FDA discards depression drug ALKS 5461 of Alkermes
The FDA has rejected approval for ALKS 5461 of Alkermes in major depressive disorder. ALKS 5461 is a fixed-dose combination of buprenorphine and samidorphan. Alkermes designed the combination to act on the mu- and kappa-opioid receptors that eventually showed improved results in people, who showed unresponsiveness to present antidepressant therapies. Alkermes said that the FDA wanted more clinical data to give significant evidence for the effectiveness of ALKS 5461.
An atlas of HIV shows escape routes that could improve vaccine design
The scientists at the Fred Hutchinson Cancer Research Center made an atlas of HIV mutations that gives insights on the ongoing search for an effective vaccine. The group showed that mutations can occur in the HIV envelope that is a layer of glycoproteins that transports the virus into host cells and interact with antibodies. Some drug makers have developed vaccines focused at triggering broadly neutralizing antibodies.
J&J launches new intraocular lens for cataract patients
Johnson & Johnson, an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company, Vision has launched its TECNIS Eyhance intraocular lens for the cataract patients in Europe. It is designed to provide vision at both intermediate and far distances. The lenses before offer better vision of objects at a distance, but cataract patients still require to wear glasses for performing the day-to-day tasks.
The vision loss gene therapy of GenSight flunks again
A phase 3 trial of GenSight Biologics’ Leber hereditary optic neuropathy (LHON) gene therapy has flunked its primary endpoint. The AAV gene therapy was no better than placebo at improving vision at 48 weeks. France’s GenSight designed GS010 to improve the vision of patients with a particular mutation in the mitochondrial ND4 gene and moved the gene therapy into a pair of phase 3 trials in 2016.