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EMA/FDA

EMA: Increasing oversight of API manufacturing through international collaboration

Report on the International API inspection programme published The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active…

FDA requests comment on international classification of marijuana, to be reviewed by WHO

Forbes: Feds want input on marijuana reclassification “…he United Nations World Health Organization is set to launch a review of the current international classification of marijuana, THC, cannabidiol, and other…

Cocrystal Pharma to study CC-31244 for the treatment of hepatitis C

Cocrystal Pharma receives FDA clearance to initiate Phase 2a clinical study evaluating CC-31244 for the treatment of hepatitis C virus – Company on track to commence patient enrollment and dosing…

ViiV Healthcare gains CHMP Positive Opinion for Juluca in Europe

London, 23 March 2018 – ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee…

Eiger BioPharmaceuticals announces positive guidance following FDA meeting on hepatitis delta virus registration program

Phase 3 D-LIVR trial planned to initiate in second half 2018 PALO ALTO, Calif., March 21, 2018 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted…

FDA: Raltegravir labeling updated

Raltegravir labeling updated with long-term data from Phase 3 HIV trial The drug labeling for Isentress (raltegravir; Merck) and Isentress HD (raltegravir; Merck) have been updated to include Week 96 data from…

FDA approves new HIV treatment for patients who have limited treatment options

Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the…

CHMP recommends extension of therapeutic indications for Isentress

At its February meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an extension of therapeutic indications for Isentress (raltegravir) with marketing authorisation holder Merck…

ContraVir announces TXL™ has been granted Orphan Drug Designation for the treatment of HBV in a pediatric population

EDISON, N.J., Feb. 22, 2018 -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the U.S. Food and…

FDA: Antibiotic commonly taken by patients with HIV may increase CV risk

Officials with the FDA warned that the antibiotic clarithromycin (Biaxin) may increase the risk of cardiovascular problems or death years later. Physicians should use caution when prescribing the treatment to…