Biogen

Trend Innovations Holding, Inc. Appoints Kenneth L. Waggoner as Chief Executive Officer

Retrieved on: 
Tuesday, April 25, 2023
Loyola University School of Law, Pancreatic cancer, Amgen, US Foods, General counsel, Diabetes, Private law, Public Interest Declassification Board, Telecommunications, Biotechnology, Bachelor of Arts, California State University, OTCQB, Intelligence, Information technology, Research, Line, Orphan drug, Investigational New Drug, Acquisition, Brobeck, Phleger & Harrison, Fortune 500, Artificial intelligence, Biogen, Food, Law, Ascites, Management, Texaco, Chiron, Sangamo Therapeutics

Trend has named Mr. Waggoner to head the Company’s day-to-day operations and provide its strategic direction and corporate focus.

Key Points: 
  • Trend has named Mr. Waggoner to head the Company’s day-to-day operations and provide its strategic direction and corporate focus.
  • Mr. Waggoner has 45 years of experience in management, business operations, and law.
  • Now, he will apply his business expertise to strengthen Trend’s management team and its focus on product development and product pipeline.
  • Simultaneous with the Nasdaq listing, Mr. Waggoner raised approximately $90 million to support PharmaCyte’s worldwide operations and research and development efforts.

Vedanta Biosciences Announces $106.5 Million Financing to Advance Pipeline of Defined Bacterial Consortia Therapies

Retrieved on: 
Tuesday, April 25, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, United States Department of Health and Human Services, Clostridioides difficile infection, JAMA, CDI, Biomedical Advanced Research and Development Authority, Drug development, Therapy, AXA, Human services, Infection, Atlantic Neptune, Administration for Strategic Preparedness and Response, Consultant, PureTech Health, Toys "R" Us, Inc. v. Step Two, S.A, Magnetar Capital, Pfizer, Vedanta, Bill & Melinda Gates Foundation, Ulcerative colitis, Trial of the century, American Medical Association, Associate, Administration, Development, Death, Journal, Patient, Investment, Partner, Labelle, BARDA, Biogen, Pharmaceutical industry

The VE303 study would be the first pivotal Phase 3 study of a therapeutic candidate based on a defined bacterial consortium, which Vedanta is pioneering as a next-generation approach to microbiome therapy.

Key Points: 
  • The VE303 study would be the first pivotal Phase 3 study of a therapeutic candidate based on a defined bacterial consortium, which Vedanta is pioneering as a next-generation approach to microbiome therapy.
  • Defined bacterial consortia are products of standardized composition manufactured from cell banks, bypassing the need to rely on donor fecal material of inconsistent composition.
  • In conjunction with their investments, Curt LaBelle, M.D., Martin Heidecker, Ph.D., and Neil Tiwari will join Vedanta’s Board of Directors .
  • Charles Sherwood III, Associate General Counsel at PureTech, will replace Dr. Chowrira on the Vedanta Board of Directors.

PureTech Founded Entity Vedanta Biosciences Announces $106.5 Million Financing to Advance Pipeline of Defined Bacterial Consortia Therapies

Retrieved on: 
Tuesday, April 25, 2023
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, United States Department of Health and Human Services, Clostridioides difficile infection, LSE, JAMA, CDI, Biomedical Advanced Research and Development Authority, Drug development, Therapy, AXA, Human services, Infection, Atlantic Neptune, PureTech Health, Administration for Strategic Preparedness and Response, Consultant, Toys "R" Us, Inc. v. Step Two, S.A, Magnetar Capital, Pfizer, Bill & Melinda Gates Foundation, Ulcerative colitis, Trial of the century, American Medical Association, Associate, Administration, Development, Death, Journal, Patient, Investment, Partner, Labelle, BARDA, PRTC, Biogen, Pharmaceutical industry, Cryptocurrency, Vedanta

The VE303 study would be the first pivotal Phase 3 study of a therapeutic candidate based on a defined bacterial consortium, which Vedanta is pioneering as a next-generation approach to microbiome therapy.

Key Points: 
  • The VE303 study would be the first pivotal Phase 3 study of a therapeutic candidate based on a defined bacterial consortium, which Vedanta is pioneering as a next-generation approach to microbiome therapy.
  • The VE303 study would be the first pivotal Phase 3 study of a therapeutic candidate based on a defined bacterial consortium, which Vedanta is pioneering as a next-generation approach to microbiome therapy.
  • Defined bacterial consortia are products of standardized composition manufactured from cell banks, bypassing the need to rely on donor fecal material of inconsistent composition.
  • Charles Sherwood III, Associate General Counsel at PureTech, will replace Dr. Chowrira on the Vedanta Board of Directors.

