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FDA has approved its new drug application for Cyclophosphamide Injection, 200mg/mL vials for use in combination therapy for various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.
Lead Product(s): Cyclophosphamide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 03, 2023
Details:
NVK002 (atropine) is an investigational, preservative-free, low-dose atropine eye drop, using Vyluma’s proprietary technology to address stability, tolerability, and safety and developed for the treatment of Pediatric Myopia.
Lead Product(s): Atropine
Therapeutic Area: Ophthalmology Product Name: NVK002
Highest Development Status: Phase IIIProduct Type: Small molecule
Recipient: Vyluma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2023
Details:
Under the agreement, Long Grove Pharmaceuticals in-licensed Norepinephrine Bitartrate in 0.9% Sodium Chloride premix formulation, indicated to raise blood pressure in adult patients with severe, acute hypotension, from Nevakar Injectables.
Lead Product(s): Norepinephrine Bitartrate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: NVK004
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Long Grove Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 04, 2023
Details:
NVK002 (atropine) is a proprietary, investigational, preservative-free eye drop administered nightly, which, if approved, would be the first-in-class pharmaceutical treatment for myopia progression in children.
Lead Product(s): Atropine
Therapeutic Area: Ophthalmology Product Name: NVK002
Highest Development Status: Phase IIIProduct Type: Small molecule
Recipient: Vyluma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2022
Details:
With the acquisition, Endo controls all remaining development, approval, launch and commercialization activities for the product candidates, NVK009 (Gabapentin). Endo's Par Sterile Products business will commercialize the products in the United States.
Lead Product(s): Gabapentin,Pregabalin,Paracetamol
Therapeutic Area: Neurology Product Name: NVK009
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Endo International
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 02, 2022
Details:
Ephedrine Sulfate Injection (“Ephedrine”) in a prefilled syringe is a widely used injectable vasopressor agent indicated for the treatment of clinically important hypotension occurring during surgery.
Lead Product(s): Ephedrine Sulfate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Par Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Ephedrine is a widely used injectable vasopressor agent indicated for the treatment of clinically important hypotension occurring during surgery, Ephedrine sulfate injection, a formulation pre-diluted to a 5mg/mL concentration and supplied in a 10mL vial.
Lead Product(s): Ephedrine Sulfate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Endo International
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
The financing will support the Phase III clinical study for NVK002, Vyluma’s first-in-class pharmaceutical treatment for slowing the progression of myopia in children.
Lead Product(s): Atropine
Therapeutic Area: Ophthalmology Product Name: NVK002
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oxford Finance LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing March 09, 2022
Details:
Under the terms of the agreement, Nevakar will develop and obtain European Medicines Agency (“EMA”) approval for NVK-002, and Théa will launch, distribute, and support the product in Europe, as well as in parts of North Africa.
Lead Product(s): Atropine
Therapeutic Area: Ophthalmology Product Name: NVK-002
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Laboratoires Thea
Deal Size: $135.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration January 28, 2021
Details:
The CHAMP Study is an FDA drug trial that evaluates the ability of its lead compound, NVK-002, to slow the progression of myopia in children. NVK-002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for patients ages 3 to 17.
Lead Product(s): Atropine
Therapeutic Area: Ophthalmology Product Name: NVK-002
Highest Development Status: Phase IIIProduct Type: Small molecule
Recipient: Zhaoke
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
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