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EMA/FDA

EMA: Consultation on revised policy on access to documents

Comments from stakeholders invited until 18 May 2017 The European Medicines Agency (EMA) launches today a public consultation on the proposed revision to its policy on access to documents. The…

Pharma industry shuns Trump push for radical shift at FDA

U.S. President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would…

VBI Vaccines receives positive EMA scientific advice regarding Sci-B-Vac™ Phase III clinical study

VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) announced today (February 7) the receipt of positive Scientific Advice from the Committee for Medicinal Products for Human Use (“CHMP”) of the…

FDA approved class labeling revisions

On February 14, 2017 FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV).…

Over 1,000 studies now recorded in EU register of post-authorisation studies

EU PAS Register increases transparency of research in medicines after they have been authorised in the EU The 1,000th study has been uploaded in the European Union (EU) electronic Register…

FDA grants priority review to AbbVie for its investigational hepatitis C regimen glecaprevir/pibrentasvir

U.S. FDA grants priority review to AbbVie for its investigational regimen of glecaprevir/pibrentasvir (G/P) for the treatment of chronic hepatitis C in all major genotypes (GT1-6) - If approved, G/P…

FDA revises Sustiva label

The Sustiva (efavirenz) label was recently revised. The following sections in the Prescribing Information and Patient Counseling Information were update to include information about catatonia. WARNINGS AND PRECAUTIONS subsection 5.5…

Trump to Pharma CEOs: 75% to 80% of FDA regulations will be eliminated

In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday (January 31) that his administration will be…

FDA revises Evotaz label

The Evotaz (atazanavir/cobicistat) label was updated to include the 144 week data from trial 114 that evaluated the safety and efficacy of atazanavir co-administered with cobicistat in HIV-1 infected treatment-naïve…

FDA revises Stribild label

The Stribild (elvitegravir, cobicistat, emtrictiabine, tenofovir disoproxil fumarate) tablet label was revised to expand the patient population to include pediatric patients 12 years of age and older weighting at least…