Vanda: Update for supplemental NDA for HETLIOZ® in Treatment of Insomnia

 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. 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. In a letter to Vanda dated July 17, 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.

Vanda has extensively studied the efficacy of HETLIOZ® in the treatment of insomnia characterized by difficulties with sleep initiation. A Phase III, multi-center, placebo-controlled, 4-week trial evaluated patients with chronic primary insomnia. Two transient insomnia studies induced by phase advance of the sleep-wake cycle were also conducted with five-hour and eight-hour phase advance, which showed a significant effect the first night in improving sleep parameters.

Vanda believes that the timing of the FDA's communication is part of an ongoing violation of the Federal Food Drug, and Cosmetic Act (FDCA). The FDCA requires the FDA to either approve a new drug application or provide an opportunity for a hearing within 180 days after the filing of an application.1 Because Vanda submitted the sNDA on May 4, 2023, the FDA's deadline under the FDCA was October 31. 2023. The FDA has not complied with the statute and has not timely approved the application or provided an opportunity for a hearing within the statutorily prescribed timeframe. 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. 

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-fda-update-for-supplemental-nda-for-hetlioz-in-the-treatment-of-insomnia-302053260.html

BioRestorative: Prelim Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc Disease

  Preliminary data includes 26 and 52-week follow-up end points as part of ongoing Phase 2 trial —

— Company to host webcasted conference call today at 8:30am EST —

BioRestorative management will host a webcasted conference call with an associated slide presentation today, February 5, at 8:30AM EST. To join the conference call via phone and participate in the live Q&A session, please dial 888-506-0062 (United States) or 973-528-0011 (International), participant access code 234972. The live webcast and audio archive of the presentation may be accessed on the investor section of the BioRestorative website at https://www.biorestorative.com/investor-relations/. An archived replay will be available for approximately 90 days following the event.

https://www.globenewswire.com/news-release/2024/02/05/2823422/0/en/BioRestorative-Therapies-Presents-Preliminary-Clinical-Data-from-Phase-2-Study-of-BRTX-100-in-Chronic-Lumbar-Disc-Disease.html

FDA website shows limited availability of some doses of Lilly's Mounjaro

 The U.S. Food and Drug Administration's website showed that three higher doses of Eli Lilly's diabetes drug Mounjaro would be available only in limited amounts through early March 2024, due to increased demand.

According to the health regulator's website, 10 milligram, 12.5 milligram and 15 milligram doses of the injection will have limited availability, while lower doses of Mounjaro were shown to be available.

In late January, the agency's website showed that only the 12.5 milligram dose would be available in limited amounts through February 2024.

Soaring demand for a type of highly effective diabetes drugs known as GLP-1 agonists, which are also used off-label and are approved for weight loss, has led to supply constraints for drugmakers such as Lilly and Novo Nordisk.

Eli Lilly did not immediately respond to a Reuters request for comment.

Lilly's Mounjaro has been approved for patients with type-2 diabetes to control their blood sugar levels since 2022.

The injection, which has the active ingredient tirzepatide, gained the FDA's approval for weight loss under the brand name Zepbound in the United States late last year.

Both Eli Lilly and Novo Nordisk have been trying to ramp up production to help meet the strong demand.

Novo's parent company, Novo Holdings, said on Monday it would buy Catalent for $11.5 billion to boost the supply for its weight-loss drug Wegovy.

https://finance.yahoo.com/news/1-fda-website-shows-limited-143041414.html

Verrica Sues Canadian Drug Manufacturer for False Advertising and Unfair Competition

 Verrica Pharmaceuticals Inc. (“Verrica” or, the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has filed a lawsuit in the Eastern District of Pennsylvania against Dormer Laboratories Inc., a Canada corporation (“Dormer Labs”) requesting, among other relief, that the court enjoin Dormer Labs from marketing, selling, and distributing drugs containing cantharidin in the United States, as well as compensatory, statutory and punitive damages for Dormer Labs’ violations of the federal Lanham Act and Pennsylvania law. The lawsuit arises out of Dormer Labs’ false and misleading advertising and promotion of unapproved cantharidin-containing drugs to health care providers and other customers in the United States.

YCANTH was the first FDA-approved treatment for molluscum contagiosum. YCANTH is also the only FDA-approved cantharidin-containing drug, meaning that it is the only cantharidin-containing drug that FDA has determined to be safe and effective. This lawsuit is part of Verrica’s commitment to patient safety by stopping the false and misleading advertising and sale of unapproved cantharidin-containing drugs within the United States.

https://www.globenewswire.com/news-release/2024/02/05/2823427/0/en/Verrica-Pharmaceuticals-Files-Lawsuit-Against-Canadian-Drug-Manufacturer-for-False-Advertising-and-Unfair-Competition.html

Softbank-Backed Medical Genetics Company Invitae Prepares For Bankruptcy

 

• SOFTBANK-BACKED MEDICAL GENETICS COMPANY INVITAE PREPARES FOR BANKRUPTCY - WSJ

• INVITAE IS WORKING WITH KIRKLAND & ELLIS AND FTI CONSULTING TO SEEK OPTIONS TO ADDRESS $1.5 BILLION OF DEBT- WSJ.

https://www.tradingview.com/news/reuters.com,2024:newsml_FWN3EQ1MT:0-softbank-backed-medical-genetics-company-invitae-prepares-for-bankruptcy-wsj/