Biogen

Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection

Retrieved on: 
Thursday, March 16, 2023
EMA, European Medicines Agency, European, General Court, Court of Justice of the European Union, EP, BIIB, European Commission, Marketing, Dimethyl fumarate, Patent, Justice, Civil service commission, Risk management, Biogen

CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection.

Key Points: 
  • CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection.
  • With this favorable decision, Biogen believes that TECFIDERA is entitled to regulatory marketing protection in the European Union until at least February 4, 2024.
  • Biogen will seek to enforce this protection and continue to enforce its EP 2 653 873 patent related to TECFIDERA, which expires in 2028.
  • Biogen’s Full Year 2023 Financial Guidance issued on February 15, 2023, assumed a favorable decision such as this in this case.

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023
The New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

Biogen Appoints Chuck Triano as Head of Investor Relations

Retrieved on: 
Tuesday, March 14, 2023
Research, Biotechnology, Therapy, University, Forest Laboratories, BIIB, Senior, Pfizer, Management, Biogen

CAMBRIDGE, Mass., March 14, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced the appointment of Chuck Triano as Senior Vice President, Head of Investor Relations effective 10 April 2023.

Key Points: 
  • CAMBRIDGE, Mass., March 14, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced the appointment of Chuck Triano as Senior Vice President, Head of Investor Relations effective 10 April 2023.
  • Prior to joining Xalud Therapeutics, Mr. Triano served as Senior Vice President of Investor Relations at Pfizer for over a decade, where he was responsible for all global investor relations functions, as well as operations planning and analysis.
  • Previously, he served as the Vice President of Investor Relations at Forest Laboratories, where he initiated the company’s first formal investor relations and corporate communications program.
  • Mike Hencke, Executive Director, Investor Relations, and the Investor Relations team will report to Mr. Triano.

Biotech Sector Working Fast to Combat Alzheimer's Disease Cases That are Set to Explode

Retrieved on: 
Wednesday, March 15, 2023
Brain, GLP, Biogen, Roche, NOT, Intraparenchymal hemorrhage, Advertising, MCI, Human, Parkinson's disease, COVID-19, Disease, CSF, Agitation, Dementia, Rat, Security (finance), Doctor of Philosophy, AD, Dog, Fast Track, MRI, RBC Capital Markets, Caffeine, Bleeding, Amyloid, Communication, A2A, The Company, Marvel, Mayo Clinic, Research, Form 10-K, Depression, Clinical professor, Risk, DSM-IV codes, CT, Patient, Annual report, MIQ, FDA, Diagnosis, Safety, News, BIIB, FNM, Toxicology, Immunotherapy, SL, Biotechnology, OTC, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Istradefylline

VANCOUVER, B.C., March 15, 2023 /PRNewswire/ -- March 15, 2023 - USA News Group - According to a 2022 study of more than 6 million patients 65 and older, the risk factor for developing Alzheimer's disease increases by 50-80% in older adults who caught COVID-19. With Statista stating nearly 11.5 million COVID-19 cases of people over 65 years old as of November 23, 2022, and the Alzheimer's Association forecasting global dementia cases to triple by 2050, society is about to get hit with a tsunami of this devastating disease. Thankfully the biotech sector is working diligently to try and combat this coming onslaught of Alzheimer's and dementia, through new diagnostic methods and treatments, including work from companies such as Marvel Biosciences Corp. (TSXV:MRVL), Biogen Inc. (NASDAQ:BIIB), Prothena Corporation plc (NASDAQ:PRTA), Intra-Cellular Therapies (NASDAQ:ITCI), and Roche Holding AG (OTC:RHHBY).

Key Points: 
  • In the case of Marvel Biosciences Corp. (TSXV:MRVL), the biotech company is moving forward with its lead asset MB-204 in targeting Alzheimer's and depression .
  • MB-204 is a novel fluorinated derivative of Istradefylline, the only clinically approved adenosine A2a receptor antagonist used for the treatment of Parkinson's disease.
  • Caffeine consumption has been associated with a reduced risk for developing Parkinson's disease, Alzheimer's disease and improving mood and concentration.
  • MB-204 will be highly disruptive to the existing market and, we believe, will be a welcomed therapy for patients who suffer from Alzheimer's Disease and Depression.

