Blas

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Retrieved on: 
Thursday, March 14, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Civil service commission, Glucose, Survival, ALT, DSM-IV codes, Associate, Blas, Medicine, Patient, Esophageal cancer, Committee, Sodium, Alkaline phosphatase, University, Cancer, EMA, BGNE, Quality of life, Tislelizumab, Lung cancer, Section, European Medicines Agency, Lymphocyte, ITT, European Commission, Anemia, Division, ESCC, Fatigue, University of Southern California, BLA, Food, Pharmaceutical industry

TEVIMBRA will be available in the U.S. in the second half of 2024.

Key Points: 
  • TEVIMBRA will be available in the U.S. in the second half of 2024.
  • The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
  • More than 900,000 patients have been prescribed TEVIMBRA globally to date.

Cryoport Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 12, 2024
Risk, FY, Maas, Form, Blas, Gene, Animal Health, Reproductive medicine, Form 10-K, Security (finance), Marketing, Investment, Annual report, Debt-to-GDP ratio, Cell, Medicine, MVE, Pharmaceutical industry

Total revenue for Q4 2023 was $57.3 million compared to $60.4 million for Q4 2022, a year-over-year decrease of 5% or $3.1 million.

Key Points: 
  • Total revenue for Q4 2023 was $57.3 million compared to $60.4 million for Q4 2022, a year-over-year decrease of 5% or $3.1 million.
  • Biopharma/Pharma revenue was $47.9 million, down 5% or $2.7 million for Q4 2023 compared to $50.6 million for Q4 2022.
  • Animal Health revenue was $6.8 million for Q4 2023, down 10% or $0.7 million compared to $7.5 million for Q4 2022.
  • Reproductive Medicine revenue was $2.6 million for Q4 2023, up 11% compared to $2.3 million for Q4 2022.

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

Retrieved on: 
Monday, March 11, 2024
Blas, Extension, Temperature, Marketing, FDA, ADMA, Commerce, Patient, Pharmaceutical industry

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: 
Thursday, March 7, 2024
Vitesse, European Commission, Marketing, DBV Technologies, Blas, FDA, Form 10-K, File, Research and development, Language, Sale, BLA, Toddler, American College, Form, Financial statement, Safety, American depositary receipt, GAAP, Good news, Immunology, Administration, Net, Food, Asthma, DBV, Initiate, Development, Bank statement, Agreement, Editorial, Cryptocurrency

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: 
Wednesday, January 17, 2024
Vertex Pharmaceuticals, Patient, Biologics license application, Therapy, Endocrine system, TGF, Heart, LAS, HBA, Spleen, Diagnosis, Anemia, Mouse, Thalassemia, Beta thalassemia, HB, CBC, RBC, Pharmacosmos, Disease, Iron overload, TDT, EU4, FDA, Blas, Prevalence, Liver, Novo Nordisk, PDUFA, Red blood cell, CRISPR Therapeutics, Hemoglobin A, Cell, Iron, Pharmaceutical industry

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: 
Wednesday, January 17, 2024
Vertex Pharmaceuticals, Patient, Biologics license application, Therapy, Endocrine system, TGF, Heart, LAS, HBA, Spleen, Diagnosis, Anemia, Mouse, Thalassemia, Beta thalassemia, HB, CBC, RBC, Pharmacosmos, Disease, Iron overload, TDT, EU4, FDA, Blas, Prevalence, Liver, Novo Nordisk, PDUFA, Red blood cell, CRISPR Therapeutics, Hemoglobin A, Cell, Iron, Pharmaceutical industry

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: 
Wednesday, November 8, 2023
Hamas, Risk, Security (finance), EBITDA, Form, Supply, Reproductive medicine, Skytrax, Medicine, Blas, SEC filing, Form 10-K, Animal Health, Maas, Collection, Cryopreservation, Investment, Debt-to-GDP ratio, Marketing, Pharmaceutical industry, Beauty salon, Cryptocurrency, Rare-earth element, Reinsurance

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: 
Monday, October 16, 2023
Peanut allergy, DBV, Virginie, Strategic planning, Blas, Grammy Award for Best Pop Duo/Group Performance, DBV Technologies, Information technology, Executive Committee of the Space Research Council, Business administration, Financial management, Food, Executive Committee, Master of Business Administration, Management, Euronext, Sanofi

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: 
Tuesday, September 5, 2023
Oncology, Health, Genetics, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Immortalised cell line, Upjohn, GMP, Amgen, IIT, Medical Affairs Bureau, University, Bureau of Oceans and International Environmental and Scientific Affairs, Blas, University of Maryland, College Park, GU, Record, American Society of Pediatric Hematology/Oncology, Dartmouth–Hitchcock Medical Center, Bladder cancer, Multimedia, Research, Priscilla Chan, Assistant, AbCellera, National Cancer Institute, Urology, Patient, Division, Oslo-Fergene, Hematology, IND, Sanofi, Indian Institutes of Technology, Growth, Merck Serono, SVP, Chemical engineering, Caregiver, Disease, Management, Nursing, Photocure, Seagen, Pfizer

View the full release here: https://www.businesswire.com/news/home/20230905869419/en/

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: 
Tuesday, September 5, 2023
University of Zurich, University, University of California, Berkeley, Blas, Biotechnology, Sparx, Eli Lilly, Kyowa Kirin, UC, Patent, Cancer, Knowledge, ADC, University of Lausanne, Fine chemical, Pharmaceutical industry

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.