Another weapon against Covid-19 could be made more prominent as results from a large, placebo-controlled trial published in the Lancet on Wednesday evening provide compelling evidence that the cheap SSRI fluvoxamine may reduce Covid-related hospitalization times.
In first-of-their-kind observations in the human brain, an international team of researchers has revealed two well-known neurochemicals — dopamine and serotonin — are at work at sub-second speeds to shape how people perceive the world and take action based on their perception.
After a rocky ride, Zogenix’s Fintepla turned up encouraging phase 3 data in a second type of rare childhood epilepsy. The drug beat placebo at cutting seizure frequency for patients with Lennox-Gastaut syndrome who typically experience dozens of seizures each month.
Clinical drug trials are never perfect, especially when it comes to real-world risks of side effects and adverse drug reactions. For example, most clinical trials for a given drug require that volunteers forego taking a long list of other drugs. But how many of us are ever really taking just one medicine at a time?
Ionis has reported that its rare disease therapy inotersen hit its efficacy objectives in a phase III trial - but also had side effects that could make getting regulatory approval a challenge.
Agilis Biotherapeutics recently announced that the first patient in the Phase IIb clinical study for its gene therapy treatment of Aromatic L-Amino Acid Decarboxylase (AADC) deficiency, AGIL-AADC, has been treated. The study is being performed under the direction of Paul Hwu, MD, PhD, Professor of Pediatrics at National Taiwan University Hospital. AGIL-AADC is an adeno-associated virus (AAV) vector containing the human gene for the AADC enzyme.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Lexicon has requested a Priority Review by the FDA as part of the NDA filing.