Musculoskeletal | Approved Drugs | Pipeline Prospector

SparingVision

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FRANCE France

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Pfenex Announces Enters New Partnership in Latin America, and Provides CRM197 Business Update

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: Livogiva

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement June 26, 2020

Details:

Adalvo recently entered into a commercialization agreement with a multinational pharmaceutical company to commercialize PF708, upon receipt of marketing authorization, in certain countries in Latin America.

Pfenex

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United States

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Pfenex Announces Positive European CHMP Opinion for PF708

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: Livogiva

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 26, 2020

Details:

Pfenex received a positive opinion for PF708 (branded in Europe as Livogiva™) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Mithra Pharmaceuticals

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BELGIUM Belgium

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Mithra Signs LSA for Commercialization of Tibelia® in Liechtenstein and Switzerland

Lead Product(s): Tibolone

Therapeutic Area: Musculoskeletal Product Name: Tibelia

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Spirig Healthcare

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement June 11, 2020

Details:

Developed by Mithra as the bioequivalent version of Livial® Tibelia® is a complex oral formulation composed of tibolone. Under the terms of this agreement, Spirig Healthcare AG will be responsible for the commercialization of Tibelia® in Liechtenstein and Switzerland.

Bayer HealthCare

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GERMANY Germany

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Strategic Distribution Between Bayer Animal Health and Bioiberica in the International Companion Animal Health Market

Lead Product(s): Chondroitin Sulfate,D-Glucosamine,Hyaluronic Acid

Therapeutic Area: Musculoskeletal Product Name: Condrovet

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Bioiberica SA

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement June 09, 2020

Details:

Under the terms of the agreement, Bayer Animal Health will distribute and market selected products from Bioiberica´s Companion Animal Health portfolio in eight countries.

Amphastar Pharmaceuticals

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United States

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Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vial

Lead Product(s): Succinylcholine Chloride

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2020

Details:

The U.S. FDA has approved Abbreviated New Drug Application for Succinylcholine Chloride Injection USP, 200 mg/10 mL Multiple-Dose Vial. Amphastar’s drug product was determined by the FDA to be therapeutically equivalent to Succinylcholine Chloride Injection USP, 200 mg/10 mL.