Safety - GoINPHARMA
Tuesday, 16 October 2018 - 19:51

Safety

FDA issues warning about Intercept’s Ocaliva after 19 patients died

The FDA has officially warned doctors about the risks from Intercept Pharmaceuticals’ Ocaliva (obeticholic acid), after 19 patients on Intercept’s drug, developed to treat PBC (Primary Biliary Cholangitis) had died. The FDA, anyway, has specified that the deaths have occurred…

The skin lightening market

The business of skin-lightening treatments is growing at an impressive rate and is expected to increase from the current $10bn to $31bn before 2024. This dramatic increase is due to an association between fair skin and beauty and success –…

Biogen/AbbVie’s Zinbryta under review by PRAC

EMA PRAC (Pharmacovigilance Risk Assessment Committee) launched a review of Biogen/AbbVie’s Zinbryta (daclizumab). The product is intended to treat adult patients with relapsing forms of multiple sclerosis. The review follows the sudden death from liver failure of a patient who…

Investors call for stop to use of antibiotics in food industry

A group of 71 investors, which collectively account for more than $2,000bn in assets, are urging the food industry to end or reduce the use of antibiotics when these are not strictly necessary. Investors are afraid that antibiotic-resistant bacterial strains…

The typically-US opioid painkiller scourge: 90 deaths a day

Between 1999 and 2014 sales of opioid painkillers almost quadrupled in the US, to the extent that US citizens are now responsible for four-fifths of the global opioid consumption. Sadly, deaths from opioid painkillers abuse have increased at the same…

Uvestérol to be available again in France

France’s authority ANSM (Agence nationale du médicament) announced that the products Uvestérol ADEC and Uvesterol D will be available again, but only at precise conditions and in hospital pharmacies. The announcement comes after ANSM suspended the commercialization of the product…

FDA assesses early life anesthetic exposure

FDA remarked that the repeated or lengthy use of general anesthetic and sedation drugs during surgical procedures on children younger than three years, and pregnant women in their third trimester, may adversely affect brain development in children. The most recent…

Phase IIb trial for Teva and Regeneron’s fasinumab placed on hold

Regeneron Pharmaceuticals’ and Teva Pharmecuticals’ shares (Wall Street) lost over 1% on Monday after FDA placed on hold the Phase IIb clinical trial enrolling 800 patients (in four dose groups) treated with the painkiller fasinumab, jointly developed by the two…

European report: use of veterinary antibiotics decreases

The European Medicines Agency has published the sixth report on the sales of veterinary antibiotics in the European area. What strongly emerges is a downward trend between 2011 and 2014. Indeed, data from 28 countries from the EU and the…

FDA warning: hepatitis C drugs entail risk of HBV reactivation

FDA has detected serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with DAA (direct-acting antiviral) drugs for hepatitis C (HCV). The US Agency has identified 24 cases of HBV…