Global News | Astellas

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Jan 4, 2023

Astellas Confirms Unfavorable Federal Circuit Decision in LEXISCAN^® 0.4 mg/mL U.S. Patent Trial

TOKYO, January 4, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) confirmed the Court of Appeals for the Federal Circuit (CAFC) affirmed the earlier decision by the U.S. District Court for the District of Delaware that all asserted...

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Dec 22, 2022

Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging

TOKYO and Osaka, December 22, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, “Astellas”), Eisai Co., Ltd. (TSE: 4523, CEO: Haruo Naito, “Eisai”), Daiichi Sankyo Company, Limited (TSE: 4568, President : Sunao Manabe, "Daiichi Sankyo") and Takeda...

Read more about Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging
Dec 20, 2022

Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

– This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting –

TOKYO, BOTHELL, Wash. and RAHWAY, N.J. – December 20, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”), Seagen Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...

Read more about Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
Dec 16, 2022

Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers

Astellas’ GLOW trial, the second Phase 3 trial in CLDN18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric and GEJ cancers, meets primary endpoint for progression-free survival (PFS) and key secondary endpoint for overall survival (OS)

TOKYO, December 16, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 GLOW clinical trial evaluating the efficacy and safety of zolbetuximab in...

Read more about Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Nov 29, 2022

Notice of Issuance of Unsecured Corporate Bonds

TOKYO, November 29, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today successfully priced its inaugural offering of dual-tranche JPY unsecured...

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Nov 17, 2022

Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers

Astellas’ SPOTLIGHT trial meets primary endpoint of progression-free survival (PFS) Full data to be presented at future scientific congress

TOKYO, November 17, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in...

Read more about Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Oct 24, 2022

Astellas and Taysha Gene Therapies Announce Strategic Investment to Support Development of Taysha’s AAV-based Gene Therapy Programs

- Taysha Gene Therapies is an emerging leader in the development of AAV gene therapies; new collaboration aimed at enhancing development of two of Taysha’s novel product candidates for rare monogenic central nervous system diseases with serious unmet medical needs -

TOKYO and DALLAS, TEXAS, October 24, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Taysha Gene Therapies, Inc. (NASDAQ: TSHA, CEO: RA Session II, “Taysha”) today announced a strategic investment to support...

Read more about Astellas and Taysha Gene Therapies Announce Strategic Investment to Support Development of Taysha’s AAV-based Gene Therapy Programs
Oct 12, 2022

Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting

SKYLIGHT 4™ study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily

TOKYO, October 12, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present 52-week results from the Phase 3 SKYLIGHT 4™ clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral...

Read more about Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting
Oct 4, 2022

Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative Medicine Programs Using Direct Reprogramming

TOKYO and Hennigsdorf, Germany, October 4, 2022 - Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pantherna Therapeutics GmbH (CEO:Klaus Giese, Ph.D., “Pantherna”) today announced that the companies...

Read more about Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative Medicine Programs Using Direct Reprogramming
Sep 30, 2022

European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Fezolinetant

If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause

TOKYO, September 30, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the European Medicines Agency (EMA) has accepted for regulatory review the company’s marketing authorization application...

Read more about European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Fezolinetant

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