European Commission

Intellia Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, February 22, 2024

Collaboration Revenue: Collaboration revenue decreased by $15.5 million to negative $1.9 million during the fourth quarter of 2023, compared to $13.6 million during the fourth quarter of 2022.

Key Points: 
  • Collaboration Revenue: Collaboration revenue decreased by $15.5 million to negative $1.9 million during the fourth quarter of 2023, compared to $13.6 million during the fourth quarter of 2022.
  • R&D Expenses: Research and development expenses increased by $9.0 million to $109.0 million during the fourth quarter of 2023, compared to $100.0 million during the fourth quarter of 2022.
  • G&A Expenses: General and administrative expenses increased by $5.4 million to $29.0 million during the fourth quarter of 2023, compared to $23.6 million during the fourth quarter of 2022.
  • Net Loss: The Company’s net loss was $132.2 million for the fourth quarter of 2023, compared to $113.4 million during the fourth quarter of 2022.

Galapagos announces full year 2023 results and outlook for 2024

Retrieved on: 
Thursday, February 22, 2024

In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.

Key Points: 
  • In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.
  • Signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of Galapagos’ CAR-T cell therapy candidates.
  • Further streamlined our operations with a reduction of approximately 100 positions across the Galapagos organization to align with the Galapagos’ renewed focus on innovation.
  • Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen Galapagos' growing early-stage oncology precision medicine pipeline.

BioCryst Launches ORLADEYO® (berotralstat) in Italy

Retrieved on: 
Monday, February 19, 2024

RESEARCH TRIANGLE PARK, N.C., Feb. 19, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA), has finalized reimbursement and recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Feb. 19, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA), has finalized reimbursement and recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older.
  • With this recommendation, HAE patients in Italy now have access to the first oral, once-daily therapy for the routine prevention of recurrent HAE attacks.
  • “The positive AIFA recommendation of ORLADEYO® (berotralstat) broadens access to modern prophylaxis in Italy and is great news for Italian clinicians and HAE patients,” said Charlie Gayer, chief commercial officer of BioCryst.
  • The AIFA decision follows European Commission (EC) marketing authorization of ORLADEYO in April 2021.

Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

Retrieved on: 
Tuesday, March 12, 2024

Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

Key Points: 


Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

Herbal medicinal product: Foeniculi amari fructusArray, F: Assessment finalised

Retrieved on: 
Tuesday, March 12, 2024

Overview

Key Points: 
  • Overview
    The European Medicines Agency is currently developing this information.
  • Key facts
    - Latin name
    - Foeniculi amari fructus
    - English common name
    - Bitter Fennel
    - Botanical name
    Foeniculum vulgare Miller subsp.
  • vulgare var.
  • vulgare
    - Therapeutic area
    - Urinary tract and genital disorders
    - Cough and cold
    - Status
    - F: Assessment finalised
    - Date added to the inventory
    - Date added to priority list
    - Outcome of European assessment
    - European Union herbal monograph
    - European Union list entry
    - Additional information
    - Date of adoption of Community list entry by HMPC: 07/09/07
    - Transmission to the European Commission: 21/12/07
    - Commission Decisions on Community list entries

Herbal medicinal product: Calendulae flosArray, C: ongoing call for scientific data

Retrieved on: 
Tuesday, March 12, 2024

Herbal medicinal product: Calendulae flosArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Calendulae flosArray, C: ongoing call for scientific data

Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2023 Financial Update and Pipeline Progress

Retrieved on: 
Thursday, March 7, 2024

“I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

Key Points: 
  • “I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • This marks the first marketing approval milestone for CSL and Arcturus since signing the Collaboration and License agreement in November 2022.
  • In November 2023, Arcturus received Orphan Drug Designation from the U.S. FDA for ARCT-032, for the treatment of Cystic Fibrosis.
  • We have achieved a total of approximately $396.0 million in upfront payments and milestones from CSL as of December 31, 2023.

Legal Services Pricing Platform Demonstrates the Need for Clear Fee Structuring Amid EU Commission and Qualcomm Fee Dispute - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 6, 2024

The recent legal dispute between Qualcomm and the European Commission, which saw the EU Commission contest Qualcomm’s legal fee claim of over €12 million, highlights the critical need for transparency and specificity in legal fee documentation.

Key Points: 
  • The recent legal dispute between Qualcomm and the European Commission, which saw the EU Commission contest Qualcomm’s legal fee claim of over €12 million, highlights the critical need for transparency and specificity in legal fee documentation.
  • This case underscores the necessity of clear, detailed documentation to support fee requests, an area where the Legal Services Pricing Platform excels.
  • As we move forward, the Legal Services Pricing Platform remains dedicated to enhancing the transparency and efficiency of legal fee management.
  • For more information on how the Legal Services Pricing Platform can transform your legal fee negotiations and strategy, visit Legal Services Pricing Platform

Geron Corporation Reports Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the fourth quarter and full year 2023.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the fourth quarter and full year 2023.
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024 to the NDA.
  • In September 2023, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for imetelstat in the same proposed indication as the NDA.
  • Geron will host a conference call at 8:00 am ET on Wednesday, February 28, 2024, to discuss business updates and fourth quarter and full year 2023 financial results.

BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

Retrieved on: 
Tuesday, February 27, 2024

“In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.

Key Points: 
  • “In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.
  • Median progression-free survival for TEVIMBRA plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]).
  • The safety profile for TEVIMBRA in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies.
  • A BLA for the treatment of patients with advanced or metastatic ESCC after prior chemotherapy is also under review by the FDA.