LGG

FDA Roundup: April 26, 2024

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Friday, April 26, 2024
FDA, Lutetium (177Lu) oxodotreotide, Sale, Answer, Public, Report, Cosmetics, Syringe, Dietary supplement, News, Safety, DCM, Food, Research, Human services, GFI, Animal, Dilated cardiomyopathy, Cardinal Health, Commitment, Diabetes, Furosemide, Glomus tumor, Vaccine, Development, VFD, Osteoporosis, Novartis, BRAF, Inflammatory bowel disease, Tablet, Patient, Rheumatoid arthritis, Psoriasis, Heated tobacco product, Macular degeneration, Multimedia, Dog, Cancer, LGG, Food and Drug Administration, BRAF V600, Heart, Pharmaceutical industry

On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.

Key Points: 
  • On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.
  • The FDA expects this firm to fully address the violations described in the warning letter.
  • This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs.
  • This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions.

XOMA Earns $9 Million Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDATM (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG)

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Thursday, April 25, 2024
FDA, Glioma, NDA, Food, Economics, New Drug Application, BRAF, Patient, Therapy, LGG, BRAF V600, Pharmaceutical industry

EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. 

Key Points: 
  • First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
    EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
  • “This is an important milestone for XOMA and our royalty portfolio, but more importantly, it is a watershed event for children living with low-grade gliomas with BRAF alterations that have relapsed or progressed,” stated Owen Hughes, Chief Executive Officer of XOMA.
  • In March 2021, XOMA paid $13.5 million upfront to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, plus a share of potential event-based economics, in addition to the economics associated with vosaroxin, from Viracta Therapeutics.

Linkage of Cancer and Lupus in Gliomas Patients

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Monday, March 25, 2024
CD86, OS, TME, Gene, Transforming growth factor beta, CD68, Survival, LGG, Ligand, TGFB2, CD276, IDH, STAT1, Inflammation, Central nervous system, Patient, RNA, Tumor microenvironment, Cancer, Messenger, Macrophage, SLE, Expression, TAM, Treatment, Neoplasm, IRF5, Therapy, TGF, IRF1, TGFB, OTCQB, Demethylation, Vaccine

Dr. Vuong Trieu, CEO and Chairman of Oncotelic, stated, ”Our R&D team has discovered crosstalk between the TGF-β and IFN signaling pathways, linking gliomas and Systemic Lupus Erythematosus (SLE).

Key Points: 
  • Dr. Vuong Trieu, CEO and Chairman of Oncotelic, stated, ”Our R&D team has discovered crosstalk between the TGF-β and IFN signaling pathways, linking gliomas and Systemic Lupus Erythematosus (SLE).
  • Understanding the role of IRF5 in both SLE and cancer opens an avenue for targeting IRF5 or its downstream pathways.
  • LGG patients expressing high levels of TGFB2 and IFNGR2 are over-represented in IDH wild-type tumor samples, suggesting that TGFB2 and IFNGR2 mRNA can be therapeutically targeted in these high-risk patients.
  • Therefore, to improve OS in LGG patients, combination therapies must target TGFB2 and IFN-γ activation (via IRF5 inhibition) or immune therapies targeted against CD276/B7-H3

Bionano Announces Extensive Lineup of Content at American College of Medical Genetics and Genomics (ACMG) Annual Meeting Including Live Product Showcase Featuring the Company’s New Stratys™ System

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Thursday, March 7, 2024
SAN, Medical college, Medical College of Wisconsin, Vancouver General Hospital, DSM-IV codes, American College, ACMG, OGM, LGG, Medical genetics, DRS, Research, Cancer, Medical device

Dr. Tara Spence from Vancouver General Hospital will present insights into her laboratory’s adoption of Stratys and its potential impact on hematological malignancy analysis

Key Points: 
  • Dr. Tara Spence from Vancouver General Hospital will present insights into her laboratory’s adoption of Stratys and its potential impact on hematological malignancy analysis
    A scientific platform presentation will feature Drs.
  • ACMG’s Annual Meeting brings together industry, medical, and academic professionals to discuss advances in clinical genetics research.
  • The ACMG conference will be held March 12-16, 2024, in Toronto, Canada.
  • All scientific posters will be presented in Exhibit Halls DE.

