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Home » Authors » Tamra Sami

Tamra Sami

Articles

ARTICLES

FDA accepts Mesoblast’s BLA resubmission for remestemcel-L in pediatric GVHD

March 9, 2023
By Tamra Sami
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
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CFIUS finally clears merger with F-star and Invox

March 8, 2023
By Tamra Sami
After placing a temporary hold on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd., citing “unresolved national security risks,” the Committee on Foreign Investment in the United States (CFIUS) has finally cleared the merger to proceed.
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Hanall’s bataclimab meets endpoints in phase III myasthenia gravis trial

March 7, 2023
By Tamra Sami
Hanall Biopharma Co Ltd.’s batoclimab met the primary and key secondary endpoints in a pivotal phase III trial in generalized myasthenia gravis (gMG) in China, marking the first positive phase III data for the candidate globally.
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Cholesterol plaque in artery

Junshi Biosciences’ PCSK9 inhibitor, ongericimab, meets primary endpoints in two phase III trials

March 7, 2023
By Tamra Sami
Junshi Biosciences Co. Ltd.’s ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, met the primary endpoints of reducing the levels of low-density lipoprotein cholesterol in two phase III trials in primary hypercholesterolemia and mixed hyperlipidemia.
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Epidermal growth factor receptor (EGFR)

Abbisko out-licenses preclinical EGFR candidate to Allist for $188M

March 7, 2023
By Tamra Sami
Abbisko Therapeutics Co. Ltd. and Allist Pharmaceuticals Co. Ltd. signed an exclusive licensing deal that gives Allist rights to develop, manufacture and commercialize Abbisko’s ABK-3376, an EGFR tyrosine kinase inhibitor for $188 million plus royalties.
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Epidermal growth factor receptor (EGFR)

Abbisko out-licenses preclinical EGFR candidate to Allist for $188M

March 3, 2023
By Tamra Sami
Abbisko Therapeutics Co. Ltd. and Allist Pharmaceuticals Co. Ltd. signed an exclusive licensing deal that gives Allist rights to develop, manufacture and commercialize Abbisko’s ABK-3376, an EGFR tyrosine kinase inhibitor for $188 million plus royalties.
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Grizzly bear hunting salmon in river
Immune

Function of mysterious ‘grizzly-like’ macrophage gives insights into autoimmunity

March 3, 2023
By Tamra Sami
Even its name is a testament to how enigmatic the tingible macrophage has been. Tingible, which means stainable, certainly gives no clues to its functions – but was, at least, one thing that was known about the cells. Now, scientists at the Garvan Institute of Medical Research have tracked the lifecycle and function of tangible macrophages in the lymph nodes, with implications for understanding autoimmune disorders, which are still poorly understood. Published March 2, 2023, in the journal Cell, the study highlights intravital imaging techniques the scientists used to observe how macrophages formed within the lymph nodes and how they behaved in real time.
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Cholesterol plaque in artery

Junshi Biosciences’ PCSK9 inhibitor, ongericimab, meets primary endpoints in two phase III trials

March 1, 2023
By Tamra Sami
Junshi Biosciences Co. Ltd.’s ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, met the primary endpoints of reducing the levels of low-density lipoprotein cholesterol in two phase III trials in primary hypercholesterolemia and mixed hyperlipidemia.
Read More

Fusion raises $60M to acquire phase II radiopharma asset targeting prostate cancer

Feb. 28, 2023
By Tamra Sami
Radiopharmaceutical company Fusion Pharmaceuticals Inc. is acquiring a phase II actinium-based alpha-emitter radiopharma program for prostate cancer from Radiomedix Inc.
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Eye illustration

Eluminex raises $40M series B for biosynthetic cornea, ophthalmology pipeline

Feb. 28, 2023
By Tamra Sami
Ophthalmic startup Eluminex Biosciences Ltd. closed a $40 million series B round to progress its pipeline of ophthalmic assets and recombinant human collagen technology. Eluminex’s pipeline includes multi-targeted antibody molecules for vision-threatening retinal diseases and an oral small molecule for rare inherited pediatric retinal dystrophies, but its lead asset, EB-301, is a biosynthetic cornea derived from recombinant human type III collagen.
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View All Articles by Tamra Sami

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