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AbbVie Inc

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AbbVie's RINVOQ Meets Primary and Key Secondary Endpoints in Phase 3 Head-to-Head Study Versus ORENCIA in RA Patients

Lead Product(s): Upadacitinib

Therapeutic Area: Immunology Product Name: Rinvoq

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 06, 2020

Details:

In SELECT-CHOICE, RINVOQ™ (upadacitinib) met both the primary and key secondary endpoints compared to ORENCIA® (abatacept) on change from baseline in DAS28-CRP at week 12 in patients with rheumatoid arthritis and inadequate response to biologic DMARDs.

AbbVie Inc

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New Long-Term Data from RINVOQ Phase 3 Studies in Rheumatoid Arthritis

Lead Product(s): Upadacitinib,Methotrexate

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 June 04, 2020

Details:

Long-term results from the SELECT-COMPARE and SELECT MONOTHERAPY studies showed that RINVOQ™ (upadacitinib, 15 mg) continued to improve signs and symptoms in patients with rheumatoid arthritis through 72 and 84 weeks, respectively.

Eli Lilly

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Lilly's Taltz Outpaces Novartis' Cosentyx with 4th FDA Approval

Lead Product(s): Ixekizumab

Therapeutic Area: Immunology Product Name: Undisclosed

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 June 01, 2020

Details:

This approval is based on the results from the Phase 3 COAST-X trial, which evaluated improvement in signs and symptoms of nr-axSpA as measured by the proportion of patients who achieved ASAS40 response criteria compared to placebo.

Adamis Pharmaceuticals

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Adamis Pharmaceuticals Terminated Distribution and Commercialization Agreement of its SYMJEPI Products with Sandoz

Lead Product(s): Epinephrine

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Sandoz Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Termination May 11, 2020

Details:

Adamis and Sandoz have reached an agreement allowing for the mutually agreed return to Adamis of SYMJEPI products' marketing, promotion and distribution rights and the termination of the deal.

Adamis Pharmaceuticals

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Adamis Pharmaceuticals Announces Distribution and Commercialization Agreement for SYMJEPI and ZIMHI with US WorldMeds

Lead Product(s): Epinephrine

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: US WorldMeds

Deal Size: $26.0 million Upfront Cash: Undisclosed

Deal Type: Agreement May 11, 2020

Details:

US WorldMeds obtained U.S. rights to commercialize and distribute the SYMJEPI products, upon the termination of Sandoz’ commercial rights, and ZIMHI.

Amphastar Pharmaceuticals

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Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial

Lead Product(s): Epinephrine

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 April 27, 2020

Details:

Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial.

CSL Behring

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CSL Behring Announces Results from Three Analyses of Hizentra® in Primary Immunodeficiency (PI)

Lead Product(s): Immunoglobulin G 285-292

Therapeutic Area: Immunology Product Name: Undisclosed

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 April 21, 2020

Details:

Positive results were observed from the expanded infusion parameters of Hizentra for most patients across all three cohorts.

Soleo Health

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Soleo Health Selected by Grifols as Limited Drug Distribution Partner for XEMBIFY®

Lead Product(s): Immune globulin human-klhw

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Grifols International

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 01, 2020

Details:

Soleo Health was chosen as a limited distributor of XEMBIFY. This is Grifols’ first 20% immune globulin.

Cumberland Pharmaceuticals

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Cumberland Pharmaceuticals Announces Initiative to Expand Availability of Caldolor for Coronavirus Patients

Lead Product(s): Ibuprofen

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 31, 2020

Details:

The collaboration aims at providing hospitals and clinics that use Caldolor® injection for the treatment of COVID-19 patients easy access financial arrangements to combat medical requirements.

ADMA Biologics

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ADMA Biologics Announces Closing of Full Exercise of Underwriters’ Option

Lead Product(s): Human Immune Globulin

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Morgan Stanley

Deal Size: $94.6 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 24, 2020

Details:

ADMA intends to use the net proceeds from this offering (i) for the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV.

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Companies

AbbVie Inc

AbbVie's RINVOQ Meets Primary and Key Secondary Endpoints in Phase 3 Head-to-Head Study Versus ORENCIA in RA Patients

AbbVie Inc

New Long-Term Data from RINVOQ Phase 3 Studies in Rheumatoid Arthritis

Eli Lilly

Lilly's Taltz Outpaces Novartis' Cosentyx with 4th FDA Approval

Adamis Pharmaceuticals

Adamis Pharmaceuticals Terminated Distribution and Commercialization Agreement of its SYMJEPI Products with Sandoz

Adamis Pharmaceuticals

Adamis Pharmaceuticals Announces Distribution and Commercialization Agreement for SYMJEPI and ZIMHI with US WorldMeds

Amphastar Pharmaceuticals

Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial

CSL Behring

CSL Behring Announces Results from Three Analyses of Hizentra® in Primary Immunodeficiency (PI)

Soleo Health

Soleo Health Selected by Grifols as Limited Drug Distribution Partner for XEMBIFY®

Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Announces Initiative to Expand Availability of Caldolor for Coronavirus Patients

ADMA Biologics

ADMA Biologics Announces Closing of Full Exercise of Underwriters’ Option