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The Lead

Ventana and Astellas Work on Targeted Cancer Treatments

April 14, 2015 11:09 am | by Ventana Medical Systems, Inc. | News | Comments

Ventana, a member of the Roche Group, announced it has entered into a master collaboration agreement with Astellas Pharma Inc.

Astellas Creates New Corporate Affairs and Corporate Development Functions

February 20, 2015 8:20 am | News | Comments

Astellas has announced organizational and personnel changes in the Americas, highlighting the...

Astellas Broadens Commitment to Clinical Trial Data Transparency

February 2, 2015 10:49 am | News | Comments

Astellas Pharma will now make trial data available through www.clinicalstudydatarequest.com, an...

FDA Panel Recommends Approval of Astellas’ CRESEMBA for Treatment of Invasive Aspergillosis and Mucormycosis

January 22, 2015 3:45 pm | News | Comments

The FDA Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of the...

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FDA Approves New Indication for the Use of XTANDI Capsules

September 11, 2014 8:29 am | News | Comments

Astellas Pharma and Medivation announced today that the FDA approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC).          

Astellas Hires Industry Veteran to Head of Corporate and Employee Communications

July 31, 2014 10:01 am | News | Comments

Astellas has appointed Moyra Knight as the head of corporate and employee communications in the Americas region. Knight will report directly to Jeff Winton, senior vice president, chief communications officer.       

Astellas Details Pipeline Progress at R&D Meeting

July 11, 2014 8:37 am | News | Comments

Astellas announced progress on the company's efforts to reshape its research framework at its R&D meeting held in Tokyo on July 10. The meeting provided an opportunity for Astellas to present a comprehensive overview of its late-stage clinical programs and corporate strategy.

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Astellas and Medivation Receive Priority Review from FDA for XTANDI

May 6, 2014 8:09 am | News | Comments

Astellas Pharma and Medivation today announced that FDA has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for XTANDI (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.

Astellas to Pay $7.3M Settlement

April 17, 2014 8:16 am | News | Comments

The U.S. Justice Department announced Wednesday that Astellas will pay $7.3 million to resolve allegations involving the marketing of the drug Mycamine.                  

XTANDI Capsules Approved in Japan for Prostate Cancer

March 25, 2014 7:20 am | News | Comments

Astellas Pharma Inc. has obtained marketing approval of their oral androgen receptor signaling inhibitor, XTANDI capsules 40mg  for the treatment of patients with castration-resistant prostate cancer in Japan.      

Cumberland Pharmaceuticals Acquires Vaprisol from Astellas Pharma US

March 3, 2014 8:20 am | News | Comments

Vaprisol is a patented, prescription brand indicated to raise serum sodium levels in hospitalized patients with hyponatremia. The product was developed and registered by Astellas and was commercially launched in 2006. It is one of two branded prescription products indicated for the treatment of hyponatremia.

AVEO and Astellas to End Collaboration & License Agreement for Development and Commercialization of Tivozanib

February 14, 2014 8:04 am | News | Comments

AVEO Oncology and Astellas Pharma Inc. today announced the companies will end their worldwide collaboration and license agreement for the development and commercialization of investigational agent tivozanib.       

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AVEO and Astellas Discontinue Phase 2 Trial of Tivozanib in Breast Cancer

January 30, 2014 8:21 am | News | Comments

AVEO Oncology today announced that AVEO and Astellas Pharma have jointly decided to discontinue the BATON ( B iomarker  A ssessment of  T ivozanib in  ON cology) breast cancer clinical trial, a Phase 2 study in patients with locally recurrent or metastatic triple negative breast cancer (TNBC), due to insufficient enrollment.

Medivation Rises on Xtandi Data

January 29, 2014 10:47 am | News | Comments

Medivation and its partner Astellas Pharma said Tuesday that men who took the drug Xtandi had larger declines in PSA levels, a protein produced by the prostate, than patients who took a placebo. The higher the PSA level, the greater the chance of prostate cancer in many cases.

Astellas to Form Strategic Partnership With ClearPath To Build Vaccine Portfolio

January 6, 2014 8:17 am | News | Comments

Astellas Pharma Inc. and ClearPath Development Company have announced a strategic partnership to form a portfolio of development companies focused on vaccines targeting infectious diseases. The partnership was established to support Astellas' goal of building a global vaccine franchise and launched its first company, RSV Corporation (RSVC), in December 2013.

Astellas Announces Growth of Global Development Team

October 22, 2013 8:17 am | News | Comments

Astellas Pharma Global Development, Inc., a subsidiary of Astellas Pharma Inc. based in Tokyo, Japan, announces today the promotion of Mark Weinberg, M.D., MBA to Vice President of Global Clinical Science and the appointment of Robin J. McGarry, M.D. to the position of Vice President,  Global Medical Safety Head.

