Vanda’s Bid to Expand Hetlioz Use to Insomnia Hits FDA Roadblock
The FDA issued a complete response letter, indicating that it cannot approve Vanda's supplemental New Drug Application for Hetlioz for insomnia in its present form.
The FDA issued a complete response letter, indicating that it cannot approve Vanda's supplemental New Drug Application for Hetlioz for insomnia in its present form.
A patient filed a federal lawsuit challenging the unlawfulness of Colorado Medicaid's prior authorization criteria for HETLIOZ coverage.
HETLIOZ (tasimelteon) improved sleep quality and increased sleep duration in patients with Smith-Magenis Syndrome (SMS) in a placebo-controlled clinical study, reports marketer Vanda Pharmaceuticals Inc. “We are extremely...
Read MoreScientists and entrepreneurs are joining forces to meet a growing demand for solutions to jet lag.
Read MoreVanda Pharmaceuticals Inc announced that a HETLIOZ patent, number 10,071,977 (‘977 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence...
Read MoreThe maker of Hetlioz (tasimelteon) presented 4 abstracts at World Sleep 2017. By Dillon Stickle...
Read MoreVanda Pharmaceuticals Inc announced that HETLIOZ (tasimelteon) is now available for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in Germany. “The launch of HETLIOZ in Germany reflects our continued focus to...
Read MoreThe European Commission (EC) approved Vanda Pharmaceuticals Inc’s Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults in the European Union (EU). “The European...
Read MoreVanda 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 MoreVanda 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 MoreEuropean 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 MoreOn 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 More“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 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 MoreVanda 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 MoreThe 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 More“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...
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