Immunology | Approved Drugs | Pipeline Prospector

Sanofi

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FRANCE France

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LTL Pharma to Take Over Sanofi’s Diregura in Japan

Lead Product(s): Fexofenadine Hydrochloride,Pseudoephedrine

Therapeutic Area: Immunology Product Name: Diregura

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: LTL Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 04, 2020

Details:

LTL Pharma will take over the Japanese marketing authorization (MA) of Sanofi’s anti-allergic medicine Diregura (fexofenadine + pseudoephedrine).

Janssen Pharmaceutical

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United States

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Health Canada Approves Janssen Pharmaceutical's TREMFYA®, a First-In-Class Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Art...

Lead Product(s): Guselkumab

Therapeutic Area: Immunology Product Name: Tremfya

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 September 10, 2020

Details:

TREMFYA® is the first and only biologic approved for the treatment of both active PsA and moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine involved in normal inflammatory and immune responses.

Strides Arcolab Limited

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INDIA India

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Strides Receives USFDA Approval for Prednisone Tablets

Lead Product(s): Prednisone

Therapeutic Area: Immunology 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 03, 2020

Details:

Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Prednisone Tablets USP, 1 mg from the United States Food & Drug Administration (USFDA).

Innovent Biologics

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CHINA China

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Innovent Announces NMPA Granted Marketing Approval for SULINNO® (Adalimumab Injection) in China

Lead Product(s): Adalimumab

Therapeutic Area: Immunology Product Name: Sulinno

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 September 03, 2020

Details:

SULINNO® (adalimumab injection), a recombinant human anti-TNF-α monoclonal antibody drug, has been officially approved by the National Medical Products Administration (NMPA) of China for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis in China.

Viela Bio

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United States

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Viela Bio Announces Data Presentations at the 8Th Joint Actrims-Ectrims Meeting, Ms Virtual 2020

Lead Product(s): Inebilizumab

Therapeutic Area: Immunology Product Name: Uplizna

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 September 03, 2020

Details:

First poster will highlights study results in AQP4-IgG seronegative patients in the N-MOmentum trial of inebilizumab in neuromyelitis optica spectrum disorder.

Hansa Biopharma

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SWEDEN Sweden

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Hansa Biopharma Provides Updated Guidance on Its Clinical Programs

Lead Product(s): Imlifidase

Therapeutic Area: Immunology Product Name: Idefirix

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 September 01, 2020

Details:

After the conditional approval recently granted by the EU Commission for Idefirix in highly sensitized kidney transplant patients in the EU, Hansa Biopharma expects the first treatments with Idefirix to be available to patients in select European countries.

Aimmune Therapeutics

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United States

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Nestlé to Acquire Aimmune Therapeutics

Lead Product(s): Peanut Allergen Powder-dnfp

Therapeutic Area: Immunology Product Name: Palforzia

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Nestle Health Sciences SA

Deal Size: $1,930.0 million Upfront Cash: $1,930.0 million

Deal Type: Acquisition August 31, 2020

Details:

Aimmune's recently approved therapy Palforzia® would expand Nestlé Health Science portfolio with first and only FDA-approved treatment to help reduce the frequency and severity of allergic reactions to peanuts in children.

Cadila Healthcare Ltd

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INDIA India

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Cadila Pharmaceuticals Launches Cadalimab™ (adalimumab Biosimilar) for India

Lead Product(s): Adalimumab

Therapeutic Area: Immunology Product Name: Cadalimab

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 August 28, 2020

Details:

Adalimumab is a disease-modifying antirheumatic drug and a monoclonal antibody that works by inactivating tumor necrosis factor-alpha (TNFα) recommended in the treatment of many diseases.

Hansa Biopharma

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SWEDEN Sweden

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Conditional Approval for Hansa's Idefirix[tm] (imlifidase) in Highly Sensitized Kidney Transplant Patients in the European Union

Lead Product(s): Imlifidase

Therapeutic Area: Immunology Product Name: Idefirix

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 August 26, 2020

Details:

The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as IdefirixTM will be the Company’s first approved drug.

EyePoint Pharmaceuticals

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United States

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EyePoint Pharmaceuticals Secures New Purchase and Marketing Agreement with Vantage Outsourcing for DEXYCU®

Lead Product(s): Dexamethasone

Therapeutic Area: Immunology Product Name: Dexycu

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Vantage Outsourcing

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 24, 2020

Details:

The agreement will enable customers in the Vantage Outsourcing network, which spans over a 25+ state service area, to incorporate DEXYCU into their surgical protocols for treating ocular inflammation associated with cataract surgery.

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Find Approved Immunology Drugs in Clinical Development

Approved

Product Type

Companies

Sanofi

LTL Pharma to Take Over Sanofi’s Diregura in Japan

Janssen Pharmaceutical

Health Canada Approves Janssen Pharmaceutical's TREMFYA®, a First-In-Class Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Art...

Strides Arcolab Limited

Strides Receives USFDA Approval for Prednisone Tablets

Innovent Biologics

Innovent Announces NMPA Granted Marketing Approval for SULINNO® (Adalimumab Injection) in China

Viela Bio

Viela Bio Announces Data Presentations at the 8Th Joint Actrims-Ectrims Meeting, Ms Virtual 2020

Hansa Biopharma

Hansa Biopharma Provides Updated Guidance on Its Clinical Programs

Aimmune Therapeutics

Nestlé to Acquire Aimmune Therapeutics

Cadila Healthcare Ltd

Cadila Pharmaceuticals Launches Cadalimab™ (adalimumab Biosimilar) for India

Hansa Biopharma

Conditional Approval for Hansa's Idefirix[tm] (imlifidase) in Highly Sensitized Kidney Transplant Patients in the European Union

EyePoint Pharmaceuticals

EyePoint Pharmaceuticals Secures New Purchase and Marketing Agreement with Vantage Outsourcing for DEXYCU®