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Ultomiris to initiate a Phase III study to treat COVID-19.-Alexion Pharma

Written by | 21 Apr 2020

Alexion Pharmaceuticals, Inc.announced plans to initiate a global Phase III study to investigate Ultomiris (ravulizumab-cwvz) in a subset of adults with COVID-19 – those who are hospitalized with… read more.

Positive topline results from pivotal phase III CheckMate -9ER trial of Cabometyx v. sunitinib for advanced renal cell carcinoma.-BMS + Exelixis

Written by | 21 Apr 2020

Bristol Myers Squibb and Exelixis, Inc. announced that CheckMate -9ER, a pivotal Phase III trial evaluating Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) compared to sunitinib in previously… read more.

Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalized COVID-19 patients .

Written by | 20 Apr 2020

Novartis has reached an agreement with the FDA to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the… read more.

Incyte announces initiation of phase III RUXCOVID study for Jakafi as a treatment for patients with COVID-19 associated cytokine storm.

Written by | 19 Apr 2020

Incyte announced the initiation of RUXCOVID, a global, randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients… read more.

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.

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