Associated tags: Eye, Science, Patient, Pain, FDA, Biotechnology, Inflammation, Drug development, Allergy, Infection, Medicine, Cancer, Monoclonal antibody, DSM-IV codes, Regeneron Pharmaceuticals, Pharmaceutical industry
Locations: UNITED STATES, FRANCE, NORTH AMERICA, TM, AE, MM, CR, NE, WA, TARRYTOWN, NY, US, EUROPEAN UNION, PARIS, MA, RARE
Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
Key Points:
- Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
- “In clinical trials, linvoseltamab treatment led to responses that occurred early, were durable and deepened over time – all critical efficacy measures for this heavily pre-treated patient population.
- Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
- The Phase 3 confirmatory trial for linvoseltamab in patients with R/R MM (LINKER-MM3) is underway.
TARRYTOWN, N.Y., April 01, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its first quarter 2024 financial and operating results on Thursday, May 2, 2024, before the U.S. financial markets open.
Key Points:
- TARRYTOWN, N.Y., April 01, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its first quarter 2024 financial and operating results on Thursday, May 2, 2024, before the U.S. financial markets open.
- The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.
- Participants may access the conference call live via webcast on the ’Investors and Media’ page of Regeneron’s website at https://investor.regeneron.com .
- A replay and transcript of the conference call and webcast will be archived on the Company’s website for at least 30 days.
Regeneron Pharmaceuticals,
Biologics license application,
Patient,
Orphan,
EMA,
European Medicines Agency,
European,
Safety,
FDA,
BLA,
DLBCL,
Lymphoma,
Food,
Pharmaceutical industry Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronextamab as part of the OLYMPIA program – one of the largest clinical programs in lymphoma.
Key Points:
- Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronextamab as part of the OLYMPIA program – one of the largest clinical programs in lymphoma.
- Regeneron is committed to working closely with the FDA and investigators to bring odronextamab to patients with R/R FL and R/R DLBCL as quickly as possible.
- Regulatory review of odronextamab remains ongoing by the European Medicines Agency (EMA) for the treatment of R/R DLBCL and R/R FL.
- The potential use of odronextamab in R/R DLBCL and R/R FL is currently under clinical development and has not been approved by any regulatory authority.
Retrieved on:
Wednesday, March 13, 2024
Lung cancer,
Pollination,
Bee,
Metabolism,
Culture,
Gene,
Algorithm,
National Medal,
Brain,
Growth,
Aditi,
Gene expression,
Survival,
Cell,
Bone marrow,
Trustee,
School,
Research,
Science News,
RET,
Highlands Ranch, Colorado,
Death,
Macrophage,
ARD International Music Competition,
Society,
Student,
Thought,
Nobel Prize,
STEM,
CO,
Cancer,
MYC,
ChatGPT,
Machine learning,
Society for Science,
Liver,
STS,
Pharmaceutical industry The 2024 finalists demonstrated extensive scientific knowledge through research and interviews while showcasing their commitment to addressing societal issues, passion for discovery, noteworthy leadership and community involvement.
Key Points:
- The 2024 finalists demonstrated extensive scientific knowledge through research and interviews while showcasing their commitment to addressing societal issues, passion for discovery, noteworthy leadership and community involvement.
- This knowledge sheds light on what these algorithms are “thinking,” which can help make them more effective, fair and safe.
- “Congratulations to the winners of this year’s Regeneron Science Talent Search,” said Maya Ajmera, President and CEO, Society for Science and Executive Publisher, Science News.
- In total, Regeneron awarded $3.1 million in prizes through the Regeneron Science Talent Search 2024, including $2,000 to each of the top 300 scholars and their schools.
“Many children with heterozygous familial hypercholesterolemia (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies.
Key Points:
- “Many children with heterozygous familial hypercholesterolemia (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies.
- Familial hypercholesterolemia (FH) is an inherited condition caused by mutations in one of several genes that control how the body processes cholesterol, which can lead to very high levels of LDL-C (bad cholesterol).
- Praluent is approved to treat both children and adults with HeFH and adults with HoFH.
- Patients were randomized to receive Praluent (N=101) or placebo (N=52) every two or four weeks in two consecutive cohorts.
FACS,
Regeneron Pharmaceuticals,
Research,
HD,
Food,
Floater,
Cataract,
Consultant,
Aflibercept,
Diabetic retinopathy,
European,
Intraocular pressure,
Safety,
DR,
Society,
Retinal,
Bayer,
Diabetes,
Patient,
Publication,
Pharmaceutical industry TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for EYLEA® HD (aflibercept) Injection 8 mg. Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
Key Points:
- Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
- “Less than a year after its approval, EYLEA HD has already made an impact in the treatment of wet age-related macular degeneration and diabetic macular edema.
- EYLEA HD has provided disease control for my tough-to-treat cases of diabetic eye disease and allowed both my diabetic and wet age-related macular degeneration patients to enjoy less frequent dosing with a similar safety profile to EYLEA.”
PULSAR and PHOTON are two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA.
- In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD.
Retrieved on:
Friday, February 23, 2024
Regeneron Pharmaceuticals,
Headache,
Diarrhea,
FDA,
Food,
Smoker,
Back pain,
Chronic obstructive pulmonary disease,
Common,
Safety,
COVID-19,
Patient,
Priority,
Disease,
Diagnosis,
Priority review,
COPD,
Pharmaceutical industry TARRYTOWN, N.Y. and PARIS, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024. Regulatory submissions are under review in China and Europe.
Key Points:
- The target action date for the FDA decision is June 27, 2024.
- Regulatory submissions are under review in China and Europe.
- In both trials, Dupixent rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
- Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.
Retrieved on:
Wednesday, February 21, 2024
Bone marrow,
Marketing,
FDA,
Food,
Regeneron Pharmaceuticals,
BLA,
Safety,
European Medicines Agency,
Patient,
Priority,
Disease,
Biologics license application,
Tissue,
Cancer,
Pharmaceutical industry Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
Key Points:
- Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
- The BLA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023.
- Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.
- Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
Retrieved on:
Friday, February 16, 2024
Regeneron Pharmaceuticals,
Ministry,
Sinusitis,
Omalizumab,
Quality of life,
Atopic dermatitis,
Prurigo nodularis,
MHLW,
Asthma,
Cell,
Safety,
Patient,
CSU,
Disease,
Polyp (medicine),
Pharmaceutical industry TARRYTOWN, N.Y. and PARIS, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
Key Points:
- Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
- CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.
- CSU is typically treated with histamine-1 (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
- In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.
Retrieved on:
Tuesday, February 6, 2024
TARRYTOWN, N.Y., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows:
Key Points:
- TARRYTOWN, N.Y., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows:
Oppenheimer 34th Annual Healthcare Life Sciences Conference at 1:20 p.m.
- ET on Wednesday, February 14, 2024
TD Cowen 44th Annual Health Care Conference at 11:10 a.m.
- ET on Wednesday, March 6, 2024
Barclays 26th Annual Global Healthcare Conference at 11:15 a.m.
- ET on Tuesday, March 12, 2024
Leerink Partners Global Biopharma Conference 2024 at 10:40 a.m.
