IMBRUVICA® (Ibrutinib) Seeks to Expand US Label with Long-Term Data in Waldenström’s Macroglobulinemia (WM)

AbbVie announced that the FDA will review a supplemental New Drug Application (sNDA) for IMBRUVICA® in combination with rituximab for the treatment of WM, a rare and incurable type of non-Hodgkin’s lymphoma.
[AbbVie Inc.]
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Marker Therapeutics Receives USAN Approval for “Zelenoleucel” as Nonproprietary Name for MT-401, Multi-Tumor-Associated Antigen Targeted T Cell Product for Acute Myeloid Leukemia

Marker Therapeutics, Inc. announced that the United States Adopted Names Council has approved “zelenoleucel” as the nonproprietary name for MT-401, a multi-tumor-associated antigen-specific T cell product candidate for the treatment of patients with acute myeloid leukemia following allogeneic stem cell transplant in both adjuvant and active disease settings.
[Marker Therapeutics, Inc.]
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Chi-Med Announces Fruquintinib Granted US FDA Fast Track Designation for Metastatic Colorectal Cancer

Hutchison China MediTech Limited announced that the FDA has granted Fast Track Designation for the development of fruquintinib, for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor therapy.
[Hutchison China MediTech Limited ]
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NMPA Accepts Bio-Thera Solutions’ Biologics License Application (BLA) for BAT1706, A Proposed Biosimilar to Avastin®

Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application for BAT1706, a proposed biosimilar to Avastin®.
[Bio-Thera Solutions (Business Wire, Inc.)]
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Drug Recently Shown to Reduce Coronavirus Death Risk Could Run Out, Experts Warn

A report that dexamethasone, a commonly used corticosteroid, reduces death rates of COVID-19 by up to one-third was greeted with enthusiasm around the globe. It also raised a question: Will there be enough of the medication?
[ScienceInsider]
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Coronavirus Misinformation, and How Scientists Can Help to Fight It

Scientists are well placed to help to hold back the tide of COVID-19 misinformation — but should they get involved in time-consuming, and sometimes bruising, efforts to do so, or just stick to doing good research?
[Nature News]
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Arcutis Enrolls Last Patient in Phase II Proof of Concept Clinical Trial Evaluating ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Seborrheic Dermatitis

Arcutis Biotherapeutics, Inc. announced it has completed enrollment of its Phase II proof of concept clinical trial evaluating roflumilast foam as a potential treatment for seborrheic dermatitis.
[Arcutis Biotherapeutics]
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Dupixent® (Dupilumab) Approved in China for Adults with Moderate-to-Severe Atopic Dermatitis

The National Medical Products Administration in China has approved Dupixent® for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
[Sanofi]
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Sarepta Therapeutics and Selecta Biosciences Enter Into Research License and Option Agreement for Selecta’s ImmTOR Immune Tolerance Platform in Neuromuscular Diseases

Sarepta Therapeutics, Inc. and Selecta Biosciences, Inc. announced that they have entered into a research license and option agreement granting Sarepta an option to license the rights to develop and commercialize Selecta’s immune tolerance platform for use in Duchenne muscular dystrophy and certain limb-girdle muscular dystrophies.
[Sarepta Therapeutics, Inc.]
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Sarepta Therapeutics and Codiak BioSciences Collaborate to Research and Develop Exosome-Based Therapeutics for Rare Diseases

Sarepta Therapeutics, Inc. and Codiak BioSciences, Inc. announced a global research and option agreement to design and develop engineered exosome therapeutics to deliver gene therapy, gene editing and RNA technologies for neuromuscular diseases.
[Sarepta Therapeutics, Inc.]
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Bio-Techne and ZERO – The End of Prostate Cancer Announce Partnership to Fund Education and Awareness Campaigns to Empower Men with Prostate Cancer

Bio-Techne Corporation announced that Exosome Diagnostics has established a new partnership with ZERO – The End of Prostate Cancer.
[Bio-Techne Corporation]
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