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Home » Keywords » Vanda Pharmaceuticals Inc.

Items Tagged with 'Vanda Pharmaceuticals Inc.'

ARTICLES

US FDA reduction-in-force delays response to Vanda

April 23, 2025
By Mari Serebrov
A U.S. FDA CDER official is among the first to say the quiet part out loud in proposing a Sept. 12 deadline for the agency to respond to Vanda Pharmaceuticals Inc.’s request for summary judgment or a hearing on CDER’s refusal to approve tradipitant to treat gastroparesis.
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Gavel and pill blister packs

US Claims Court rules Vanda’s trade secrets not so secret

Jan. 24, 2025
By Mari Serebrov
A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.
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Red blood cells
Hematologic

Vanda’s VGT-1849A gets orphan designation for polycythemia vera

Dec. 23, 2024

Vanda Pharmaceuticals Inc.’s VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor, has been awarded orphan drug designation by the FDA for the treatment of polycythemia vera.


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Laptop displaying FDA logo

US FDA issues CRL for Vanda’s tradipitant for gastroparesis

Sep. 19, 2024
By Karen Carey
Clearly frustrated by the U.S. FDA’s rejection of tradipitant to treat gastroparesis, Vanda Pharmaceuticals Inc. CEO Mihael Polymeropoulos said the agency is discouraging drug development for the serious gastric emptying condition for which there has been no new treatment in 40 years. The complete response letter (CRL) issued on the Sept. 18 PDUFA date for the neurokinin-1 receptor antagonist, which Vanda licensed from Eli Lilly and Co. in 2012, requested additional studies that the company said are not in line with the advice of experts in the field.
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Coins and financial paperwork

Takeout interest continues for Vanda: Cycle offers $8 a share

June 6, 2024
By Karen Carey
Washington-based Vanda Pharmaceuticals Inc. has faced a challenging few years involving a federal lawsuit against the U.S. FDA, patent infringement litigation, increasing generic competition and dwindling sales, as well as a complete response letter nixing plans to expand its melatonin receptor agonist Hetlioz (tasimelteon) into insomnia, yet it has recently received a higher, unsolicited acquisition offer of $466 million from a second company, Cycle Pharmaceuticals Ltd.
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Neurology/Psychiatric

Vanda receives IND clearance for ASO for Charcot-Marie-Tooth disease type 2S

Jan. 24, 2024
Vanda Pharmaceuticals Inc. has announced FDA approval of its IND application to evaluate VCA...
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Judge's gavel with US flag

US FDA’s trade secret disclosure still a live legal question

Jan. 22, 2024
By Mari Serebrov
Is it an unconstitutional taking when U.S. FDA reviewers disclose a brand company’s claimed trade secrets or confidential commercial information to would-be competitors? That’s a question the U.S. Court of Federal Claims has yet to answer. While the court dismissed some of Vanda Pharmaceuticals Inc.’s claims against the FDA, its Jan. 18 opinion left open the debate of whether such disclosures, intentional or inadvertent, are a per se or regulatory taking.
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Illustration of nerve cells
Neurology/Psychiatric

Vanda's ASO VCA-894A awarded US orphan drug designation for Charcot-Marie-Tooth disease type 2S

June 2, 2023
Vanda Pharmaceuticals Inc.'s antisense oligonucleotide (ASO) VCA-894A has been awarded orphan drug designation by the FDA for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within IGHMBP2.
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As USTR calls foul over trade secrets theft, FDA accused of the same

May 3, 2023
By Mari Serebrov
While the U.S. continues to call out other countries for weak enforcement of intellectual property rights, trade secret theft and forced technology transfers in the life sciences sector, some companies in the sector claim similar things are happening in the U.S. In its 2023 Special 301 Report, released April 26, the Office of the U.S. Trade Representative (USTR) noted “the growing need for trading partners to provide effective protection and enforcement of trade secrets.”
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Lab mouse
Drug design, drug delivery & technologies

US spending bill spares animals in preclinical drug development

Dec. 30, 2022
By Mari Serebrov
Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
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More Articles Tagged with 'Vanda Pharmaceuticals Inc.'

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