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

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Friday, January 5, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Fever, Fatigue, ATC, Vincristine, HGG, BRAF, EMA, Xeroderma, Carboplatin, International, Bleeding, Cough, Headache, Nausea, Neutropenia, Language, Neoplasm, Cancer, Mutation, Neutrophil, Radiation, Water, European Medicines Agency, Tablet, MEK, Growth, Select, Patient, Cell, LGG, Safety, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Fever, Fatigue, ATC, Vincristine, HGG, BRAF, EMA, Xeroderma, Carboplatin, International, Bleeding, Cough, Headache, Nausea, Neutropenia, Language, Neoplasm, Cancer, Mutation, Neutrophil, Radiation, Water, European Medicines Agency, Tablet, MEK, Growth, Select, Patient, Cell, LGG, Safety, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Fever, Fatigue, ATC, Vincristine, HGG, BRAF, EMA, Xeroderma, Carboplatin, International, Bleeding, Cough, Headache, Nausea, Neutropenia, Language, Neoplasm, Cancer, Mutation, Neutrophil, Radiation, Water, European Medicines Agency, Tablet, MEK, Growth, Select, Patient, Cell, LGG, Safety, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Retrieved on: 
Monday, December 18, 2023
Carboplatin, Vomiting, Cough, Anatomy, Select, ATC, Safety, Radiation, Neutrophil, European Medicines Agency, Rash, MEK, HGG, International, INN, Headache, Language, Tablet, EMA, Patient, IIA, Marketing, Neoplasm, Medical Subject Headings, Diarrhea, Neutropenia, BRAF, Vincristine, Bleeding, Cancer, Nausea, Water, Growth, Fatigue, Xeroderma, LGG, Fever, Mutation, Cell, Instrumentation, Medical imaging, Pharmaceutical industry, Medicinal plants, Medical device, Vaccine, Mobile phone, Online shopping, Bookkeeping, Glioma, Medicine

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Atlas Air Takes Delivery of Second of Four New Boeing 777-200 Freighters

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Thursday, July 20, 2023
Insurance, LGG, Maintenance, Partnership, Atlas Air, NLU, Senior, Boeing, Air cargo, Airport, XMN, MSC, Boeing 777, Atmosphere of Earth, ICN, ACMI, Aircraft, Airline, IND

This is the second of four Boeing 777-200 Freighters that Atlas Air will operate for MSC, which will complement the existing weekly service for the world’s largest shipping company.

Key Points: 
  • This is the second of four Boeing 777-200 Freighters that Atlas Air will operate for MSC, which will complement the existing weekly service for the world’s largest shipping company.
  • “Building on the successful launch of MSC’s Air Cargo Solution, we are very pleased to welcome this second 777 delivery as part of our long-term strategic partnership.
  • We expect our remaining two 777 aircraft to be delivered in the fourth quarter,” said Michael Steen, Chief Executive Officer, Atlas Air Worldwide.
  • In partnership with Atlas Air, we have built a solid foundation on which to expand our air cargo solution,” said Jannie Davel, Senior Vice President Air Cargo at MSC.

Vinamilk forms strategic partnerships with top global companies and receives Purity Award for children's milk powder

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Friday, June 16, 2023
LGG, CHR, DSM, Partnership, Nucleotide, Nutrient, Research, USD, Trust, AAK, Probiotic, Breast milk, Drug, Pharmaceutical industry, Vinamilk, GNOSIS

The collaboration reinforces Vinamilk's international reputation and its strong commitment to providing high-quality baby milk powder of international standards.

Key Points: 
  • The collaboration reinforces Vinamilk's international reputation and its strong commitment to providing high-quality baby milk powder of international standards.
  • Six leading global nutrition and bioscience companies have partnered with Vinamilk in Vietnam including DSM (Switzerland), CHR HANSEN (Denmark), BENEO (Germany), GNOSIS (Italy), AAK (Sweden), and KANEMATSU (Japan).
  • Through these strategic collaborations, Vinamilk is committed to delivering international-quality nutritional solutions, featuring superior formulations to the young generation of Vietnam.
  • Hence, I believe that with this stronger strategic partnership, Vinamilk will soon conquer the highest global standards in the dairy industry."