FDA Panel Recommends Approval of Astellas’ CRESEMBA for Treatment of Invasive Aspergillosis and MucormycosisJanuary 22, 2015 3:45 pm | News | Comments
The FDA Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral broad-spectrum CRESEMBA for the treatment of invasive aspergillosis, and 8 to 2 with one abstention to recommend approval for the treatment of invasive mucormycosis.
Astellas Pharma and Medivation announced today that the FDA approved a new indication for the...
Astellas has appointed Moyra Knight as the head of corporate and employee communications in the...
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.
The U.S. Justice Department announced Wednesday that Astellas will pay $7.3 million to resolve allegations involving the marketing of the drug Mycamine.
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.
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 TivozanibFebruary 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.
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 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 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 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.
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...
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.
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 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 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.
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, 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 InhibitorsMarch 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 CarcinomaNovember 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 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 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.
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.
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.
NEW YORK (AP) — Shares of Dendreon Corp. sank Wednesday after a Jefferies & Co. analyst said the company's prostate cancer therapy Provenge will be eclipsed by two newer competitors.
Medivation, Inc. and Astellas Pharma Inc. announced that Medivation has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for enzalutamide (formerly MDV3100). The compound has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.
Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced today that the Reproductive Health Drugs Advisory Committee of the FDA voted that the overall risk/benefit assessment supports approval of mirabegron (YM178) for the treatment of overactive bladder.
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