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Monthly Archives: June, 2020

European Commission approves daurismotm™ for acute myeloid leukaemia

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 June 29, 2020: "Pfizer announced that the European Commission approved DAURISMOTM™ (glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type...

Roche’s ENSPRYNG®️ approved in Japan for adults and children with neuromyelitis optica spectrum disorder

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June 29, 2020: "Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of...

FDA approves Roche’s Phesgo for HER2-positive breast cancer

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"FDA approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer June 29, 2020: Roche announced that the US...

Novartis announces MET inhibitor Tabrecta™ approved in Japan for advanced NSCLC with METex14

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Jun 29, 2020: "Novartis Pharma announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta™ (capmatinib, formerly INC280), an oral...

GSK receives first regulatory approval for Duvroq in Japan

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"The approval marks a significant step in GSK’s global efforts to help patients with anaemia due to chronic kidney disease (CKD). June 29, 2020: GlaxoSmithKline...

Coronavirus (COVID-19) Update: Daily Roundup June 29, 2020

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June 29, 2020: "The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA...

Primary Endpoint and Secondary Endpoint (outcome measures)

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By Deeksha Soni- ...

How to resolve reference ranges issue in RAVE eDC- CRA, CRC and DM prospective.

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Whether you are a Clinical Research Associate (CRA), Clinical Research Coordinator (CRC) or a Clinical Data Manager (CDM), you all face some common issues...

What is the Phase-IV Clinical Trial?

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Phase IV trial is also known as post-marketing trial, or informally as a confirmatory trial. Phase IV trials include a drug's health surveillance (pharmacovigilance) and continuing clinical assistance...

What is Phase-III Clinical Trial?

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"Phase III trials are conducted to confirm and expand on the safety and effectiveness results from Phase I and II trials, to compare the drug to the standard...

What is Phase II Clinical Trial?

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"If a new treatment is found to be reasonably safe in phase I clinical trials, it can then be tested in phase II clinical...

Best books on clinical research-Must read for all

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Please note that this blog contains the affiliate links from Amazon and this is not a sponsored post. Selection and reviews of best books...
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