Vanda

Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

Retrieved on: 
Wednesday, March 6, 2024
Symantec Endpoint Protection, FDA, Food, Shanda, CRL, New Drug Application, Insomnia, Vanda, Pharmaceutical industry

In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.

Key Points: 
  • In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA.
  • As previously reported, on February 4, 2024, the FDA provided a notification stating that it identified deficiencies that precluded discussion of labeling and postmarketing requirements/commitments.
  • Consistent with that notification, the FDA has issued a CRL, indicating that the FDA cannot approve the sNDA in its present form.
  • Vanda is reviewing the CRL and evaluating its next steps.

Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

Retrieved on: 
Monday, February 5, 2024
Hearing, Sleep, Patient, Shanda, New Drug Application, FDCA, FDA, Food, Insomnia, Communication, Vanda, Pharmaceutical industry

No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review.

Key Points: 
  • No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review.
  • Vanda has extensively studied the efficacy of HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation.
  • Vanda is also challenging the FDA's approvals of several generic versions of HETLIOZ®, which have been marketed since 2023.
  • Vanda remains committed to its efforts to hold the FDA accountable to the law, ensuring predictable regulatory conduct.

Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2023 Financial Results on February 7, 2024

Retrieved on: 
Wednesday, January 31, 2024
Vanda

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2023 on Wednesday, February 7, 2024, after the market closes.  

Key Points: 
  • WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2023 on Wednesday, February 7, 2024, after the market closes.
  • Vanda will host a conference call at 4:30 PM ET on Wednesday, February 7, 2024, during which management will discuss the fourth quarter and full year 2023 financial results and other corporate activities.
  • To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 8053170.
  • Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VTR-297 a Topical Antifungal Candidate for the Treatment of Onychomycosis

Retrieved on: 
Wednesday, January 31, 2024
Streptomyces, Fungal infection, Investigational New Drug, Venous stasis, Nail disease, Prevalence, IND, HDAC, Dermatophytosis, FDA, Ciclopirox, Onycholysis, Food, Vanda, Onychomycosis, Fungus, Antibiotics

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis.

Key Points: 
  • WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis.
  • Onychomycosis, or tinea unguium, is a fungal infection of the nail.
  • Onychomycosis can result in discoloration of the nail, onycholysis (nail separation from the nail bed), and nail plate thickening.
  • There have not been any new onychomycosis treatments approved by the FDA since 2014.4
    Centers for Disease Control and Prevention.

Court Orders FDA to Resolve Vanda Pharmaceuticals' Jet Lag Hearing Request by March 5, 2024

Retrieved on: 
Tuesday, January 30, 2024
Policy, Hearing, Congress, Therapy, Patient, Shanda, FDCA, FDA, District court, Vanda, Court, Pharmaceutical industry

The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing.

Key Points: 
  • The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing.
  • Following multiple attempts to informally resolve the complete response letter, Vanda requested an opportunity for a hearing in July 2022, and the FDA provided Vanda a private notice of an opportunity for a hearing.
  • As the Court explained, "the statute requires that a hearing shall commence within 300 days after an application is filed.
  • Vanda's application has been pending for almost 2,000 days and it has been over 500 days since Vanda made its most recent request for hearing."

Court Orders FDA to Resolve Vanda Pharmaceuticals' Jet Lag Hearing Request by March 5, 2024

Retrieved on: 
Tuesday, January 30, 2024
Patient, Shanda, Policy, District court, Court, Congress, FDA, Therapy, Vanda, FDCA, Hearing, Pharmaceutical industry

The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing.

Key Points: 
  • The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing.
  • Following multiple attempts to informally resolve the complete response letter, Vanda requested an opportunity for a hearing in July 2022, and the FDA provided Vanda a private notice of an opportunity for a hearing.
  • As the Court explained, "the statute requires that a hearing shall commence within 300 days after an application is filed.
  • Vanda's application has been pending for almost 2,000 days and it has been over 500 days since Vanda made its most recent request for hearing."

Vanda Pharmaceuticals Announces a U.S. Patent Allowance for PONVORY® (ponesimod) in the U.S.

