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Yearly Archives: 2020

FDA Accepts BLA for Ascendis TransCon™ hGH for Pediatric Growth Hormone Deficiency

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"Ascendis Pharma A/S Announces U.S.FDA Accepts Biologics License Application (BLA) for TransCon™ hGH for Pediatric Growth Hormone Deficiency (GHD) Sept. 04, 2020: Ascendis Pharma A/S, a biopharmaceutical...

Novartis Post hoc analysis complements findings from pivotal Phase III IRIDIUM study

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Novartis post hoc analysis shows high-dose Enerzair® Breezhaler® reduces asthma exacerbations versus medium-dose, complementing key pivotal IRIDIUM study findings. September 7, 2020: "Novartis announced that...

Coronavirus (COVID-19) Update: Daily Roundup September 4, 2020

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September 04, 2020: "The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The FDA issued...

What are Cancer biomarkers?

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"Cancer biomarkers (CB) are biomolecules produced in response to the tumour by either the tumour cells or other cells within the body. Each type...

Coronavirus (COVID-19) Update: Daily Roundup September 3, 2020

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September 03, 2020: "The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The FDA’s COVID-19-related...

Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 vaccine

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Sept. 3, 2020: "Sanofi and GSK started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate, developed in partnership by...

Roche to launch SARS-CoV-2 Rapid Antigen Test

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September 01, 2020: "Roche announced that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Roche...

What is Toxicokinetics?

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"Toxicokinetics is basically the study of "how and what happens to a substance in the body" What is Toxicokinetics? Toxicokinetics (TK) is characterised as the generation...

FDA Approves Onureg® as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia

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SEPTEMBER 1, 2020: BMS announced that the U.S.FDA has approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid...

Medtronic Announces FDA Approval for Minimed, 770G Insulin Pump System with Smartphone Connectivity for People with Type 1 Diabetes

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September 1, 2020: "Medtronic, the global leader in medical technology announced it has received U.S. FDA approval of its MiniMed™ 770G hybrid closed loop...

Coronavirus (COVID-19) Update: Daily Roundup September 1, 2020

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September 01, 2020: "The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The FDA has,...

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

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September 1, 2020: "The Food and Drug Administration approved azacitidine tablets (ONUREG®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who...
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