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 •  November 27, 2017

The American Depositary Receipts of Indivior plc (INVVY.OB), a global specialty pharmaceutical company focused on developing opioid dependence treatments, are up nearly 38% year-to-date. After getting thumbs up from an FDA panel for RBP-6000, its investigational treatment for opioid use disorder, Indivior now awaits the regulatory agency's final...

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 •  September 29, 2017

After a harsh internal review on Tuesday, there was very little hope of PTC Therapeutics' (PTCT) Duchenne muscular dystrophy drug Translarna being recommended for approval by the panel of outside experts convened by the FDA on September 28, 2017. As expected, yesterday, the FDA panel voted 10-1 that the data provided by the Company was inconclusive...

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 •  September 25, 2017

Today's Daily Dose brings you news about FDA approval of Bristol-Myers' Opdivo and Merck's Keytruda for additional indications; Allergan's disappointment over its antipsychotic medicine VRAYLAR and Auris' progress with its phase III clinical trial of Keyzilen. Read on... The FDA has refused to accept for review Allergan plc's (AGN) supplemental New...

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 •  September 9, 2017

Drug maker AstraZeneca (AZN) announced the full results of Phase III FLAURA trial, which support TAGRISSO's clear potential as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). U.S. shares of AstraZeneca...

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 •  August 22, 2017

Today's Daily Dose brings you news about European approval of Alexion's Soliris for an additional indication; Alkermes' New Drug Application for a major depressive disorder drug; Astellas' MORPHO trial progress; Axovant's move to NASDAQ from the Big Board; Cardiome's disappointing update related to its antiarrhythmic drug and FDA approval of...

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 •  August 4, 2017

Today's Daily Dose brings you news about FDA approval of AbbVie's new hepatitis C drug; ARCA biopharma's anticipated milestones; the delay in approval of Dynavax's experimental hepatitis B vaccine; the approval of the first new chemotherapy advance in the U.S. in more than 40 years for adults with certain types of AML, and the clinical trial...

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 •  July 20, 2017

Japan-based Astellas Pharma Inc. (ALPMY, ALPMF) announced Thursday that the U.S. Food and Drug Administration granted orphan-drug designation to gilteritinib in patients with acute myeloid leukemia or AML. Gilteritinib is a receptor tyrosine kinase inhibitor of FLT3 and AXL, which are involved in the growth of cancer cells. The company said...

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 •  July 19, 2017

Today's Daily Dose brings you news about Aeterna's upcoming make or break event; Aldeyra's clinical trial catalyst of this quarter; FDA approval of Gilead's HCV drug; Inovio's proposed stock offering; Nektar's oral Human Abuse Potential study of NKTR-181 and Vertex Pharma's cystic fibrosis trial results. Read on... Shares of Aeterna Zentaris Inc....

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 •  April 24, 2017

Akari Therapeutics Plc (AKTX), a clinical-stage biopharmaceutical company, reported positive results in a mid-stage clinical trial for its lead drug Coversin for a rare blood disease. The company's shares which surged almost 10 percent in pre-market activity, are currently losing more than 11 percent. Coversin's potential is being explored in the...

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 •  February 14, 2017

Medigene AG (MDGEF.PK) announced that the company's phase I/II clinical trial with its dendritic cell vaccine for the treatment of acute myeloid leukaemia has started. The multi-centre, open-label trial will include 20 AML patients after completion of standard chemotherapy to reduce the risk of recurrence of leukaemia by using Medigene's DC...