Search Results for “Astellas” – Page 3 – media

Astellas Submits New Drug Application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, June 9, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients. “Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer,” said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-Oncology Development, Astellas. “Astellas’ submission ...
- Source: drugdu
- 123
- June 12, 2023
After costly setback, Astellas’ menopause drug crosses FDA finish line

After Astellas’ shot at a speedy FDA approval for its menopause drug was derailed in February, the therapy has finally crossed the FDA finish line. The drug, branded as Veozah, won FDA approval to treat moderate to severe menopause-related vasomotor symptoms. It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat the condition. It’s been a bit of a bumpy road to the green light. After shelling out 13.1 billion Japanese yen ($97 million) to secure a priority review voucher and speed up the regulatory timeline, the FDA extended its review just days before the drug’s prior regulatory decision date. Vasomotor symptoms, or hot flashes and night sweats, are the hallmark of menopause. Some 60% to 80% of women experience the symptoms during or after menopausal transition, Astellas said in its release. The drug’s nonhormonal aspect is key because some people with menopause can’t take hormone therapies, the ...
- Source: drugdu
- 110
- May 16, 2023
Pfizer and Astellas’ Xtandi shows promise in phase 3 prostate cancer study

Pfizer and Astellas have reported positive top line results from a phase 3 trial of their androgen receptor signalling inhibitor, Xtandi (enzalutamide), in non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). The medicine is already a standard of care in the US for metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC), and for one or more of these indications in more than 100 countries. Compared with those indications, nmHSPC represents an earlier stage of disease, in which there is no detectable evidence of the cancer spreading to distant parts of the body, and it still responds to testosterone-lowering treatments. However, some patients remain at a higher risk for BCR following primary treatment, which may result in metastases. The EMBARK trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated daily ...
- Source: drugdu
- 150
- March 21, 2023
Astellas and Seattle Genetics Announce Updated Enfortumab Vedotin Phase 1 Data in Metastatic Urothelial Cancer at 2017 ASCO Annual Meeting -Pivotal Monotherapy Phase 2 Trial Initiation Planned for 2017-

Astellas and Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) 52nd Annual Meeting in Chicago. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.
- Source: newsroom.astellas.us
- 546
- March 28, 2018
Astellas monotherapy mUC Seattle Genetics
Astellas Takes Out Massachusetts’ Biotech Mitobridge in $390M Deal

Tokyo-based Astellas Pharma is buying Cambridge, Mass.-based Mitobridge for a total of $390 million. Astellas is pulling the trigger on an acquisition option from a partnership deal the two companies formed in 2013. Under that deal, the two companies collaborated on discovering and developing drugs that target mitochondrial function. The most advanced program from the collaboration is MA-0211, which is presently in Phase I clinical trials for Duchenne muscular dystrophy (DMD). Astellas is an equity investor in Mitobridge already, and is paying $165.5 million in cash in addition to the $60 million in equity it already owns. There is also an additional $225 million in potential milestone payments. John Carroll, with Endpoints News, writes, “For years now, Salk’s Ron Evans—a celebrated serial entrepreneur in scientific circles—has been concentrating on the potential of a new pathway for turning your average couch potato rodent into Mighty Mouse—without exercise…. A couple of ...
- Source: biospace
- 703
- December 5, 2017
acquisition Astellas Clinical Trials Duchenne muscular dystrophy Market Views Series
Over 5.7 billion! China’s dual antibody ADC goes global+1

On November 18th, VelaVigo Cayman Limited announced a global strategic partnership agreement with Avenzo Therapeutics, Inc. (Avenzo). According to the agreement, Orange Sail Pharmaceuticals will grant Avenzo the development, production, and commercialization of Nectin4/TROP2 bispecific antibody conjugates worldwide (excluding Greater China), while retaining relevant rights in Greater China. Both parties will jointly promote the development and clinical application of the project on a global scale. The project plans to submit an IND to the US Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) of China by 2025. According to the terms of the agreement, Orange Sail Pharmaceuticals will receive a down payment of up to $50 million and recent milestone payments. After achieving key milestones in development, regulatory approval, and sales, the company is expected to receive up to $750 million in follow-up milestone payments and tiered royalty payments based on sales in the Avenzo region. ...
- Source: drugdu
- 43
- November 21, 2024
AI+Gene Therapy | Dyno partners with Roche, with a prepayment of $50 million and a total value exceeding $1 billion

