Regeneron Pharmaceuticals

Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC)

Retrieved on: 
Saturday, October 21, 2023
Clinical Science (journal), MPR, Hypophysitis, ESMO, MD Anderson Cancer Center, Clinical research, Regeneron Pharmaceuticals, Carcinoma, Lymph, Congress, European Society for Medical Oncology, PCR, PD-1, The Lancet, Observation, Senior, Quality of life, Radiation, Risk, Recurrence, The New England Journal of Medicine, Oncology, University, Safety, Cancer, CSCC, AE, Patient, Translation, Death, Heart failure, Pharmaceutical industry, Medical imaging, Gasoline, Cemiplimab

TARRYTOWN, N.Y., Oct. 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The results from an international Phase 2 trial were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology.

Key Points: 
  • “Advanced, resectable cutaneous squamous cell carcinoma can lead to reduced patient function and quality of life following the cumulative effects of treatment, typically surgery and radiation.
  • “Results from both the single-institution pilot trial and the multi-center Phase 2 trial found neoadjuvant cemiplimab was highly active in patients with resectable cutaneous squamous cell carcinoma.
  • These robust responses were durable, translating into event-free survival for the vast majority of patients at one and two years.”
    The multicenter, single-arm Phase 2 trial included two parts.
  • In Part 1, patients (n=79) received Libtayo 350 mg every three weeks for up to four doses, followed by curative-intent surgery.

Regeneron and Sanofi Provide Update on Dupixent® (dupilumab) sBLA for Chronic Spontaneous Urticaria

Retrieved on: 
Friday, October 20, 2023
CSU, FDA, Food, Regeneron Pharmaceuticals, Symantec Endpoint Protection, Skin, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CRL, Clinical trial, Swelling, Safety, Patient, Pharmaceutical industry, Sanofi, Dupilumab

CSU is an inflammatory skin condition, which causes sudden and debilitating hives and swelling on the skin.

Key Points: 
  • CSU is an inflammatory skin condition, which causes sudden and debilitating hives and swelling on the skin.
  • The CRL states that additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing.
  • An ongoing clinical trial (Study C) continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data.
  • Regeneron and Sanofi remain committed to working with the FDA to advance the study of Dupixent for patients living with CSU who are inadequately controlled by antihistamines.

Alnylam Reports Additional Positive Interim Phase 1 Results for ALN-APP, in Development for Alzheimer’s Disease and Cerebral Amyloid Angiopathy

Retrieved on: 
Wednesday, October 25, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Medicare Part D, Patient, AD, AFL, UCL Queen Square Institute of Neurology, University College London, Biomarker, Therapy, Fluid mechanics, CSF, Medication, Regeneron Pharmaceuticals, Alnylam Pharmaceuticals, Gene silencing, CNS, Clinical trial, APP, ALNY, Cerebral amyloid angiopathy, Cerebrospinal fluid, RNA interference, ALN, Brain, Safety, CAA, Peptide, Central nervous system, Medical device, Pharmaceutical industry

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced additional positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA).

Key Points: 
  • Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced additional positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA).
  • The data were presented today in a late-breaker session at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) conference, being held October 24-27, 2023, in Boston, MA.
  • “Today’s results showcase the exciting emerging profile of ALN-APP.
  • In this study to date, blinded single doses of ALN-APP, which are administered by intrathecal injection, have been well tolerated.

Prevent Blindness Provides Informational Resources to Professionals and the Public for November's Diabetes-related Eye Disease Awareness Month

Retrieved on: 
Wednesday, October 25, 2023
UnitedHealth Group, Social media, Population health, US, American Diabetes Association, Diabetic retinopathy, Prevalence, Health, Mental, Disease, Risk, Eye, Public, Paratriathlon, Potential, Retina, Parent, Mental health, MHS, Yale School of Medicine, Organization, Prediabetes, National Eye Institute, CDC, Centers for Disease Control and Prevention, Vision, VSP Vision Care, Research, JAMA Ophthalmology, Visual impairment, Microsoft PowerPoint, Research to Prevent Blindness, MBA, Database, Johns Hopkins School of Medicine, Associate, Pharmaceutical industry, Ophthalmology, Regeneron Pharmaceuticals, MD, Diabetes

CHICAGO, Oct. 25, 2023 /PRNewswire-PRWeb/ -- A recent study, "Prevalence of Diabetic Retinopathy in the US in 2021," estimated that more than 26 percent of people with diabetes had diabetic retinopathy. Diabetic retinopathy, the most common form of diabetes-related eye disease, is the leading cause of blindness in adults age 20–74, according to the National Eye Institute.

