Uveitis

Alumis Announces Upsized $259M Series C Financing to Advance Clinical-stage Pipeline of Oral Therapies Designed to Address Immune Dysfunction

Retrieved on: 
Wednesday, March 6, 2024

SOUTH SAN FRANCISCO, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Alumis Inc., a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced an upsized $259M Series C financing. Alumis plans to use the proceeds of the financing to initiate pivotal Phase 3 clinical trials for its lead candidate ESK-001, a highly selective and potentially best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor, in moderate to severe plaque psoriasis in the second half of 2024, as well as support the two ongoing Phase 2 clinical trials for ESK-001 in systemic lupus erythematosus (SLE), and non-infectious uveitis. The financing will also support the further advancement of Alumis’ precision data analytics and multi-platform approach to explore ESK-001’s potential application in other autoimmune indications, as well as A-005, a TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases, and its earlier-stage internal pipeline programs.

Key Points: 
  • Srinivas Akkaraju, M.D., Ph.D., Founder and Managing General Partner of Samsara BioCapital, and Richard Gaster, M.D., Ph.D., Managing Partner at venBio Partners, will join Alumis’ Board of Directors.
  • “This investment will support the continued clinical development of ESK-001, building on promising data that have demonstrated full, sustained target inhibition leading to a potentially best-in-class oral TYK2 inhibitor profile.
  • We are now starting to see how this will translate into outcomes for patients.
  • We are proud of the company’s progress and happy to continue to support and work with the Alumis team and Board of Directors in this next stage of the company’s growth.”

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

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.
  • SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection.
  • An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
  • Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva’s extensive experience and sales and marketing infrastructure.

TRS01 for Autoimmune Uveitis in Seven Major Markets: Size, Forecasts, and Emerging Insights, 2019-2023 and 2024-2032 - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 7, 2024

This report provides comprehensive insights about TRS01 for autoimmune uveitis in the seven major markets.

Key Points: 
  • This report provides comprehensive insights about TRS01 for autoimmune uveitis in the seven major markets.
  • Further, it also consists of future market assessments inclusive of the TRS01 market forecast analysis for autoimmune uveitis in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in autoimmune uveitis.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of TRS01 in autoimmune uveitis.
  • The report also features the SWOT analysis with analyst views for TRS01 in autoimmune uveitis.

Global Anterior Uveitis (Iritis) Drug Pipeline Research Report 2024 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 6, 2024

This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Anterior Uveitis pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Anterior Uveitis pipeline landscape.
  • A detailed picture of the Anterior Uveitis pipeline landscape is provided which includes the disease overview and Anterior Uveitis treatment guidelines.
  • The assessment part of the report embraces, in depth Anterior Uveitis commercial assessment and clinical assessment of the pipeline products under development.
  • Anterior Uveitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

United States HUMIRA Market Analysis, Size, Forecast, and Insights Report, 2019-2023 and 2024-2032 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 1, 2024

The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about HUMIRA for autoimmune uveitis in the US.
  • Further, it also consists of future market assessments inclusive of the HUMIRA market forecast analysis for autoimmune uveitis in the US, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in autoimmune uveitis.
  • What are the other emerging products available and how are these giving competition to HUMIRA for autoimmune uveitis?

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

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.

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

Retrieved on: 
Friday, March 1, 2024

DUBLIN, March 1, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as "SelfJect"), a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.2 SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration.1,3

Key Points: 
  • "We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions.
  • Mallinckrodt also offers a team of field-based experts who provide education for healthcare professionals on the reimbursement process as well as tools available for patients.
  • Acthar Gel will continue to be available as an injection with a vial and syringe.
  • Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis.

OKYO Pharma Announces Distinguished Ophthalmologists with Expertise in the Medical and Surgical Treatment of Ocular Surface Diseases Join its Scientific Advisory Board

Retrieved on: 
Wednesday, January 31, 2024

and Anat Galor, M.D., both from the Bascom Palmer Eye Institute, and Mark Milner, M.D., of the Goldman Eye in Palm Beach Gardens, Florida, have joined OKYO’s Scientific Advisory board.

Key Points: 
  • and Anat Galor, M.D., both from the Bascom Palmer Eye Institute, and Mark Milner, M.D., of the Goldman Eye in Palm Beach Gardens, Florida, have joined OKYO’s Scientific Advisory board.
  • Dr Victor Perez is a Director of Cornea Research at Bascom Palmer Eye Institute, at the University of Miami Miller School of Medicine.
  • He is a clinician-scientist investigator in the field of ocular immunology and ocular surface diseases and served as Director of Duke Eye Center’s Ocular Immunology Center before joining Bascom Palmer Eye Institute.
  • OKYO's Scientific Advisory Board now has an ideal blend of clinical expertise, including ocular surface disease and neuropathic corneal pain, from the leading experts in those fields."

Tarsier Pharma Receives FDA Agreement Under Special Protocol Assessment (SPA) for Tarsier-04 Phase 3 Trial of TRS01 Ophthalmic Solution for the Treatment of Non-infectious Uveitis including Uveitic Glaucoma

Retrieved on: 
Tuesday, January 16, 2024

A SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application.

Key Points: 
  • A SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application.
  • "The SPA agreement with the FDA provides a clear regulatory path for TRS01.
  • Tarsier received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the Tarsier-04 Phase 3 trial of TRS01 address objectives supporting regulatory submission and a potential future marketing application in this indication.
  • "With this swift agreement, we are now focused on gearing up preparations toward the trial start-up activities.

Alimera Sciences Appoints Todd Wood as President of U.S. Operations and Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, December 12, 2023

Sales, Eye Care, Area Director, Facial Aesthetics and Senior Product Manager, Lumigan (glaucoma product).

Key Points: 
  • Sales, Eye Care, Area Director, Facial Aesthetics and Senior Product Manager, Lumigan (glaucoma product).
  • He most recently served as Chief Commercial Officer at Dermtech International, a leading genomics company in dermatology.
  • in business administration from Grand Valley State University, Allendale, Mich.
    “I’m looking forward to building upon Alimera’s strong foundation to establish a program for long-term success,” said Mr. Wood.
  • The Inducement Option is an inducement material to Mr. Wood entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).