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TELIX GRANTED FDA ORPHAN DRUG DESIGNATION FOR BONE MARROW CONDITIONING TREATMENT

Telix Pharmaceuticals Limited | March 29, 2022

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Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Orphan Drug Designation for TLX66 for conditioning treatment prior to hematopoietic stem cell transplant. The granting of an ODD for TLX66 qualifies Telix for various drug development incentives, which may include FDA administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs. Bone marrow co...

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Business Insights

AMPLICORE, INC. ANNOUNCES US FDA CLEARANCE OF FIRST INVESTIGATIONAL NEW DRUG APPLICATION (IND) AND ADDITION OF EXPERIENCED FINANCIAL LEADER TO BOARD

Amplicore, Inc. | July 15, 2022

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Amplicore Inc., a Mason, OH-based, early-stage biopharmaceutical company specializing in the development of minimally invasive therapeutic solutions for musculoskeletal disorders, today announced that the Food and Drug Administration has cleared their first application for AM3101, a novel treatment to promote healing of acute meniscal tears. The move enables the initiation of a Department of Defense-sponsored phase 1/2b clinical study in concert with the University of Cincinnati. ...

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OPTUM DRIVES UNITEDHEALTH’S BETTER-THAN-EXPECTED EARNINGS

MedCity News - | January 16, 2020

news image

In a year when healthcare costs continued to increase, UnitedHealth Group reported better-than-expected results at the end of 2019. The company reported earnings of $19.68 billion in 2019, up 13 percent year-over-year. UnitedHealth saw improving margins in most of its business segments, with its Optum segment reporting double-digit growth across the board. The company also managed to grow its already large presence in the Medicare Advantage market, despite several new competitors. Overall, Unite...

Read More

Pharmacy Market

SUNOVION AND OTSUKA INITIATE PHASE 3 CLINICAL DEVELOPMENT OF NON-RACEMIC AMISULPRIDE FOR THE TREATMENT OF PEOPLE WITH BIPOLAR DEPRESSION

Sunovion Pharmaceuticals Inc. | February 10, 2022

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Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Development And Commercialization, Inc. announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride is being jointly developed and commercialized as part of a collaboration between Sunovion, its parent company Sumitomo Dainippon Pharma and Otsuka P...

Read More
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Business Insights

TELIX GRANTED FDA ORPHAN DRUG DESIGNATION FOR BONE MARROW CONDITIONING TREATMENT

Telix Pharmaceuticals Limited | March 29, 2022

Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Orphan Drug Designation for TLX66 for conditioning treatment prior to hematopoietic stem cell transplant. The granting of an ODD for TLX66 qualifies Telix for various drug development incentives, which may include FDA administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs. Bone marrow co...

Read More
news image

Business Insights

AMPLICORE, INC. ANNOUNCES US FDA CLEARANCE OF FIRST INVESTIGATIONAL NEW DRUG APPLICATION (IND) AND ADDITION OF EXPERIENCED FINANCIAL LEADER TO BOARD

Amplicore, Inc. | July 15, 2022

Amplicore Inc., a Mason, OH-based, early-stage biopharmaceutical company specializing in the development of minimally invasive therapeutic solutions for musculoskeletal disorders, today announced that the Food and Drug Administration has cleared their first application for AM3101, a novel treatment to promote healing of acute meniscal tears. The move enables the initiation of a Department of Defense-sponsored phase 1/2b clinical study in concert with the University of Cincinnati. ...

Read More
news image

OPTUM DRIVES UNITEDHEALTH’S BETTER-THAN-EXPECTED EARNINGS

MedCity News - | January 16, 2020

In a year when healthcare costs continued to increase, UnitedHealth Group reported better-than-expected results at the end of 2019. The company reported earnings of $19.68 billion in 2019, up 13 percent year-over-year. UnitedHealth saw improving margins in most of its business segments, with its Optum segment reporting double-digit growth across the board. The company also managed to grow its already large presence in the Medicare Advantage market, despite several new competitors. Overall, Unite...

Read More
news image

Pharmacy Market

SUNOVION AND OTSUKA INITIATE PHASE 3 CLINICAL DEVELOPMENT OF NON-RACEMIC AMISULPRIDE FOR THE TREATMENT OF PEOPLE WITH BIPOLAR DEPRESSION

Sunovion Pharmaceuticals Inc. | February 10, 2022

Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Development And Commercialization, Inc. announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride is being jointly developed and commercialized as part of a collaboration between Sunovion, its parent company Sumitomo Dainippon Pharma and Otsuka P...

Read More

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C-Suite On Deck

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Feature market insights and perspectives from top C-Level executives, elite technology influencers and thought leaders from your company here. This signature initiative has garnered immense support...

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