Key Points: 
  • Diabetic retinopathy, the most common form of diabetes-related eye disease, is the leading cause of blindness in adults age 20–74, according to the National Eye Institute .
  • The longer a person has diabetes, the greater the risk for diabetes-related eye disease.
  • Prevent Blindness , the nation's leading nonprofit eye health and safety organization, has declared November as Diabetes-related Eye Disease Awareness Month, providing the public with a variety of helpful tools to prevent unnecessary vision loss from diabetes.
  • Vision Integration Library - The Center for Vision and Population Health at Prevent Blindness offers the free "Vision Integration Library: Vision and Eye Health Resource Center at Prevent Blindness."

Together for CHANGE Genomics and Equity Initiative Launched by a Coalition of Meharry Medical College, Regeneron Genetics Center, AstraZeneca, Novo Nordisk, and Roche to Improve Health Outcomes for People of African Ancestry

Retrieved on: 
Wednesday, October 18, 2023
STEM, Genetic counseling, Research, African Americans, EVP, AstraZeneca, Genetic testing, Ethics, Innovation, Health care, Biopharmaceutical, Regeneron Pharmaceuticals, Meharry Medical College, Novo Nordisk, Phenotype, DNA, Senior, Cannabinoid Research Initiative of Saskatchewan, Genomics, Black Europeans of African ancestry, University, Disease, Health equity, Student, Biology, Diaspora, Partnership, RGC, Health, Roche, Research and Innovative Technology Administration, Together for Change, Accenture, Management, Pharmaceutical industry, Nursing, Black, Doctor of Philosophy

NASHVILLE, Tenn. and TARRYTOWN, N.Y. and WILMINGTON, Del. and BAGSVAERD, Denmark and BASEL, Switzerland, Oct. 18, 2023 (GLOBE NEWSWIRE) -- Meharry Medical College, along with partners Regeneron Genetics Center® (RGC™), AstraZeneca, Novo Nordisk, and Roche, today announced the launch of the Together for CHANGE™ (“Changing Healthcare for People of African Ancestry through an InterNational Genomics & Equity”) initiative to create better health care and outcomes for all.

Key Points: 
  • The Together for CHANGE initiative seeks to address inequities in STEM careers and research with a two-pronged approach.
  • Meharry Medical College, one of the oldest and largest historically Black academic health sciences centers in the U.S., is a co-founder and academic convener of this initiative.
  • The DHGI, a newly chartered non-profit organization, will serve as the governing organization for Together for CHANGE.
  • Additionally, the DHGI will form an ethics committee with leaders from the Black community to provide stewardship of the data.

Regeneron builds on Together for CHANGE™ initiative with five-year, $5 million commitment to fuel the STEM talent pipeline in Nashville, TN

Retrieved on: 
Wednesday, October 18, 2023
STEM, Regeneron Science Talent Search, Society for Science, Way, Health, Mathematics, Life, Meharry Medical College, Corporate Affairs, Organization, Entrepreneurship, Research, Engineering, Senior, Environment, City, University, Diaspora, Ecosystem, Student, School, STS, Science education, ISEF, Vanderbilt, Society, Chairperson, Pharmaceutical industry, Management, Tutoring, Black, Science, Regeneron Pharmaceuticals, Education

TARRYTOWN, N.Y., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a five-year, $5 million strategic investment to bolster Nashville, Tennessee’s science, technology, engineering and mathematics (STEM) ecosystem through high-quality, equitable engagement programs for students and science teachers. Regeneron’s goal is to engage and inspire the next generation of scientific leaders and innovators to help address some of humanity’s most challenging existential threats.

Key Points: 
  • With its partners, Regeneron will assess Nashville’s current landscape and continuously evolve and adapt its programs for maximum impact on the region's education system.
  • These initiatives have proven successful in helping students excel in STEM fields and consistently secure placements at these premier competitions.
  • A key component of this initiative is to empower educational change by improving the STEM pipeline for Black students.
  • “At Regeneron, our commitment to STEM education is a holistic endeavor focused on strengthening the entire ecosystem,” said Christina Chan, Senior Vice President, Corporate Affairs at Regeneron.

Intellia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application to Initiate a Pivotal Phase 3 Trial of NTLA-2001 for the Treatment of Transthyretin (ATTR) Amyloidosis with Cardiomyopathy

Retrieved on: 
Wednesday, October 18, 2023
FDA, IND, Food, ATTR, Regeneron Pharmaceuticals, Cardiomyopathy, CRISPR, Intellia Therapeutics, Regulation of tobacco by the U.S. Food and Drug Administration, Medicine, Webcast, Amyloidosis, Therapy, NTLA, Investigational New Drug, Pharmaceutical industry

The global Phase 3 study of NTLA-2001, an in vivo CRISPR-based gene editing candidate, is expected to initiate by year-end 2023.

Key Points: 
  • The global Phase 3 study of NTLA-2001, an in vivo CRISPR-based gene editing candidate, is expected to initiate by year-end 2023.
  • “The FDA clearance of the NTLA-2001 IND application allows us to initiate a pivotal Phase 3 trial in the United States, marking the first in vivo CRISPR-based candidate to begin late-stage clinical development.
  • “We are thrilled to further advance NTLA-2001 and our pipeline of investigational gene editing therapies as we embark on a new era in medicine.
  • We look forward to sharing additional information about the Phase 3 study at our upcoming quarterly earnings webcast, being held on Thursday, November 9.”

