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FDA grants Breakthrough Therapy designation for lecanemab in Alzheimer's disease

Retrieved on:

Thursday, June 24, 2021

Life sciences, Health sciences, Health care, Breakthrough therapy, Pharmacy, Priority review, Alzheimer's disease, Eisai

STOCKHOLM, June 23, 2021 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A) protofibril antibody for the treatment of Alzheimer's disease.

Key Points:

STOCKHOLM, June 23, 2021 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A) protofibril antibody for the treatment of Alzheimer's disease.
Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions.
The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.
In March 2021, the enrollment of 1,795 patients with early Alzheimer's disease in the Phase 3 study of lecanemab, Clarity AD, was completed.

Eisai and Bristol Myers Squibb Enter Into Global Strategic Collaboration for Eisai’s MORAb-202 Antibody Drug Conjugate

Retrieved on:

Thursday, June 17, 2021

Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC).

Key Points:

Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC).
MORAb-202 is Eisais first ADC and combines Eisais in house developed anti-folate receptor alpha (FR) antibody, and Eisais anticancer agent eribulin, using an enzyme cleavable linker.
Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories.
The parties will share profits, research and development and commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories.

Eisai to Divest Rights for Zonegran in Europe and Other Regions to Advanz Pharma

Retrieved on:

Tuesday, June 15, 2021

Eisai, Anticonvulsants, Sodium channel blockers, Zonisamide, Advanz Pharma, Life sciences, Industry economics), Drugs

Under this agreement, Eisai will divest its rights associated with Zonegran in such European countries, the Middle East, Russia, and Australia to Advanz Pharma.

Key Points:

Under this agreement, Eisai will divest its rights associated with Zonegran in such European countries, the Middle East, Russia, and Australia to Advanz Pharma.
Eisai will continue to act as the distributor in Russia, through its local affiliate Limited Liability Company Eisai, and Australia through its local affiliate Eisai Australia Pty.
Eisai will retain its rights to Zonegran in Canada, Mexico and Asian countries and continue to distribute the product in certain licensed Asian countries.
Eisai believes that this divestiture agreement with Advanz Pharma will lead to maximization of the antiepileptic agent's product value.

Eisai Receives Special Prize at Platinum Career Award 2021

Retrieved on:

Wednesday, June 9, 2021

Eisai, Industry economics), Japanese culture

TOKYO, June 9, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received a special prize at the Platinum Career Award 2021.

Key Points:

TOKYO, June 9, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received a special prize at the Platinum Career Award 2021.
The awards ceremony was held via online at the symposium on June 8, 2021.
The Platinum Career Award was established in 2019 with the aim of commending companies that aspire to provide opportunities for employees to develop their career and play an active role, in order to realize career paths that Japanese employees are aiming for in the era of the 100 years' life.
Eisai received a special prize dedicated to companies that are implementing "new working styles initiated to adjust with the era of Corona (COVID-19 Pandemic)".

Biogen and Eisai launch initiatives to help patients with Alzheimer's disease access ADUHELM

Retrieved on:

Tuesday, June 8, 2021

Life sciences, Industry economics), Biotechnology, Biogen, Spinal muscular atrophy, Eisai, LabCorp, Alzheimer's disease

These initiatives aim to help patients and their families understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment.

Key Points:

These initiatives aim to help patients and their families understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment.
Biogen and Eisai have also established a program with Labcorp and Mayo Clinic Laboratories to help physicians and patients access cerebrospinal fluid (CSF) diagnostic laboratory testing to aid in the diagnosis of Alzheimer's disease.
Biogen and Eisai are committed to addressing health equity for underserved and underrepresented populations that are at higher risk for Alzheimer's disease.
Biogen and Eisai are committed to providing access to ADUHELM for patients across a spectrum of financial situations.

Alzheimer's Association Statement: Alzheimer's Association Welcomes FDA Approval of Aducanumab

Retrieved on:

Monday, June 7, 2021

Life sciences, Monoclonal antibodies, Health sciences, Drugs, Aducanumab, Alzheimer's Association, Biogen, Alzheimer's disease, Eisai

CHICAGO, June 7, 2021 /PRNewswire/ --On behalf of those impacted by Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes today's historic FDA approval of aducanumab (Biogen/Eisai) for treatment of Alzheimer's disease.