Retrieved on: 
Friday, January 26, 2024
Multiple sclerosis, Janssen, Actelion, Orange Book, Food, Ponesimod, Vanda, The Orange Book, Patent, Pharmaceutical industry

WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses.

Key Points: 
  • WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its PONVORY® (ponesimod) patent application, number 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinitiating treatment after missed doses.
  • When issued, this patent is anticipated to expire on October 10, 2042.
  • Upon issuance, Vanda intends to list this patent in the U.S. Food and Drug Administration publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
  • Vanda acquired rights to U.S. and Canadian rights to PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company.

Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VCA-894A, a Novel Antisense Oligonucleotide Candidate for the Treatment of Charcot-Marie-Tooth Disease, Type 2S

Retrieved on: 
Tuesday, January 23, 2024
Patient, Life, Peripheral neuropathy, NMD, CMT, Genetics, Medicine, IND, Food, Journal, Journal of Biological Chemistry, Central nervous system, FDA, Vanda, Investigational New Drug, Atrophy, Neuromuscular disease, Charcot–Marie–Tooth disease, Asos, Gene expression, Prevalence

CMT2S is a rare subtype of Charcot-Marie-Tooth disease (CMT), an inherited peripheral neuropathy for which there is no available treatment.

Key Points: 
  • CMT2S is a rare subtype of Charcot-Marie-Tooth disease (CMT), an inherited peripheral neuropathy for which there is no available treatment.
  • VCA-894A is a novel antisense oligonucleotide (ASO) with a mechanism of action that specifically targets a cryptic splice site variant within immunoglobulin mu-binding protein 2 (IGHMBP2).
  • Truncating and missense mutations in IGHMBP2 cause Charcot-Marie Tooth disease type 2.
  • https://doi.org/10.1016/j.nmd.2021.08.001
    Crooke, S. T., Liang, X. H., Baker, B. F., & Crooke, R. M. (2021).

Federal Court Allows Vanda Pharmaceuticals' Lawsuit to Proceed Against the U.S. Food and Drug Administration

Retrieved on: 
Friday, January 19, 2024
Vanda, Court, Food, Disclosure, FDA, Pharmaceutical industry

Vanda is seeking compensation from the United States for the takings it contends occurred through the FDA's improper communication and disclosure of trade secrets and confidential information to certain generic drug manufacturers.

Key Points: 
  • Vanda is seeking compensation from the United States for the takings it contends occurred through the FDA's improper communication and disclosure of trade secrets and confidential information to certain generic drug manufacturers.
  • Vanda filed this lawsuit on May 1, 2023, and the United States moved to dismiss.
  • On January 8, 2024, the Court held an oral argument on the government's motion.
  • On January 18, 2024, the Court denied the government's motion in part, allowing Vanda's takings claim to move forward.

Vanda Pharmaceuticals Comments on FDA's Recently Announced Guidance on Communication with Health Care Professionals Regarding FDA-Approved Drugs

Retrieved on: 
Friday, January 12, 2024
Speech, Patient, Research, Policy, Medicine, Comment, Public, Congress, FDA, Vanda, Letter, Constitutional right, Marketing, Communication, Medical device

WASHINGTON, Jan. 12, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) submitted a comment letter ( here ) on January 5, 2024, regarding the FDA's recently announced policy—by way of a draft guidance document—that substantially restricts drug manufacturers' ability to communicate truthful, non-misleading information about FDA-approved drugs.

Key Points: 
  • WASHINGTON, Jan. 12, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) submitted a comment letter ( here ) on January 5, 2024, regarding the FDA's recently announced policy—by way of a draft guidance document—that substantially restricts drug manufacturers' ability to communicate truthful, non-misleading information about FDA-approved drugs.
  • Communication of novel scientific findings and emerging therapies is crucial to inform healthcare providers about new treatment options that did not exist at the time of their medical training.
  • Innovators who conduct this research play a significant role in communicating this new information to healthcare providers.
  • The FDA's guidance in fact sets binding standards, even though the FDA describes the guidance as a "nonbinding statement of policy."