1-Year Outcomes of Phase 3 Study for SB15, Proposed biosimilar to Eylea (aflibercept), Presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

Retrieved on: 
Monday, April 24, 2023
PK, ARVO, AAO, Week, Biogen, Safety, NAMD, Pharmacokinetics, American Academy, Patient, CST, Annual general meeting, Ranibizumab, Research, Visual acuity, ADA, AFL, Vaccine, Pharmaceutical industry, Generic drug, Ophthalmology

In addition, new analytical data on similarity between SB15 and reference product in terms of structural and physicochemical properties and biological functions were also presented.

Key Points: 
  • In addition, new analytical data on similarity between SB15 and reference product in terms of structural and physicochemical properties and biological functions were also presented.
  • At the meeting, researchers presented 56-week results from the Phase 3 clinical study between SB15 and reference aflibercept (AFL) in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK).
  • In the switching group (AFL/SB15), least square (LS) mean change from baseline CST was well maintained and comparable to the continuing group (AFL/AFL).
  • Based on the comprehensive analytical similarity assessment, SB15 showed high similarity to AFL with respect to structural, physicochemical, and biological properties.

KBI Biopharma Appoints David Stewart as Site Head of Durham Mammalian cGMP Manufacturing Facility

Retrieved on: 
Monday, April 24, 2023
Medical Supplies, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Medical Devices, Research, Infectious Diseases, Science, Clinical Trials, Marine Corps Expeditionary Medal, Aerospace, University, Fujifilm Diosynth Biotechnologies, Patriot Park, Engineering, Biogen, Business, Genentech, Process control, KBI, Quantic School of Business and Technology, CDMO, Avionics, Patient, Center For Naval Aviation Technical Training Unit Keesler, Growth, Indiana State University, SVP, Fine chemical, Management

KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, today announced the appointment of David Stewart as the new SVP and Site Head of KBI’s mammalian cGMP manufacturing facility in Durham, North Carolina.

Key Points: 
  • KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, today announced the appointment of David Stewart as the new SVP and Site Head of KBI’s mammalian cGMP manufacturing facility in Durham, North Carolina.
  • “The addition of Dave Stewart to the Patriot Park team will enable it to become our flagship site and play an integral role in our ongoing transformation,” said J.D.
  • In this role, Stewart will leverage his extensive science, technical, and business background to help fuel the facility and KBI to a new level of growth.
  • “I’m excited to lead KBI’s Patriot Park site during this pivotal company growth phase,” said Stewart.

BrainStorm Cell Therapeutics Strengthens Leadership Team with Appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer

Retrieved on: 
Monday, April 24, 2023
San Francisco, Biologics license application, Late Phases, University, Verastem Oncology, Therapy, Senior, Brainstorm, File, Harvard University, Advisory Committee, EVP, University of California, San Francisco, Stanford University, Merck Group, CMO, Patient, INSEAD, Pain management, Yale University, Faculty, Growth, Merck, Hospital, Rare, Albert Einstein College of Medicine, Merck Serono, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, ALS, Neurology, BLA, Food, Pfizer, Management, Pharmaceutical industry, Biogen

NEW YORK, April 24, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer (EVP, CMO), effective May 1, 2023. Dr. Taylor will serve on BrainStorm's executive leadership team reporting to Stacy Lindborg, Ph.D., co-CEO of BrainStorm.

Key Points: 
  • NEW YORK, April 24, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer (EVP, CMO), effective May 1, 2023.
  • Dr. Taylor will serve on BrainStorm's executive leadership team reporting to Stacy Lindborg, Ph.D., co-CEO of BrainStorm.
  • "Kirk's appointment is the first important step in strengthening a targeted, capability build to expand our medical, regulatory and advocacy teams in preparation for anticipated growth," said Chaim Lebovits, President and CEO of BrainStorm.
  • We are thrilled to welcome Kirk to BrainStorm and look forward to the contributions he will make."