Cytokinetics, Astellas Pharma to Collaborate

June 25, 2013 1:29 pm | by The Associated Press | News | Comments

Drug developer Cytokinetics and Astellas Pharma Inc. are teaming up on the research, development and commercialization of skeletal muscle activators. The companies said Tuesday that the main goal is to advance some therapies for diseases and medical conditions related to muscle weakness. Japan's...

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Astellas Introduces Option for Men with Advanced Prostate Cancer

June 13, 2013 9:39 am | News | Comments

On May 30, 2013, Health Canada approved Xtandi for the treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC, who have received prior docetaxel therapy (chemotherapy medication). The announcement was made today by Astellas Pharma Canada, Inc., the Canadian subsidiary of Tokyo-based Astellas Pharma, Inc.

Astellas, Amgen to Form Joint Venture in Japan

May 29, 2013 7:56 am | News | Comments

Tokyo-based Astellas Pharma Inc. said today it will form a joint venture with major U.S. biotechnology company Amgen Inc. to develop and market drugs in Japan. The new company will start business operations in October to develop five drugs, including for gastric cancer and osteoporosis, under a plan to launch drug sales in 2016.

Astellas to Close Some US Units

May 14, 2013 9:24 am | by Matthew Dennis | News | Comments

Astellas announced Tuesday a restructuring of its R&D operations including the closure of its OSI Pharmaceuticals and Perseid Therapeutics units in the US. The company, which said the move is designed to "further enhance the ability to generate innovative drugs," also noted that activities at its Astellas Research Institute of America will be scaled back to focus on CNS therapies.

Astellas and Drais Partner to Develop Third Astellas Compound Through Tacurion

May 7, 2013 8:04 am | News | Comments

Astellas Pharma and Drais Pharmaceuticals today announced that they have entered into a third partnership in the past year to develop and commercialize an Astellas compound. Astellas will license ASP7035, of which a phase I study has been completed and is a phase IIa-ready, vasopressin V2 receptor selective agonist for the treatment of nocturia, to Tacurion Pharma, Inc., a virtual company that will be operated by the Drais executive team.

Aveo Plunges as FDA Recommends Against Cancer Drug

May 3, 2013 8:12 am | News | Comments

Shares of Aveo Pharmaceuticals plunged almost 50 percent Thursday after the company said a Food and Drug Administration panel recommended its drug Tivopath not be approved as a treatment for advanced kidney cancer. Aveo Oncology and its partner Astellas Pharma of Japan said the panel voted 13-to-1 that the benefits of the once-per-day pill did not justify the risks it poses to patients.

Medivation and Astellas Provide Update on PREVAIL

April 1, 2013 8:00 am | News | Comments

Medivation, Inc. and Astellas Pharma Inc. today announced that the companies have established an updated interim analysis plan for the PREVAIL trial, a global Phase 3 clinical trial evaluating XTANDI® (enzalutamide) capsules in men with metastatic castration-resistant prostate cancer (mCRPC) who have not yet received chemotherapy.

Astellas and Ambit to End Collaboration for Joint Development and Commercialization of FLT3 Kinase Inhibitors

March 12, 2013 8:03 am | News | Comments

Astellas Pharma Inc. and Ambit Biosciences Corporation today announced the companies will end their collaboration for the joint development and commercialization of FMS-like tyrosine kinase-3 (FLT3) inhibitors, including quizartinib, effective September 3, 2013.

AVEO and Astellas Announce FDA Acceptance of NDA Filing for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma

November 28, 2012 2:54 am | News | Comments

AVEO Oncology and Astellas Pharma Inc. today announced that the FDA has accepted for filing the New Drug Application (NDA) for tivozanib with the proposed indication for the treatment of patients with advanced renal cell carcinoma (RCC).

Astellas Pharma Europe Appoints New Senior Director, Market Access

August 15, 2012 4:38 am | News | Comments

Astellas Pharma Europe Ltd., the European subsidiary of Tokyo-based Astellas Pharma Inc. has appointed Dr Susan Wood as Senior Director, Market Access for Astellas Pharma Europe Ltd (APEL).

Astellas to Close Urogenix, North Carolina-based Urology Research Facility

August 6, 2012 4:50 am | News | Comments

Astellas Pharma Inc. has announced that it decided to close Urogenix, Inc., an Astellas subsidiary, which is a research facility focusing on drug discovery in the field of urology.

FDA Approves Overactive Bladder Treatment

June 29, 2012 4:18 am | News | Comments

Astellas Pharma US, has announced today that the FDA has approved Myrbetriq (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.  

Optimer Gets Milestone Payment from Astellas

June 8, 2012 3:55 am | News | Comments

SAN DIEGO (AP) — Optimer Pharmaceuticals Inc. said Thursday it received a 10 million euro milestone payment from partner Astellas Pharma, which recently began marketing Optimer's Dificlir anti-infection tablets overseas.  

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