The US Food and Drug Administration has approved Brintellix (vortioxetine), an inhibitor of serotonin reuptake, for the treatment of major depressive disorder (MDD). The developers are H. Lundbeck A/S and Takeda Pharmaceutical Company Ltd.
The US Food and Drug Administration has expanded the indication for an artificial heart valve manufactured by Edwards Lifesciences Corp to include the treatment of patients who have inoperable aortic valve stenosis.
Roche’s antibody-drug conjugate for HER2-positive breast cancer, Kadcyla, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), paving the way for marketing authorisation by the end of the year.
Drisapersen, an antisense oligonucleotide being developed by GlaxoSmithKline Plc for Duchenne muscular dystrophy (DMD), has failed to meet its primary endpoint in a Phase 3 study – intended to lead to registration in the US.
Skyepharma Plc has received a double endorsement of its technology with the approval by the Japanese health authority of the company’s proprietary asthma treatment flutiform, as well as the approval of a GSK product using Skyepharma technology.
The Food and Drug Administration has granted ‘breakthrough therapy’ designation to the Genmab A/S-developed therapeutic antibody ofatumumab and to Boehringer Ingelheim’s (BI) kinase inhibitor volasertib for indications in oncology.
For more than a decade, the European Medicines Agency has maintained a policy for handling problems that arise if the judgement of one of its scientific experts is clouded by an association with the pharmaceutical industry. The policy started out as a code of conduct. It was later strengthened to become a formal policy on conflicts-of interest, together with a requirement that experts publicly declare their interests and submit to a breach-of-trust procedure if they failed to tell the truth.
Sanofi SA has taken the unusual step of withdrawing its new drug application (NDA) for the Type 2 diabetes drug, lixisenatide, from the US Food and Drug Administration in order to allow a cardiovascular outcomes study of the drug to finish. The French company said the decision is not related to any safety issues or deficiencies with the application.
The US Food and Drug Administration has expanded the indication for Abraxane (paclitaxel protein-bound particles for injectable suspension) to treat patients with late-stage pancreatic cancer.
The US Food and Drug Administration has approved a new treatment for HIV-1 infection developed by ViiV Healthcare. Tivicay (dolutegravir) is an integrase strand transfer inhibitor to be used in combination with other antiretroviral drugs.