Hidradenitis suppurativa

JJP Biologics Announces Positive Decision to Execute a First-in-Human Clinical Trial of Anti-Inflammatory mAb JJP-1212 (anti-CD89)

Retrieved on: 
水曜日, 5月 29, 2024

Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody.

Key Points: 
  • Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody.
  • According to Paweł Szczepański, COO and Management Board Member at JJP Biologics - “This is a historically unprecedented approval of a first-in-human clinical trial for a novel large molecule therapy from Poland.
  • JJP Biologics is exploring the development of companion diagnostics in various indications using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212.
  • JJP Biologics pursues the development of its product candidates as well as projects executed in cooperation with scientific partners.

Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S.

Retrieved on: 
火曜日, 5月 21, 2024

“We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva.

Key Points: 
  • “We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva.
  • “Biosimilars create opportunities for cost savings across the healthcare system, and SIMLANDI’s launch now offers the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. market.
  • Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure.
  • Humira is a registered trademark of AbbVie Biotechnology Ltd. Stelara is a registered trademark of Johnson & Johnson.

Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S.

Retrieved on: 
火曜日, 5月 21, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240520679234/en/
    “We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva.
  • “Biosimilars create opportunities for cost savings across the healthcare system, and SIMLANDI’s launch now offers the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. market.
  • Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure.
  • Humira is a registered trademark of AbbVie Biotechnology Ltd.
    Stelara is a registered trademark of Johnson & Johnson.

ACELYRIN, INC. Provides Business Update and Highlights Key Upcoming Milestones

Retrieved on: 
木曜日, 5月 9, 2024

LOS ANGELES, May 09, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on various corporate milestones.

Key Points: 
  • This Phase 2b/3 trial, designed to be the first of two registrational trials in TED, is planned to be initiated in the second half of 2024.
  • Izokibep in Uveitis (UV): ACELYRIN expects to complete enrollment in the ongoing Phase 2b/3 trial this month and top line data are anticipated by year-end 2024.
  • ACELYRIN expects to report cash, cash equivalents, and short-term marketable securities of $678.5 million at March 31, 2024.
  • Gil Labrucherie, who serves as ACELYRIN’s Chief Financial Officer, has also been named Chief Business Officer in addition to Chief Financial Officer.

Aclaris Therapeutics Reports First Quarter 2024 Financial Results and Provides a Corporate Update

Retrieved on: 
火曜日, 5月 7, 2024

WAYNE, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2024 and provided a corporate update.

Key Points: 
  • WAYNE, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2024 and provided a corporate update.
  • In September 2023, Aclaris reported positive results from its Phase 1 multiple ascending dose (MAD) trial of ATI-2138.
  • Net loss was $16.9 million for the first quarter of 2024 compared to $28.2 million for the first quarter of 2023.
  • Total revenue was $2.4 million for the first quarter of 2024 compared to $2.5 million for the first quarter of 2023.

U.S. Commercialization Agreement with Quallent to Drive Patient Savings with First High-Concentration Citrate-Free Interchangeable Biosimilar to Humira® (adalimumab)

Retrieved on: 
火曜日, 4月 30, 2024

The interchangeable biosimilar will be distributed under Quallent’s private label.

Key Points: 
  • The interchangeable biosimilar will be distributed under Quallent’s private label.
  • “We are pleased to be working with Alvotech to bring adalimumab-ryvk to more patients.
  • Our intent is to offer a copay assistance program, which will provide eligible patients access,” said John Caufield, President of Quallent Pharmaceuticals Health, LLC.
  • Alvotech’s high concentration interchangeable biosimilar to Humira® (adalimumab) was the first biosimilar approved under the strategic partnership, and Teva expects to launch it to patients in the U.S. imminently.

MoonLake Immunotherapeutics inks three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions 

Retrieved on: 
水曜日, 4月 10, 2024

San Francisco, US and Zug, Switzerland, April 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX) a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.

Key Points: 
  • San Francisco, US and Zug, Switzerland, April 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX) a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.
  • Through this multiyear technology partnership, MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision making across its clinical operations, medical, marketing, and market access teams.
  • Komodo’s data and technology applications will support MoonLake’s in-depth market research, clinical trial site selection, go-to-market strategies, and patient journey mapping – all aimed at accelerating the development of new treatment options and improving outcomes for patients with inflammatory skin and joint diseases.
  • Tino Anthamatten, VP Marketing & Market Access & Pricing, MoonLake Immunotherapeutics, commented: “We need an experienced technology partner that can help accelerate our disease insights for our clinical, medical, and commercial endeavors.

Zura Bio Announces Oversubscribed $112.5 Million Private Placement

Retrieved on: 
木曜日, 4月 18, 2024

Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that it has entered into subscription agreements for a private placement that is expected to result in gross proceeds of approximately $112.5 million, before deducting placement agent fees and offering expenses (the “Private Placement”).

Key Points: 
  • Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that it has entered into subscription agreements for a private placement that is expected to result in gross proceeds of approximately $112.5 million, before deducting placement agent fees and offering expenses (the “Private Placement”).
  • The Private Placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rules).
  • The private placement is expected to close on April 22, 2024, subject to satisfaction of customary closing conditions.
  • Piper Sandler, Guggenheim Securities, and Cantor served as lead placement agents for the Private Placement.

MoonLake Immunotherapeutics Inks Three-Year Technology Partnership With Komodo Health To Advance Research on Inflammatory Skin and Joint Conditions

Retrieved on: 
水曜日, 4月 10, 2024

MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.

Key Points: 
  • MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve treatment for people living with inflammatory skin and joint diseases.
  • View the full release here: https://www.businesswire.com/news/home/20240410438883/en/
    Through this multiyear technology partnership, MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision-making across its clinical operations, medical, marketing, and market access teams.
  • Tino Anthamatten, VP, Marketing & Market Access & Pricing, MoonLake Immunotherapeutics, commented: “We need an experienced technology partner that can help accelerate our disease insights for our clinical, medical, and commercial endeavors.
  • The real-world insights from Komodo helped validate a future HS market size projected to exceed $10B by 2035.

UCB Launches Make HStory, an Educational Campaign Offering Resources and Support for Those Living with Hidradenitis Suppurativa

Retrieved on: 
水曜日, 4月 10, 2024

"My UCB colleagues and I are incredibly grateful to those who have already shared their HS journeys and stories as part of the Make HStory campaign.

Key Points: 
  • "My UCB colleagues and I are incredibly grateful to those who have already shared their HS journeys and stories as part of the Make HStory campaign.
  • Their own experiences and personal histories are what will provide hope and a path forward for so many others."
  • UCB is proud to contribute to advancing the understanding of HS and is committed to continuing its mission to address unmet needs for those living with this severe disease.
  • To stay up to date on the latest HS resources, visit https://www.makehstory.com/ and follow Make HStory on Instagram at @MakeHStory and on Facebook at www.facebook.com/makehstory .