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Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA


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THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo.
1 Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials. ....

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AbbVie (ABBV) Receives Positive CHMP Opinion for VENCLYXTO® (venetoclax) | FinancialContent Business Page


April 23, 2021 at 08:49 AM EDT
AbbVie Receives Positive CHMP Opinion for VENCLYXTO® (venetoclax) as a Combination Regimen for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
AbbVie (NYSE: ABBV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for VENCLYXTO® (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision on VENCLYXTO combination therapy for use in AML in the first half of 2021. ....

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AbbVie Receives Positive CHMP Opinion for VENCLYXTO® as a Combination Regimen for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy


ABBVie today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for VENCLYXTO® in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the …
ABBVie (NYSE: ABBV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for VENCLYXTO® (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision on VENCLYXTO combination therapy f ....

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Immunotherapy Drugs Industry Assessment 2021 Featuring Comprehensive Profiles of Amgen, Bayer, Johns


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01-Apr-2021
Immunotherapy Drugs Industry Assessment 2021 Featuring Comprehensive Profiles of Amgen, Bayer, Johnson & Johnson, Novartis, Pfizer, and Other Major Players - ResearchAndMarkets.com
DUBLIN (BUSINESS WIRE) The Immunotherapy Drugs: Global Markets report has been added to
ResearchAndMarkets.com s offering.
The global immunotherapy market can be segmented into the following types: checkpoint inhibitors, monoclonal antibodies, interferons and interleukins.
The monoclonal antibodies segment accounted for the largest share of the global market for immunotherapy drugs in 2019. This large share can be attributed to several factors including their high specificity and fewer side-effects; the increasing focus on personalized medicines; initiatives by industry players; and the growing target disease incidence and patient pool. In 2019, the market for monoclonal antibodies was $106.8 billion. ....

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