Biotech Sector Working Fast to Combat Alzheimer's Disease Cases That are Set to Explode

Retrieved on: 
Wednesday, March 15, 2023
Brain, GLP, Biogen, Roche, NOT, Intraparenchymal hemorrhage, Advertising, MCI, Human, Parkinson's disease, COVID-19, Disease, CSF, Agitation, Dementia, Rat, Security (finance), Doctor of Philosophy, AD, Dog, Fast Track, MRI, RBC Capital Markets, Caffeine, Bleeding, Amyloid, Communication, A2A, The Company, Marvel, Mayo Clinic, Research, Form 10-K, Depression, Clinical professor, Risk, DSM-IV codes, CT, Patient, Annual report, MIQ, FDA, Diagnosis, Safety, News, BIIB, FNM, Toxicology, Immunotherapy, SL, Biotechnology, OTC, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Istradefylline

VANCOUVER, B.C., March 15, 2023 /PRNewswire/ -- March 15, 2023 - USA News Group - According to a 2022 study of more than 6 million patients 65 and older, the risk factor for developing Alzheimer's disease increases by 50-80% in older adults who caught COVID-19. With Statista stating nearly 11.5 million COVID-19 cases of people over 65 years old as of November 23, 2022, and the Alzheimer's Association forecasting global dementia cases to triple by 2050, society is about to get hit with a tsunami of this devastating disease. Thankfully the biotech sector is working diligently to try and combat this coming onslaught of Alzheimer's and dementia, through new diagnostic methods and treatments, including work from companies such as Marvel Biosciences Corp. (TSXV:MRVL), Biogen Inc. (NASDAQ:BIIB), Prothena Corporation plc (NASDAQ:PRTA), Intra-Cellular Therapies (NASDAQ:ITCI), and Roche Holding AG (OTC:RHHBY).

Key Points: 
  • In the case of Marvel Biosciences Corp. (TSXV:MRVL), the biotech company is moving forward with its lead asset MB-204 in targeting Alzheimer's and depression .
  • MB-204 is a novel fluorinated derivative of Istradefylline, the only clinically approved adenosine A2a receptor antagonist used for the treatment of Parkinson's disease.
  • Caffeine consumption has been associated with a reduced risk for developing Parkinson's disease, Alzheimer's disease and improving mood and concentration.
  • MB-204 will be highly disruptive to the existing market and, we believe, will be a welcomed therapy for patients who suffer from Alzheimer's Disease and Depression.

Caroline Dorsa to Succeed Stelios Papadopoulos as Chair of Biogen Board of Directors

Retrieved on: 
Wednesday, March 8, 2023
BIIB, Growth, Merck, Merck & Co., Retirement, Public Service Enterprise Group, Spinal muscular atrophy, Integration, Annual general meeting, Multiple sclerosis, Patient, Audit committee, Intelligence, Management, Biogen, Shareholder

(NASDAQ: BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective immediately following the Company’s 2023 Annual Meeting of Stockholders (the “Annual Meeting”), scheduled to take place on June 14, 2023.

Key Points: 
  • (NASDAQ: BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective immediately following the Company’s 2023 Annual Meeting of Stockholders (the “Annual Meeting”), scheduled to take place on June 14, 2023.
  • Ms. Dorsa will succeed Stelios Papadopoulos, Ph.D., who announced he would not stand for reelection to the Board at the Annual Meeting.
  • Dr. Papadopoulos said: “The entire Board has great respect for Caroline and the tremendous contributions she has made during her 13-year tenure and as Chair of our Audit Committee, where she has exhibited exceptional judgement, integrity, and dedication.
  • I’m stepping down knowing that the Board will be in very good hands under Caroline’s outstanding leadership.”
    Ms. Dorsa joined the Biogen Board in 2010.

