Ulcerative colitis

Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®

Retrieved on: 
Saturday, February 24, 2024
Biotechnology, FDA, Health, Pharmaceutical, Managed Care, Pharmacy, Ulcerative colitis, Psoriasis, Uveitis, Ankylosing spondylitis, Multimedia, TEVA, Marketing, Teva, Partnership, Food, Teva Pharmaceuticals, Volunteering, Biosimilar, IC, Safety, Juvenile idiopathic arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Patient, Prescription, Environment, Generic drug

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

Key Points: 
  • Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • As the only interchangeable adalimumab biosimilar with the high-concentration formulation, SIMLANDI can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.

Celltrion presents new two-year data for subcutaneous infliximab (CT-P13 SC) in inflammatory bowel disease (IBD) at the 19th ECCO Congress

Retrieved on: 
Friday, February 23, 2024
Health, Pharmaceutical, Celltrion, Ulcerative colitis, Week, Crohn's disease, European, Safety, UC, Abstract, Patient, IBD, Congress, ECCO

These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.

Key Points: 
  • These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.
  • The LIBERTY-CD and LIBERTY-UC studies were continued up to 102 weeks as extension phase treatments, building on the initial LIBERTY trials.
  • The two-year studies assessed the long-term efficacy and safety of CT-P13 SC in patients with Crohn's disease (CD) and ulcerative colitis (UC), respectively.
  • “The early observation of mucosal healing at Week 22 showcases the potential of subcutaneous infliximab treatment in improving patient care,” said Nam Lee, Medical Director at Celltrion.

Teva Presents New Data Supporting Safety, Tolerability and Target Engagement of Anti-TL1A (TEV-‘574) Antibody at the 2024 ECCO Annual Meeting

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Tuesday, February 20, 2024
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, SNY, SAN, Ulcerative colitis, Crohn's disease, TEVA, Inflammation, European, Teva, Teva Pharmaceuticals, Asthma, Gastrointestinal tract, Safety, UC, Immunoglobulin G, Inflammatory bowel disease, Patient, Fibrosis, TL1A, IBD, Medication, TNF, ECCO, Pharmaceutical industry

“These results from the first-in-human trials of anti-TL1A (TEV-’574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated.

Key Points: 
  • “These results from the first-in-human trials of anti-TL1A (TEV-’574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated.
  • “We are currently investigating the efficacy and safety of anti-TL1A (TEV-’574) in IBD through the RELIEVE UCCD Phase 2 trial, which features an innovative and efficient basket study design allowing the inclusion of patients with either type of IBD (ulcerative colitis and Crohn’s disease).
  • Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement, and Sanofi will lead the development of the Phase 3 program.
  • Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world.

European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Monday, February 19, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Janus, Ulcerative colitis, European Commission, EMA, Committee, Headache, Doctor of Philosophy, MD, FDA, European, Food, PFE, KU Leuven, Lymphocytopenia, Safety, Civil service commission, JAK, UC, CHMP, Patient, Proctitis, Inc., Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
  • “For the 2.6 million people in Europe living with UC, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating.
  • This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023.
  • Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY.

With Colorectal Cancer Rates Rising, the American Cancer Society and Colorectal Cancer Alliance Join Forces to Increase Screening

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Thursday, February 29, 2024
Large intestine, Ulcerative colitis, Incidence, American Cancer Society, Woman, Crohn's disease, Diet, Colorectal cancer, Smoking, Cancer, ACS, Hereditary nonpolyposis colorectal cancer, Weight loss, Polyp, Colorectal Cancer Alliance, Exercise, Calcium, Meat, Risk, Weakness, Survival rate, Alaska Natives, Vegetable, Rectum, USPSTF, Fatigue, Chronic pain, Death, Black, Locator, Ageing, Dairy

ATLANTA, Feb. 29, 2024 /PRNewswire/ -- The American Cancer Society (ACS) and the Colorectal Cancer Alliance (Alliance) are joining forces on Your Colon is 45 - an initiative aimed at promoting colorectal cancer screening for individuals aged 45 and above.

Key Points: 
  • ATLANTA, Feb. 29, 2024 /PRNewswire/ -- The American Cancer Society (ACS) and the Colorectal Cancer Alliance (Alliance) are joining forces on Your Colon is 45 - an initiative aimed at promoting colorectal cancer screening for individuals aged 45 and above.
  • According to the American Cancer Society's Cancer Fact & Figures, 2024 report , colorectal cancer is now the leading cause of cancer death in men and the second in women under 50 years old.
  • "By joining forces with the Colorectal Cancer Alliance, we can reach more individuals and empower them with vital information that can save lives."
  • Matching an American Cancer Society 2018 update to colorectal cancer screening guidelines , and the Alliance's call for earlier screening, the United States Preventive Services Task Force (USPSTF) released a recommendation statement lowering the age to begin colorectal cancer screening from age 50 to age 45 in 2021.

Biocon Biologics Secures US Market Entry Date for Bmab 1200, a Proposed Biosimilar to Stelara®

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Thursday, February 29, 2024
Psoriatic arthritis, Ulcerative colitis, Crohn's disease, Psoriasis, Ustekinumab, Trademark, FDA, Patent, Johnson & Johnson, BLA, Inflammation, IPR, PTAB, Inter partes review, Patient, Science, BBL, Pharmaceutical industry

The agreement licenses the Company to launch in the United States, in February 2025, once approved by the U.S. FDA.

Key Points: 
  • The agreement licenses the Company to launch in the United States, in February 2025, once approved by the U.S. FDA.
  • The U.S. FDA has accepted the Company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.
  • Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "This settlement agreement reflects our commitment and focus on science and innovation.
  • As a fully integrated biosimilars company, Biocon Biologics is committed to expanding access to life-changing treatments with our broad portfolio of products."