On October 24, 2024, Dyno Therapeutics, a gene technology company that utilizes artificial intelligence for in vivo gene delivery, announced its second research collaboration with Roche to jointly develop the next generation of adeno-associated virus (AAV) vectors for gene therapy targeting neurological diseases.Dyno and Roche previously announced a research collaboration and licensing agreement in October 2020 for neurological disorders and liver targeted therapies. According to this new collaboration agreement, Dyno Therapeutics will provide Roche with more opportunities to utilize the company’s leading platform and sequence design technology in the field to achieve in vivo gene delivery. The existing gene therapies mainly use a small amount of naturally occurring AAV vectors, which have problems such as low delivery efficiency, pre-existing immunity, and manufacturability. To overcome these challenges, Dyno took the lead in applying artificial intelligence and high-throughput in vivo data acquisition technology to engineer the AAV virus capsid, in order to ...
- Source: drugdu
- 54
- November 1, 2024
When Hengrui Medicine “gave up” going overseas independently

Going overseas is not only a dream, but also a big adventure that Hengrui Medicine has to take. Even under the new measurement standards, there is such a voice that the success of going overseas will be the key to determining whether Hengrui Medicine can maintain its “number one” status. Indeed, Hengrui Medicine, which has accelerated its innovation transformation, has come to a crossroads. First, relying on the domestic market in the past, Hengrui Medicine may not be in a hurry to layout overseas markets. However, with the involution of domestic innovative drugs and pharmaceutical companies going overseas to find incremental growth, internationalization has also been raised to a more important level. Although Hengrui Medicine proposed the direction of “internationalization” as early as in its 2020 annual report, its internationalization has not been smooth in the past few years. Secondly, carrelizumab has already fallen behind, and the internationalization of PD-1 ...
- Source: drugdu
- 66
- October 24, 2024
The second half of the battle to defend the Medicine King

Recently, Astellas announced that Japan’s MHLW has approved its ADC drug ennozumab PADCEV and Merck’s K drug as a first-line combination therapy for adult patients with fundamentally unresectable urothelial cancer. With excellent data, this combination treatment regimen was approved by the Japanese MHLW in such a short time after Merck announced on September 4 that it had been approved by the European Commission (EC) as a first-line therapy. However, sporadic victories cannot conceal the plight of K-drugs. For the pharmaceutical industry, the biggest hot spot in the past two weeks is definitely the announcement by Kangfang Biologics on September 8 that ivocilimab has become the world’s first and only single-drug head-to-head phase III clinical study to prove that its efficacy is significantly better than that of pabrolib. The drug Zizumab. On the day the results were announced, Merck’s stock price fell in response, and the dilemma was obvious. Under the ...
- Source: drugdu
- 85
- September 30, 2024
Merck Sees Pipeline Diversification Opportunity in $1.3B EyeBio Acquisition

Merck’s EyeBio acquisition brings a lead program ready for pivotal testing in diabetic macular edema. The therapy could pose competition to Eylea, the blockbuster Regeneron Pharmaceuticals eye drug. By Frank VinluanMerck is on the hunt for drugs with blockbuster potential to make up for declining revenue when its top product, the cancer immunotherapy Keytruda, loses patent protection in the next few years. The pharmaceutical giant is getting a contender through the acquisition of a clinical-stage startup whose lead program is on track to begin pivotal testing in diabetic macular edema. According to deal terms announced Wednesday, Merck is acquiring Eyebiotech Limited, or EyeBio, for $1.3 billion in cash up front. Shareholders of the New York-based company could receive up to $1.7 billion more in milestone payments. EyeBio develops drug for retinal conditions in which inflammation leads to the breakdown of the inner blood-retinal barrier. This breakdown leads to vascular leakage, ...
- Source: drugdu
- 99
- June 1, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.