Summit Therapeutics Reports Financial Results and Operational Progress for the Fourth Quarter and Year Ended December 31, 2022

Retrieved on: 
Thursday, March 9, 2023
Biotechnology, Pharmaceutical, Health, PD-1, Prostate cancer, Amgen, Research, Compugen (company), Sale, Patient, GSK, Rights, Collaboration, Stanford University School of Medicine, Senior, EPIX, MD, Webcast, Lung cancer, Interest, BTK, Entrepreneurship, Monoclonal antibody, US Foods, Hematological Cancer Research Investment and Education Act, VEGF, Executive, NSCLC, Immunotherapy, FDA, Panitumumab, Knowledge, R, Doctor of Philosophy, Colorectal cancer, SMMT, Celera Corporation, Crown Bioscience International, Biogen, Communication, Roche, Therapy, Quality of life, CMO, Pharmaceutical industry, Security (finance), Cryptocurrency, Management, Bayer, Pharmacyclics

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the fourth quarter and year ended December 31, 2022.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the fourth quarter and year ended December 31, 2022.
  • Summit is initiating development activities for SMT112 and will do so first in non-small cell lung cancer (NSCLC) indications.
  • Summit intends to start treating patients in clinical studies during the second quarter of 2023.
  • Summit’s management team will host an earnings call to discuss its fourth quarter 2022 financial results and provide an operational update for the Company today, March 9, 2023, at 9:00am ET.

Acorda Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Thursday, March 9, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, OPEX, ACOR, SG, Therapy, GAAP, Esteve, EBITDA, Government, Alkermes, Biotie Therapies, R, Acorda Therapeutics, Catalent, Cryptocurrency, Pharmaceutical industry, Video game, Reinsurance, Clothing, Music, Bookkeeping, Biogen, Açorda, 4-Aminopyridine, Nepicastat

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today reported its financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • Acorda Therapeutics, Inc. (Nasdaq: ACOR) today reported its financial results for the fourth quarter and full year ended December 31, 2022.
  • “Acorda’s operating and financial performance improved throughout the year, meeting our financial guidance for 2022 AMPYRA net revenue, INBRIJA U.S. net revenue, cash, and adjusted OPEX.
  • For the quarter ended December 31, 2022, the Company reported AMPYRA net revenue of $18.8 million, a 16.6% decrease compared to the same quarter in 2021.
  • Additionally, for the quarter ended December 31, 2022, the Company reported FAMPYRA royalty revenues of $2.7 million, a 25.1% decrease compared to the same quarter in 2021.

Twist Bioscience Announces Robust Antibody Discovery Services Integrating In Vivo, In Vitro and In Silico Approaches

Retrieved on: 
Thursday, March 9, 2023
Health, Technology, Nanotechnology, Research, Science, Pharmaceutical, Biotechnology, MBA, Biogen, CSO, G protein-coupled receptor, Factory, Engineering, Acquisition, Workflow, Martek Biosciences Corporation, Epitope mapping, Antibody, Integration, Silicon, Machine learning, DNA, Business, Technology transfer, Twist Bioscience, VHH, Quantic School of Business and Technology, Doctor of Philosophy, Acceleration, Spacecraft, AI, Festival, Future, Massachusetts Institute of Technology, Immunoglobulin G, Management, Vaccine, Library, Immunization

The combined team will be led by Tracey Mullen, MBA, who was appointed senior vice president of biopharma for Twist Bioscience.

Key Points: 
  • The combined team will be led by Tracey Mullen, MBA, who was appointed senior vice president of biopharma for Twist Bioscience.
  • “By integrating our platforms into a robust service menu, we now offer premium throughput, resolution and speed to customers looking to outsource antibody discovery and optimization,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience.
  • Supported by high-throughput DNA synthesis and IgG antibody production, Twist constructs large and highly specific synthetic antibody libraries with discovery beginning with either in vivo or in vitro diversity.
  • The integrated offering of antibody discovery services will be highlighted at the Festival of Biologics occurring March 20-22, 2023 in San Diego.