Type 1 diabetes

Diamyd Medical receives U.S. FDA Fast Track designation for Diamyd®

Retrieved on: 
Thursday, February 15, 2024

STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.

Key Points: 
  • STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.
  • The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need.
  • Fast Track designation is intended to bring promising medicines to patients sooner.
  • "We are very pleased with the FDA's decision to grant Fast Track designation for Diamyd and the potential this provides to accelerate Diamyd's path to entering the US market", says Ulf Hannelius, CEO of Diamyd Medical.

Diamyd Medical receives U.S. FDA Fast Track designation for Diamyd®

Retrieved on: 
Thursday, February 15, 2024

STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.

Key Points: 
  • STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.
  • The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need.
  • Fast Track designation is intended to bring promising medicines to patients sooner.
  • "We are very pleased with the FDA's decision to grant Fast Track designation for Diamyd and the potential this provides to accelerate Diamyd's path to entering the US market", says Ulf Hannelius, CEO of Diamyd Medical.

Biodexa CEO Issues Shareholder Letter Highlighting Progress in 2023 and Expected Milestones in 2024

Retrieved on: 
Monday, January 22, 2024

In December 2023, we completed an in-licensing of a new, potentially disease modifying, orally delivered clinical stage molecule for Type I diabetes, an unmet medical disease.

Key Points: 
  • In December 2023, we completed an in-licensing of a new, potentially disease modifying, orally delivered clinical stage molecule for Type I diabetes, an unmet medical disease.
  • Tolimidone is an activator of lyn kinase which has been shown to play a significant role in cell proliferation, differentiation, apoptosis, migration and metabolism.
  • We expect to report data from the in vivo LMD efficacy model by the end of the first quarter of 2024.
  • Certain statements in this shareholder letter may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States.

Diamyd Medical gains market research findings to guide U.S. commercial strategy

Retrieved on: 
Monday, January 8, 2024

"These results both confirm and exceed our previous insights regarding pricing and the market potential of Diamyd in the US", says Ulf Hannelius, CEO of Diamyd Medical.

Key Points: 
  • "These results both confirm and exceed our previous insights regarding pricing and the market potential of Diamyd in the US", says Ulf Hannelius, CEO of Diamyd Medical.
  • Educational Needs and Market Preparation: The research highlighted some gaps in awareness regarding type 1 diabetes staging and the diversity in first-line therapy approaches.
  • These findings underscore the importance of continuous educational efforts in tandem with the introduction of new treatments like Diamyd®.
  • The research pointed to Integrated Delivery Networks (IDNs) as a natural and effective delivery channel for Diamyd® outpatient treatment.

Diamyd Medical gains market research findings to guide U.S. commercial strategy

Retrieved on: 
Monday, January 8, 2024

"These results both confirm and exceed our previous insights regarding pricing and the market potential of Diamyd in the US", says Ulf Hannelius, CEO of Diamyd Medical.

Key Points: 
  • "These results both confirm and exceed our previous insights regarding pricing and the market potential of Diamyd in the US", says Ulf Hannelius, CEO of Diamyd Medical.
  • Educational Needs and Market Preparation: The research highlighted some gaps in awareness regarding type 1 diabetes staging and the diversity in first-line therapy approaches.
  • These findings underscore the importance of continuous educational efforts in tandem with the introduction of new treatments like Diamyd®.
  • The research pointed to Integrated Delivery Networks (IDNs) as a natural and effective delivery channel for Diamyd® outpatient treatment.

SAB Biotherapeutics Announces 1-for-10 Reverse Stock Split

Retrieved on: 
Tuesday, January 2, 2024

Upon the effectiveness of the reverse stock split at 12:01 a.m. January 5, 2024, every ten shares of issued and outstanding common stock will automatically be combined and converted into one issued and outstanding share of common stock.

Key Points: 
  • Upon the effectiveness of the reverse stock split at 12:01 a.m. January 5, 2024, every ten shares of issued and outstanding common stock will automatically be combined and converted into one issued and outstanding share of common stock.
  • The reverse stock split will not reduce the number of authorized shares of common stock or change the par value of the common stock.
  • The reverse stock split will affect all stockholders uniformly and will not affect any stockholder's ownership percentage of SAB’s shares of common stock (except to the extent that the reverse stock split would result in some of the stockholders receiving cash in lieu of fractional shares).
  • The common stock issued pursuant to the reverse stock split will remain fully paid and non-assessable.

SAB Biotherapeutics Announces Commencement of the HUMAN Phase 1 Clinical Trial with SAB-142, a Potential Disease-Modifying Treatment for Type 1 Diabetes

Retrieved on: 
Wednesday, November 29, 2023

SIOUX FALLS, S.D., Nov. 29, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing fully-human anti-thymocyte immunoglobulin (hIgG) for disease-modification of Type 1 Diabetes (T1D) through delaying the onset and/or progression of the disease, today announced that the first participants of a HUMAN trial (Fully HUman anti-thymocyte biologic in first-in-MAN clinical study) have been dosed in Australia. This Phase 1 randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D. SAB-142 is a first-in-class fully-human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D.

Key Points: 
  • SAB-142 is a first-in-class fully-human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D.
  • In October 2023 , SAB received approval by the Australian Human Research Ethics Committee (HREC) to commence the Phase 1 clinical trial investigating safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of SAB-142.
  • More information about the Phase 1 clinical trial with SAB-142 (ACTRN:12623001089628) can be found here .
  • “We are grateful to partner with SAB on this Phase 1 investigation that will explore the therapeutic potential of a new, potentially best-in-class immunotherapeutic option for patients.”

Donor Alliance Volunteer to Represent Colorado, Wyoming in 2024 Rose Parade

Retrieved on: 
Wednesday, December 20, 2023

Rhonda will be aboard the OneLegacy Donate Life Rose Parade float , which is celebrating 21 years on the Rose Parade.

Key Points: 
  • Rhonda will be aboard the OneLegacy Donate Life Rose Parade float , which is celebrating 21 years on the Rose Parade.
  • The 2024 Donate Life Rose Parade float, “Woven Together: The Dance of Life,” features a beautiful Butterfly Dancer wearing an impressive and intricate headdress.
  • “Donor Alliance is proud to return to the Rose Parade in 2024 to share Rhonda’s remarkable story with viewers across the globe,” said Jennifer Prinz, president and CEO of Donor Alliance.
  • The 2024 Rose Parade will start at 7 a.m. MST on January 1, 2024, and be broadcast live.

Enable Biosciences Receives $3M Phase IIB SBIR Award from NIDDK for Advanced T1D Testing Technology

Retrieved on: 
Tuesday, December 19, 2023

A key objective of this funding is to pursue FDA clearance for the T1D test, a critical step towards commercialization.

Key Points: 
  • A key objective of this funding is to pursue FDA clearance for the T1D test, a critical step towards commercialization.
  • Dr. Jason Tsai, PhD, Chief Technical Officer at Enable Biosciences, shared his enthusiasm: "This Phase IIB SBIR award from NIDDK is a testament to our dedication to transforming T1D testing.
  • The NIDDK's support is pivotal for Enable Biosciences in its pursuit of FDA clearance for its innovative T1D test.
  • For more information about Enable Biosciences and their cutting-edge approach to T1D testing, visit www.enablebiosciences.com or contact their media team for further details and inquiries.

TC BioPharm Announces Formation of Commercial Development Division, Led by Industry Veteran, Dr. Lauren Bor Ph.D

Retrieved on: 
Monday, December 18, 2023

Additionally, TC BioPharm's Commercial Development Division will explore new opportunities with third parties to monetize the company's production capabilities using the GMP licensed facility.

Key Points: 
  • Additionally, TC BioPharm's Commercial Development Division will explore new opportunities with third parties to monetize the company's production capabilities using the GMP licensed facility.
  • Prior to serving as TC BioPharm's Head of Process Development, Dr. Bor completed a Bsc Hons degree in Immunology from the University of Glasgow.
  • Lauren Joined TC BioPharm in 2019, and her area of research has been the process development and technology transfer of TC BioPharm's Unmodified cryopreserved Vγ9Vδ2 T cell manufacturing process.
  • "TC BioPharm understands that early-stage biotech companies have different needs and expectations than that of large pharmaceutical companies.