Key Points:

CHICAGO, June 7, 2021 /PRNewswire/ --On behalf of those impacted by Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes today's historic FDA approval of aducanumab (Biogen/Eisai) for treatment of Alzheimer's disease.
"This approval is a victory for people living with Alzheimer's and their families," said Harry Johns , Alzheimer's Association president and chief executive officer.
"This FDA drug approval ushers in a new era in Alzheimer's treatment and research," said Maria C. Carrillo , Ph.D., Alzheimer's Association chief science officer.
"The Alzheimer's Association will do everything in its power to ensure access to the drug for all who will benefit.

Biogen and Eisai launch multiple initiatives to help patients with Alzheimer’s disease access ADUHELM™

Retrieved on:

Monday, June 7, 2021

Life sciences, Spinal muscular atrophy, Industry economics), Biogen, Biotechnology, Eisai

These initiatives aim to help patients and their families understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment.

Key Points:

These initiatives aim to help patients and their families understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment.
Biogen and Eisai have also established a program with Labcorpand Mayo Clinic Laboratoriesto help physicians and patients access cerebrospinal fluid (CSF) diagnostic laboratory testing to aid in the diagnosis of Alzheimers disease.
Biogen and Eisai are committed to addressing health equity for underserved and underrepresented populations that are at higher risk for Alzheimers disease.
Biogen and Eisai are committed to providing access to ADUHELM for patients across a spectrum of financial situations.

New Data on KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Versus Sunitinib in First-Line Treatment for Patients With Advanced Renal Cell Carcinoma From Pivotal Phase 3 CLEAR/KEYNOTE-581 Trial Presented at 2021 ASCO Annual Meeting

Retrieved on:

Monday, June 7, 2021

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points:

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Eisai and ITO EN Enter Into Business Alliance Aiming to Support People Living with Dementia and to Prevent Dementia

Retrieved on:

Monday, May 31, 2021

Articles, Cognitive disorders, Learning disabilities, Psychiatric diagnosis, Dementia, Ito En, Eisai, Health

TOKYO, May 31, 2021 - (JCN Newswire) - Eisai Co., Ltd. and ITO EN, LTD. announced today that both parties have entered into a business alliance agreement concerning the initiatives for supporting people living with and preventing dementia with the aim of realizing a healthy and long-lived society.

Key Points:

TOKYO, May 31, 2021 - (JCN Newswire) - Eisai Co., Ltd. and ITO EN, LTD. announced today that both parties have entered into a business alliance agreement concerning the initiatives for supporting people living with and preventing dementia with the aim of realizing a healthy and long-lived society.
The specific initiatives planned are as follows.
As support for holding seminars on exercise and food related to dementia disease awareness and brain health by local governments for residents, the packaged solution plans to be provided through ITO EN's 186 business offices nationwide.
At the events and campaigns hosted by ITO EN, participants will be provided with the information on brain health and the opportunity to check brain performance using "NouKNOW".

Eisai to Present Data on Oncology Pipeline and Products at ASCO Annual Meeting

Retrieved on:

Thursday, May 20, 2021

Chemical compounds, Cancer treatments, Drugs, Orphan drugs, Antineoplastic drugs, Eisai, Lenvatinib, Eribulin, Halichondrin B, Pembrolizumab, Merck & Co., Protein kinase inhibitor

b'TOKYO, May 20, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that the latest data regarding its oncology pipeline and products including in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: LENVIMA, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: HALAVEN, "eribulin") will be presented at the American Society of Clinical Oncology (2021 ASCO Annual Meeting*), to be held virtually from June 4 to 8, 2021.\nAt this meeting, there will be an oral presentation on the analysis of health-related quality-of-life (HRQoL) (Abstract No: 4502) of the pivotal Phase 3 CLEAR Study (Study 307/KEYNOTE-581) evaluating lenvatinib in combination with pembrolizumab (product name: KEYTRUDA, "pembrolizumab"), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma.

Key Points:

b'TOKYO, May 20, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that the latest data regarding its oncology pipeline and products including in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: LENVIMA, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: HALAVEN, "eribulin") will be presented at the American Society of Clinical Oncology (2021 ASCO Annual Meeting*), to be held virtually from June 4 to 8, 2021.\nAt this meeting, there will be an oral presentation on the analysis of health-related quality-of-life (HRQoL) (Abstract No: 4502) of the pivotal Phase 3 CLEAR Study (Study 307/KEYNOTE-581) evaluating lenvatinib in combination with pembrolizumab (product name: KEYTRUDA, "pembrolizumab"), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma.
Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.\nThis release discusses investigational compounds and investigational uses for FDA-approved products.
It is not intended to convey conclusions about efficacy and safety.
There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.\n'