Regeneron Pharmaceuticals

Praluent® (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol

Retrieved on: 
Monday, March 11, 2024

“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.

EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet

Retrieved on: 
Friday, March 8, 2024

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.

Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of COPD with Type 2 Inflammation

Retrieved on: 
Friday, February 23, 2024

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.

Intellia Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, February 22, 2024

Collaboration Revenue: Collaboration revenue decreased by $15.5 million to negative $1.9 million during the fourth quarter of 2023, compared to $13.6 million during the fourth quarter of 2022.

Key Points: 
  • Collaboration Revenue: Collaboration revenue decreased by $15.5 million to negative $1.9 million during the fourth quarter of 2023, compared to $13.6 million during the fourth quarter of 2022.
  • R&D Expenses: Research and development expenses increased by $9.0 million to $109.0 million during the fourth quarter of 2023, compared to $100.0 million during the fourth quarter of 2022.
  • G&A Expenses: General and administrative expenses increased by $5.4 million to $29.0 million during the fourth quarter of 2023, compared to $23.6 million during the fourth quarter of 2022.
  • Net Loss: The Company’s net loss was $132.2 million for the fourth quarter of 2023, compared to $113.4 million during the fourth quarter of 2022.

Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review

Retrieved on: 
Wednesday, February 21, 2024

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.

Foundational V3 Framework Extended to Incorporate Usability Validation of Sensor-Based Digital Health Technologies

Retrieved on: 
Tuesday, February 27, 2024

BOSTON, Feb. 27, 2024 /PRNewswire/ -- To support the rapid evolution of digital clinical measures, today, the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) released an extension of its foundational Verification, Analytical Validation, and Clinical Validation (V3). The V3+ extension adds a fourth component of "Usability Validation," incorporating the evaluation of user experience at scale. Additional resources, a supporting manuscript, and new educational material are now available to make it easy for developers to implement it as they build sensor-based digital health technologies (sDHTs).

Key Points: 
  • BOSTON, Feb. 27, 2024 /PRNewswire/ -- To support the rapid evolution of digital clinical measures, today, the Digital Health Measurement Collaborative Community ( DATAcc ) by the Digital Medicine Society ( DiMe ) released an extension of its foundational Verification, Analytical Validation, and Clinical Validation (V3).
  • The V3+ extension adds a fourth component of "Usability Validation," incorporating the evaluation of user experience at scale.
  • The three components of the original V3 framework remain unchanged; the V3+ framework is now extended to evaluate the ease of use, efficiency, and user satisfaction of sDHTs.
  • "I was proud to join DATAcc in the development of V3+ to include usability as a requirement in this framework.

Society for Science Fuels Innovation with $110K in Educator Grants, Transforming Classrooms for Student STEM Research

Retrieved on: 
Wednesday, February 21, 2024

These educators will be receiving the STEM Research Grants in two forms: (1) research kits assembled and distributed to teachers by Society for Science and (2) funds paid directly to teachers intended for STEM-related equipment.

Key Points: 
  • These educators will be receiving the STEM Research Grants in two forms: (1) research kits assembled and distributed to teachers by Society for Science and (2) funds paid directly to teachers intended for STEM-related equipment.
  • "Congratulations to the 41 recipients of this year's STEM Research Grants.
  • These grants serve as a catalyst in classrooms across the country, igniting student curiosity and exposing learners to tangible, real-world applications of STEM.
  • Over the past several years, the Society has remained steadfast in its dedication to propelling STEM education forward by providing classrooms with improved research equipment.

Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)

Retrieved on: 
Friday, February 16, 2024

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.

Ocular Therapeutix™ Appoints Steve Meyers to Chief Commercial Officer

Retrieved on: 
Thursday, February 15, 2024

BEDFORD, Mass., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the appointment of Steve Meyers as Chief Commercial Officer.

Key Points: 
  • BEDFORD, Mass., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the appointment of Steve Meyers as Chief Commercial Officer.
  • “As we continue our commitment to advancing our drug portfolio in order to enhance the quality of life for patients, I am thrilled to announce the promotion of Steve Meyers to the role of Chief Commercial Officer,” said Antony Mattessich, CEO of Ocular Therapeutix.
  • With his expertise and dedication, I am confident he will play a pivotal role in driving Ocular’s commercial efforts forward.”
    “I am truly honored by this opportunity to serve as Chief Commercial Officer," said Steve Meyers.
  • Prior to joining Ocular, Mr. Meyers served as Vice President of Sales at Flexion Therapeutics in the orthopedic space.

Stakes Are High for Regeneron's Eylea HD as Genentech's Vabysmo Continues to Gain Momentum, Prompting Doctors to Weigh Their Options Between Two Industry Titans, According to Spherix Global Insights

Retrieved on: 
Thursday, February 8, 2024

Wet AMD poses a particularly severe threat to vision, necessitating treatment with biologic therapies administered in four to twelve-week intervals.

Key Points: 
  • Wet AMD poses a particularly severe threat to vision, necessitating treatment with biologic therapies administered in four to twelve-week intervals.
  • However, the current treatment landscape often burdens elderly patients with high treatment frequencies, impacting their ability to attend all appointments.
  • Spherix Global Insights conducted an in-depth analysis through its RealTime Dynamix™ report series, delving into the evolving perceptions of ophthalmologists (n=101) regarding approved therapies for wet AMD.
  • In January 2024, ophthalmologists were surveyed on their preferred biologic treatment for wet AMD among other topics.