BIIB

Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®

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목요일, 4월 25, 2024
BIIB, Biogen, Adalimumab, Methotrexate, Etanercept, Safety, Pharmacokinetics, European Commission, CHMP, Condylar resorption, Tocilizumab, European, Patient, Rheumatoid arthritis, EMA, Infliximab, Committee, Civil service commission, COVID-19, European Medicines Agency, Vaccine

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA®

Key Points: 
  • CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA®
    CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1.
  • The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE.
  • “The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen.
  • Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan).

Biogen Inc. (BIIB) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Seek Compensation for Alleged Wrongdoings

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목요일, 3월 21, 2024
Class Action Lawsuit, Professional Services, Legal, BIIB, Biogen, News

Attorney Advertising--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Biogen Inc. (“Biogen Inc.” or “the Company”) (NASDAQ: BIIB).

Key Points: 
  • Attorney Advertising--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Biogen Inc. (“Biogen Inc.” or “the Company”) (NASDAQ: BIIB).
  • Investors who purchased Biogen Inc. securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/BIIB .
  • You can also contact Peretz Bronstein or his law clerk and client relations manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660.
  • Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits.

Biogen Inc. (BIIB) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Seek Compensation for Alleged Wrongdoings

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목요일, 3월 14, 2024
Class Action Lawsuit, Professional Services, Legal, BIIB, Biogen, News

Attorney Advertising--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Biogen Inc. (“Biogen Inc.” or “the Company”) (NASDAQ: BIIB).

Key Points: 
  • Attorney Advertising--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Biogen Inc. (“Biogen Inc.” or “the Company”) (NASDAQ: BIIB).
  • Investors who purchased Biogen Inc. securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/BIIB .
  • You can also contact Peretz Bronstein or his law clerk and client relations manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660.
  • Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits.

AbCellera to Collaborate with Biogen to Discover Therapeutic Antibodies for Neurological Conditions

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월요일, 3월 11, 2024
Health, Neurology, Research, Pharmaceutical, Science, Biotechnology, BIIB, SVP, Brain, Doctor of Philosophy, Biogen, Antibody, Neuroscience, ABCL

AbCellera (Nasdaq: ABCL) and Biogen Inc. (Nasdaq: BIIB) have entered into a strategic collaboration to discover antibodies for a novel target that enables the delivery of biotherapeutics to the brain for indications in neuroscience.

Key Points: 
  • AbCellera (Nasdaq: ABCL) and Biogen Inc. (Nasdaq: BIIB) have entered into a strategic collaboration to discover antibodies for a novel target that enables the delivery of biotherapeutics to the brain for indications in neuroscience.
  • “Delivering biologics across the blood brain barrier is one of the most important and long-standing problems in neuroscience,” said Murray McCutcheon, Ph.D., SVP, Partnering at AbCellera.
  • “We are excited to work with Biogen on this innovative program, which has the potential to unlock multiple new approaches to treating neurological conditions.”
    Under the terms of the agreement, AbCellera will receive an upfront payment and is eligible to receive additional milestone payments should the research programs achieve certain research, developmental and regulatory milestones.
  • AbCellera is also eligible to receive potential royalties on future net sales of products that result from the collaboration.

New Biomarker Data Add Further Evidence Supporting the Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs after Gene Therapy

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수요일, 3월 6, 2024
ALS, Aes, Research, RESPOND, BIIB, SMN2, Spinal muscular atrophy, Conference, Biogen, SMA, Safety, Biomarker, AFL, Patient, MDA, Development, Episcopal conference, Birth control

* The Phase 4 study evaluates clinical outcomes and safety following treatment with SPINRAZA over a 2-year period in infants and toddlers with spinal muscular atrophy (SMA) who have unmet clinical needs after treatment with Zolgensma® (onasemnogene abeparvovec).

Key Points: 
  • * The Phase 4 study evaluates clinical outcomes and safety following treatment with SPINRAZA over a 2-year period in infants and toddlers with spinal muscular atrophy (SMA) who have unmet clinical needs after treatment with Zolgensma® (onasemnogene abeparvovec).
  • The new data show that plasma neurofilament light chain (NfL) levels, an objective biomarker of axonal injury and neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA.
  • These data will be presented at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 3-6, 2024).
  • “Our evolving understanding of gene therapy indicates there may be an opportunity for better outcomes,” said Crystal Proud, M.D., Pediatric Neurologist at Children’s Hospital of the King’s Daughters.

