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FDA has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System, designed to keep arteries open and deliver a drug (Everolimus) to support vessel healing prior to completely dissolving in patients with for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
Lead Product(s): Everolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Esprit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2024
Details:
Under the agreemeent, Abbott will commercialize several biosimilar molecules in key emerging markets in Latin America, Southeast Asia, the Middle East and Africa, and mAbxience will develop, manufacture and supply the biosimilar molecules.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Large molecule
Recipient: Mabxience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 20, 2023
Details:
Under the agreement, Abbott has exclusive worldwide commercialization rights for the SurVeil (paclitaxel) drug-coated balloon (DCB) for which Surmodics received FDA approval.
Lead Product(s): Paclitaxel
Therapeutic Area: Cardiology/Vascular Diseases Product Name: SurVeil
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Surmodics
Deal Size: $92.0 million Upfront Cash: $25.0 million
Deal Type: Agreement June 20, 2023
Details:
EleCare formulas are hypoallergenic and are used by infants and children who have severe food allergies or gastrointestinal (GI) disorders that require amino acid-based formulas.
Lead Product(s): Amino Acid-Based Therapeutic
Therapeutic Area: Nutrition and Weight Loss Product Name: Elecare
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
The novel, room-temperature-stable (RTS), single-dose formulation of Carbetocin will address prevailing challenges with existing protocols that require cold-chain storage and transportation.
Lead Product(s): Carbetocin Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Details:
Estradiol, also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles.
Lead Product(s): Estradiol,Dydrogesterone
Therapeutic Area: Musculoskeletal Product Name: Femoston
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 15, 2021
Details:
After termination of the agreement, AstraZeneca India will continue to independently market Dapagliflozin, the combinations of Dapagliflozin and Metformin as well as Dapagliflozin and Saxagliptin in India under the brand names Forxiga, Xigduo and Qtern respectively.
Lead Product(s): Dapagliflozin Propanediol Monohydrate,Metformin
Therapeutic Area: Endocrinology Product Name: Xigduo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination May 28, 2021
Details:
This is the first Investigational Device Exemption (IDE) trial in the U.S. to evaluate a fully resorbable device to treat blocked arteries below the knees, or critical limb ischemia (CLI), in people battling advanced stages of peripheral artery disease (PAD).
Lead Product(s): Everolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ESPRIT BTK
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
Approval marks the first once-a-day formulation for Ivabradine in India, which will help increase adherence to therapy for chronic heart failure and chronic stable angina.
Lead Product(s): Ivabradine Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases 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 September 02, 2020