Together for CHANGE Genomics and Equity Initiative Launched by a Coalition of Meharry Medical College, Regeneron Genetics Center, AstraZeneca, Novo Nordisk, and Roche to Improve Health Outcomes for People of African Ancestry

Retrieved on: 
Wednesday, October 18, 2023
Men, Managed Care, General Health, Professional Services, Science, Genetics, DEI (Diversity, Equity and Inclusion), Consumer, Biotechnology, Health, Research, University, Primary, Secondary, Education, Socially Responsible Investing, Women, Pharmaceutical, STEM, Genetic counseling, Medical college, African Americans, EVP, AstraZeneca, Genetic testing, Ethics, Innovation, Health care, Biopharmaceutical, Regeneron Pharmaceuticals, Meharry Medical College, Novo Nordisk, Phenotype, DNA, Senior, Cannabinoid Research Initiative of Saskatchewan, Genomics, Black Europeans of African ancestry, Disease, Health equity, Student, Biology, Diaspora, Partnership, RGC, Roche, Research and Innovative Technology Administration, Together for Change, Accenture, Pharmaceutical industry, Nursing, Management, Black, Doctor of Philosophy

The Together for CHANGE initiative seeks to address inequities in STEM careers and research with a two-pronged approach.

Key Points: 
  • The Together for CHANGE initiative seeks to address inequities in STEM careers and research with a two-pronged approach.
  • Meharry Medical College, one of the oldest and largest historically Black academic health sciences centers in the U.S., is a co-founder and academic convener of this initiative.
  • The DHGI, a newly chartered non-profit organization, will serve as the governing organization for Together for CHANGE.
  • Additionally, the DHGI will form an ethics committee with leaders from the Black community to provide stewardship of the data.

BioNTech to Present Multiple Program Updates Across Modalities at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023
Congress, Abstract, NSCLC, Regeneron Pharmaceuticals, TACSTD2, Risk, PD-L1, Safety, Entrepreneurship, ESMO, BioNTech, European Society for Medical Oncology, Messenger, ADC, BNTX, Patient, Vaccine, Pharmaceutical industry

Program updates include new data for investigational CAR-T and ex-vivo T cell therapies, a novel ADC, a FixVac off-the-shelf mRNA cancer vaccine, and a bi-specific antibody

Key Points: 
  • Program updates include new data for investigational CAR-T and ex-vivo T cell therapies, a novel ADC, a FixVac off-the-shelf mRNA cancer vaccine, and a bi-specific antibody
    MAINZ, Germany, October 16, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present data across its oncology pipeline, covering multiple solid tumor types and novel mechanisms of action, at the European Society for Molecular Oncology (“ESMO”) Congress 2023 in Madrid, Spain from October 20-24, 2023.
  • The initial results show a manageable safety profile and tumor regression in several patients with anti-PD-1 and anti-CTLA4 pretreated advanced or metastatic melanoma.
  • The Company will present first-in-human data of BNT325 (DB-1305) ( NCT05438329 ), a next-generation Trop-2-targeting antibody-drug conjugate (“ADC”), which is being jointly developed with Duality Biologics.
  • In addition, BioNTech will also present pre-clinical data from its BNT314 (GEN1059) program, which is being jointly developed with Genmab.

Regeneron to Showcase Progress from Innovative Oncology Portfolio in Several Difficult-to-Treat Cancers at ESMO

Retrieved on: 
Sunday, October 15, 2023
Congress, Histology, Senior, Fast track (FDA), NSCLC, Regeneron Pharmaceuticals, Genetics, Lung cancer, Survival, Translation, Carcinoma, Oncology, ESMO, Ovarian cancer, Melanoma, Immune system, CSCC, European Society for Medical Oncology, MUC16, Patient, Medical imaging, Pharmaceutical industry, Vaccine, Cemiplimab

TARRYTOWN, N.Y., Oct. 15, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the latest clinical data in early- and late-stage cancers from its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 from October 20 to 24 in Madrid, Spain. The presentations demonstrate the role of Libtayo® (cemiplimab) as both a monotherapy and a backbone of novel investigational combinations for various solid tumors.

Key Points: 
  • The presentations demonstrate the role of Libtayo® (cemiplimab) as both a monotherapy and a backbone of novel investigational combinations for various solid tumors.
  • Beyond ESMO, we are excited by recent progress across our oncology portfolio, including FDA Fast Track Designation for fianlimab (LAG-3) plus Libtayo in melanoma.
  • Regeneron will also debut Phase 1 dose-escalation results for its investigational combination of Libtayo and ubamatamab in patients with heavily pretreated recurrent ovarian cancer in a poster session.
  • Ubamatamab is a CD3-targeting bispecific designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation.