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ADMA Biologics Announces FDA Approvals of Extended Room Temperature Storage Conditions for ASCENIV™ & BIVIGAM®

Retrieved on: 
Lunedì, Marzo 11, 2024

RAMSEY, N.J. and BOCA RATON, Fla., March 11, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature (25°C) storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.

Key Points: 
  • Approval of Extended Ambient Storage Conditions for ASCENIV & BIVIGAM is Immediately Effective and Now Commercially Available to U.S. Healthcare Providers
    RAMSEY, N.J. and BOCA RATON, Fla., March 11, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature (25°C) storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life.
  • The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.
  • “With the FDA-approved extension of room temperature storage conditions, the Company expects to reach more customers who were previously inaccessible due to limited refrigeration space and cold chain capacity constraints,” said Adam Grossman, President and Chief Executive Officer of ADMA.
  • “We believe that this added storage flexibility for both ASCENIV and BIVIGAM will meaningfully enhance our products’ market offerings, enabling more versatile utilization and better inventory management for providers.”
    The newly approved extension of room temperature storage conditions for both ASCENIV and BIVIGAM is immediately effective, and both products are commercially available to U.S. healthcare providers and patients.

DBV Technologies Reports Full Year 2023 Financial Results and Business Update

Retrieved on: 
Giovedì, Marzo 7, 2024

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the full year 2023.

Key Points: 
  • DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the full year 2023.
  • Published EPITOPE results in the New England Journal of Medicine with an accompanying editorial, entitled, Good News for Toddlers with Peanut Allergy.
  • ET to discuss full year 2023 financial results and provide a business update.
  • The conference call may be accessed by dialing:
    A webcast of the call will also be available under "Events" in the Investors section of the DBV Technologies website: https://dbv-technologies.com/investor-overview/events .

Beta-thalassemia Market to Witness Upsurge in Growth During the Study Period (2019-2032), Evaluates DelveInsight | Leading Companies - Vertex Pharmaceuticals, CRISPR Therapeutics, Agios Pharmaceuticals, Celgene, Forma Therapeutics

Retrieved on: 
Mercoledì, Gennaio 17, 2024

LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Beta-thalassemia Market Insights report includes a comprehensive understanding of current treatment practices, beta-thalassemia emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • According to DelveInsight's analysis, the market size for beta-thalassemia across the 7MM is expected to grow with a significant CAGR by 2032.
  • The promising beta-thalassemia therapies in the pipeline include CTX001, EDIT-301, Mitapivat, ACE-536, Panobinostat, Etavopivat tablets, and others.
  • In September 2023, Pharmacosmos has initiated a Phase II trial of SP-420 in patients with transfusion-dependent β-thalassemia.
  • In June 2023, FDA accepted the Biologics License Application (BLAs) of exagamglogene autotemcel (exa-cel) for transfusion-dependent beta thalassemia (TDT).

Beta-thalassemia Market to Witness Upsurge in Growth During the Study Period (2019-2032), Evaluates DelveInsight | Leading Companies - Vertex Pharmaceuticals, CRISPR Therapeutics, Agios Pharmaceuticals, Celgene, Forma Therapeutics

Retrieved on: 
Mercoledì, Gennaio 17, 2024

LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Beta-thalassemia Market Insights report includes a comprehensive understanding of current treatment practices, beta-thalassemia emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • According to DelveInsight's analysis, the market size for beta-thalassemia across the 7MM is expected to grow with a significant CAGR by 2032.
  • The promising beta-thalassemia therapies in the pipeline include CTX001, EDIT-301, Mitapivat, ACE-536, Panobinostat, Etavopivat tablets, and others.
  • In September 2023, Pharmacosmos has initiated a Phase II trial of SP-420 in patients with transfusion-dependent β-thalassemia.
  • In June 2023, FDA accepted the Biologics License Application (BLAs) of exagamglogene autotemcel (exa-cel) for transfusion-dependent beta thalassemia (TDT).

Cryoport Reports Third Quarter 2023 Financial Results

Retrieved on: 
Mercoledì, Novembre 8, 2023

A total of six Cryoport supported Biologic License Applications (BLAs) or Marketing Authorization Applications (MAAs) were filed in the third quarter of 2023.

Key Points: 
  • A total of six Cryoport supported Biologic License Applications (BLAs) or Marketing Authorization Applications (MAAs) were filed in the third quarter of 2023.
  • Biopharma/Pharma revenue was $47.0 million, down 3% or $1.6 million for Q3 2023 compared to $48.6 million for Q3 2022.
  • Revenue from the support of commercial cell and gene therapies increased by $2.3 million, or 54%, to $6.6 million for Q3 2023.
  • Reproductive Medicine revenue was $2.3 million for Q3 2023, consistent with Q3 2022, reflecting sustained demand for our CryoStork® logistics solutions.

DBV Technologies Announces Appointment of Virginie Boucinha as Chief Financial Officer

Retrieved on: 
Lunedì, Ottobre 16, 2023

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the appointment of Virginie Boucinha as its Chief Financial Officer, effective November 6, 2023.

Key Points: 
  • DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the appointment of Virginie Boucinha as its Chief Financial Officer, effective November 6, 2023.
  • “I am pleased to welcome Virginie to the DBV Executive Committee to lead our global financial organization,” said Daniel Tassé, Chief Executive Officer, DBV Technologies.
  • I am looking forward to this mission and to collaborating alongside the broader DBV Executive team.”
    Sébastien Robitaille, Chief Financial Officer, DBV Technologies, will be leaving the Company to pursue other opportunities on November 17th.
  • “It has been a privilege to work alongside colleagues that are dedicated and passionate about making a difference in the lives of others,” said Sébastien Robitaille, Chief Financial Officer, DBV Technologies.

CG Oncology Announces Key Executive Appointments in Commercialization, Medical and Manufacturing Operations

Retrieved on: 
Martedì, Settembre 5, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230905869419/en/
    Ambaw Bellete, President and Chief Operating Officer, CG Oncology (Photo: Business Wire)
    “CG Oncology is at an important stage in our growth, advancing our late-stage clinical pipeline to address unmet medical needs in bladder cancer.
  • Ambaw, Swapnil and Vijay bring decades of experience and proven track records in developing immunotherapy agents from research to commercialization,” said Arthur Kuan, Chief Executive Officer, CG Oncology.
  • Previously, Vijay was the VP, Clinical Development and Medical Affairs and a member of the executive leadership team at AVEO.
  • He was also SVP of Scientific Affairs at FerGene, leading Medical Affairs, Clinical Operations, Regulatory and Clinical Development.

Sparx Biopharmaceutical Welcomes Dr. Roland Meier as Chief Medical Officer

Retrieved on: 
Martedì, Settembre 5, 2023

CHICAGO, Sept. 5, 2023 /PRNewswire/ -- Spearheading the field of powered antibody therapies, SparX Biopharmaceutical Corp. proudly announces the addition of Dr. Roland Meier as their esteemed Chief Medical Officer.

Key Points: 
  • CHICAGO, Sept. 5, 2023 /PRNewswire/ -- Spearheading the field of powered antibody therapies, SparX Biopharmaceutical Corp. proudly announces the addition of Dr. Roland Meier as their esteemed Chief Medical Officer.
  • Dr. Guidong Zhu, CEO and founder of SparX, commented, "Dr. Meier's esteemed reputation in immuno-oncology drug development is unparalleled.
  • With Roland on board, we are poised to transition SparX from a discovery-centric to a clinical-driven biotech entity."
  • On becoming a part of the SparX family, Dr. Meier shared, "SparX exemplifies innovation in biotechnology.

SAB Biotherapeutics Provides Company Update for Q2 2023 Financial Results

Retrieved on: 
Lunedì, Agosto 21, 2023

SIOUX FALLS, S.D., Aug. 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulins (hIgG), also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the second quarter ended June 30, 2023, and provided a company update.

Key Points: 
  • SIOUX FALLS, S.D., Aug. 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulins (hIgG), also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the second quarter ended June 30, 2023, and provided a company update.
  • "We are pleased to share the significant progress achieved during the second quarter of 2023.
  • On August 21, 2023, we announced that EisnerAmper LLP was appointed as our independent registered public accounting firm for the fiscal year ending December 31, 2023, effective August 22, 2023.
  • The decrease was primarily due to discretionary cost reduction measures and increased efficiencies as we continue to mature as a publicly traded company.

Wound Healing Technology Company Merakris Adds Two Executives to Leadership Team

Retrieved on: 
Martedì, Agosto 15, 2023

The Research Triangle Park-headquartered company is pioneering the development of a first-in-class biological drug product to promote healing of damaged tissue.

Key Points: 
  • The Research Triangle Park-headquartered company is pioneering the development of a first-in-class biological drug product to promote healing of damaged tissue.
  • Roger Ilagan, Ph.D., has joined Merakris as Vice President, Research and Development, and Mark Rogers, MBA has been named Vice President, Quality and Regulatory Affairs.
  • Before joining Merakris, he was Chief Quality and Regulatory Officer at Arizona-headquartered human cellular and tissue-based products company, Surgenex.
  • “We are delighted that Dr. Ilagan and Mark have joined our team at Merakris,” said company CEO Chris Broderick.