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Yearly Archives: 2020

KEYTRUDA® Plus LENVIMA® shows promise in hard-to-treat cancers

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September 20, 2020: "Merck and Eisai announced new investigational data from two trials under the LEAP (LEnvatinib And Pembrolizumab) clinical program evaluating KEYTRUDA, Merck’s...

FDA Announces Key FSMA Rule to Advance Traceability of Foods

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September 21, 2020: "The FDA has proposed a new rule that lays the foundation for the end-to-end food traceability across the food industry that we’ll be...

Novartis Kisqali® receives the highest rating of any CDK4/6 inhibitor

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 September 21, 2020: "Novartis proudly announces that Kisqali® (ribociclib) has achieved a score of five out of five on the European Society for Medical Oncology-Magnitude...

AstraZeneca’s Lynparza recommended for metastatic castration-resistant prostate cancer

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September 21, 2020: "AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the EU for patients with metastatic castration-resistant prostate cancer (mCRPC) with...

Coronavirus (COVID-19) Update: Daily Roundup September 18, 2020

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September 18, 2020: "The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The FDA reissued...

AstraZeneca’s Tagrisso reduced risk of disease recurrence in brain in EGFR-mutated lung cancer

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September 19, 2020: "Results from a prespecified exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a clinically meaningful improvement in...

GSK receives CHMP approval of Zejula for the treatment of ovarian cancer

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September 18, 2020: "GlaxoSmithKline announced the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion recommending Zejula...

Novartis Piqray® data show survival benefit in HR+/HER2- breast cancer

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September 19, 2020: "Novartis announced results of the final overall survival (OS) analysis from the SOLAR-1 trial, which evaluated Piqray® (alpelisib) in combination with fulvestrant,...

Development Safety Update Report (DSUR)

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"DSURs are new, globally harmonised safety documents (which became obligatory in the Member States of the European Union in September 2011) covering the safety...

Coronavirus (COVID-19) Update: Daily Roundup September 17, 2020

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September 17, 2020: "The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: Today, the FDA...

WAYLIVRA®, the first and only therapy for FCS to be available on the NHS in England

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September 18, 2020: "Akcea Therapeutics UK Ltd., a subsidiary of Akcea Therapeutics Inc., announced that the National Institute for Health and Care Excellence (NICE)...

Opdivo Plus Yervoy benefits Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

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September 17, 2020: "Bristol Myers Squibb announced that more than half of advanced renal cell carcinoma (RCC) patients treated with the Opdivo®(nivolumab)plus Yervoy®(ipilimumab)combination were alive after...
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