Astellas Pharma

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Astellas is Awarded Grant from the U.S. National Institutes of Health (NIH) to Fund Early Clinical Studies of ASP8062

Lead Product(s): ASP8062

Therapeutic Area: Psychiatry/Psychology Product Name: ASP8062

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: National Institutes of Health

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Funding July 22, 2020

Details:

This NIH grant will help fund Astellas's two phase 1 clinical studies to evaluate the safety and efficacy of ASP8062, an oral small molecule GABAB receptor Positive Allosteric Modulator (PAM), as an add-on maintenance therapy for Opioid Use Disorder (OUD).

Astellas Pharma

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Gilteritinib Becomes First NICE-Approved Oral Therapy for Relapsed or Refractory Acute Myeloid Leukaemia

Lead Product(s): Gilteritinib

Therapeutic Area: Oncology Product Name: Xospata

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 16, 2020

Details:

With the submission of supplementary clinical data showing that gilteritinib demonstrated superior overall survival benefit compared to chemotherapy, increasing median OS from 5.6 months to 9.3 months.

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Roxadustat Reports Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Patients with CDK

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 08, 2020

Details:

The data showed non-inferiority of roxadustat to darbepoetin alfa in the correction of hemoglobin levels during the first 24 weeks of treatment, meeting the study's primary endpoint.

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XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis

Lead Product(s): Enzalutamide

Therapeutic Area: Oncology 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 May 29, 2020

Details:

With this approval, XTANDI is now indicated for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.

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Pfizer Together with Partner Astellas, Reports Final Prosper Results Show Xtandi Extends Overall Survival In Men With Non-Metastatic Castrat...

Lead Product(s): Enzalutamide,Androgen deprivation therapy

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Recipient: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 29, 2020

Details:

Phase 3 PROSPER trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) vs placebo plus ADT in men with non-metastatic castration-resistant prostate cancer, revealed that XTANDI plus ADT reduced the risk of death by 27% compared to placebo plus ADT.

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FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients

Lead Product(s): Solifenacin Succinate

Therapeutic Area: Urology 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 May 27, 2020

Details:

VESIcare LS is an oral suspension dosage form that was specifically developed to facilitate dosing and administration in the pediatric population.

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European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 20, 2020

Details:

The MAA is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.

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Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China

Lead Product(s): Gilteritinib

Therapeutic Area: Oncology 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 10, 2020

Details:

New drug application for XOSPATA, for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation, has been accepted by the NMPA for regulatory review in China.

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XTANDI Improves Overall Survival in Phase III PROSPER Trial

Lead Product(s): Enzalutamide,Androgen deprivation therapy

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 11, 2020

Details:

The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT.

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Amgen Astellas Biopharma To Become A Wholly Owned Amgen Affiliate On April 1, 2020 The New Company Name Will Be Amgen K.K. The Headquarters ...

Lead Product(s): Evolocumab

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Amgen Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition January 23, 2020

Details:

Under the acquisition, Amgen Astellas BioPharma will change its name to Amgen K.K., and simultaneously relocate its Headquarters to Tokyo Midtown.

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Astellas Pharma

Astellas is Awarded Grant from the U.S. National Institutes of Health (NIH) to Fund Early Clinical Studies of ASP8062

Astellas Pharma

Gilteritinib Becomes First NICE-Approved Oral Therapy for Relapsed or Refractory Acute Myeloid Leukaemia

Astellas Pharma

Roxadustat Reports Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Patients with CDK

Astellas Pharma

XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis

Astellas Pharma

Pfizer Together with Partner Astellas, Reports Final Prosper Results Show Xtandi Extends Overall Survival In Men With Non-Metastatic Castrat...

Astellas Pharma

FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients

Astellas Pharma

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat

Astellas Pharma

Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China

Astellas Pharma

XTANDI Improves Overall Survival in Phase III PROSPER Trial

Astellas Pharma

Amgen Astellas Biopharma To Become A Wholly Owned Amgen Affiliate On April 1, 2020 The New Company Name Will Be Amgen K.K. The Headquarters ...