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FDA approves Pemazyre to treat cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion.- Incyte Corpn.

Written by | 19 Apr 2020

Incyte announced that the FDA has approved Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with… read more.

FDA approves Tukysa + trastuzumab + capecitabine to treat unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases.- Seattle Genetics

Written by | 18 Apr 2020

Seattle Genetics, Inc. announced the FDA granted approval to Tukysa(tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable (cannot be surgically removed) or… read more.

AXS 07 eliminated migraine pain, and substantially and significantly prevented progression of migraine pain in the INTERCEPT phase III trial in the early treatment of migraine.- Axsome Therapeutics

Written by | 17 Apr 2020

Axsome Therapeutics, Inc. announced that AXS 07 substantially and significantly eliminated migraine pain, and substantially and significantly prevented progression of migraine pain intensity in the INTERCEPT Phase III… read more.

Abbott launches antibody test for COVID-19.

Written by | 17 Apr 2020

Abbott announced the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had… read more.

Ontruzant biosimilar to reference product Herceptin, is launched in the US- Merck Inc.

Written by | 16 Apr 2020

Merck INc., announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and… read more.

FDA grants Fast Track designation for vutrisiran to treat the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.- Alnylam Pharma

Written by | 15 Apr 2020

Alnylam Pharmaceuticals, Inc. announced that the FDA has granted Fast Track designation to vutrisiran, an investigational therapeutic for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis… read more.

AstraZeneca initiates CALAVI study of Calquence to treat cytokine storm associated with COVID-19 infection.

Written by | 15 Apr 2020

AstraZeneca will initiate a randomised, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19… read more.

Phase III trial of tislelizumab + pemetrexed for first-line NSCLC met the primary endpoint of progression-free survival at interim analysis,- BeiGene

Written by | 15 Apr 2020

BeiGene, Ltd. a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the Phase III trial evaluating… read more.

FDA approves Koselugo to treat paediatric patients two years of age and older with neurofibromatosis type 1 (NF1). – AstraZeneca + Merck Inc.

Written by | 14 Apr 2020

AstraZeneca and Merck Inc.announced that the FDA has approved the kinase inhibitor Koselugo (selumetinib) for the treatment of paediatric patients two years of age and older with neurofibromatosis… read more.

Studies MTI-105 and MTI-106 of oral serlopitant did not meet their respective primary endpoint of reduction of pruritus.-Menlo Therapeutics

Written by | 13 Apr 2020

Menlo Therapeutics Inc. announced top line results from two Phase III clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus… read more.

Data on 53 patients treated with remdesivir through the compassionate use program is published in New England Journal of Medicine.- Gilead Sciences

Written by | 12 Apr 2020

Gilead Sciences, Inc. announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an… read more.

Immunomedics announces phase III ASCENT study of sacituzumab govitecan to treat metastatic triple-negative breast cancer to be stopped for compelling efficacy.

Written by | 12 Apr 2020

Immunomedics, Inc. has announced that its Phase III confirmatory ASCENT study will be halted due to compelling evidence of efficacy. This decision was based on the unanimous recommendation… read more.

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