » 22 Okt 2018 07:42

announced it will present data from its Alzheimer’s disease (AD) clinical development portfolio at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting in Barcelona, Spain (October 24-27). The data being presented are part of Biogen’s ongoing research programs targeting possible causes of the disease through multiple modalities.
“We are excited to engage with the scientific community at CTAD, to share learnings from our Alzheimer’s disease clinical research and to learn from the work of our colleagues around the world. We have hopes that our collective research will one day help the millions of people living with Alzheimer’s disease,” said Samantha Budd Haeberlein, Ph.D., vice president, Alzheimer’s disease, dementia and movement disorders, late stage clinical development at Biogen.
Biogen will share a late-breaking oral presentation and a late-breaking poster on the efficacy of aducanumab and the cumulative safety data from the Phase 1b PRIME long-term extension study of patients with prodromal and mild Alzheimer’s disease. Aducanumab is Biogen’s late-stage Alzheimer’s disease investigational treatment, and is being co-developed with Eisai.
In addition to presentations from our clinical research programs, Dr. Budd Haeberlein will deliver a keynote titled “What Have We Learned from Aducanumab?” that focuses on the lessons learned from the aducanumab research.
Biogen presentations will highlight:
Oral Presentation: Aducanumab Titration Dosing Regimen: 36-Month Analyses from PRIME, a Phase 1b Study in Patients with Early Alzheimer’s Disease – Friday, October 26, 3:15-3:30 p.m. CEST
Keynote: What Have We Learned from Aducanumab? – Thursday, October 25, 1:30-2:00 p.m. CEST
Poster Presentation: Cumulative Aducanumab Safety Data from PRIME: A Randomized, Double-blind, Placebo-controlled, Phase 1b Study – Wednesday, October 24, through Saturday, October 27. The poster will be available on Biogen.com
Poster Presentation: Aducanumab 48-Month Analyses from PRIME, a Phase 1b Study in Patients with Early Alzheimer’s Disease – Wednesday, October 24, through Saturday, October 27. The poster will be available on Biogen.com
Biogen will also host live webcasts of its oral presentation and keynote address, as well as a Q&A session related to its Alzheimer’s disease investigational therapies. To access the live webcasts, please go to the Investors section of Biogen’s website at investors.biogen.com. Following the live webcasts, archived versions will be available on the website.
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