Samsung Bioepis to Present New Data for SB15, a proposed biosimilar to Eylea (aflibercept), at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

Retrieved on: 
Thursday, April 20, 2023
ARVO, AAO, Biogen, Pharmacokinetics, American Academy, Patient, Annual general meeting, Ranibizumab, Research, Safety, Pharmaceutical industry, Ophthalmology

Final 56-week results from the Phase 3 study for SB15 compared with reference aflibercept in neovascular age-related macular degeneration to be presented, in addition to analytical similarity data between SB15 and reference aflibercept

Key Points: 
  • Final 56-week results from the Phase 3 study for SB15 compared with reference aflibercept in neovascular age-related macular degeneration to be presented, in addition to analytical similarity data between SB15 and reference aflibercept
    INCHEON, Korea, April 20, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that it will present new data on SB15, a proposed biosimilar to Eylea1 (aflibercept), at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held from April 23 to 27, in New Orleans, Louisiana.
  • At the meeting, researchers will present new analytical data on similarity between SB15 and reference product in terms of structural and physicochemical properties and biological functions, as well as 56-week results from the Phase 3 randomized clinical study between SB15 and the reference product in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK).
  • 32-week interim results from the Phase 3 study were previously presented at the 2022 American Academy of Ophthalmology (AAO) Annual Meeting in September 2022.2
    Details about Samsung Bioepis’s abstract are as follows:
    Samsung Bioepis and Biogen announced in November 2019 that they had entered into an exclusive commercialization agreement for two ophthalmology biosimilar candidates, SB11/BYOOVIZ™ (ranibizumab) and SB15 (aflibercept) in major markets around the world.
  • SB15, if approved, will strengthen the portfolio offerings of the two companies with two of the most widely prescribed anti-VEGF therapies, extending options for patients, prescribers while helping enable healthcare sustainability.

Keros Therapeutics Appoints Alpna Seth, Ph.D., to its Board of Directors

Retrieved on: 
Wednesday, April 19, 2023
Molecular biology, University of Massachusetts Chan Medical School, Advanced Management Program, Biotechnology, Drug development, University, Biochemistry, Doctor of Philosophy, Harvard University, Biogen, Howard Hughes Medical Institute, Patient, Naval Information Warfare Systems Command Program Executive Offices, Harvard Business School, Therapy, KROS, Management

“Dr.

Key Points: 
  • “Dr.
  • From July 2017 to January 2019, Dr. Seth was the Chief Operating Officer of Vir Biotechnology, Inc.
  • Prior to joining Vir, Dr. Seth was Senior Vice President and Global Head of the Biosimilars business for Biogen, Inc. since 2014.
  • She is also a graduate of the Advanced Management Program at Harvard Business School.

Agios Appoints Jeffrey Capello to Board of Directors

Retrieved on: 
Wednesday, April 19, 2023
University, Beacon Health Options, Boston Scientific, Biogen, OvaScience, Ortho Clinical Diagnostics, MBA, AGIO, PerkinElmer, Option, Patient, Triple accreditation, Hematology, Harvard Business School, R, Agios Pharmaceuticals, Rare, Management

CAMBRIDGE, Mass., April 19, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that Jeffrey Capello has been appointed to its board of directors. Agios also announced that Paul Clancy will step down from the board of directors at the end of his term, effective June 13, 2023.

Key Points: 
  • CAMBRIDGE, Mass., April 19, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that Jeffrey Capello has been appointed to its board of directors.
  • Agios also announced that Paul Clancy will step down from the board of directors at the end of his term, effective June 13, 2023.
  • “Agios is dedicated to cultivating a diverse board that is focused on the company’s long-term value creation for patients and shareholders.
  • “We would also like to express our gratitude to Paul for his 10 years of dedicated service to our board.

Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 18, 2023
Biotechnology, Pharmaceutical, Health, Amgen, Asthma, CMS, Etanercept, Fresenius (company), Prevalence, Diabetes, Trastuzumab, Ustekinumab, Medicare, Inflation, Chronic condition, Patient, Analysis, Conditional sentence, Biosimilar, Rheumatoid arthritis, Centers for Medicare & Medicaid Services, Research, EMA, Tocilizumab, Ophthalmology, Fresenius, Knowledge, Growth, FDA, Celltrion, Legislation, Welfare, Arthritis, COVID-19, Cancer, Medicare Part D, Competitive landscape, Novartis, AbbVie, Inflation Reduction Act of 2022, Teva Pharmaceuticals, Biogen, Rituximab, Education, Eating, IRA, Sale, Movement, Scott Richter, Local Investing Opportunity Network, Physician, Fine chemical, Generic drug, Vaccine, Pharmaceutical industry, Natalizumab, Adalimumab, Ranibizumab

The "Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update" report has been added to ResearchAndMarkets.com's offering.
  • In these volatile market conditions, the biosimilars market is still expanding dramatically, and the outlook is as promising.
  • It provides a detailed analysis of biosimilar market dynamics, covering clinical trials, patent data, financial deals, and company profiling details.
  • In addition, this report provides analyst commentary on key trends, drivers, strategies, innovations, and regulations in the field of biosimilars.