Musculoskeletal | Approved Drugs | Pipeline Prospector

Neurana Pharmaceuticals

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United States

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Neurana Pharmaceuticals to Present Tolperisone Data at PAINWeek® National Conference

Lead Product(s): Tolperisone

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 September 02, 2020

Details:

The presentation will highlight results from a double-blind, randomized, placebo-controlled, multicenter phase 3 study evaluating Tolperisone 100 and 200 mg Three Times Daily (TID) for acute muscle spasm of the back.

Mayne Pharma

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Australia

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Mayne Pharma Launches Chlorzoxazone Tablet in the United States

Lead Product(s): Chlorzoxazone

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 July 28, 2020

Details:

FDA has granted approval of its Abbreviated New Drug Application (ANDA) for chlorzoxazone tablet, 375 mg, 500 mg and 750 mg, in the United States.

Global Stem Cell Technology

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BELGIUM Belgium

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Boehringer Ingelheim Acquires GST to Strengthen its Stem Cell Capabilities in Animal Health

Lead Product(s): Mesenchymal stem cell therapy

Therapeutic Area: Musculoskeletal Product Name: Arti-Cell

Highest Development Status: Approved Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Boehringer Ingelheim GmbH

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition July 27, 2020

Details:

The acquisition follows two years of successful partnership that brought the first-ever registered stem cell-based veterinary medicine to the European market.

ANTARES PHARMA INC

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United States

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First Commercial Product Using Antares Pharma’s Multi-Dose Pen Platform Launches in Europe

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

Antares development partner Teva, launched Teriparatide Injection (“teriparatide”), the generic version of Eli Lilly’s brand product Forsteo® featuring the Antares multi-dose pen platform in Austria, Croatia, Hungary,

Unichem Laboratories Limited

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INDIA India

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Unichem Lab Gets USFDA Nod for Baclofen Tablets; Stock Ends Higher

Lead Product(s): Baclofen

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 July 10, 2020

Details:

Baclofen Tablets are indicated for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Ipsen

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FRANCE France

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Ipsen Announces Updated Indication for Dysport® (abobotulinumtoxinA) for the Treatment of Spasticity in Children

Lead Product(s): Botulinum toxin type A

Therapeutic Area: Musculoskeletal Product Name: Dysport

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 09, 2020

Details:

United States Food and Drug Administration (FDA) has approved the expanded use of Dysport® (abobotulinumtoxinA) in pediatric patients.

Avadel Pharmaceuticals

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IRELAND Ireland

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Avadel Sells Sterile Injectables Portfolio; will Focus on Narcolepsy

Lead Product(s): Neostigmine Methyl Sulfate

Therapeutic Area: Musculoskeletal Product Name: Bloxiverz

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Exela Pharma Sciences, LLC.

Deal Size: $42.0 million Upfront Cash: $14.5 million

Deal Type: Divestment July 01, 2020

Details:

Company announced the sale of its portfolio of sterile injectable drugs used in the hospital setting, including three commercial products, Bloxiverz®, Vazculep®, and Akovaz®, as well as Nouress™ o Exela Sterile Medicines LLC.

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.

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Companies

Neurana Pharmaceuticals

Neurana Pharmaceuticals to Present Tolperisone Data at PAINWeek® National Conference

Mayne Pharma

Mayne Pharma Launches Chlorzoxazone Tablet in the United States

Global Stem Cell Technology

Boehringer Ingelheim Acquires GST to Strengthen its Stem Cell Capabilities in Animal Health

ANTARES PHARMA INC

First Commercial Product Using Antares Pharma’s Multi-Dose Pen Platform Launches in Europe

Unichem Laboratories Limited

Unichem Lab Gets USFDA Nod for Baclofen Tablets; Stock Ends Higher

Ipsen

Ipsen Announces Updated Indication for Dysport® (abobotulinumtoxinA) for the Treatment of Spasticity in Children

Avadel Pharmaceuticals

Avadel Sells Sterile Injectables Portfolio; will Focus on Narcolepsy

SparingVision

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

Pfenex

Pfenex Announces Positive European CHMP Opinion for PF708

Mithra Pharmaceuticals

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