During a conference call with investors, Baudax Bio Inc. CEO Gerri Henwood let out an exuberant “woohoo!” to celebrate the FDA’s approval – after two turndowns and much haggling over data – of Anjeso (meloxicam) for moderate to severe pain. Echoing her sentiment was Piper Sandler analyst David Amsellem. “It’s nice to see the pain division finally get this one right,” he said.
Teva Pharmaceutical Industries Ltd.’s Austedo (deutetrabenazine) lived up to the lack of expectations in pediatric Tourette syndrome (TS), missing identical primary endpoints in a pair of late-stage trials.
PERTH, Australia – Medicinal cannabis company Zelira Therapeutics Ltd. reported that its ZLT-101 therapy met the primary endpoint of a statistically significant improvement in insomnia in a phase Ib/IIa study in patients diagnosed with chronic insomnia.
What with the lawsuits, declining prescriptions and approval hurdles that seem to be the U.S. answer to a nationwide opioid epidemic, drug companies have to think long and hard before spending the resources to develop yet another opioid drug. And patients are paying the price.
Parkinson’s disease (PD) is a neurodegenerative disorder. But not just. And it may not start that way.
There is increasing evidence that a-synuclein, the protein whose aggregates eventually destroy midbrain dopaminergic neurons in PD (and that are the cause of other diseases collectively known as the synucleinopathies), first aggregates “in enteric neurons, the neurons that control gastrointestinal function,” Collin Challis told BioWorld.
SEATTLE – Applying single cell transcriptomics to brain tissue from living donors is laying bare the vast differences between the human brain and the mouse brain, calling into question the use of animal models in psychiatric drug discovery.
Privately held Zhittya Genesis Medicine Inc. received approval from Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) to begin a phase I trial at the Zambrano Hospital in Monterrey for patients with Parkinson’s disease.
Mark Tepper, the founder of newly launched Eumentis Therapeutics Inc., plans to use the company’s recent $2 million Small Business Innovation Research (SBIR) grant to fund IND-enabling studies for EM-036, a nitro-aminoadamantane N-methyl-D-aspartate receptor antagonist to treat Alzheimer's disease and autism spectrum disorders.
The hormone prolactin is known for and named after its role in breastfeeding. But that is far from its only role. There are more than 300 identified functions of prolactin, which is present in both men and women, though women have higher levels, and extremely high levels late in pregnancy and during breastfeeding. Now, scientists at the University of Arizona have identified another function of prolactin signaling.
A high-profile test of two experimental medicines in people with autosomal dominant Alzheimer’s disease (ADAD), a rare inherited form of the disease, found that neither drug significantly slowed rates of cognitive decline vs. placebo, the primary endpoint.
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