Eisai

PharmaShots Weekly Snapshots (September 27 – October 01, 2021)

BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, …

PharmaShots Weekly Snapshots (September 27 – October 01, 2021) Read More »

Eisai Initiates Rolling Submission of BLA to the US FDA for Lecanemab to Treat Alzheimer’s Disease

Shots: The submission is based on clinical, biomarker & safety data of Study 201 POC study evaluates lecanemab (10mg/kg, q2w) in 856 patients with MCI due to AD with confirmed presence of amyloid pathology. The BLA is being submitted under accelerated approval The results showed a reduction in brain amyloid by 0.306 SUVr units @18mos. …

Eisai Initiates Rolling Submission of BLA to the US FDA for Lecanemab to Treat Alzheimer’s Disease Read More »

Biogen, Eisai double down on Alzheimer’s with lecanemab filing

Biogen and Eisai’s first Alzheimer’s disease drug Aduhelm is facing an uphill battle in the US market, but the partners are forging ahead with their second candidate lecanemab, starting a rolling submission to the FDA. Like Aduhelm (aducanumab) lecanemab – also known as BAN2401 – is another amyloid-directed antibody but has a slightly different mechanism, …

Biogen, Eisai double down on Alzheimer’s with lecanemab filing Read More »

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021)

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, …

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Health insurer Excellus will not fund Alzheimer’s drug Aduhelm

Health insurer Excellus BlueCross BlueShield has said it will not cover treatment with Biogen and Eisai’s new Alzheimer’s disease drug Aduhelm because it has not been shown to be medically effective. The company – said to be the largest health insurer in New York – said in a statement that Aduhelm (aducanumab) remains an investigational …

Health insurer Excellus will not fund Alzheimer’s drug Aduhelm Read More »

Biogen and Eisai unveil details for five-year, real-world Aduhelm clinical trial

Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational study, which is one of three post-marketing clinical programs planned to generate more data about the drug

Biogen adds real-world test for Aduhelm to its confirmatory trial

Biogen and partner Eisai have said they will run a large-scale observational study of Alzheimer’s drug Aduhelm in the US to build evidence for the drug’s efficacy following its controversial approval. The ICARE AD-US study will provide information on the long-term effectiveness and safety of Aduhelm (aducanumab) as prescribed in routine clinical practice within the …

Biogen adds real-world test for Aduhelm to its confirmatory trial Read More »

Insights+: The US FDA New Drug Approvals in June 2021

The US FDA has approved 6 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 37 novel products in 2021 Additionally, last year in 2020, the US FDA …

Insights+: The US FDA New Drug Approvals in June 2021 Read More »

FDA staffers defend Aduhelm approval in JAMA editorial

Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that to do otherwise would have left millions of patients in limbo for years. The trio say that the decision to approve Aduhelm (aducanumab) was extremely challenging as “evidence was strongly …

FDA staffers defend Aduhelm approval in JAMA editorial Read More »

US starts review of Aduhelm coverage amid fears of Medicare hit

The US government has started a review of how Biogen and Eisai’s pricey new Alzheimer’s disease therapy Aduhelm will be covered by Medicare, to see if a national strategy needs to be adopted. At the moment, the coverage for $56,000-a-year Aduhelm (aducanumab) is currently determined at the local level by Medicare administrative contractors representing 12 …

US starts review of Aduhelm coverage amid fears of Medicare hit Read More »

Aduhelm approval controversy dials up as FDA seeks probe

In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. The acting FDA commissioner has sent a letter to the Department of Health and Human Services (HHS) inspector general Christi Grimm on Friday, asking for a review of the …

Aduhelm approval controversy dials up as FDA seeks probe Read More »

FDA whittles back Aduhelm approval amid concern over broad label

One of the criticisms levelled at the FDA over its approval of Biogen and Eisai’s Alzheimer’s disease drug Aduhelm was its decision to clear use of the drug in a broader group of patients than was included in clinical trials. Now, it has backtracked on that decision. The updated label for Aduhelm (aducanumab) says it …

FDA whittles back Aduhelm approval amid concern over broad label Read More »

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …

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BMS pays $650m upfront for Eisai’s first ADC candidate for cancer

Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 billion.  BMS is making a hefty $650 million upfront payment to Eisai for global co-development and co-commercialisation rights to MORAb-202, which couples an anti-folate receptor …

BMS pays $650m upfront for Eisai’s first ADC candidate for cancer Read More »

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 …

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Biogen and Eisai’s Aduhelm (aducanumab-avwa) Receive the US FDA’s Accelerated Approval for Alzheimer Disease

Shots: The approval is based on the two P-III clinical trials i.e EMERGE and ENGAGE along with P-Ib PRIME study involves assessing the efficacy of Aduhelm vs PBO in patients with early stages of AD with confirmed presence of amyloid pathology Results: the therapy consistently showed a dose and time-dependent effect on the reduction of …

Biogen and Eisai’s Aduhelm (aducanumab-avwa) Receive the US FDA’s Accelerated Approval for Alzheimer Disease Read More »

PharmaShots Weekly Snapshots (May 03 – 07, 2021)

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: May 7, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV Non-Small Cell Lung Cancer Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + …

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Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma

Shots: The 1st sNDA and sBLA is based on results from the P-III CLEAR Study evaluating Lenvima + Keytruda or in combination with everolimus vs sunitinib in a ratio (1:1:1) in 1,069 patients with advanced RCC, demonstrated improved PFS, OS, and ORR The 2nd application is based on results from the P-III KEYNOTE-775/Study 309 trial …

Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma Read More »

Voluntis Collaborates with Eisai to Develop Digital Therapeutics for Oncology Patients

Shots: Voluntis enters into a license agreement with Eisai to design & develop DTx for patients and healthcare professionals to support cancer treatment, utilizing the Theraxium technology platform The DTx will be designed with the intent to be commercialized in the US, Japan and EU, which will boost Voluntis’ pipeline and global footprint Additionally, the …

Voluntis Collaborates with Eisai to Develop Digital Therapeutics for Oncology Patients Read More »

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease

Shots: The P-IIb POC Study 201 involves assessing lecanemab in patients with early AD Results: @18mos, prespecified analysis showed a consistent reduction of clinical decline across several clinical and biomarker EPs at highest doses and reduction in brain Aβ & clinical decline. The results are published in a peer-reviewed journal In March, the companies have …

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease Read More »

DZNE and Eisai Enter Into Research Collaboration Agreement Aiming for Novel Drug Discovery for Neurodegenerative Disorders

Deutsches Zentrum fur Neurodegenerative Erkrankungen and Eisai Co., Ltd. today announced that both parties have entered into a research collaboration agreement aiming to create potential novel treatments for neurodegenerative disorders including Alzheimer’s disease (AD) which modulate immune competence in neurons and glia cells. DZNE is a world-leading interdisciplinary public research organization constituted with ten research …

DZNE and Eisai Enter Into Research Collaboration Agreement Aiming for Novel Drug Discovery for Neurodegenerative Disorders Read More »

Merck gets a leg-up for Keytruda in first-line kidney cancer

New phase 3 data have shored up the position of Merck & Co’s cancer immunotherapy Keytruda in the increasingly competitive first-line kidney cancer market.  The data from the KEYNOTE-581/CLEAR study reveal that the combination of PD-1 inhibitor Keytruda (pembrolizumab) with Eisai’s targeted tyrosine kinase inhibitor Lenvima (lenvatinib) reduced the risk of disease progression of death …

Merck gets a leg-up for Keytruda in first-line kidney cancer Read More »

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects?

When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results. Some analysts have intimated that given the small size of the study at just over 270 patients, …

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects? Read More »

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …

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Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies

Shots: The companies entered into an exclusive research agreement for the discovery of novel small molecules targeting α-synuclein for the potential treatment of synucleinopathies including PD and dementia with Lewy bodies The collaboration will use Wren’s network kinetics drug discovery platform along with Eisai’s experience in drug discovery for neurodegenerative disorders, to accelerate the development …

Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies Read More »

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Shots: The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were judged to be unsuitable for local treatment Result: The proportion …

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum Read More »

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, …

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PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine BD Acquires the Medical Business Assets of …

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Merck & Co/Eisai eye kidney cancer use for immunotherapy combination

Merck & Co and Eisai are to file results from a phase 3 trial testing a combination of the former’s immunotherapy Keytruda, combined with the latter’s cancer drug Lenvima in untreated patients. Keytruda (pembrolizumab) and Lenvima (lenvatinib) outperformed standard care – Pfizer’s Sutent (sunitinib) – in untreated patients with advanced renal cell carcinoma when measured …

Merck & Co/Eisai eye kidney cancer use for immunotherapy combination Read More »

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Shots: The P-II 218 study involves assessing Lenvima (14mg, qd) + everolimus (5mg, qd) vs Lenvima (18mg, qd) + everolimus (5mg qd) in patients with clear-cell RCC, following treatment with an anti-angiogenic therapy, with prior anti-PD-1/PD-L1 therapy permitted In the primary analysis, @24wks. ORR (32.1% vs 34.8%) i.e. lower dose did not meet the threshold …

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma Read More »

Eisai and Cogstate Expand their Agreement to Develop and Commercialize Digital Cognitive Assessment Technologies

Shots: Eisai gets the global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the CBB for use in healthcare and other markets. The agreement allows the two companies to replicate the advancements that have already been launched in Japan, where Eisai has developed and launched a new digital …

Eisai and Cogstate Expand their Agreement to Develop and Commercialize Digital Cognitive Assessment Technologies Read More »

Biogen to get speedy FDA review for Alzheimer’s drug despite not using voucher to request it

Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen’s stock rose 10%, but analysts had mixed opinions.

Japan trials app to help coronavirus patients recover at home

A smartphone app developed by medical software specialist Allm is being trialled in Japan to see if it can help patients with milder coronavirus symptoms recuperate at home, without tying up healthcare resources. The app – called MySOS – provides “non-contact body monitoring”, harnessing artificial intelligence to measure vital signs such as oxygen levels in …

Japan trials app to help coronavirus patients recover at home Read More »

Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.

The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug’s clinical benefit.

Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder

Shots: The P-III SUNRISE 1 (Study 304) study involves assessing of DAYVIGO (lemborexant, 5 or 10 mg) vs an active comparator or PBO in 1,006 patients with insomnia disorder aged 55 years of age or older Results of P-III [email protected] 5/10 mg of DAYVIGO: headache (6.4%, 4.9 % vs 6.2%, 5.3%), somnolence (4.1%, 7.1% vs …

Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder Read More »