SAN CARLOS, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc. , a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint-resistant cancers, and a subsidiary of Grifols , announced today that the first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of the first recombinant polyclonal drug candidate, GIGA-2339, for... Read More

Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasis Grifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a... Read More

Initiative will test Grifols ocular surface immunoglobulin (OSIG) eye drops to evaluate their nonclinical efficacy in neutralizing symptoms from exposure to sulfur mustard, a chemical warfare agent A successful preclinical study of this potentially innovative therapeutic could lead to an FDA license for one of the first medical treatments for sulfur mustard ocular injury Grifols also plans to start a phase 2 clinical trial... Read More

The contract will provide an initial commitment of $19.6 million and up to $135.2 million over a six-year period, supporting drug manufacturing and phase 1 trials for the two programs GigaGen’s recombinant polyclonals are part of Grifols’ robust innovation strategy and commitment to delivering the next generation of antibody drugs for patients and healthcare professionals SAN CARLOS, Calif., Oct. 03, 2024 (GLOBE NEWSWIRE) --... Read More

GIGA-2339 is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic hepatitis B virus (HBV) infection; trial initiation expected in Q4 2024 Containing more than 1,000 fully human recombinant anti-HBV antibodies, GIGA-2339 reproduces the human body’s natural immune response GigaGen’s recombinant polyclonals are part of Grifols’ robust innovation strategy and commitment to delivering... Read More

XEMBIFY is the first and only 20% subcutaneous immunoglobulin (SCIg) with FDA-approved dosing for treatment-naïve patients, enabling them to go straight to SCIg without initial intravenous therapy Approval, which also includes biweekly dosing, follows phase 4 study data demonstrating comparable total Ig levels when administering XEMBIFY every two weeks versus weekly The expanded label for XEMBIFY provides added flexibility... Read More

Biotest, a Grifols Group company, is expected to launch its recently FDA-approved intravenous immunoglobulin in the U.S. in first quarter 2025 Yimmugo will be distributed by Kedrion in the U.S. as part of a broader Group channel strategy, with Grifols focusing on continued growth of its current portfolio for this market It adds to Grifols’ strong franchise of intravenous and subcutaneous immunoglobulins to meet growing... Read More

With today’s announcement of the transaction completion, Grifols and Haier Group will work together through Shanghai RAAS (SRAAS) to drive synergies that enhance China’s healthcare system Through a share purchase agreement Grifols has sold a 20% equity stake in SRAAS to Haier Group for RMB 12.5 billion (approximately EUR 1.6 billion) Grifols and SRAAS extend their exclusive albumin distribution agreement over the next 10... Read More

With Biotest-developed Yimmugo, Grifols adds to its remarkable franchise of intravenous and subcutaneous immunoglobulins to meet strong demand Yimmugo, already approved for production and marketing in Europe, is the first U.S.-approved medicine in Biotest’s portfolio and is manufactured with an innovative process at Biotest’s new FDA-certified ‘Next Level’ facility U.S. approval of Yimmugo paves the way for other Biotest... Read More

BARCELONA, Spain , April 19, 2024 /PRNewswire/ -- Grifols, S.A. ("Grifols") (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announces the filing of its Annual Report on Form 20-F for the fiscal year ended December 31, 2023 , with the United States Securities and Exchange Commission ("SEC"). Grifols' annual report on Form 20-F provides investors... Read More

The addition of the Clayton site in 2011 marked a new milestone for Grifols, turning the company into a top-three plasma industry leader and setting the stage for sustained business growth The flagship Grifols campus is a touchstone of Grifols’ leadership in plasma therapeutics, producing about 40% of the company’s total medicinal output globally and helping enhance the quality of life of patients all over the world An... Read More

Grifols’ in vitro nucleic acid test detects four types of arboviruses, helping mitigate the risk of transfusion-transmitted infections Arboviruses are a growing emerging threat, with changes in climate and increasing global connectivity making the geographic spread more prevalent CE mark for Grifols’ Procleix ArboPlex Assay reinforces the company’s leadership in transfusion medicine and commitment to ensuring the safety of... Read More

