Vanda Preps sNDA for HETLIOZ in Insomnia
Vanda’s trial results of HETLIOZ (tasimelteon) for insomnia suggest that circadian misalignment may be the etiology behind chronic primary insomnia for many patients.
Tag: Vanda Pharmaceuticals
All
Latest
All
LatestVanda Receives FDA Deficiencies Notice for Hetlioz Supplemental New Drug Application for Jet Lag Disorder; Vanda Plans to Work with FDA to Resolve
Vanda Pharmaceuticals Inc received a notification from the US Food and Drug Administration (FDA) on July 19 stating that as part of its ongoing review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ...
All
LatestSorry, No Posts Found
Vanda Receives Innovation Award from the National Organization for Rare Disorders
Vanda Pharmaceuticals Inc received the 2015 Industry Innovation Award from the National Organization of Rare Disorders (NORD) in recognition of Vanda’s work in developing Hetlioz (tasimelteon) for the treatment of...
Read MoreIn 1Q2015, Hetlioz Net Product Sales Up 24% Over Prior Quarter
Vanda Pharmaceuticals Inc today announced financial and operational results for the first quarter ended March 31, 2015. “The first quarter of 2015 was a record quarter for product sales driven by Hetlioz and Fanapt. As we...
Read MoreIn Europe, Hetlioz Receives Positive CHMP Opinion
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Vanda Pharmaceuticals’ Hetlioz (tasimelteon) for the treatment of...
Read MoreNational Organization for Rare Disorders to Honor Hetlioz
On May 19, the National Organization for Rare Disorders (NORD) will honor the patients, leaders, and innovators who are moving the rare disease community forward at its annual Portraits of Courage Gala in Washington DC. NORD is...
Read MoreIn Q42014, Hetlioz Sales Increase 15% Compared to Q32014
“2014 was a transformational year for Vanda with the Hetlioz launch in the US for the treatment of Non-24-Hour Sleep-Wake Disorder. We are impressed with the continued growth of HETLIOZ and are fortunate to be able to...
Read MoreVanda Pharmaceuticals Prices Public Offering of Common Stock
Vanda Pharmaceuticals Inc this week announced the sale of 5,000,000 shares of its common stock in an underwritten public offering at a price to the public of $11.60 per share. The net offering proceeds to Vanda from the sale of...
Read MoreHetlioz US Sales Grow to $5.2 Million in First Full Quarter Since Launch
Vanda Pharmaceuticals Inc generated total revenues of $14.8 million for the third quarter of 2014, up from $10.9 million for the second quarter of 2014 and $8.7 million for the third quarter of 2013. Net product revenues related...
Read More
2014’s FDA-Approved and FDA-Cleared Products
The US Food and Drug Administration cleared and approved these products in the sleep medicine space between January 1 and October 13, 2014. Products likely to be cleared or approved (per the manufacturer’s guidance) between October 11, 2015 and April 30, 2015 are described in the pipeline section.
Read MoreMore Than 420 Prescriptions Written for Hetlioz
“We are encouraged by the early positive reception of Hetlioz by patients, physicians, and payors. We look forward to more patients benefiting from Hetlioz in the coming months and years,” says Mihael Polymeropoulos...
Read MoreEuropean Medicines Agency Accepts Hetlioz Marketing Authorization Application
Vanda Pharmaceuticals Inc’s Marketing Authorization Application (MAA) for oral Hetlioz (tasimelteon) capsules has been accepted for evaluation by the European Medicines Agency (EMA) for the treatment of Non-24-Hour...
Read MoreVanda Reports Net Loss of $26.5 Million Due in Part to Hetlioz Launch Expenses
This year, Vanda Pharmaceuticals received Food and Drug Administration (FDA) approval for Hetlioz for the treatment of Non-24-Hour Sleep-Wake Disorder and launched the drug in the United States. However, the launch dramatically...
Read MoreHetlioz for Non-24-Hour Disorder Now Available
Vanda Pharmaceuticals Inc this week announced the availability of Hetlioz. Hetlioz is the first treatment approved by the US Food and Drug Administration (FDA) for Non-24-Hour Sleep-Wake Disorder (Non-24), a chronic circadian...
Read MoreBlind Adventurer Raises Awareness of Non-24 with Vanda Pharmaceuticals
Vanda Pharmaceuticals Inc, maker of Hetlioz, has partnered with Erik Weihenmayer, the only blind person to climb Mount Everest, to raise awareness of Non-24 Hour Sleep-Wake Disorder. Weihenmayer will support the Non-24 Share...
Read MoreFDA Approves Hetlioz for Non-24-Hour Disorder
The FDA today approved Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Hetlioz, manufactured by Vanda Pharmaceuticals, treats the chronic circadian rhythm disorder that affects up to 70% of...
Read MoreVanda Reports Positive Results in Second Phase III Study of Tasimelteon
The drug, which currently has orphan drug status in the US and EU, works to establish a normal “body clock” for blind patients with Non-24-Hour Disorder.
Read More