Biogen Highlights New Data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024 Annual Meeting

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월요일, 3월 4, 2024
OGA, Research, BIIB, Investment, Eisai, Alpha-synuclein, Amyloid, Conference, Biogen, Quantitative systems pharmacology, Dementia, MCI, QSP, Clarity, MAPT, Brain, Vaccine

The presentations include new data for its oral small molecule inhibitor of tau aggregation (BIIB113), as well as presentations providing insights into the underlying mechanisms of Alzheimer’s disease.

Key Points: 
  • The presentations include new data for its oral small molecule inhibitor of tau aggregation (BIIB113), as well as presentations providing insights into the underlying mechanisms of Alzheimer’s disease.
  • In addition to BIIB113, Biogen is researching the potential of tau reduction in AD with its investigational antisense oligonucleotide targeting the microtubule associated protein tau (MAPT) gene (BIIB080).
  • Oral presentation: Results of the first in-human, randomized, blinded, placebo-controlled, single- and multiple-ascending dose study of BIIB113 in healthy volunteers.
  • Oral presentation: Lecanemab for the treatment of early Alzheimer’s disease; the extension of efficacy results from Clarity AD.

BIOGEN ALERT: Bragar Eagel & Squire, P.C. is Investigating Biogen Inc. on Behalf of Biogen Stockholders and Encourages Investors to Contact the Firm

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토요일, 2월 24, 2024
News, Telephone, BIIB, P.C

NEW YORK, Feb. 24, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB) on behalf of Biogen stockholders.

Key Points: 
  • NEW YORK, Feb. 24, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB) on behalf of Biogen stockholders.
  • Our investigation concerns whether Biogen has violated the federal securities laws and/or engaged in other unlawful business practices.
  • Click here to participate in the action.
  • On this news, Biogen’s stock price fell $5.91, or 2.6%, to close at $220.74 per share on February 14, 2024, thereby injuring investors.

Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP

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금요일, 2월 23, 2024
Fever, European Commission, EMA, ALS, Committee, MND, Myalgia, Intracranial pressure, BIIB, Cerebrospinal fluid, Pain, Hope, Biogen, European, SOD1, Arthralgia, Civil service commission, Biomarker, Fatigue, CHMP, AFL, European Medicines Agency, Protein, Disease, UZ Leuven, Mutation, Myelitis, Neurology, Aseptic meningitis, Research, Chronic pain, Vaccine

If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).

Key Points: 
  • If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).
  • “The CHMP’s positive opinion reinforces the impact QALSODY can have in SOD1-ALS and further demonstrates Biogen’s commitment to address the unmet needs of people living with ALS and neuromuscular diseases,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen.
  • Trends towards improvement in the physical abilities of participants who received QALSODY were seen compared to those who received placebo, as measured by the ALS Functional Ratings Scale-Revised (ALSFRS-R).
  • Serious neurologic events, including myelitis and/or radiculitis; papilledema and elevated intracranial pressure; and aseptic meningitis have also been reported.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Biogen Inc. (BIIB) on Behalf of Investors

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금요일, 2월 23, 2024
Class Action Lawsuit, Professional Services, Legal, Biogen, GPM, News, DOJ, Person, BIIB

Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) investors concerning the Company’s possible violations of the federal securities laws.

Key Points: 
  • Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) investors concerning the Company’s possible violations of the federal securities laws.
  • If you suffered a loss on your Biogen investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at www.glancylaw.com/cases/Biogen-Inc-1/ .
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • Whistleblower Notice: Persons with non-public information regarding Biogen should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Biogen Inc. (BIIB) on Behalf of Investors

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목요일, 2월 22, 2024
Class Action Lawsuit, Professional Services, Legal, Biogen, News, DOJ, Suite, BIIB, Telephone

Law Offices of Howard G. Smith announces an investigation on behalf of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB ) investors concerning the Company’s possible violations of federal securities laws.
  • On February 14, 2024, Biogen disclosed that it had received a subpoena from the DOJ seeking information about its “business operations in several foreign countries.” On this news, Biogen’s stock price fell $5.91, or 2.6%, to close at $220.74 per share on February 14, 2024, thereby injuring investors.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
  • View source version on businesswire.com: https://www.businesswire.com/news/home/20240222700198/en/