In the AdFIrst study, Biotest's fibrinogen concentrate (FC), BT524, met the primary endpoint, demonstrating its effectiveness in treating acquired fibrinogen deficiency (AFD) as equivalent to standard of care, while maintaining an excellent safety profile Regulatory approval process in Europe and United States set to begin in Q4 2024. It would be the first FC approved for an AFD indication in the U.S. in a global market for... Read More

Study designed to demonstrate impact of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% (Alpha-1 15%), an alpha 1 antitrypsin treatment, compared with Liquid Alpha1-Proteinase Inhibitor (Human) intravenous This first in-human subcutaneous approach to treating alpha 1 -antitrypsin deficiency, if proven successful in clinical trials, could give patients the convenience and flexibility to administer their medication from... Read More

Researchers from the National Cancer Institute will conduct the Phase 1 trial, as established in a recently signed Cooperative Research and Development Agreement (CRADA) GigaGen anticipates trial initiation in 2024 GIGA-564 is a differentiated anti-CTLA-4 antibody with potential to enhance anti-tumor activity and mitigate immune-related toxicities associated with traditional CTLA-4 blockade SAN CARLOS, Calif., Nov. 06, 2023... Read More

Trial met primary endpoints, confirming vaccine’s safety, tolerability and robust immune response against the Aβ40 peptide in early-stage Alzheimer's patients ABvac40 treatment slowed disease progression up to 38% compared with placebo as measured by the Mini-Mental State Examination score Vaccine’s unique design offers a new approach to address growing need for effective Alzheimer’s treatments as the prevalence of... Read More

SOUTH SAN FRANCISCO, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- GigaGen Inc . , a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols , announced today the company has been granted an expansion of its contract with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological,... Read More

Collaboration sets stage for GigaGen’s first oncology asset to enter clinical development GIGA-564 is a differentiated anti-CTLA4 antibody with potential to enhance anti-tumor activity and mitigate immune-related toxicities associated with traditional CTLA-4 blockade GigaGen and NCI will present investigational new drug (IND)-enabling data and clinical trial strategy for GIGA-564 at the 2023 Society for Immunotherapy of... Read More

Grifols will apply artificial intelligence technologies, including large language models, to speed up the development of new biopharma therapeutics Agreement is latest Grifols initiative to reinforce the robustness of its therapeutic pipeline and strengthen its innovation culture BARCELONA, Spain, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer... Read More

Clinical trial met primary endpoint demonstrating comparable total immunoglobulin (Ig) levels when administering XEMBIFY ® (Grifols’ subcutaneous Ig) every two weeks, compared with weekly, in patients with primary immunodeficiencies Study designed to support extending U.S. Food and Drug Administration labeling of XEMBIFY ® to include biweekly dosing, providing added flexibility and convenience for patients Grifols is... Read More

PRECIOSA clinical trial is designed to evaluate efficacy and safety of Grifols Albutein ® plus standard medical treatment to increase survival time in patients with decompensated cirrhosis awaiting transplant Albumin’s antioxidant and anti-inflammatory properties have the potential to mitigate the complications associated with decompensated cirrhosis Grifols continues innovating across its plasma-protein franchise and is... Read More

Target of 339 patients enrolled has been met in the SPARTA clinical trial, designed to evaluate efficacy and safety of two separate weekly doses of Grifols’ Prolastin ® -C (Alpha1-Proteinase Inhibitor [Human]) to slow emphysema progression in patients with alpha-1-antitrypsin (AAT) deficiency (known as alpha-1) Alpha-1 is the most common genetic risk factor for chronic obstructive pulmonary disease (COPD), a group of... Read More

Now available in the U.S., this free, innovative genetic health risk service lets consumers screen for their risk of alpha 1 -antitrypsin deficiency (alpha-1) through a small saliva sample they can collect right at home without needing to visit a healthcare professional Alpha-1 is the most common genetic risk factor for chronic obstructive pulmonary disease (COPD), a group of respiratory diseases affecting around 16 million... Read More

CHICAGO , March 6, 2023 /PRNewswire/ -- Selagine, Inc. , a spin-out company from the University of Illinois at Chicago (UIC), announced today that it has entered into a research, development and sublicense agreement with Grifols (Nasdaq: GRFS), a global leader in plasma-derived medicines, for the development and... Read More