Prior to treatment, patients involved in the studies reported moderate to severe migraine pain, with symptoms such as nausea and sensitivity to light and sound. Results showed that a high percentage of patients were able to gain relief from their migraine pain, some in as little as two hours after treatment. The most common side effect reported was nausea and dry mouth.
In studies, the Dayvigo was found to statistically improve sleep onset and keep patients asleep,when compared to the placebo. Dayvigo was also not found to cause rebound insomnia, a common problem with some sleep medications. This describes worsened sleep compared to the baseline after drug discontinuation. There was also no evidence of withdrawal effects.
Palforzia is seen as an important test case for a new generation of therapies expected to transform how food allergies are treated. Doctors who have had few tools other than counseling their patients to assiduously avoid peanuts expect that other drugs will follow — additional drugs for the peanut allergy, as well as egg and tree nut allergies. Aimmune Therapeutics, which makes Palforzia, has several other food allergy treatments in its pipeline.
“Despite industry advancements, there are limited therapeutic options for treating patients with epithelioid sarcoma who struggle with high rates of recurrence and toxicities associated with currently used therapies,” said Gary K. Schwartz, M.D., chief of hematology and oncology at Columbia University and NewYork-Presbyterian Hospital, deputy director of the Herbert Irving Comprehensive Cancer Center, professor of oncology at Columbia University Vagelos College of Physicians and Surgeons and an investigator in Epizyme’s Phase 2 trial. “The TAZVERIK data from the ES cohort in Epizyme’s Phase 2 trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of TAZVERIK represents an important advancement in the treatment of patients with ES.”
Lannett Company (NYSE:LCI), a small-cap drug manufacturer, received FDA approval for Numbrino, the first branded drug in the company's 78-year history. The nasal spray will be marketed to doctors as a local anesthetic for minor surgeries around the nasal cavities of patients, but will not be available in retail pharmacies.
PreludeDx has appointed Edwin Hendrick as the company's chief commercial officer. He has more than 30 years of related commercial experience and was most recently at Biocept. Before that, he was at Decipher Biosciences, formerly called GenomeDx, and at Plus Diagnostics. Laguna Hills, California-based PreludeDx's main product is the DCISionRT risk assessment test for patients with ductal carcinoma in situ.
DNAnexus CEO Richard Daly said that the new contract demonstrates his company's understanding of "FDA's evolving needs for data stewardship, security, and quality, and the increasing complexity of bioinformatics in regulatory review." He said that the expanded relationship will help PrecisionFDA "enhance the regulatory process and provide better options for patients and healthcare providers."
Comparing a patient’s DNA to reference data will allow doctors to find other people with similar DNA variants and see how they were diagnosed and treated. SolveBio’s founding team is currently focused on building a system that can integrate genomics data into diagnostic and research applications, which it will make available as an API.
More than a decade after the immense promise unleashed by the completion of Human Genome Project, precision medicine has struggled with its own “last mile.” Despite major leaps in the field as a whole, the technical work needed to integrate a patient’s genomic information into the day-to-day practice of medicine has lagged far behind.
Bempedoic acid is a once-a-day oral medication that will be commercially known as Nexletol. The FDA approved it for use with a healthy diet and the maximum dose of statins a patient tolerates. Studies show the new drug can reduce what doctors call low-density lipoprotein cholesterol, what you may know as LDL, the "bad" cholesterol that can lead to heart problems or strokes.