AbbVie Unveils New Data from Robust Gastroenterology Portfolio at the 19th Congress of European Crohn's and Colitis Organisation (ECCO)

Retrieved on: 
Monday, February 19, 2024
ABBV, Ulcerative colitis, Collection, Crohn's disease, Research, Inflammatory Bowel Diseases, University of Calgary, Risankizumab, AbbVie, INSPIRE, Safety, University, UC, Boehringer Ingelheim, Burrill Bernard Crohn, Abstract, Inflammatory bowel disease, Patient, Ustekinumab, Pharming, Medicine, IBD, Disease, Congress, ECCO, Pharmaceutical industry

NORTH CHICAGO, Ill., Feb. 19, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that 17 AbbVie-sponsored abstracts, including new data from its inflammatory bowel disease (IBD) portfolio, have been accepted for presentation at the 19th Congress of European Crohn's and Colitis Organisation (ECCO) taking place in Stockholm, Sweden from February 21-24.

Key Points: 
  • The research spans risankizumab (SKYRIZI®) and upadacitinib (RINVOQ®) in both Crohn's disease (CD) and ulcerative colitis (UC).
  • "Despite continued advancements, many patients are still suffering from the debilitating effects of living with IBD," said Sofie Berg, Pharm.D, Ph.D., therapeutic area head, international immunology, International Medical Affairs, AbbVie.
  • "It is critically important that as the treatment paradigm shifts, the gastroenterology community shifts with it.
  • SKYRIZI® (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

CollPlant Issues Letter to Shareholders

Retrieved on: 
Thursday, February 15, 2024
Therapy, United Nations Global Compact, CLGN, Cancer, Ulcerative colitis, Regeneration, Regenerative medicine, Inflammatory Bowel Diseases, Breast augmentation, Polymerization, 3D, Patent, Social, AbbVie, Connective tissue, Drug discovery, ESG, Letter, 3D bioprinting, Epidermis, Breast, Genetic engineering, Safety, UC, Stratasys, Hyaluronic acid, Ecosystem, Patient, Medicine, Environment, Tissue

Our long-term collaboration with AbbVie to develop a paradigm-shifting regenerative dermal and soft tissue filler continues to advance.

Key Points: 
  • Our long-term collaboration with AbbVie to develop a paradigm-shifting regenerative dermal and soft tissue filler continues to advance.
  • In June of last year, we announced the achievement of an important milestone under this collaboration which triggered a $10 million payment from AbbVie to CollPlant.
  • Per CollPlant's agreement with AbbVie, CollPlant has the potential to receive additional milestones and option products payments, as well as receive meaningful royalties on product sales.
  • In the second quarter of 2023, CollPlant hired a dedicated expert to lead our Environment, Social and Governance (ESG) effort.

EnLiSense CCM Advances Validation of Real-Time IBD Inflammatory Biomarker Monitoring with Two Recent Peer-Reviewed Longitudinal Studies

Retrieved on: 
Thursday, February 15, 2024
Hardware, Health Technology, Data Management, Other Health, Technology, Professional Services, Biometrics, Medical Devices, Genetics, Artificial Intelligence, Wearables, Mobile Technology, Biotechnology, Science, Data Analytics, Research, Health, Biosensor, Digital health, Ulcerative colitis, Senior, Doctor of Philosophy, Translation, Hasso Plattner Institute, Moses Austin, MD, Professor, Inflammation, Blood, IL-6, Quality of life, Bioelectronics, Gastrointestinal tract, Trial of the century, Scientific Reports, Management, University, Perspiration, CRP, Clinical, Inflammatory bowel disease, Patient, Biological engineering, Optimism, IBD, Conditional sentence, TNF, Endoscopy, National Institutes of Health, Medical imaging

Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.

Key Points: 
  • Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.
  • EnLiSense's journey reaches a significant milestone with over half a million human biomarker readings, underscoring the extensive validation of our technology.
  • These readings provide crucial data points, enhancing the precision and trustworthiness of inflammatory biomarker monitoring.
  • The studies involved measuring inflammation markers CRP, TNF-α, and IL-6 in subjects' blood and sweat continuously in subjects with and without IBD.

Takeda Supports the Canadian IBD Research Consortium's $1 Million Pioneer Grant for Second Year

Retrieved on: 
Tuesday, February 13, 2024
Ulcerative colitis, Crohn's disease, Randomized controlled trial, Letter, Physician, Quality of life, McGill University, EST, Inflammatory bowel disease, Associate, Patient, CIRC, RCT, IBD, Disease, Research, Partnership

TORONTO, Feb. 13, 2024 /CNW/ - Takeda Canada Inc. (Takeda) is pleased to announce its support of the Canadian Inflammatory Bowel Disease Research Consortium's (CIRC) $1 million PIONEER Grant in its second year.

Key Points: 
  • TORONTO, Feb. 13, 2024 /CNW/ - Takeda Canada Inc. (Takeda) is pleased to announce its support of the Canadian Inflammatory Bowel Disease Research Consortium's (CIRC) $1 million PIONEER Grant in its second year.
  • This grant, with Takeda contributing $500,000 of the $1,000,000 award, will continue to support high-quality, impactful Canadian clinical research to improve patient outcomes and quality of life for people living with inflammatory bowel disease (IBD).
  • "We are immensely proud of our research community, this program and are grateful for Takeda partnership and dedication to advancing research in Canada."
  • "The PIONEER Grant, established through $1,000,000 in support from Takeda, gives Canadian IBD researchers an amazing and truly unique opportunity to conduct practice changing investigator-initiated research.